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There is limited information regarding the impact of anastomotic leakage on oncologic outcome in exclusively colon cancer patients.The colorectal database of the Department of Surgery of the University of Heidelberg was used to assess the impact of anastomotic leakage on oncologic outcome in patients undergoing curative resection for Stage I-III colon cancer. Risk-adjusted Cox regression analysis and propensity score methods were used to assess overall, disease-free, and relative survival.628 patients of which 26 (4.1%) experienced anastomotic leakage were analysed. Anastomotic leakage was associated with significantly worse overall, disease-free and relative survival in univariate and multivariate analysis. The analysis after exact propensity score matching confirmed the negative impact of anastomotic leakage on overall (HR 2.62, 95% CI 1.33-5.18, p = .011), disease-free (HR 2.28, 95% CI 1.16-4.47, p = .027) and relative survival (HR 3.70, 95% CI 1.82-7.52, p .001). 5-year overall survival was 51.6% (95% CI 34.5-77.2%) for patients with anastomotic leakage compared to 77.7% (95% CI 73.0-82.8%) for patients without anastomotic leakage.All conceivable efforts should be made to avoid anastomotic leakage after colon resection for cancer not only to evade short-term consequences but also to allow for adequate long-term outcome.

Adrenalectomy can be performed via open and various minimally invasive approaches. The aim of this systematic review was to summarize the current evidence on surgical techniques of adrenalectomy. Systematic literature searches (MEDLINE, EMBASE, Web of Science, Cochrane Library) were conducted to identify randomized controlled trials (RCTs) and controlled clinical trials (CCTs) comparing at least two surgical procedures for adrenalectomy. Statistical analyses were performed, and meta-analyses were conducted. Furthermore, an indirect comparison of RCTs and a network meta-analysis of CCTs were carried out for each outcome. Twenty-six trials (1710 patients) were included. Postoperative complication rates did not show differences for open and minimally invasive techniques. Operation time was significantly shorter for open adrenalectomy than for the robotic approach (p

Objective This dual-center, randomized, controlled, noninferiority trial aimed to prove that omission of drains does not increase reintervention rates after pancreatic surgery. Background There is considerable uncertainty regarding intra-abdominal drainage after pancreatoduodenectomy. Methods Patients undergoing pancreatic head resection with pancreaticojejunal anastomosis were randomized to intra-abdominal drainage versus no drainage. Primary endpoint was overall reintervention rate (relaparotomy or radiologic intervention). Secondary endpoints were clinically relevant pancreatic fistula (grade B/C), mortality, morbidity, and hospital stay. The planned sample size was 188 patients per group. Results A total of 438 patients were randomized. Forty-three patients (9.8%) were excluded because no pancreatic anastomosis was performed, and 395 patients (202 drain, 193 no-drain) were analyzed. Reintervention rates were not inferior in the no-drain group (drain 21.3%, no-drain 16.6%; P = 0.0004). Overall in-hospital mortality (3.0%) was the same in both groups (drain 3.0%, no-drain 3.1%; P = 0.936). Overall surgical morbidity (41.8%) was comparable (P = 0.741). Clinically relevant pancreatic fistula (grade B/C: drain 11.9%, no-drain 5.7%; P = 0.030) and fistula-associated complications (drain 26.4%; no drain 13.0%; P = 0.0008) were significantly reduced in the no-drain group. Operation time (P = 0.093), postoperative hemorrhage (P = 0.174), intra-abdominal abscess formation (P = 0.199), biliary leakage (P = 0.382), delayed gastric emptying (P = 0.062), burst abdomen (P = 0.480), wound infection (P = 0.758), and hospital stay (P = 0.487) did not show significant differences. Conclusions Omission of drains was not inferior to intra-abdominal drainage in terms of postoperative reintervention and superior in terms of clinically relevant pancreatic fistula rate and fistula-associated complications. There is no need for routine prophylactic drainage after pancreatic resection with pancreaticojejunal anastomosis.

