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Internal rectal prolapse and rectocele are frequent clinical findings in patients with obstructed defecation syndrome (ODS). However, there is still no evidence whether stapled transanal rectal resection (STARR) provides a safe and effective surgical option. Therefore, the German STARR registry was initiated to assess safety, effectiveness, and quality of life. The German STARR registry was designed as an interventional, prospective, multicenter audit. Primary outcomes include safety (morbidity and adverse events), effectiveness (ODS, symptom severity, and incontinence scores), and quality of life (PAC-QoL and EQ-5D) documented at baseline and at 6 and 12 months. Statistical evaluation was performed by an independent research organization of clinical epidemiology. Complete data of 379 patients (78% females, mean age 57.8 years) were entered into the registry database. Mean operative time was 40 min, mean hospitalization was 5.5 days. A total of 103 complications and adverse events were reported in 80 patients (21.1%) including staple line complications (minor bleeding, infection, or partial dehiscence; 7.1%), major bleeding (2.9%), and postsurgical stenosis (2.1%). Comparisons of ODS and symptom severity scores (SSS) demonstrated a significant reduction in ODS score between baseline (mean 11.14) and 6 months (mean 6.43), which was maintained at 12 months (mean 6.45), and SSS at preoperative and at 6- and 12-month follow-up (13.02 vs. 7.34 vs. 6.59; paired t test, p < 0.001). Significant reduction in ODS symptoms was matched by an improvement in quality of life as judged by symptom-specific PAC-QoL and generic ED-5Q (utility and visual analog scale) scores and was not associated with an impairment of incontinence score following STARR ( p > 0.05). However, 11 patients (2.9%) showed de novo incontinence, and new-onset symptoms of fecal urgency were observed in 25.3% of patients. These data indicate that STARR is a safe and effective procedure. However, conclusions are limited due to the selection and reporting bias of a registry. The problem of fecal urgency needs cautious reassessment. [ABSTRACT FROM AUTHOR]

The efficacy and feasibility of laparoscopic resection for rectal cancer has been proved, but the results of prospective, randomized studies are not yet available. Here we present a prospective observational study evaluating oncological and clinical outcome after laparoscopic surgery in patients with rectal cancer. Between January 1998 and March 2005, 225 patients with rectal adenocarcinoma underwent laparoscopic surgery at the University of Regensburg Medical Center. Clinical and oncological outcome of these patients including perioperative and long-term complications was evaluated. Survival curves were calculated according to the Kaplan–Meier method. Minimum follow-up was 24 months. The distribution of the International Union against Cancer (UICC) stages was: 37.7% stage I, 20.5% stage II, 24.9% stage III, and 16.9% stage IV. Local recurrence was diagnosed in 5.8% and distant metastases in 8.1% of cases after mean follow-up of 36.4 months. The 5-year overall survival rate was 75.7% after curative and 40.7% after palliative surgery ( p < 0.05). The stage-related survival rates were 86.7% for UICC stage I, 61.7% for stage II, 68.1% for stage III, and 40.1% for stage IV. Our results demonstrate the efficacy and technical feasibility of laparoscopic surgery for rectal cancer regarding the perioperative morbidity and the oncological outcome. [ABSTRACT FROM AUTHOR]

Local surgical procedures in the presence of Crohn’s disease have a markedly reduced success rate, especially in the treatment of recurrent anovaginal and distant rectovaginal fistulas. In these patients, local surgery (e.g., flap closure) has unsatisfactory results if the anal canal is destroyed by ulceration and indurations or in patients with extensive defects of the perineum. Over a period of 6 years (2000 to 2006), 12 patients with recurrent rectovaginal fistulas were treated with graciloplasty. The age of the female patients ranged from 24 to 47 years, the mean age being 38 years. The presence of Crohn’s disease in all patients had a mean duration of 12 years. Corticosteroids, mesalazin, or azathioprin were administered preoperatively. All patients were diverted by a temporary ileostomy before graciloplasty. Rectovaginal fistula was closed in 11 of 12 patients after graciloplasty with a mean follow-up of 3.4 years. One rerecurrence of a rectovaginal fistula was documented. One of 12 ileostomies was not closed due to persistence of the fistula tract. One patient had a pouch-anal and, additionally, a pouch-vaginal fistula. In this patient, the first transposition of the gracilis muscle was unsuccessful. After a few months, she underwent renewed graciloplasty. There was no recurrence of a fistula within the follow-up period. Reconstruction of the perineum constituted an additional positive effect of the graciloplasty. In one patient, the preexisting fecal incontinence persisted, even after secondary implantation of a pacemaker. Due to diarrhea and persistent fecal incontinence, the patient opted for a renewed ileostomy. In our series, gracilis transposition in the treatment of recurrent anovaginal and rectovaginal fistulas in patients with Crohn’s disease has excellent short-term results. In addition, graciloplasty can reconstruct the perineal defect. [ABSTRACT FROM AUTHOR]

