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Objectives PORTAS-3 was designed to compare the frequency of pneumothorax or haemothorax in a primary open versus closed strategy for port implantation. Background data The implantation strategy for totally implantable venous access ports with the optimal benefit/risk ratio remains unclear. Methods PORTAS-3 was a multicentre, randomized, controlled, parallel-group superiority trial. Adult patients with oncological disease scheduled for elective port implantation were randomized to a primary open or closed strategy. Primary endpoint was the rate of pneumothorax or haemothorax. Assuming a difference of 2.5% between the 2 groups, a sample size of 1154 patients was needed to prove superiority of the open group. A logistic regression model after the intention-to-treat principle was applied for analysis of the primary endpoint. Results Between November 9, 2014 and September 5, 2016, 1205 patients were randomized. Of these, 1159 (open n = 583; closed n = 576) were finally analyzed. The rate of pneumothorax or haemothorax was significantly reduced with the open strategy [odds ratio 0.27, 95% confidence interval (CI) 0.09-0.88; P = 0.029]. Operation time was shorter for the closed strategy. Primary success rates, tolerability, morbidity, dose rate of radiation, and 30-day mortality did not differ significantly between the groups. Conclusion A primary open strategy by cut-down of the cephalic vein, if necessary enhanced by a modified Seldinger technique, reduces the frequency of pneumothorax or haemothorax after central venous port implantation significantly compared with a closed strategy by primary puncture of the subclavian vein without routine sonographic guidance. Therefore, open surgical cut-down should be the reference standard for port implantation in comparable cohorts. Trial registration German Clinical Trials Register DRKS 00004900.

Incisional hernias are one of the most common long-term complications associated with open abdominal surgery. The aim of this review and meta-analysis was to systematically assess laparoscopic versus open abdominal surgery as a general surgical strategy in all available indications in terms of incisional hernia occurrence. A systematic literature search was performed to identify randomized controlled trials comparing incisional hernia rates after laparoscopic versus open abdominal surgery in all indications. Random effects meta-analyses were calculated and presented as risk differences (RD) with their corresponding 95 % confidence intervals (CI). 24 trials (3490 patients) were included. Incisional hernias were significantly reduced in the laparoscopic group (RD −0.06, 95 % CI [−0.09, −0.03], p = 0.0002, I 2 = 75). The advantage of the laparoscopic procedure persisted in the subgroup of total-laparoscopic interventions (RD −0.14, 95 % CI [−0.22, −0.06], p = 0.001, I 2 = 87 %), whereas laparoscopically assisted procedures did not show a significant reduction of incisional hernias compared to open surgery (RD −0.01, 95 % CI [−0.03, 0.01], p = 0.31, I 2 = 35 %). Wound infections were significantly reduced in the laparoscopic group (RD −0.06, 95 % CI [−0.09, −0.03], p

Summary Background There is substantial uncertainty regarding the optimal surgical treatment for chronic pancreatitis. Short-term outcomes have been found to be better after duodenum-preserving pancreatic head resection (DPPHR) than after partial pancreatoduodenectomy. Therefore, we designed the multicentre ChroPac trial to investigate the long-term outcomes of patients with chronic pancreatitis within 24 months after surgery. Methods This randomised, controlled, double-blind, parallel-group, superiority trial was done in 18 hospitals across Europe. Patients with chronic pancreatitis who were planned for elective surgical treatment were randomly assigned to DPPHR or partial pancreatoduodenectomy with a central web-based randomisation tool. The primary endpoint was mean quality of life within 24 months after surgery, measured with the physical functioning scale of the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire. Primary analysis included all patients who underwent one of the assigned procedures; safety analysis included all patients who underwent surgical intervention (categorised into groups as treated). Patients and outcome assessors were masked to group assignment. The trial was registered, ISRCTN38973832. Recruitment was completed on Sept 3, 2013. Findings Between Sept 10, 2009, and Sept 3, 2013, 250 patients were randomly assigned to DPPHR (n=125) or partial pancreatoduodenectomy (n=125), of whom 226 patients (115 in the DPPHR group and 111 in the partial pancreatoduodenectomy group) were analysed. No difference in quality of life was seen between the groups within 24 months after surgery (75·3 [SD 16·4] for partial pancreatoduodenectomy vs 73·0 [16·4] for DPPHR; mean difference −2·3, 95% CI −6·6 to 2·0; p=0·284). The incidence and severity of serious adverse events did not differ between the groups. 70 (64%) of 109 patients in the DPPHR group and 61 (52%) of 117 patients in the partial pancreatoduodenectomy group had at least one serious adverse event, with the most common being reoperations (for reasons other than chronic pancreatitis), gastrointestinal problems, and other surgical morbidity. Interpretation No differences in quality of life after surgery for chronic pancreatitis were seen between the interventions. Results from single-centre trials showing superiority for DPPHR were not confirmed in the multicentre setting. Funding German Research Foundation (DFG).

Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the standard surgical procedure for ulcerative colitis (UC) and familial adenomatous polyposis (FAP). While minimal invasive techniques have been applied increasingly, clear evidence of superiority for laparoscopic pouch procedures is not yet available. The aim of the LapConPouch Trial was to compare the effectiveness of laparoscopic (LAP) versus conventional (CON) ileoanal pouch procedure in patients undergoing elective restorative proctocolectomy. The trial was designed as a single-centre, pre-operatively randomized, controlled trial using a two-group parallel superiority design. Eligible for participation were patients scheduled for restorative proctocolectomy either for FAP or for UC. Patients and outcome assessors were blinded to group assignment. The primary endpoint was defined as the amount of blood loss. Statistical analyses were explorative since the trial had to be stopped prematurely. A total of 42 patients (21 LAP (50.0 %); 21 CON (50.0 %)) were randomized. The trial had to be stopped prematurely due to insufficient patient recruitment. There was no difference in the amount of blood loss between both groups: LAP 261.5 ± 195.4 ml, CON 228.1 ± 119.5 ml. Secondary endpoints differ in both groups. Laparoscopic surgery was superior regarding the length of skin incision; in contrast, the conventional approach was superior in duration of operation. There were no discrepancies in length of hospital stay, postoperative pain, bowel function, and quality of life between both approaches. The conversion rate from LAP to CON approach was 23.8 %. There was no difference with respect to blood loss between the LAP and the CON group. The LAP approach is feasible for restorative proctocolectomy, and IPAA seems at least as safe as CON surgery. The most obvious advantage of the minimal invasive technique is the improved cosmesis.

Faecal immunochemical tests (FITs) for haemoglobin are increasingly used for non-invasive screening for colorectal cancer (CRC) but large scale comparative studies of different FITs for detection of CRC, overall and by stage, are sparse. We aimed to determine and compare performance of different FITs for the detection of CRC, and to assess their stage-specific sensitivities.We assessed sensitivity, specificity and their corresponding 95% confidence intervals for six qualitative FITs among 74 CRC cases (59% stage I or II cancers) and 1480 controls free of colorectal neoplasm. Overall and stage-specific receiver operating characteristic curves were derived for three quantitative FITs. The areas under the curves (AUCs) were calculated and compared.Pairs of overall sensitivity and specificity of the qualitative FITs ranged from 66% and 96% to 92% and 62%, respectively. For the three quantitative tests, AUCs ranged from 0.90 to 0.92, with sensitivities ranging from 80% to 87% at cut-offs yielding 90% specificity. AUCs ranged from 0.85 to 0.92, 0.94 to 0.96, and 0.86 to 0.93 for stage I, stage II and advanced stages (stage III and IV) cancers, respectively. At a specificity of 90%, the tests detected 65%-85% of stage I cancers.The diagnostic performance of FITs regarding detection of CRC is promising, even though the pre-defined cut-offs of some of the qualitative FITs need to be adjusted to limit false-positive rates in screening setting. At cut-off levels yielding 90% specificity, the quantitative tests detected the vast majority of CRCs, even at early stages.