The aims of this study are to compare the 30-day rate of bowel obstruction for stapled vs. handsewn closure of loop ileostomy, and to further assess efficacy and safety for each technique by secondary endpoints such as operative time, rates of anastomotic leakage, and other post-operative complications within 30 days. A systematic literature search (MEDLINE, The Cochrane Library, EMBASE and ISI Web of Science) was performed to identify randomized controlled trials (RCTs) comparing stapled and handsewn closure of loop ileostomy after low anterior resection. Random effects meta-analyses were calculated and presented as risk ratio (RR) and mean difference (MD) with corresponding 95 % confidence intervals. Forty publications were retrieved and 4 RCTs (649 patients) were included. There was methodological and clinical heterogeneity of included trials, but statistical heterogeneity was low for most endpoints. Stapler use significantly reduced the rate of bowel obstruction compared to hand-sewn closure (RR 0.53 [0.32, 0.88]; P = 0.01). The operation time was significantly lower for stapling compared to hand suture (MD −15.5 min [−18.4, 12.6]; P

Background Despite improvements in liver surgery over the past decades, hemostasis during hepatic resections remains challenging. This multicenter randomized study compares the hemostatic effect of a collagen hemostat vs. a carrier-bound fibrin sealant after hepatic resection. Methods Patients scheduled for elective liver resection were randomized intraoperatively to receive either the collagen hemostat (COLL) or the carrier-bound fibrin sealant (CBFS) for secondary hemostasis. The primary endpoint was the proportion of patients with hemostasis after 3 min. Secondary parameters were the proportions of patients with hemostasis after 5 and 10 min, the total time to hemostasis, and the complication rates during a 3 months follow-up period. Results A total of 128 patients were included. In the COLL group, 53 out of 61 patients (86.9 %) achieved complete hemostasis within 3 min after application of the hemostat compared to 52 out of 65 patients (80.0 %) in the CBFS group. The 95 % confidence interval for this difference [−6.0 %, 19.8 %] does not include the lower noninferiority margin (−10 %). Thus, the COLL treatment can be regarded as noninferior to the comparator. The proportions of patients with hemostasis after 3, 5, and 10 min were not significantly different between the two study arms. Postoperative mortality and morbidity were similar in both treatment groups. Conclusion The collagen hemostat is as effective as the carrier-bound fibrin sealant in obtaining secondary hemostasis during liver resection with a comparable complication rate. Electronic supplementary material The online version of this article (doi:10.1007/s00423-014-1203-9) contains supplementary material, which is available to authorized users.

Novel surgical methods and procedures used to be introduced by experts and were established depending on the corresponding success that was noted. Surgical trials representing evidence level 1b were and still are called into question for different reasons. Prospective randomized controlled trials comparing various surgical strategies that were conducted over the past 11 years in the clinical trial unit in the department of general, visceral, and transplantation surgery of the University of Heidelberg pointed out problems as well as possible solutions for surgical trials’ characteristics. When planning a study within a department of surgery, several aspects have to be considered. The article aims at outlining pitfalls that have to be dealt with as well as possible solutions by outlining experiences within several conducted trials. The compilation of solutions announcing the challenges of surgical studies shows that valid high-quality trials are feasible.

Background: Since its introduction more than 20 years ago, evidence-based medicine has become an important principle in the daily routine of clinicians around the globe. Nevertheless, many surgical interventions are still not based on high-quality evidence from clinical trials. This is partially due to the fact that surgical trials pose some specific obstacles, which have to be overcome during the planning and conduct of such a trial. Objective: In this study, we will highlight specific challenges and discuss explicit obstacles of surgical clinical research. Moreover, potential solutions will be substantiated by the experience of the Study Centre of the German Surgical Society (SDGC) in surgical clinical research. Conclusions: Surgical researchers should be equipped with a basic knowledge of research methodology to be able to overcome the common impediments posed by surgical trials. Collaborations between surgeons and methodologists as well as trial networks have proven to be useful in accomplishing high-quality surgical research in various randomized controlled trials. By maintaining and refining this work and with sufficient and prompt translation of investigational knowledge into daily practice, the treatment of surgical patients should result in an improved outcome in the future.

Background Incisional hernia is the most frequent long-term complication after visceral surgery, with an incidence of between 9 and 20 per cent 1 year after operation. Most controlled studies provide only short-term follow-up, and the actual incidence remains unclear. This study evaluated the incidence of incisional hernia up to 3 years after midline laparotomy in two prospective trials. Methods Three-year follow-up data from the ISSAAC (prospective, multicentre, historically controlled) and INSECT (randomized, controlled, multicentre) trials focused on the rate of incisional hernia 1 and 3 years after surgery. Differences between the two groups were compared using t tests for continuous data and the χ2 test for categorical data. Results Analysis of 775 patients included in the two trials suggested that the incisional hernia rate increased significantly from 12·6 per cent at 1 year to 22·4 per cent 3 years after surgery (P < 0.001), a relative increase of more than 60 per cent. Conclusion This follow-up of two trials demonstrated that 1 year of clinical follow-up for detection of incisional hernia is not sufficient; follow-up for at least 3 years should be mandatory in any study evaluating the rate of postoperative incisional hernia after midline laparotomy.