Background: Creeping fat represents a characteristic feature of Crohn’s disease (CD) and adipose tissue is currently being recognized as a complex compartment secreting highly active molecules. Pro- or anti-inflammatory adipose tissue-derived secretory products (adipocytokines) might play a role in the pathogenesis of CD. Methods: Adipose tissue specimens were obtained from creeping fat contiguous to the involved intestine of 10 patients with CD. Mesenteric adipose tissue specimens resected in 13 patients with colon cancer (CC) and in seven patients with diverticulitis (DIV) served as controls. Three fat tissue specimens per well and n = 6–8 wells per patient were incubated ex vivo for 24 h. The release of regulated on activation, T-cell expressed and secreted (RANTES) and interleukin (IL)-10 into the supernatant was measured by ELISA. Results: Both RANTES and IL-10 secretion could be demonstrated from total adipose tissue explants. The RANTES secretion is increased from creeping fat in CD (3691 ± 597 pg/g fat per 24 h) when compared to mesenteric adipose tissue from patients with CC (1690 ± 191 pg/g fat per 24 h; P < 0.0001) or DIV (1672 ± 336 pg/g fat per 24 h; P < 0.0001). In contrast, IL-10 secretion is downregulated significantly only in patients with DIV (1418 ± 180 pg/g fat per 24 h; P = 0.016) when compared to CC patients (2368 ± 259 pg/g fat per 24 h). Crohn’s disease patients receiving steroids had a higher secretion rate of RANTES and IL-10. Conclusions: Both RANTES and IL-10 secretion can be detected from mesenteric adipose tissue and from creeping fat. The elevated RANTES and IL-10 secretion from creeping fat in CD is not due to a CD-specific effect but caused by steroid treatment. [ABSTRACT FROM AUTHOR]

Background: Creeping fat represents a characteristic feature of Crohn’s disease (CD), and adipose tissue secretes adipocytokines and chemokines/growth factors such as vascular endothelial growth factor (VEGF). Because VEGF serum levels and mucosal VEGF expression is elevated in CD patients, the aim of the present paper was to investigate creeping fat-derived VEGF secretion in CD. Material and Methods: Adipose tissue was obtained from creeping fat of 10 patients with CD. Mesenteric adipose tissue was resected from 13 patients with colon cancer (CC) and from seven patients with diverticulitis (DIV). Three fat tissue specimens per well, and several wells (6–8) per patient were incubated ex vivo for 24 h. The release of VEGF into the supernatant was measured by ELISA. Results: There was stable VEGF secretion from mesenteric adipose tissue of patients with CC or DIV and from creeping fat of patients with CD. Whereas the VEGF secretion rate was not different between patients with CD (465 ± 98 pg/g fat per 24 h) and CC (399 ± 48 pg/g fat per 24 h), VEGF secretion was significantly reduced in patients suffering from DIV (115 ± 41 pg/g fat per 24 h; P < 0.0001 and P = 0.001, respectively). The CD patients treated with steroids had significantly lower VEGF secretion rates (294 ± 42 pg/g fat per 24 h) than CD patients not receiving steroids (607 ± 105 pg/g fat per 24 h; P = 0.001). Conclusions: Creeping fat is an important source of VEGF secretion. The characteristics of the inflammatory changes in CD might be due to the lack of VEGF downregulation that is seen in DIV. [ABSTRACT FROM AUTHOR]

Background: Transanal total mesorectal excision (TaTME), a novel approach for treating low rectal cancer, holds promise. However, concerns exist in certain countries about their oncologic safety due to less-than-optimal outcomes on global studies. This research seeks to evaluate the long-term oncologic outcomes focusing on local recurrence rate and overall survival after TaTME surgery in Germany. Patients and methods: This study analyzed data from patients who underwent elective TaTME surgery between 2014 and 2021 in four certified colorectal cancer centers in Germany. Primary endpoints were 3-year local recurrence rate and local recurrence-free survival (LRFS). Secondary outcomes encompassed overall survival (OS), operative time, completeness of local tumor resection, lymph node resection, and postoperative complications. Results: A total of 378 patients were analyzed (mean age 61.6 years; 272 males, 72%). After a median follow-up period of 2.5 years, 326 patients with UICC-stages I–III and tumor operability included in survival analyses. Local recurrence was observed in 8 individuals, leading to a 3-year cumulative local recurrence rate of 2.2% and a 3-year LRFS rate of 88.1%. The 3-year OS rate stood at 88.9%. Within 30 days after surgery, anastomotic leakage occurred in 19 cases (5%), whereas a presacral abscess was present in 12 patients (3.2%). Conclusion: TaTME proves effective in addressing the anatomical and technical challenges of low rectal surgery and is associated with pleasing short- and long-term results. However, its safe integration into surgical routine necessitates sufficient knowledge and a previously completed training program. [ABSTRACT FROM AUTHOR]