Colonoscopy with detection and removal of neoplasms strongly reduces risk of colorectal cancer (CRC). Nevertheless, CRCs occur after colonoscopic polypectomy. We assessed agreement beyond chance of location of polyps detected at colonoscopy and of subsequent CRCs to estimate the share of cancers that might be due to field effects or neoplasm recrudescence. In a population-based case-control study conducted in Germany (3,148 cases), detailed history and results of colonoscopies conducted within 10 years before cancer diagnosis were obtained by interview and from medical records. We determined the observed proportion of cancers for which a polyp had been detected at the same colorectal subsite at the preceding colonoscopy and compared it to the proportion expected by chance. A total of 155 cases with physician validated polyp detection at the preceding colonoscopy were identified. Among 148 cases with cancer restricted to a single subsite, 43 (29.1%) had a polyp detected in the same colorectal subsite at the preceding colonoscopy. Agreement of location of cancer occurrence and preceding polyp detection would have been expected by chance for 27 cases, and agreement beyond chance was estimated to account for 16 cases (10.8%, 95% confidence interval 2.7%-19.3%). Our study suggests that less than one of nine CRCs occurring within 10 years after colonoscopy with polyp detection may be due to field effects or polyp recrudescence.

Background Pancreatic exocrine insufficiency (PEI) often occurs following pancreatic surgery. Aim To demonstrate the superior efficacy of pancreatin 25 000 minimicrospheres (Creon 25000 MMS; 9–15 capsules/day) over placebo in treating PEI after pancreatic resection. Methods A 1-week, double-blind, randomised, placebo-controlled, parallel-group, multicentre study with a 1-year, open-label extension (OLE). Subjects ≥18 years old with PEI after pancreatic resection, defined as baseline coefficient of fat absorption (CFA)

This randomized controlled multicenter pilot trial was conducted to find robust estimates for the rates of recurrence of 2 surgical strategies for secondary hyperparathyroidism (SHPT) within 36 months of follow-up.SHPT is a frequent consequence of chronic renal failure. Total parathyroidectomy with autotransplantation (TPTX+AT) and subtotal parathyroidectomy (SPTX) are the standard surgical procedures. Total parathyroidectomy alone (TPTX) might be a good alternative, as morbidity and recurrence rates are low according to small-scale retrospective studies.The trial was performed as a nonconfirmatory randomized controlled pilot trial with 100 patients on long-term dialysis with otherwise uncontrollable SHPT to generate data on the rate of recurrent disease within a 3-year follow-up period after TPTX or TPTX+AT. Parathyroid hormone (PTH) and calcium levels, recurrent or persistent hyperparathyroidism, parathyroid reoperations, morbidity, and mortality were evaluated during a 3-year follow-up.A total of 52 patients underwent TPTX and 48 TPTX+AT. Patient characteristics, preoperative baseline data, duration of surgery (02:29 vs 02:47 hrs, P = 0.17) and mean hospital stay (10 ± 7.1 vs 8 ± 3.7 days, P = 0.11) did not differ significantly. Persistent SHPT developed in 1 TPTX and 2 TPTX+AT patients. None of the TPTX patients required delayed parathyroid AT to treat permanent hypoparathyroidism. Serum-calcium values were similar (2.1 ± 0.3 vs 2.1 ± 0.2, P = 0.95) whereas PTH rose by time in the TPTX+AT group and was significantly higher at the end of follow-up when compared with the TPTX group (31.7 ± 43.6 vs 98.2 ± 156.8, P = 0.02). Recurrent SHPT developed in 4 TPTX+AT and none of the TPTX patients.TPTX+AT and TPTX seem to be safe and equally effective for the treatment of otherwise uncontrollable SHPT. TPTX seems to suppress PTH more effectively and showed no recurrences after 3 years. The hypothesis that TPTX is superior to TPTX+AT referring to the rate of recurrent SHPT has to be tested in a large-scale confirmatory trial. Nevertheless, TPTX seems to be a feasible alternative therapeutic option for the surgical treatment of SHPT.

Surgery and other invasive therapies are complex interventions, the assessment of which is challenged by factors that depend on operator, team, and setting, such as learning curves, quality variations, and perception of equipoise. We propose recommendations for the assessment of surgery based on a five-stage description of the surgical development process. We also encourage the widespread use of prospective databases and registries. Reports of new techniques should be registered as a professional duty, anonymously if necessary when outcomes are adverse. Case series studies should be replaced by prospective development studies for early technical modifications and by prospective research databases for later pre-trial evaluation. Protocols for these studies should be registered publicly. Statistical process control techniques can be useful in both early and late assessment. Randomised trials should be used whenever possible to investigate efficacy, but adequate pre-trial data are essential to allow power calculations, clarify the definition and indications of the intervention, and develop quality measures. Difficulties in doing randomised clinical trials should be addressed by measures to evaluate learning curves and alleviate equipoise problems. Alternative prospective designs, such as interrupted time series studies, should be used when randomised trials are not feasible. Established procedures should be monitored with prospective databases to analyse outcome variations and to identify late and rare events. Achievement of improved design, conduct, and reporting of surgical research will need concerted action by editors, funders of health care and research, regulatory bodies, and professional societies. © 2009 Elsevier Ltd. All rights reserved.

Hintergrund: Taglich werden im Bereich Medizin und Gesundheitsinterventionen ca. 75 klinische Studien und 11 systematische Ubersichtsarbeiten veroffentlicht. Diese stetig wachsende Zahl an Publikationen erschwert deren zeitnahe Wahrnehmung. Dadurch kann sich die Umsetzung von neuen wirksamen Diagnostik- und Therapieverfahren in die klinische Routine verzogern. Umgekehrt kommen moglicherweise unwirksame oder gar schadliche Verfahren weiterhin zum Einsatz. Die evidenzbasierte Medizin (EBM) verlangt bei der Entscheidungsfindung fur den individuellen Patienten die Berucksichtigung aktueller hochwertiger Evidenz. Randomisiert-kontrollierte Studien (RCTs) zum Nachweis der Wirksamkeit und Sicherheit von chirurgischen Interventionen stellen in der patientenorientierten Forschung den „Goldstandard“ dar. Systematische Ubersichtsarbeiten (Systematic Reviews) bundeln die Ergebnisse einzelner Studien zu einer bestimmten Fragestellung. Zum Auffinden relevanter Publikationen sind Grundkenntnisse der systematischen Literatursuche notwendig und hilfreich. Material und Methoden: Der vorliegende Artikel illustriert anhand von bebilderten Anleitungen verschiedene Moglichkeiten der Literatursuche in der Datenbank Medline zum Auffinden von klinischen Studien und Systematic Reviews. Ergebnisse und Schlussfolgerung: Abhangig vom Thema und dem Ziel der Literatursuche konnen Zeit und Aufwand variieren. Im Praxisalltag ist eine systematische Literatursuche meist unrealistisch. Kliniker, die sich einen schnellen Einblick uber die aktuelle Evidenz zu einem klinischen Problem verschaffen mochten, konnen dazu auf aktuelle systematische Ubersichtsarbeiten zuruckgreifen. Wahrend einer systematischen Literatursuche konnen mehrere Herangehensweisen und verschiedene Strategien notig sein.