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.

[This corrects the article DOI: 10.1371/journal.pone.0139547.].

Anastomotic leakage is one of the most severe complications following esophageal resection. Among other strategies, gastric ischemic preconditioning has been proposed to improve anastomotic integrity. The aim of this systematic review is to investigate whether gastric preconditioning has influence on peri- or postoperative outcomes after esophageal resection. A systematic literature search was performed to identify studies comparing gastric preconditioning with non-preconditioned patients for any indication of esophageal resection. Random-effects meta-analyses were conducted for main outcomes. Gastric preconditioning did not reduce anastomotic leakages (OR 0.76; 95%-CI 0.51 to 1.13; p = 0.18), anastomotic strictures (OR 1.10; 95%-CI 0.58 to 2.10; p = 0.76;), major complications (OR 1.14; 95%-CI 0.60 to 2.14; p = 0.69), or in-hospital mortality (OR 0.62; 95%-CI 0.28 to 1.40; p = 0.25). However, preconditioning reduced the rate of severe leaks requiring reoperation (OR 0.20; 95%-CI 0.08 to 0.53; p = 0.001). Increasing the period between preconditioning and esophageal resection over 2 weeks did not reduce anastomotic leakage compared to shorter waiting times (OR 0.65; 95%-CI 0.38 to 1.13; p = 0.13). With current evidence, gastric preconditioning does not seem to reduce overall rates of anastomotic leakage after esophageal resection but seems to reduce severity of leakages.

Background The objective of this study was to evaluate the potential benefits of immunonutrition in major abdominal surgery with special regard to subgroups and influence of bias. Methods A systematic literature search from January 1985 to July 2015 was performed in MEDLINE, Embase and CENTRAL. Only RCTs investigating immunonutrition in major abdominal surgery were included. Outcomes evaluated were mortality, overall complications, infectious complications and length of hospital stay. The influence of different domains of bias was evaluated in sensitivity analyses. Evidence was rated according to the GRADE Working Group grading of evidence. Results A total of 83 RCTs with 7116 patients were included. Mortality was not altered by immunonutrition. Taking all trials into account, immunonutrition reduced overall complications (odds ratio (OR) 0·79, 95 per cent c.i. 0·66 to 0·94; P = 0·01), infectious complications (OR 0·58, 0·51 to 0·66; P < 0·001) and shortened hospital stay (mean difference –1·79 (95 per cent c.i. –2·39 to –1·19) days; P < 0·001) compared with control groups. However, these effects vanished after excluding trials at high and unclear risk of bias. Publication bias seemed to be present for infectious complications (P = 0·002). Non-industry-funded trials reported no positive effects for overall complications (OR 1·13, 0·88 to 1·46; P = 0·34), whereas those funded by industry reported large effects (OR 0·66, 0·48 to 0·91; P = 0·01). Conclusion Immunonutrition after major abdominal surgery did not seem to alter mortality (GRADE: high quality of evidence). Immunonutrition reduced overall complications, infectious complications and shortened hospital stay (GRADE: low to moderate). The existence of bias lowers confidence in the evidence (GRADE approach).

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.