Laparoscopic total mesorectal excision (TME) for rectal cancer has been proved in various studies. The minimal invasive procedure is feasible and safe which was demonstrated in many studies. However, the results of prospective, randomized studies providing valuable evidence are still not available. Compared to conventional surgery, the laparoscopic technique has short-term advantages including less pain, shorter duration of postoperative ileus, less fatigue, better pulmonary function, and less blood loss (Leung et al., Lancet 363:1187–1192, ; Braga et al., Dis Colon Rectum 48:217–223, ; Jayne et al., J Clin Oncol 25:3061–3068, ; Agha et al., Surg Endosc 22:2229–2237, ). The autonomic nerve sparing TME technique is the gold standard in rectal cancer resection even in conventional or laparoscopic procedure. With regard of the oncological dimension, the laparoscopic TME technique is not different compared to the open procedure. However, a standardized laparoscopic step-by-step procedure may simplify the operation and can reduce operation time. There are no studies available which compare different types of TME procedures. Most surgeons start the operation left laterally mobilizing the sigmoid colon first. In the laparoscopic technique, we recommend the medial to lateral approach starting the operation at the right side of the rectum and sigmoid colon. A nerve sparing TME technique can be performed easier, and the identification of the left ureter may be simplified. After multiple workshops and extensive discussion with national and international experts, we developed a standardized laparoscopic “10 step TME procedure.” Reviewing the results of laparoscopic TME the studies do not allow firm conclusions as to the questions of whether the safety and efficacy of laparoscopic TME is equal or superior to open TME (Breukink et al. ). Actually, we are waiting for large prospective randomized studies comparing laparoscopic TME with the traditional open procedure (Bonjer et al., Dan Med Bull 56:89–91, ). Laparoscopic TME appears to have clinically measurable short-term advantages in patients with primary resectable rectal cancer based on evidence mainly from nonrandomized studies (Breukink et al. ). In nearly all published studies, the efficacy and technical feasibility of laparoscopic surgery for rectal cancer could be demonstrated regarding perioperative morbidity and oncological outcome. A standardized laparoscopic TME technique can be strongly recommended. [ABSTRACT FROM AUTHOR]

Background: Certified cancer centers aim to ensure high-quality care by establishing structural and procedural standards according to evidence-based guidelines. Despite the high clinical and health policy relevance, evidence from a nation-wide study for the effectiveness of care for colorectal cancer in certified centers vs. other hospitals in Germany is still missing. Methods: In a retrospective cohort study covering the years 2009–2017, we analyzed patient data using demographic information, diagnoses, and treatments from a nationwide statutory health insurance enriched with information on certification. We investigated whether patients with incident colon or rectal cancer did benefit from primary therapy in a certified cancer center. We used relative survival analysis taking into account mortality data of the German population and adjustment for patient and hospital characteristics via Cox regression with shared frailty for patients in hospitals with and without certification. Results: The cohorts for colon and rectal cancer consisted of 109,518 and 51,417 patients, respectively, treated in a total of 1052 hospitals. 37.2% of patients with colon and 42.9% of patients with rectal cancer were treated in a certified center. Patient age, sex, comorbidities, secondary malignoma, and distant metastases were similar across groups (certified/non-certified) for both colon and rectal cancer. Relative survival analysis showed significantly better survival of patients treated in a certified center, with 68.3% (non-certified hospitals 65.8%) 5-year survival for treatment of colon cancer in certified (p < 0.001) and 65.0% (58.8%) 5-year survival in case of rectal cancer (p < 0.001), respectively. Cox regression with adjustment for relevant covariates yielded a lower hazard of death for patients treated in certified centers for both colon (HR = 0.92, 95% CI = 0.89–0.95) and rectal cancer (HR = 0.92, 95% CI = 0.88–0.95). The results remained robust in a series of sensitivity analyses. Conclusions: This large cohort study yields new important evidence that patients with colorectal cancer have a better chance of survival if treated in a certified cancer center. Certification thus provides one powerful means to improve the quality of care for colorectal cancer. To decrease the burden of disease, more patients should thus receive cancer care in a certified center. [ABSTRACT FROM AUTHOR]