Purpose Empirical evidence for recommendations of surveillance intervals after detection and removal of adenomas at colonoscopy is still sparse and mostly based on observations of adenoma recurrence. We aimed to assess risk of colorectal cancer (CRC) according to time since polypectomy and factors that might be relevant for risk stratification. Methods In a population-based case-control study conducted in Germany, detailed history and results of previous large-bowel endoscopies were obtained by interview and from medical records. Risk of CRC among participants with detection of at least one adenoma at a preceding colonoscopy compared with participants without previous large-bowel endoscopy was assessed according to time since polypectomy among 2,582 cases with CRC and 1,798 matched controls. Results Adjusted odds ratios (95% CIs) of CRC for participants with polypectomy less than 3, 3 to 5, and 6 to 10 years ago (using participants without previous endoscopy as reference group) were 0.2 (0.2 to 0.3), 0.4 (0.3 to 0.6), and 0.9 (0.5 to 1.5), respectively. Strong, significant risk reduction within 5 years was consistently seen for women and men, younger and older participants, patients with and without high-risk polyps (three or more polyps, at least one polyp ≥ 1 cm, at least one polyp with villous components), and those with and without polypectomy in the right colon. With adjusted odds ratios of 0.1 (0.1 to 0.2), 0.3 (0.2 to 0.5) and 0.4 (0.2 to 0.8) for patients with polypectomy less than 3, 3 to 5, and 6 to 10 years ago, risk reduction was particularly strong for left-sided CRC. Conclusion Extension of surveillance intervals to 5 years should be considered, even after detection and removal of high-risk polyps.

New techniques using vascular clips or ultrasonically activated shears have been suggested to shorten operation time without compromising safety. The objective of the CLIVIT Trial was to compare ligatures with vascular clips for hemostasis in elective benign thyroid surgery. This multicenter, randomized, controlled, parallel group superiority trial was conducted in 13 German surgical centers. Patients scheduled for at least subtotal resection bilaterally were intraoperatively randomized. The primary endpoint was resection time. Secondary endpoints were the amount of postoperative bleeding, reoperation due to bleeding, wound infection, temporary (reversal within 12 months) and permanent (over 1 year) recurrent laryngeal nerve (RLN) paralysis, length of hospital stay, and safety. Registration: ISRCTN 96901396. Two hundred fifty patients were treated with ligatures and 241 with vascular clips. No differences in patients' baseline and surgical characteristics were observed. No difference was detected for mean resection time (clip 63.5 min ± 29.6, ligature 66.1 min ± 29.3, P = 0.258). Postoperative bleeding (mean 86 ml ± 93), reoperation due to bleeding (clips 4, ligature 2), wound infections (clips 4, ligature 4), postoperative hospital stay (mean 3.0 ± 1.9), and safety data also did not vary significantly. The rates of temporary and permanent RLN paralysis were 6.9 % (34/491) and 2.9 % (14/491), respectively. Not using a surgical drain (123 patients) was not associated with a higher rate of complications. Vascular clips did not reduce the resection time. However, a 2.9 % rate of permanent RLN paralysis is of concern. Drains in elective surgery may be of no benefit.

Objective The risk of colorectal cancer after a previous negative colonoscopy is very low. Nevertheless, interval cancers occur. We aimed to assess the characteristics and predictors of interval cancers after negative colonoscopy. Methods A population-based case-control study was conducted in Southern Germany in 2003–7. Sociodemographic and tumour characteristics were compared among 78 patients with interval cancers occurring 1–10 years after a negative colonoscopy and 433 colorectal cancers detected at screening. In addition, the indication for the preceding negative colonoscopy and its completeness were compared between patients with interval cancers and 515 controls with a preceding negative colonoscopy. Results 56.4% of interval cancers occurred among women compared with 33.7% of cases detected by screening (p=0.0001). After adjustment for covariates, female sex (OR 2.28, 95% CI 1.35 to 3.83) and location in the caecum or ascending colon (OR 1.98, 95% CI 1.17 to 3.35) were independently associated with occurrence of interval cancers. The preceding negative colonoscopy was more commonly conducted because of a positive faecal occult blood test (26.0% vs 12.9%, p=0.009) and was more often incomplete (caecum not reached: 18.1% vs 6.7%, p=0.001) among interval cancer cases than among controls. Characteristics of the preceding negative colonoscopy strongly and independently associated with occurrence of interval cancers were follow-up of a positive faecal occult blood test among men (OR 5.49, 95% CI 2.10 to 14.35) and incompleteness among women (OR 4.38, 95% CI 1.69 to 11.30). Conclusions The observed patterns suggest that a substantial proportion of interval cancers are due to neoplasms missed at colonoscopy and are potentially preventable by enhanced performance of colonoscopy.

Different suture techniques and various suture materials are in use to close midline incisions after primary laparotomy. The ISSAAC study aimed to assess the safety and efficacy of the new ultra-long-term absorbable, elastic monofilament suture material MonoMax® for abdominal wall closure.This is a single-arm, multicentre prospective study that included 150 patients undergoing a primary elective midline incision. The control group consists of 141 patients from the INSECT study who received MonoPlus® or PDS® for abdominal wall closure. The incidences of burst abdomen and wound infection until the day of discharge were defined as the primary composite endpoints. The rate of incisional hernias 1 year after surgery, the length of postoperative hospital stay and safety parameters served as secondary endpoints. The study has been registered under www.clinicaltrials.gov [NCT005725079].Eleven patients in the ISSAAC study [7.3%; 95% CI = (3.9; 13.1%)] experienced wound infection or burst abdomen until the day of discharge as compared to 16 [11.3%; 95% CI = (6.6; 17.8%)] patients in the INSECT control group (p = 0.31). The length of postoperative hospital stay was comparable in both study groups. One year after surgery, incisional hernias were observed in 21 ISSAAC patients (14.0%) in contrast to 30 hernias (21.3%) in the INSECT control group.The ultra-long-term absorbable, elastic monofilament suture material MonoMax® is safe and efficient for abdominal wall closure.

Purpose Colonoscopy is thought to be a powerful and cost-effective tool to reduce colorectal cancer (CRC) incidence and mortality. Empirical evidence for overall and risk group–specific definition of screening intervals is sparse. We aimed to assess the risk of CRC according to time since negative colonoscopy, overall, and by sex, smoking, and family history of CRC, in a large population-based case-control study. Patients and Methods In all, 1,945 patients with CRC and 2,399 population controls were recruited in 22 hospitals and through population registers in the Rhine-Neckar region of Germany from 2003 to 2007. Data on history of colonoscopy and important covariates were obtained by personal interviews and from medical records. Results Compared with people who had never undergone colonoscopy, people with a previous negative colonoscopy had a strongly reduced risk of CRC. Adjusted odds ratios for time windows of 1 to 2, 3 to 4, 5 to 9, 10 to 19, and 20+ years after negative colonoscopy were 0.14 (95% CI, 0.10 to 0.20), 0.12 (95% CI, 0.08 to 0.19), 0.26 (95% CI, 0.18 to 0.39), 0.28 (95% CI, 0.17 to 0.45), and 0.40 (95% CI, 0.24 to 0.66), respectively. Low risks even beyond 10 years after negative colonoscopy were observed for both left- and right-sided CRC and in all risk groups assessed except current smokers, who had a risk similar to that of never smokers with no previous colonoscopy 10 or more years after a negative colonoscopy. Conclusion These results support suggestions that screening intervals for CRC screening by colonoscopy could be longer than the commonly recommended 10 years in most cases, perhaps even among men and people with a family history of CRC, but probably not among current smokers.