Background Increasing experience with minimally invasive surgery and the development of new instruments has resulted in a tendency toward reducing the number of abdominal skin incisions. Retrospective and randomized prospective studies could show the feasibility of single-incision surgery without any increased risk to the patient. However, large prospective multicenter observational datasets do not currently exist. Objective This prospective multicenter observational quality study will provide a relevant dataset reflecting the feasibility and safety of single-incision surgery. This study focuses on external validity, clinical relevance, and the patients’ perspective. Accordingly, the single-incision multiport/single port laparoscopic abdominal surgery (SILAP) study will supplement the existing evidence, which does not currently allow evidence-based surgical decision making. Methods The SILAP study is an international prospective multicenter observational quality study. Mortality, morbidity, complications during surgery, complications postoperatively, patient characteristics, and technical aspects will be monitored. We expect more than 100 surgical centers to participate with 5000 patients with abdominal single-incision surgery during the study period. Results Funding was obtained in 2012. Enrollment began on January 01, 2013, and will be completed on December 31, 2018. As of January 2016, 2119 patients have been included, 106 German centers are registered, and 27 centers are very active (>5 patients per year). Conclusions This prospective multicenter observational quality study will provide a relevant dataset reflecting the feasibility and safety of single-incision surgery. An international enlargement and recruitment of centers outside of Germany is meaningful. Trial Registration German Clinical Trials Register: DRKS00004594; https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00004594 (Archived by WebCite at http://www.webcitation.org/6jK6ZVyUs)

Einleitung: Der negative Einfluss von Mangelernahrung auf das klinische Outcome ist fur viele medizinische Bereiche erwiesen. Die Definition der Mangelernahrung variiert zwischen den gebrauchlichen klinischen Ernahrungsscores. Fur die Pankreaschirurgie gibt es nur sparliche Evidenz, inwiefern klinische Ernahrungsscores in der Lage sind, eine relevante Mangelernahrung zu evaluieren. Ziele: Das Ziel dieser Studie war es, den klinischen Ernahrungsscore zu ermitteln, bei welchem eine praoperative Mangelernahrung mit schlechtem postoperativem Outcome einhergeht. Methodik: Alle Patienten, die sich einer elektiven Pankreasoperation unterzogen, wurden um Einwilligung gebeten. Praoperativ erfolgte eine Beurteilung des Ernahrungsstatus mittels zwolf klinischen Ernahrungsscores (NRI, NRS, NRS 2002, SGA, MUST, MNA, MNA-SF, SNAQ, INSYST I+II, NRC, und ESPEN malnutrition criteria). Anhand der Ernahrungsscores wurden die Patienten als mangelernahrt oder nicht mangelernahrt eingeteilt. Postoperative Komplikationen wurden bis zur Entlassung erhoben. Fur jeden Ernahrungsscore wurde der Zusammenhang zwischen dem Vorhandensein einer Mangelernahrung und dem Auftreten einer schwerwiegenden postoperativen Komplikation (Clavien-Dindo III-V) als diagnostisches Odds Ratio (OR) erfasst und in einer univariablen und multivariablen Analyse auf einem Signifikanzniveau von 5% getestet. Ergebnis: Insgesamt 279 Patienten wurden untersucht (134 Pankreatikoduodenektomien, 81 distale Pankreatektomien, 47 totale Pankreatektomien und 17 andere Resektionen). Im Durchschnitt waren die Patienten 62.5 (± 12.5) Jahre alt und hatten einen BMI von 25.5 (± 4.92)kg/m2. Eine schwerwiegende Komplikation trat bei 61 Patienten (21.9%) auf. Der Anteil an Patienten, welche mangelernahrt waren, schwankte zwischen 1,08% (Nutritional Risk Index) und 79,57% (Nutritional Risk Classification). Die Assoziation zwischen Ernahrungsscores und postoperativen Komplikationen war fur keinen der Scores signifikant. Schlussfolgerung: Keiner der gebrauchlichen klinischen Ernahrungsscores ist fahig eine Mangelernahrung zu definieren, welche mit einer erhohten Rate an postoperativen Komplikationen nach Pankreaseingriffen einhergeht.

Background Postoperative pancreatic fistula represents the most important complication after distal pancreatectomy. The aim of this study was to evaluate the use of a preoperative endoscopic injection of botulinum toxin into the sphincter of Oddi to prevent postoperative pancreatic fistula (German Clinical Trials Register number: DRKS00007885). Methods This was an investigator-initiated, prospective clinical phase I/II trial with an exploratory study design. We included patients who underwent preoperative endoscopic sphincter botulinum toxin injection (100 units of Botox). End points were the feasibility, safety, and postoperative outcomes, including postoperative pancreatic fistula within 30 days after distal pancreatectomy. Botulinum toxin patients were compared with a control collective of patients undergoing distal pancreatectomy without botulinum toxin injection by case-control matching in a 1:1 ratio. Results Between February 2015 and February 2016, 29 patients were included. All patients underwent successful sphincter of Oddi botulinum toxin injection within a median of 6 (range 0–10) days before operation. One patient had an asymptomatic, self-limiting (48 hours) increase in serum amylase and lipase after injection. Distal pancreatectomy was performed in 24/29 patients; 5 patients were not resectable. Of the patients receiving botulinum toxin, 7 (29%) had increased amylase levels in drainage fluid on postoperative day 3 (the International Study Group of Pancreatic Surgery definition of postoperative pancreatic fistula grade A) without symptoms or need for reintervention. Importantly, no clinically relevant fistulas (International Study Group of Pancreatic Surgery grades B/C) were observed in botulinum toxin patients compared to 33% postoperative pancreatic fistula grade B/C in case-control patients (P Conclusion Preoperative sphincter of Oddi botulinum toxin injection is a novel and safe approach to decrease the incidence of clinically relevant postoperative pancreatic fistula after distal pancreatectomy. The results of the present trial suggest its efficacy in the prevention of clinically relevant postoperative pancreatic fistula and are validated currently in the German Federal Government–sponsored, multicenter, randomized controlled PREBOT trial.

This systematic review was performed to investigate the ethical justification, methodological quality, validity and safety of placebo controls in randomized placebo-controlled surgical trials. Central, MEDLINE, and EMBASE were systematically searched to identify randomized controlled trials comparing a surgical procedure to a placebo. “Surgical procedure” was defined as a medical procedure involving an incision with instruments. Placebo was defined as a blinded sham operation involving no change to the structural anatomy and without an expectable physiological response in the target body compartment. Ten randomized placebo-controlled controlled surgical trials were included, all of them published in high-ranking medical journals (mean impact factor: 20.1). Eight of 10 failed to show statistical superiority of the experimental intervention. Serious adverse events did not differ between the groups (rate ratio [RR] 1.38, 95% confidence interval [CI]: 0.92–2.06, P = 0.46). None of the trials had a high risk of bias in any domain. The ethical justification for the use of a placebo control remained unclear in 2 trials. Placebo-controlled surgical trials are feasible and provide high-quality data on efficacy of surgical treatments. The surgical placebo entails a considerable risk for study participants. Consequently, a placebo should be used only if justified by the clinical question and by methodological necessity. Based on the current evidence, a pragmatic proposal for the use of placebo controls in future randomized controlled surgical trials is made.

The objective of the HASTA trial was to compare hand suture versus stapling loop ileostomy closure in a randomized controlled trial.Bowel obstruction is one of the main and the clinically and economically most relevant complication following closure of loop ileostomy after low anterior resection. The best surgical technique for closure of loop ileostomy has not been defined yet.HASTA trial is a multicenter pragmatic randomized controlled surgical trial with 2 parallel groups to compare hand suture versus stapling for closure of loop ileostomy. The primary endpoint was the rate of bowel obstruction within 30 days after ileostomy closure.A total of 337 randomized patients undergoing closure of loop ileostomy after low anterior resection because of rectal cancer in 27 centers were included. The overall rate of postoperative ileus after ileostomy closure was 13.4%. Seventeen of 165 (10.3%) patients in the stapler group and 27 of 163 (16.6%) in the hand suture group developed bowel obstruction within 30 days postoperatively [odds ratio (OR) = 1.72; 95% confidence interval (CI): 0.89-3.31 = 0.10]. Duration of surgical intervention was significantly shorter in the stapler group (15 minutes; P< 0.001). Multivariable analysis of potential risk factors did not reveal any significant correlation with development of postoperative ileus. Rate of anastomotic leakage (stapler: 3.0%, hand suture: 1.8%, P = 0.48) did not differ significantly as well as all other secondary endpoints.Hand-sewn anastomosis versus stapler ileo-ileostomy for ileostomy closure are equally effective in terms of postoperative bowel obstruction, with stapler anastomosis leading to a shorter operation time. Postoperative ileus after ileostomy reversal remains a relevant complication.

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.

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.

Das Studienzentrum der Deutschen Gesellschaft fur Chirurgie (SDGC) hat die Aufgabe, die klinische Forschung in der Chirurgie nachhaltig zu unterstutzen. Besonderer Fokus liegt hierbei auf der Entwicklung und Durchfuhrung von klinischen Studien in Deutschland an Universitatskliniken, aber auch an nichtuniversitaren Hausern. Die vorliegende Ubersicht skizziert aktuelle Handlungsfelder des SDGC mit Blick in die Zukunft.