Comparison of two different insertion techniques for implantation of totally implantable access ports (TIAP).TIAP are introduced through different open and closed cannulation strategies and by various medical experts. The aim of this expertise-based randomized trial was to compare venous cutdown approach with puncture of subclavian vein.One hundred and ten patients scheduled for primary implantation of a TIAP were randomly assigned to either open insertion technique performed by surgeons or puncture of the subclavian vein under fluoroscopic guidance by radiologists at an outpatient single university center. The primary endpoint was the primary success rate of the cannulation strategy. A logistic regression model was used for analysis adjusting for age, Karnofsky index, body mass index and surgeons', and the radiologists' experience.Percutaneus cannulation was not superior to surgical venous cutdown in the intention-to-treat analysis (odds ratio, 0.37; 95% CI, 0.07; 2.15) and the as-treated analysis (odds ratio, 0.16; 95% CI, 0; 1.28). The procedure was shorter with surgery (median, 21 minutes; 95% CI, 14; 30) than with radiology (median, 45 minutes; 95% CI, 43; 50) (P0.001), and the dose of radiation was lower with surgery (median, 37 cGy/cm(2); 95% CI, 26; 49) than with radiology (200 cGy/cm(2); 95% CI, 200; 300) (P0.001).Central venous cannulation for insertion of TIAPs can be performed safely and effectively with both approaches. The open direct surgical access requires further strategies for successful placement of a TIAP, and percutaneous Seldinger technique requires more time and a higher dose of radiation and is associated with risk of pneumothorax.

Summary Background The ideal closure technique of the pancreas after distal pancreatectomy is unknown. We postulated that standardised closure with a stapler device would prevent pancreatic fistula more effectively than would a hand-sewn closure of the remnant. Methods This multicentre, randomised, controlled, parallel group-sequential superiority trial was done in 21 European hospitals. Patients with diseases of the pancreatic body and tail undergoing distal pancreatectomy were eligible and were randomly assigned by central randomisation before operation to either stapler or hand-sewn closure of the pancreatic remnant. Surgical performance was assessed with intraoperative photo documentation. The primary endpoint was the combination of pancreatic fistula and death until postoperative day 7. Patients and outcome assessors were masked to group assignment. Interim and final analysis were by intention to treat in all patients in whom a left resection was done. This trial is registered, ISRCTN18452029. Findings Between Nov 16, 2006, and July 3, 2009, 450 patients were randomly assigned to treatment groups (221 stapler; 229 hand-sewn closure), of whom 352 patients (177 stapler, 175 hand-sewn closure) were analysed. Pancreatic fistula rate or mortality did not differ between stapler (56 [32%] of 177) and hand-sewn closure (49 [28%] of 175; OR 0·84, 95% CI 0·53–1·33; p=0·56). One patient died within the first 7 days after surgery in the hand-sewn group; no deaths occurred in the stapler group. Serious adverse events did not differ between groups. Interpretation Stapler closure did not reduce the rate of pancreatic fistula compared with hand-sewn closure for distal pancreatectomy. New strategies, including innovative surgical techniques, need to be identified to reduce this adverse outcome. Funding German Federal Ministry of Education and Research.

Durch eine perioperative Antibiotikaprophylaxe konnen bei gegebener Indikation postoperative Infektionen sicher und wirksam vermieden werden. Die bisher gultige Leitlinie (S1) der Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF) von 2004 wurde 2010 durch die Empfehlungen einer Expertenkommission der Paul-Ehrlich-Gesellschaft fur Chemotherapie e.V. (PEG) ersetzt, in der neueste Daten von 2000 bis 2008 berucksichtigt wurden. Die Indikation und Auswahl der entsprechenden Antibiotika orientiert sich an patientenabhangigen und operationsspezifischen Risikofaktoren. Dieser Artikel stellt die aktuellen Empfehlungen der PEG fur die Allgemein- und Viszeralchirurgie dar.

Background: The aim of this trial was to confirm previous results demonstrating the efficacy and safety of a fixed combination tissue sealant versus argon beam coagulation (ABC) treatment in liver resection. Methods: This trial was designed as an international, multicenter, randomized, controlled surgical trial with 2 parallel groups. Patients were eligible for intra-operative randomization after elective resection of ≥1 liver segment and primary hemostasis. The primary end point was the time to hemostasis after starting the randomized intervention to obtain secondaty hemostasis. Secondary end points were drainage duration, volume, and content. Adverse events were collected to evaluate the safety of treatments. The trial was registered internationally (Eudract number 2008-006407-23). Results: Among 119 patients (60 TachoSil and 59 ABC) randomized in 10 tertiary care centers in Europe, the mean time to hemostasis was less when TachoSil was used (3.6 minutes) compared with ABC (5.0 minutes; P = .0018). The estimated ratio of mean time to hemostasis for TachoSil/ABC ws 0.61 (95% confidence interval, 0.47-0.80; P = .0003). Postoperative drainage volume, drainage fluid, and drainage duration did not differ between the 2 groups. Mortality (2 vs. 4 patients) and adverse reactions (24 vs. 28 patients) for TachoSil versus ABC did not differ. Conclusion: This trial confirmed that TachoSil achieved significantly faster hemostasis after liver resection compared with ABC. Postoperative morbidity and mortality remained unchanged between both groups.

Clinical trials play a key role in patient care, academic education and research in surgery. Without valid studies the practice of evidence-based medicine is limited. Surgery is supported through funding by the German Ministry of Education and Research to establish an infrastructure for clinical trials. So far seven universities have worked together in a network since 2007 and successfully obtained funding for six large randomized trials from a program existing since 2004. Until now 2,249 patients have been randomized within 11 trials and 910 patients have been treated at local hospitals without academic responsibilities. An increase in the interest in clinical trials in daily practice has resulted through the certification of hospitals for special treatment that specifies that at least 5% of all patients are included in clinical trials.

Incisional hernias are the most common long-term complication after laparotomy with a cumulative incidence up to 20%. Generally all injuries to the integrity of the abdominal wall can result in the development of an incisional hernia. Midline and transverse incisions cause similar hernia rates. By selection of a sufficient closure technique and appropriate suture material as well as taking appropriate accompanying treatment (antibiotic prophylaxis) and risk factors into consideration, surgery can reduce surgical site infections, wound dehiscence and incisional hernias. Results from randomized controlled trials have not yet demonstrated a superiority of laparoscope-assisted procedures compared to laparotomy for the prevention of incisional hernias. Access through natural orifices and removal of specimens through the same approach (NOTES) may prevent incisional hernias completely. The approach to the abdominal cavity has to be chosen according to the underlying disease of the patient, the anatomical conditions and further circumstances (e.g. urgency, extensibility, preservation of function of the abdominal wall and safety).

BackgroundTwo surgical procedures are mainly performed for the treatment of pancreatic head cancer and periampullary carcinoma: the classical Whipple operation and the pylorus-preserving Whipple operation.MethodsThis manuscript represents an extension of a systematic review and meta-analysis previously published in the Annals of Surgery. A systematic literature search was performed in MEDLINE, EMBASE and the Cochrane Library (central) to identify randomized controlled trials (RCTs) and observational studies. A meta-analysis based on a random-effects model was performed for the hazard ratios (HR) of survival and the odds ratios (OR) of postoperative mortality. The results of the different studies on quality of life (QoL) could not be summarized quantitatively in a meta-analysis and were therefore summarized qualitatively. Subgroup analyses were performed by study type, RCTs, prospective cohort studies (PSs), retrospective cohort studies (RSs), study quality and tumor localization (pancreatic head cancer versus periampullary carcinoma).ResultsThe systematic literature search retrieved 4,503 studies of which 4,460 did not fulfill the inclusion criteria. The remaining 43 studies (6 RCTs, 12 PSs and 25 RSs) representing 3,893 patients were finally included in the review.There was neither a significant survival difference for patients with pancreatic head cancer in the pooled estimate of the RCTs (HR 0.80; 95% CI 0.53-1.22; p=0.16) nor in the pooled estimate of the PSs (HR 0.84; 95% CI 0.7-1.0; p=0.95) or the RSs (HR 0.84; 95% CI 0.7-1.01; p=0.21). Survival of patients with periampullary carcinoma was not significantly different in the RCTs (HR 1.02; 95% CI 0.49-2.13; p=0.3), the PSs (HR 1.26; 95% CI 0.46-3.42; p=0.65) or the RSs (HR 0.86; 95% CI 0.6-1.24; p=0.33).Postoperative mortality was not significantly different after both types of operations (RCTs: HR 0.49; 95% CI 0.17-1.4; p=0.18; PSs: HR 0.63; 95% CI 0.34-1.18; p=0.15; RSs: HR 0.7; 95% CI 0.37-1.31; p=0.27). QoL was reported as either the same in both groups or in favor of the pylorus-preserving Whipple operation.ConclusionsMortality, survival and QoL were not significantly different between the classical Whipple and the pylorus-preserving Whipple operations. Given the poor quality of the underlying trials a pragmatic RCT is recommended to prove the findings of this systematic review.