Zusammenfassung Die Chirurgie ist auf den Einsatz von wissenschaftlich gepruften Therapieverfahren angewiesen und legitimiert ihren Anspruch in der Krankenversorgung durch Operationen, die einen nachgewiesenen Nutzen in Form von Heilung oder Linderung von Beschwerden haben. Die klinische Forschung in der Chirurgie hat daruber hinaus bei der Beurteilung von chirurgischer Technik, Taktik und Innovation immer Bezug zu Medizinprodukten. Eine Nutzenbewertung von Medizinprodukten in der chirurgischen Praxis liegt regulativ auserhalb des Arzneimittel- und Medizinproduktegesetzes, folgt aber den wissenschaftlichen und ethischen Grundlagen der klinischen Epidemiologie und evidenzbasierten Medizin. Um den Nutzen von Medizinprodukten und der Chirurgie zu definieren und evaluieren, sind Standardisierung der Technik und des perioperativen Settings in klinischen Studien unerlasslich. Das Studienzentrum der Deutschen Gesellschaft fur Chirurgie hat eine tragfahige Infrastruktur fur die Durchfuhrung dieser Studien in Deutschland geschaffen und beteiligt sich an der Weiterentwicklung der wissenschaftlichen Methodik, um die aktuelle Evidenzlage zu verbessern. (Wie vom Gastherausgeber eingereicht)

Seit der Grundung im Jahre 2003 steht das Studienzentrum der Deutschen Gesellschaft fur Chirurgie (SDGC) allen Chirurgen bei der Umsetzung ihrer Studienideen in multizentrische randomisierte Studien zur Verfugung. Sowohl in der Planungsphase (Fallzahlberechnung, Protokollerstellung, Forderantrage) als auch in der Durchfuhrung (Ethikantrag, Datenmanagement, Monitoring) und Auswertung (statistische Analyse, Publikation) bietet das SDGC seine Unterstutzung an und kooperiert dabei eng mit der medizinischen Biometrie und dem Datenmanagement. Bisher konnten uber 2500 Patienten in insgesamt 11 Studien eingeschlossen werden. Die bisher groste Studie des SDGC (SYNCHRONOUS) mit bis zu 80 teilnehmenden Zentren wurde im September 2011 aktiviert. Fur Studienplanung und Ergebniszusammenfuhrung gewinnen systematische Reviews mit Metaanalysen zunehmend an Bedeutung. Daher etablierte das SDGC eine interne Arbeitsgruppe zur Erstellung solcher systematischen Ubersichtsarbeiten. Bisher konnten 13 Arbeiten erfolgreich publiziert werden, 8 weitere sind aktuell in Bearbeitung.

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.

BACKGROUND: Systematic reviews are fundamental decision-making tools for the assessment of the effectiveness of healthcare interventions and for determining future research fields. In the field of hand surgery, so far, there exists only a limited number of systematic reviews. According to the diversity and multitude of hand surgical topics, relevant fields for systematic reviews were identified by means of an expert ranking. MATERIAL AND METHODS: A catalogue of 24 topics was extracted from publications of representative hand surgical journals. These topics were categorized and integrated into a questionnaire which was presented to 30 experts in the field of hand surgery. Every single topic had to be rated by marks from 1 (very relevant) to 5 (not relevant). Further topics could have been indicated. Averaging of the marks allowed to define a ranking and a prioritisation of the topics. RESULTS: 29 of 30 questionnaires were returned. The ranking showed scapholunate ligament injury, Kienboeck's disease and scaphoid nonunion to have the highest relevance, followed by 5 other topics dealing with wrist problems. The lowest relevance was attributed to neck fractures of the fifth metacarpal, ulnar collateral ligament injury of the thumb metacarpophalangeal joint and postoperative management following replantation. CONCLUSION: The results of the presented survey allow for a prioritisation of topics for systematic reviews in hand surgery. The ranking of the topics emphasises the particular relevance of injuries and diseases of the wrist.

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.

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 detailed literature search was performed to investigate whether the increasing importance of evidence-based hand surgery is reflected in the actual status of Cochrane reviews. Fourteen Cochrane reviews were found and evaluated. Of these, five reviews were in the field of distal radial fractures and four concerned carpal tunnel syndrome. Cochrane reviews were also found for antibiotic treatment, rehabilitation after flexor tendon injuries, mallet finger injuries, little finger metacarpal neck fractures and thumb joint arthritis. All 14 reviews were compromised by methodological flaws and significant clinical heterogeneity of the included studies. Within most reviews the underlying evidence was insufficient and only a very limited number of clinical recommendations could be made. In conclusion, the existing Cochrane reviews in the field of hand surgery show both an increasing interest in establishing systematically summarised knowledge and an enormous demand for good-quality randomised controlled trials.

Background The effect of portal triad clamping (PTC) on outcome after hepatic resection is uncertain. Methods A systematic literature search was conducted to detect randomized controlled trials (RCTs) assessing the effectiveness and safety of PTC alone and of PTC with ischaemic preconditioning (IPC) of the liver. Studies on clamping of the inferior vena cava or hepatic veins were excluded. Endpoints included postoperative overall morbidity and mortality, cardiopulmonary and hepatic morbidity, blood loss, transfusion rates and alanine aminotransferase (ALT) levels. Meta-analyses were performed using a random-effects model. Results Eight RCTs published between 1997 and 2006 containing a total of 558 patients were eligible for final analysis. The design of the identified studies varied considerably. Analyses of endpoints revealed no difference between intermittent PTC and no PTC. Meta-analyses of PTC with and without previous IPC revealed no differences, but postoperative ALT levels were significantly lower with IPC. Conclusion On currently available evidence, the routine use of PTC does not offer any benefit in perioperative outcome after liver resection. It cannot be recommended as a standard procedure.

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.

Hintergrund Fur die Erstellung qualitativ hochwertiger systematischer Ubersichtsarbeiten ist die Identifizierung aller verfugbaren und relevanten Studienberichte uber randomisierte (RCTs) und kontrollierte klinische Studien (CCTs) von entscheidender Bedeutung. Unvollstandige Erfassung medizinischer Zeitschriften in elektronischen Datenbanken und fehlerhafte Indexierung der Studienberichte konnen das Ergebnis einer systematischen Literatursuche beintrachtigen. Eine hohere Prazision der Suche kann nur durch eine zusatzlich durchgefuhrte Handsuche erzielt werden.

The objective of this study was to identify potential risk factors for mortality and morbidity after distal pancreatectomy, with special focus on the formation of pancreatic fistula.Distal pancreatectomy can be performed with low mortality and acceptable morbidity rates. Pancreatic fistulas, occurring in 10% to 20% of cases, remain a problem that contributes significantly to morbidity, length of stay, and overall costs.From November 1993 to February 2006, perioperative and postoperative data of 302 consecutive patients were recorded. Univariate and multivariate analyses of potential risk factors for morbidity and for the formation of pancreatic fistula were performed. The surgical techniques used for closure were categorized into 4 groups: 1) anastomosis, 2) seromuscular patch, 3) closure by suture, and 4) closure using a stapling device.Indications for resection were pancreatic tumors in 62% of patients, nonpancreatic tumors in 23%, chronic pancreatitis in 12%, and others in 3%. The spleen was preserved in 24% of patients. The morbidity and mortality rates for distal pancreatectomy in this series were 35% and 2%, respectively. The prevalence of pancreatic fistula was 12%. Univariate and multivariate analyses indicated that closure using a stapling device and an operating timeor=480 minutes were associated with a higher incidence of pancreatic fistula (odds ratio = 2.6 and 4.2, respectively). Overall morbidity was mainly influenced by the extent of resection (multivisceral vs. conventional; odds ratio = 1.7).Pancreatic leak remains a common complication after distal pancreatectomy. Our series suggests that stapler closure of the pancreatic remnant is associated with a significantly higher fistula rate.

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.