Knot tying is regarded as a basic surgical skill. However, there is no consensus in the literature on the best/safest technique. The aim of this study was to survey the various techniques used by German surgeons at the different stages of their training. A knot tying technique was defined based on three criteria, i.e., both thread ends are crossed at the beginning at least two throws tied pulling at the same free end of the thread (standing part) and at least one knot tied changing the standing part. The knot tying techniques of 192 randomly chosen German surgeons practicing in 102 different hospitals were compared against this standard. Besides the status of the participating surgeons, the type of hospital in which they were currently working was recorded. Of the192 participants, 69 were consultants, 56 fellows, and 67 residents. Forty-three surgeons (22.4%) worked in primary care centers (PCC), 81 (42.2%) in secondary care centers (SCC), and 68 (35.4%) in tertiary care centers (TCC). 62.5% crossed both thread ends at the beginning, 75.5% performed at least two identical throws keeping the same standing part, and 45.3% changed the standing part. Assessed against the technique defined as standard, 19.8% of all surgeons performed similar surgical knots. Even though consultants crossed both thread ends at the beginning and changed the standing part significantly more often (p = 0.007 and p = 0.031 respectively, Fisher’s exact test), the overall rate of identical knots was independent of the status of participants and the type of hospital (p > 0.1, Fisher’s exact test). This explorative study detected a high variability of knot tying techniques among German surgeons. In the absence of any evidence of the superiority of one particular technique, continuing education should focus on the quality of each single knot and perfect the details of the technique used.

Background This empirical study analyzes the current status of Cochrane Reviews (CRs) and their strength of recommendation for evidence-based decision making in the field of general surgery. Methods Systematic literature search of the Cochrane Database of Systematic Reviews and the Cochrane Collaboration's homepage to identify available CRs on surgical topics. Quantitative and qualitative characteristics, utilization, and formulated treatment recommendations were evaluated by 2 independent reviewers. Association of review characteristics with treatment recommendation was analyzed using univariate and multivariate logistic regression models. Results Ninety-three CRs, including 1,403 primary studies and 246,473 patients, were identified. Mean number of included primary studies per CR was 15.1 (standard deviation [SD] 14.5) including 2,650 (SD 3,340) study patients. Two and a half (SD 8.3) nonrandomized trials were included per analyzed CR. Seventy-two (77%) CRs were published or updated in 2005 or later. Explicit treatment recommendations were given in 45 (48%). Presence of a treatment recommendation was associated with the number of included primary studies and the proportion of randomized studies. Utilization of surgical CRs remained low and showed large inter-country differences. The most surgical CRs were accessed in UK, USA, and Australia, followed by several Western and Eastern European countries. Conclusion Only a minority of available CRs address surgical questions and their current usage is low. Instead of unsystematically increasing the number of surgical CRs it would be far more efficient to focus the review process on relevant surgical questions. Prioritization of CRs needs valid methods which should be developed by the scientific surgical community.

Objective: There are 2 main types of access for patients requiring major open, elective abdominal surgery: the midline or the transverse approach. The aim of this study is to compare both approaches by focusing on postoperative pain, complications, and frequency of incisional hernias. Summary Background Data: A recent Cochrane review suggested that transverse incisions may be less painful but incisional hernia rates do not differ. Methods: Randomized, patient- and observer-blinded, monocentric, equivalence clinical trial. Patients were scheduled for elective primary abdominal incisions. Composite primary end point measured 48 hours after surgery was the total amount of analgesics (piritramide) required in the last 24 hours and pain (Visual Analogue Scale). Secondary end points were early-onset and late complications. This study is registered in the ISRCTN registry and has the ID number ISRCTN60734227. Results: Two hundred patients (101 midline and 99 transverse) were randomized. Both incision types resulted in similar amounts of required analgesics (95% confidence interval [―0.38; ―0.33] was included in the equivalence level). For the Visual Analogue Scale, both the 95% and 90% CI (0―10) were neither within the equivalence levels nor were their differences significant at the 5% level. No relevant differences between midline and transverse incisions were observed for 30-day mortality (2 vs. 2, P = 0.99), mortality after one year (15 vs. 23, P = 0.15), pulmonary complications (13 vs. 17, P = 0.43), median length of hospital stay (11 vs. 12 days, P = 0.08), median time to tolerance of solid food (12 vs. 14 days, P = 0.30), and incisional hernias after one year (13 vs. 8, P = 0.48). More wound infections occurred in the transverse group (15 vs. 5, P = 0.02). Conclusion: The decision about the incision should be driven by surgeon preference with respect to the patient's disease and anatomy.

Objective: In patients undergoing midline incisions, the abdominal fascia can be closed with a continuous or interrupted suture using various materials. The aim of this study is to compare: (1) interrupted technique with rapidly absorbable sutures and (2) continuous techniques with different slowly absorbable sutures, focusing on the incidence of incisional hernias within 1 year. of Background Data: A meta-analysis suggested that the incidence of incisional hernias can be more effectively reduced with slowly absorbable continuous sutures. Methods: Multicenter randomized surgical trial with 3 parallel groups. Patients were scheduled for primary elective midline incisions. All surgeons were trained (4:1 suture wound length in continuous groups) and monitored. Primary end point, measured within 1 year after surgery, was the frequency of incisional hernias diagnosed by clinical examination and confirmed by ultrasound. Complications and safety were used as secondary end points. This study has been registered with the ISRCTN Register (INSECT: ISRCTN24023541). Results: Conducted on 625 randomized patients (210 interrupted Vicryl, 205 continuous polydioxanone suture (PDS), 210 continuous Monoplus), the primary analysis showed an incidence of 28 incisional hernias (15.9%) versus 15 (8.4%) versus 22 (12.5%) for the 3 closure techniques, respectively (P = 0.09). No significant difference was observed between the 3 groups with regard to burst abdomen (4 [2.0%] vs. 6 [3.0%] vs. 8 [4.0%], P = 0.46), wound infection (26 [12.7%] vs. 39 [19.4%] vs. 33 [16.3%], P = 0.19), pulmonary infections (9 [4.4%] vs. 5 [2.5%] vs. 5 [2.5%], P = 0.46), serious adverse events (63 [30.0%] vs. 57 [27.8%] vs. 61 [29.1%], P = 0.89), and 1-year mortality (16 [7.9%] vs. 11 [5.5%] vs. 16 [7.9%], P = 0.54). Conclusions: The incidence of incisional hernias and the frequency of wound infection was higher than expected in all groups. New concepts need to be developed and studied to substantially reduce the frequency of incisional hernias.

Proof of safety and effectiveness of surgical procedures follows the same scientific principles as for drugs. Control of bias and chance when evaluating new operations has to be considered and should generally be followed using randomized controlled trials (RCT). The expenditure for study design, execution and analysis can be substantial due to specific characteristics of surgical treatments. The largest challenges represent the maintenance of comparable treatment and assessment within and between the study groups of a RCT, such as, blinding of surgeons, learning curves, standardization of procedures, and monitoring interventions to ensure execution according to protocol. This evaluation is made even more difficult due to lack of broadly accepted definitions of surgically relevant endpoints in daily practice and research. Since 2004, new methods and procedures are being tested to demonstrate the feasibility of surgical RCTs through a grant program for surgical clinical trial centers in Germany. In six surgical trial centers, a number of surgical RCTs have been designed and conducted. The first results of high-quality surgical RCTs are described.

A prospective, randomized study was performed to evaluate two variations of the duodenum-preserving pancreatic head resection (DPPHR), either with (Beger procedure) or without (Berne modification) the division of the pancreas anterior to the portal vein, in patients with chronic pancreatitis.Randomized, controlled, patient-blinded trial of patients with inflammatory pancreatic head tumors. The primary endpoint was the duration of surgery. Other a priori-ordered endpoints were length of ICU stay, postoperative complication, length of hospital stay, and quality of life after 24 months.Sixty-five patients were randomized to the Berne or Beger procedures. The Berne modification could be performed faster (46 minutes difference, P.05). The median length of stay on the ICU was one day in both groups (P = .97) but the median hospital stay was shorter in the Berne group (11 (8-39) versus 15 (8-47); P = .015). The quality of life two years after surgery did not differ significantly between the two groups (EORTC-QLQ-C30, Beger 65.6% vs. Berne 71.3%, P = .371). Three patients who had received the Berne procedure were reoperated on during the follow-up period due to ongoing pancreatitis and bile duct obstruction (P = .22).The Berne technique is technically simpler compared with the original Beger procedure, reflected in its significantly shorter operation times and hospital stays. The quality of life is similar after both procedures. The Berne modification of DPPHR adds to our panel of surgical procedures that can be applied with effective early and late outcomes.

Hintergrund Chirurgische multizentrische randomisiert-kontrollierte Studien (MRCT) in Deutschland konnen nach Prufung von definierten Aufnahmekriterien seit genau einem Jahr in der Rubrik „Klinische Studien“ in Form einer monatlich aktualisierten Studienliste aufgenommen werden.

The objective of this study was to analyze factors leading to explantation of totally implanted access ports (TIAPs) and to assess its occurrence and clinical relevance. Of 438 patient consecutive patients with a port explantation, 385 were eligible for this retrospective cohort study. Reasons for explantation as well as demographic, clinical, and surgical characteristics were analyzed by univariate and multivariate models. The diagnoses leading to TIAP implantation were hematological malignancies in 142 patients (36.8%), breast cancer in 103 patients (26.8%), gastrointestinal cancer in 76 patients (19.8%), nonmalignant diseases in 46 patients (11.9%), and other malignant diseases in 18 patients (4.7%). The reasons for TIAP explantation were infection in 178 patients (46.2%), end of treatment in 129 patients (33.5%), thrombosis in 44 patients (11.4%), TIAP dysfunction in 22 patients (5.7%), and other reasons in 12 patients (3.2%). At the time of TIAP explantation, 115 patients (29.9%) were receiving chemotherapy, and 49 patients (12.7%) were considered immunocompromised. In case of TIAP explantation due to infection, the median length of TIAP in situ time was 303.3 days, whereas the cumulative 10-day and 30-day explantation rates were 2.8% and 10.6%, respectively. By multivariate models, TIAP explantation due to infection is statistically significantly decreased in patients with breast cancer (P

After introduction of the randomized controlled trial (RCT) into clinical research within the second half of the 20th century, the number of high-quality RCTs comparing surgical techniques has been low, although this trial design has widely been acknowledged to provide the highest available level of evidence. Reasons for the paucity of RCTs dealing with surgical techniques have been attributed to specific challenges of these trials requiring elaborate methodologic considerations, as well as complex organization, raising questions regarding their feasibility. However, unrelenting efforts of certain clinicians who realized surgical trials, even in times of weak infrastructure for clinical research in surgery, have proved that RCTs are feasible, even within daily clinical routine. Furthermore, these trials helped to increase awareness for the need of more surgical RCTs among clinicians and individuals in charge of funding institutions. As a result, a positive development of patient-oriented surgical research has been observed within the last years. The number of surgeons willing to participate in trials is rising. In addition, increased financial support from governmental institutions could be obtained to establish a working infrastructure for surgical research. Nonetheless, there are still issues of surgical RCTs regarding their quality, reporting, and study design. Addressing these aspects is essential for successful continuation of what was initiated with the first surgical RCT more than 40 years ago.

Regardless of improved diagnostics and therapeutic options, complicated intraabdominal infections remain a challenge in medicine. The prognosis of secondary peritonitis depends upon diagnosis and therapy in time. Diagnostic gold-standard is the computed tomography enhanced by contrast medium. Antimicrobial and supportive therapy is initiated before surgery and should be continued throughout and after the operation. Surgery aims on clearing the focus with a one-step-procedure in order to reduce perioperative morbidity and mortality.

We aimed to estimate the proportions of colorectal cancer cases that might be prevented by sigmoidoscopy compared with colonoscopy among women and men. In a population-based case control study conducted in Germany, 540 cases with a first diagnosis of primary colorectal cancer and 614 controls matched for age, sex, and county of residence were recruited. A detailed lifetime history of endoscopic examinations of the large bowel was obtained by standardized personal interviews, validated by medical records, and compared between cases and controls, paying particular attention to location of colorectal cancer and sex differences. Overall, 39%, 77%, and 64% of proximal, distal, and total colorectal cancer cases were estimated to be preventable by colonoscopy. The estimated proportion of total colorectal cancer cases preventable by sigmoidoscopy was 45% among both women and men, assuming that sigmoidoscopy reaches the junction of the descending and sigmoid colon only and findings of distal polyps are not followed by colonoscopy. Assuming that sigmoidoscopy reaches the splenic flexure and colonoscopy is done after detection of distal polyps, estimated proportions of total colorectal cancer preventable by sigmoidoscopy increase to 50% and 55% (73% and 91% of total colorectal cancer preventable by primary colonoscopy) among women and men, respectively. We conclude that colonoscopy provides strong protection against colorectal cancer among both women and men. The proportion of this protection achieved by sigmoidoscopy with follow-up colonoscopy in case of distal polyps may be larger than anticipated. Among men, this regimen may be almost as effective as colonoscopy, at least at previous performance levels of colonoscopy. (Cancer Epidemiol Biomarkers Prev 2007;16(3):494–9)

Objective: To examine the current ethical review process (ERP) of ethics committees in a non-pharmacological trial from the perspective of a clinical investigator. Design: Prospective collection of data at the Study Centre of the German Surgical Society on the duration, costs and administrative effort of the ERP of a randomised controlled multicentre surgical INSECT Trial (INterrupted or continuous Slowly absorbable sutures—Evaluation of abdominal Closure Techniques Trial, ISRCTN 24023541) between November 2003 and May 2005. Setting: Germany. Participants: 18 ethics committees, including the ethics committee handling the primary approval, responsible overall for 32 clinical sites throughout Germany. 8 ethics committees were located at university medical schools (MSU) and 10 at medical chambers. Duration was measured as days between submission and receipt of final approval, costs in euros and administrative effort by calculation of the product of the total number of different types of documents and the mean number of copies required (primary approval acting as the reference standard). Results: The duration of the ERP ranged from 1 to 176 (median 31) days. The median duration was 26 days at MSUs compared with 34 days at medical chambers. The total cost was €2947. 1 of 8 ethics committees at universities (€250) and 8 of 10 at medical chambers charged a median fee of €162 (mean €269.70). The administrative effort for primary approval was 30. Four ethics committees required a higher administrative effort for secondary approval (37, 39, 42 and 104). Conclusion: The ERP for non-pharmacological multicentre trials in Germany needs improvement. The administrative process has to be standardised: the application forms and the number and content of the documents required should be identical or at least similar. The fees charged vary considerably and are obviously too high for committees located at medical chambers. However, the duration of the ERP was, with some exceptions, excellent. A centralised ethics committee in Germany for multicentre trials such as the INSECT Trial can simplify the ERP for clinical investigators in and outside the country.