OBJECTIVE Laparoscopic mesh-augmented hiatoplasty with cardiophrenicopexy (LMAH-C) might represent an alternative treatment of gastroesophageal reflux disease (GERD) and may provide durable reflux control without fundoplication. The expected benefit is the prevention of fundoplication-related side effects. Aim of the present trial was to compare LMAH-C with laparoscopic Nissen fundoplication (LNF) in patients with GERD. METHODS In a double-center randomized controlled trial (RCT) patients with proven GERD were eligible and assigned by central randomization to either LMAH-C (n = 46) or LNF (n = 44). The indigestion subscore of the Gastrointestinal Symptom Rating Scale questionnaire (GSRS) indicating gas-related symptoms as possible side effects of LNF was the primary endpoint. Secondary endpoints comprised pH testing and endoscopy and other symptoms measured by the GSRS, dysphagia, and the Gastrointestinal Quality of Life Index. The follow-up period was 36 months. RESULTS Indigestion subscore (LMAH-C 2.9 ± 1.5 vs LNF 3.7 ± 1.6; P = 0.031) but not dysphagia (2.8 ± 1.9 vs 2.3 ± 1.7; P = 0.302) and quality of life (106.9 ± 25.5 vs 105.8 ± 24.9; P = 0.838) differed between the groups at 36 months postoperatively. Although the reflux subscore improved in both groups, it was worse in LMAH-C patients (2.5 ± 1.6 vs 1.6 ± 1.0; P = 0.004) corresponding to a treatment failure of 77.3% in LMAH-C patients and of 34.1% in LNF patients (P

Background Resections of the pancreatic body and tail reaching to the left of the superior mesenteric vein are defined as distal pancreatectomy. Most distal pancreatectomies are elective treatments for chronic pancreatitis, benign or malignant diseases, and they have high morbidity rates of up to 40%. Pancreatic fistula formation is the main source of postoperative morbidity, associated with numerous further complications. Researchers have proposed several surgical resection and closure techniques of the pancreatic remnant in an attempt to reduce these complications. The two most common techniques are scalpel resection followed by hand-sewn closure of the pancreatic remnant and stapler resection and closure. Objectives To compare the rates of pancreatic fistula in people undergoing distal pancreatectomy using scalpel resection followed by hand-sewn closure of the pancreatic remnant versus stapler resection and closure. Search methods We searched Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Biosis and Science Citation Index from database inception to October 2015. Selection criteria We included randomised controlled trials (RCTs) comparing stapler versus scalpel resection followed by hand-sewn closure of the pancreatic remnant for distal pancreatectomy (irrespective of language or publication status). Data collection and analysis Two authors independently assessed trials for inclusion and extracted the data. Taking into consideration the clinical heterogeneity between the trials (e.g. different endpoint definitions), we analysed data using a random-effects model with Review Manager (RevMan), calculating risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI). Main results In two eligible trials, a total of 381 participants underwent distal pancreatic resection and were randomised to closure of the pancreatic remnant either with stapler (n = 191) or scalpel resection followed by hand-sewn closure (n = 190). One was a single centre pilot RCT and the other was a multicentre blinded RCT. The single centre pilot RCT evaluated 69 participants in five intervention arms (stapler, hand-sewn, fibrin glue, mesh and pancreaticojejunostomy), although we only assessed the stapler and hand-sewn closure groups (14 and 15 participants, respectively). The multicentre RCT had two interventional arms: stapler (n = 177) and hand-sewn closure (n = 175). The rate of postoperative pancreatic fistula was the main outcome, and it occurred in 79 of 190 participants in the hand-sewn group compared to 65 of 191 participants in the stapler group. Neither the individual trials nor the meta-analysis showed a significant difference between resection techniques (RR 0.90; 95% CI 0.55 to 1.45; P = 0.66). In the same way, postoperative mortality and operation time did not differ significantly. The single centre RCT had an unclear risk of bias in the randomisation, allocation and both blinding domains. However, the much larger multicentre RCT had a low risk of bias in all domains. Due to the small number of events and the wide confidence intervals that cannot exclude clinically important benefit or harm with stapler versus hand-sewn closure, there is a serious possibility of imprecision, making the overall quality of evidence moderate. Authors' conclusions The quality of evidence is moderate and mainly based on the high weight of the results of one multicentre RCT. Unfortunately, there are no other completed RCTs on this topic except for one relevant ongoing trial. Neither stapler nor scalpel resection followed by hand-sewn closure of the pancreatic remnant for distal pancreatectomy showed any benefit compared to the other method in terms of postoperative pancreatic fistula, overall postoperative mortality or operation time. Currently, the choice of closure is left up to the preference of the individual surgeon and the anatomical characteristics of the patient. Another (non-European) multicentre trial (e.g. with an equality or non-inferiority design) would help to corroborate the findings of this meta-analysis. Future trials assessing novel methods of stump closure should compare them either with stapler or hand-sewn closure as a control group to ensure comparability of results.