Comparison of effectiveness between the pylorus-preserving pancreaticoduodenectomy ("pylorus-preserving Whipple" [PPW]) and the classic Whipple (CW) procedure.A systematic literature search (Medline, Embase, Cochrane Library, Biosis, Science Citation Index, Ovid Journals) was performed to identify all eligible articles. Randomized controlled trials (RCTs) comparing PPW versus CW for periampullary and pancreatic carcinoma were eligible for inclusion. The methodologic quality of included studies was evaluated independently by 2 authors. Quantitative data on perioperative parameters (blood loss, transfusion, operation time, and length of hospital stay), mortality, morbidity, and survival were extracted from included studies for meta-analysis. Pooled estimates of overall treatment effect were calculated using a random effects model.In total, 1235 abstracts were retrieved and checked for eligibility and 6 RCTs finally included. The critical appraisal revealed vast heterogeneity with respect to methodologic quality and outcome parameters. The comparison of overall in-hospital mortality (odds ratio, 0.49; 95% CI, 0.17 to 1.40; P = 0.18), morbidity (odds ratio 0.89; 95% CI, 0.48 to 1.62; P = 0.69), and survival (hazard ratio, 0.74; 95% CI, 0.52 to 1.07; P = 0.11) showed no significant difference. However, operating time (weighted mean difference, -68.26 minutes; 95% CI, -105.70 to -30.83; P = 0.0004), and intraoperative blood loss (weighted mean difference, -766 mL; 95% CI, -965.26 to -566.74; P = 0.00001) were significantly reduced in the PPW group.Hence, in the absence of relevant differences in mortality, morbidity, and survival, the PPW seems to be as effective as the CW. Given obvious clinical and methodological interstudy heterogeneity, efforts should be intensified in the future to perform high quality RCTs of complex surgical interventions on the basis of well defined outcome parameters.

Die Zusammenfassung randomisierter kontrollierter und kontrollierter klinischer Studien (englisch: RCT und CCT) in systematischen Ubersichtsarbeiten setzt die vollstandige Erfassung aller Studien zu einer Fragestellung voraus. Ziel dieser Arbeit war die quantitative und qualitative Darstellung aller RCTs und CCTs in der Zeitschrift „Der Chirurg“. Es erfolgte eine Handdurchsuchung mit quantitativer und qualitativer Merkmalserfassung der Studien in „Der Chirurg“ von 1948 bis 2005 und ein Vergleich der Publikationshaufigkeiten (RCTs) mit fuhrenden chirurgischen Zeitschriften. Es wurden 112 (90 RCTs, 22 CCTs) Studien identifiziert. Eine Fallzahlberechnung wurde in 12 (13%), eine Beschreibung der Randomisierungstechnik in 44 (49%) und eine Analyse nach „intention to treat“ in 5 (6%) RCTs angegeben. Ab dem Jahr 2000 nehmen die RCTs in „Der Chirurg“ im Gegensatz zum internationalen Trend ab. Verbesserte Rahmenbedingungen fur Studien in der Chirurgie, die Umsetzung internationaler Standards (CONSORT Statement) und eine Anderung der Publikationsstrategie konnten die Quantitat und Qualitat deutschsprachiger RCTs und CCTs in „Der Chirurg“ steigern.

Hintergrund Patientenorientierte Forschung, insbesondere die Durchfuhrung von randomisierten, kontrollierten, multizentrischen klinischen Studien ist eine Herausforderung fur chirurgische Prufarzte. Um das Hintergrundwissen und die notwendigen Kenntnisse zu vermitteln, sind die eher am Arzneimittelgesetz (AMG) orientierten Prufarztkurse spezifisch fur den chirurgischen Bereich fortzuentwickeln. Die Hauptunterschiede liegen im regulatorischen und inhaltlichen Bereich, insbesondere in der Erarbeitung und Sicherstellung der Struktur, in der Behandlungs- und Beobachtungsgleichheit durch spezielle Randomisierungstechniken sowie in der Standardisierung der Operationsverfahren.

Das Studienzentrum der Deutschen Gesellschaft fur Chirurgie (SDGC) soll multizentrische randomisiert kontrollierte Studien in der Chirurgie planen, durchfuhren und auswerten. Das Ziel dieser Arbeit ist es, den Entscheidungsprozess des SDGC von einer Studienidee bis zum finalen Studienprotokoll transparent darzustellen. Der Prozess ist in 4 Stufen gegliedert. Studienideen konnen elektronisch uber die Homepage des SDGC von Mitgliedern der Deutschen Gesellschaft fur Chirurgie eingereicht werden. Die Ideen werden innerhalb von 4 Wochen vom SDGC bezuglich methodischer Aspekte und klinischer Relevanz bewertet. Durchfuhrbare und neuartige Ideen werden anschliesend in Kooperation mit dem Einreicher in eine Studienskizze uberfuhrt. Der Vorstand des SDGC entscheidet uber die Annahme oder begrundete Ablehnung der Studienidee anhand definierter Kriterien. In der 4. Stufe wird das SDGC zusammen mit dem Einreicher ein Studienprotokoll erstellen. Die Ideen und Entscheidungen werden auf der Homepage einsehbar sein. Der beschriebene Prozess kann helfen, relevante Projekte auszuwahlen, finanzielle Unterstutzung zu erhalten und den Ablauf von der Idee zum Studienprotokoll transparent darzustellen.

The concept of evidence-based medicine (EBM) has been introduced into the field of surgery in Germany since 1996, initially focussing on the application of the classical five-step-concept of EBM to the individual patient. Despite the international efforts of the Cochrane Collaboration, few systematic reviews address surgical procedures and the number of high quality randomized-controlled trials (RCTs) are low. External evidence in surgery is a major problem and requires new strategies in research and patient care. Therefore, in the Department of Surgery at the University of Heidelberg a clinical trial unit was founded to create more evidence via two approaches. First, patients admitted to hospital should be treated within RCTs. Since May 2002 1808 patients have been enrolled into a total of 38 pharmaceutical (19 trials with 470 patients enrolled) and investigator initiated (19 trials with 1338 patients enrolled) studies. Second, the clinical site develops and conducts surgical efficacy RCTs and follows new standards including publication and registration of the protocols. Within 3 years it was possible to change practice in an academic setting from the traditional concept to an evidence-based approach.

The use of the terms evidence-based medicine (EBM) and healthcare (EBHC) has become commonplace in the medical as well as in the surgical literature. Using the best available evidence, however, is not yet a working routine among surgeons because of the large amount and complexity of published research and the lack of user-friendly tools and necessary skills for the use of research results. This article encourages to formulate surgically relevant questions and to answer them on the basis of high-quality research, preferably by using systematic reviews which are based on the quality criteria of the Cochrane Collaboration. As currently only 77 Cochrane reviews address surgical procedures; much work remains to be done to enlarge the number of high-quality and relevant reviews. Similarly, the number and quality of randomized controlled trials need to be increased in all surgical specialties.

The overwhelming increase in the quantity of clinical evidence has led to detachment of the evidence and practice because new evidence can be integrated into clinical practice only after it has been critically appraised and synthesized on the basis of the existing evidence. Because many clinicians lack the skills and the time for such information processing, systematic reviews and meta-analyses, their quantitative counterparts, play an important role in health care. Well performed systematic reviews provide clinically relevant information for surgeons, abrogating the need to identify, read, and evaluate many individual studies. This article reviews the basic principles of meta-analysis, discusses its potential weaknesses such as heterogeneity and publication bias, and highlights special situations when dealing with surgical trials.

Background The objective of this study was to analyze factors that may have an impact on the failure rate of the surgical implantation technique for totally implantable access ports (TIAP) and to assess whether morbidity rates differ between a primarily successful surgical and a secondary Seldinger approach. Methods Four hundred consecutive patients receiving a primary TIAP in local anesthesia were included into this retrospective cohort study. A logistic regression-model was used to evaluate reasons for failure of the TIAP method. Results Three hundred eighteen (79.5%) patients had a successful TIAP procedure, 82 patients were intraoperatively converted to a Seldinger technique. Reasons for failure were: correct positioning impossible n = 54, no or only an undersized vessel for insertion available n = 17, other reasons n = 11. Logistic regression analysis did not reveal any significant factor for failure of the primary surgical approach. In the group with primarily successful TIAP, 8 of 318 patients (3%) developed complications compared to 7 of 82 patients (9%) converted to a Seldinger technique. Conclusion Failure of the surgical approach for implanting totally implantable access ports is related to insertion and positioning. Conversion to a Seldinger technique results in a higher complication rate. A modified approach for surgical port placement should be considered in order to reduce complications. J. Surg. Oncol. 2006;93:24–29. © 2005 Wiley-Liss, Inc.

The assessment of the optimal treatment option based on best current knowledge is called evidence-based medicine (EBM). Considering the cost explosion in public health systems, EBM should also incorporate proper utilization of the restricted economical resources and should enforce quality assurance in medicine. It is imperative that surgeons realize that randomized controlled trials are applicable to the operative specialties in a large scale, and are necessary to provide evidence-based surgery. So far, only 3.4% of all publications in the leading surgical journals are randomized controlled trials. Furthermore, only 44.1% of the published surgical randomized controlled studies compared different surgical procedures, whereas 55.9% of the articles compared medical therapies in surgical patients. Evidence-based surgical therapy is essential for further development of a high- quality surgical standard, which will also provide quality assurance in future surgical care. This article presents the definition of EBM and discusses specific problems involved in the introduction of its principles into the surgical discipline.

BACKGROUND: Pancreatic cancer is the fourth‐leading cause of cancer death for both, men and women. The standard treatment for resectable tumours consists of a classic Whipple (CW) operation or a pylorus‐preserving pancreaticoduodenectomy (PPW). It is unclear which of these procedures is more favourable in terms of survival, postoperative mortality, complications, and quality of life. OBJECTIVES: The objective of this systematic review was to compare the effectiveness of CW and PPW techniques for surgical treatment of cancer of the pancreatic head and the periampullary region. SEARCH METHODS: We conducted searches on 28 March 2006, 11 January 2011, 9 January 2014, and 18 August 2015 to identify all randomised controlled trials (RCTs), while applying no language restrictions. We searched the following electronic databases on 18 August 2015: the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Database of Systematic Reviews (CDSR) and the Database of Abstracts of Reviews of Effects (DARE) from the Cochrane Library (2015, Issue 8); MEDLINE (1946 to August 2015); and EMBASE (1980 to August 2015). We also searched abstracts from Digestive Disease Week and United European Gastroenterology Week (1995 to 2010); we did not update this part of the search for the 2014 and 2015 updates because the prior searches did not contribute any additional information. We identified two additional trials through the updated search in 2015. SELECTION CRITERIA: RCTs comparing CW versus PPW including participants with periampullary or pancreatic carcinoma. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data from the included trials. We used a random‐effects model for pooling data. We compared binary outcomes using odds ratios (ORs), pooled continuous outcomes using mean differences (MDs), and used hazard ratios (HRs) for meta‐analysis of survival. Two review authors independently evaluated the methodological quality and risk of bias of included trials according to the standards of The Cochrane Collaboration. MAIN RESULTS: We included eight RCTs with a total of 512 participants. Our critical appraisal revealed vast heterogeneity with respect to methodological quality and outcome parameters. Postoperative mortality (OR 0.64, 95% confidence interval (CI) 0.26 to 1.54; P = 0.32), overall survival (HR 0.84, 95% CI 0.61 to 1.16; P = 0.29), and morbidity showed no significant differences, except of delayed gastric emptying, which significantly favoured CW (OR 3.03, 95% CI 1.05 to 8.70; P = 0.04). Furthermore, we noted that operating time (MD ‐45.22 minutes, 95% CI ‐74.67 to ‐15.78; P = 0.003), intraoperative blood loss (MD ‐0.32 L, 95% CI ‐0.62 to ‐0.03; P = 0.03), and red blood cell transfusion (MD ‐0.47 units, 95% CI ‐0.86 to ‐0.07; P = 0.02) were significantly reduced in the PPW group. All significant results were associated with low‐quality evidence based on GRADE (Grades of Recommendation, Assessment, Development and Evaluation) criteria. AUTHORS' CONCLUSIONS: Current evidence suggests no relevant differences in mortality, morbidity, and survival between the two operations. However, some perioperative outcome measures significantly favour the PPW procedure. Given obvious clinical and methodological heterogeneity, future high‐quality RCTs of complex surgical interventions based on well‐defined outcome parameters are required.

Summary Background Postoperative surgical site infections are one of the most frequent complications after open abdominal surgery, and triclosan-coated sutures were developed to reduce their occurrence. The aim of the PROUD trial was to obtain reliable data for the effectiveness of triclosan-coated PDS Plus sutures for abdominal wall closure, compared with non-coated PDS II sutures, in the prevention of surgical site infections. Methods This multicentre, randomised controlled group-sequential superiority trial was done in 24 German hospitals. Adult patients (aged ≥18 years) who underwent elective midline abdominal laparotomy for any reason were eligible for inclusion. Exclusion criteria were impaired mental state, language problems, and participation in another intervention trial that interfered with the intervention or outcome of this trial. A central web-based randomisation tool was used to randomly assign eligible participants by permuted block randomisation with a 1:1 allocation ratio and block size 4 before mass closure to either triclosan-coated sutures (PDS Plus) or uncoated sutures (PDS II) for abdominal fascia closure. The primary endpoint was the occurrence of superficial or deep surgical site infection according to the Centers for Disease Control and Prevention criteria within 30 days after the operation. Patients, surgeons, and the outcome assessors were masked to group assignment. Interim and final analyses were by modified intention to treat. This trial is registered with the German Clinical Trials Register, number DRKS00000390. Findings Between April 7, 2010, and Oct 19, 2012, 1224 patients were randomly assigned to intervention groups (607 to PDS Plus, and 617 to PDS II), of whom 1185 (587 PDS Plus and 598 PDS II) were analysed by intention to treat. The study groups were well balanced in terms of patient and procedure characteristics. The occurrence of surgical site infections did not differ between the PDS Plus group (87 [14·8%] of 587) and the PDS II group (96 [16·1%] of 598; OR 0·91, 95% CI 0·66–1·25; p=0·64). Serious adverse events also did not differ between the groups—146 of 583 (25·0%) patients treated with PDS Plus had at least one serious adverse event, compared with 138 of 602 (22·9%) patients treated with PDS II; p=0·39). Interpretation Triclosan-coated PDS Plus did not reduce the occurrence of surgical site infection after elective midline laparotomy. Innovative, multifactorial strategies need to be developed and assessed in future trials to reduce surgical site infections. Funding Johnson & Johnson Medical Limited.