The benefit of adjuvant chemotherapy in Union for International Cancer Control (UICC) stage III colon cancer has been demonstrated in numerous studies. While adjuvant chemotherapy is generally not recommended in stage II patients, its role in high-risk UICC stage II disease (e.g. T4 tumours) remains controversial. The present population-based multicenter cohort study investigated the influence of adjuvant chemotherapy on survival and recurrence rates in high-risk UICC stage II T4N0M0 tumours. Based on an anonymised nationwide ADT data set from 31 clinical cancer registries, we identified a total of 6651 patients with a T4 tumour of the colon, of whom 6131 were eligible for survival analysis. A matched-pair analysis based on propensity scores (PSM) was performed with a subset of 3986 patients. Multivariable analyses demonstrated a significant benefit of adjuvant chemotherapy for overall survival (OS) (hazard ratio [HR]: 0.711, 95% confidence interval [CI]: 0.643–0.785, p < 0.001), cumulative recurrence rate (HR: 0.780, 95% CI: 0.681–0.893, p < 0.001), and recurrence-free survival (HR: 0.715, 95% CI: 0.652–0.785, p < 0.001) further confirmed by the matched-pair cohort. This large and representative study demonstrated a significant advantage of adjuvant chemotherapy for patients with T4 UICC stage II colon cancer in terms of OS, recurrence rate, and relapse-free survival. Based on these results, adjuvant chemotherapy should be recommended for these patients. • What is already known about this subject? ·Adjuvant chemotherapy is generally not recommended in stage II patients. Administration of adjuvant chemotherapy in high-risk UICC stage II disease (e.g., T4 tumors) remains controversial. Robust data supporting adjuvant chemotherapy in high-risk UICC stage II disease (e.g., T4 tumors) are lacking. • What are the new findings? We demonstrated a markedly prolonged overall survival in subjects who received adjuvant chemotherapy. We demonstrated a highly significant improvement in relapse-free survival achieved by adjuvant chemotherapy. Our analysis was performed on large registry data. • How might it impact on clinical practice in the foreseeable future? Our findings will change current clinical practice, because based on our results, adjuvant chemotherapy should generally be recommended for T4 UICC stage II colon cancer patients. [ABSTRACT FROM AUTHOR]

Simple Summary: Certification in oncology aims to establish structural and procedural standards according to evidence-based guidelines. The WiZen study is the largest study so far to analyze the effect of the certification of designated cancer centers on survival in Germany. Based on clinical cancer registry data of 47.440 colorectal cancer patients treated between 2009 and 2017, the present study shows that treatment at colorectal cancer centers has been associated with significantly better outcomes. Patients treated at certified facilities had an eleven percent (colon)/nine percent (rectum) lower risk of dying within the first five years after diagnosis. These findings support the shift towards a more structured cancer care system. (1) Background: The WiZen study is the largest study so far to analyze the effect of the certification of designated cancer centers on survival in Germany. This certification program is provided by the German Cancer Society (GCS) and represents one of the largest oncologic certification programs worldwide. Currently, about 50% of colorectal cancer patients in Germany are treated in certified centers. (2) Methods: All analyses are based on population-based clinical cancer registry data of 47.440 colorectal cancer (ICD-10-GM C18/C20) patients treated between 2009 and 2017. The primary outcome was 5-year overall survival (OAS) after treatment at certified cancer centers compared to treatment at other hospitals; the secondary endpoint was recurrence-free survival. Statistical methods included Kaplan–Meier analysis and multivariable Cox regression. (3) Results: Treatment at certified hospitals was associated with significant advantages concerning 5-year overall survival (HR 0.92, 95% CI 0.89, 0.96, adjusted for a broad range of confounders) for colon cancer patients. Concentrating on UICC stage I–III patients, for whom curative treatment is possible, the survival benefit was even larger (colon cancer: HR 0.89, 95% CI 0.84, 0.94; rectum cancer: HR 0.91, 95% CI 0.84, 0.97). (4) Conclusions: These results encourage future efforts for further implementation of the certification program. Patients with colorectal cancer should preferably be directed to certified centers. [ABSTRACT FROM AUTHOR]

Simple Summary: Colorectal cancer (CRC) is mainly treated by surgical resection. However, surgery induces a state of immunosuppression and leads to attenuation of the cellular immunity that is so vital for successful defense against infections and malignant cells. Because this immunosuppression depends on the extent of the surgical trauma, it is hypothesized that minimally invasive surgical approaches such as laparoscopy have beneficial effects for cellular immunity, leading to fewer infectious complications as well as lower rates of locoregional recurrence and distant metastasis. Better short- and long-term oncologic outcomes are reported by clinical trials, and immunologic mechanisms might substantially contribute to these observations. Herein, the authors systematically compare minimally invasive laparoscopic surgery with open surgery in terms of their respective influences on certain aspects of cellular immunity. Colorectal cancer (CRC) is the third most common cancer worldwide. The main treatment options are laparoscopic (LS) and open surgery (OS), which might differ in their impact on the cellular immunity so indispensable for anti-infectious and antitumor defense. MEDLINE, Embase, Web of Science (SCI-EXPANDED), the Cochrane Library, Google Scholar, ClinicalTrials.gov, and ICTRP (WHO) were systematically searched for randomized controlled trials (RCTs) comparing cellular immunity in CRC patients of any stage between minimally invasive and open surgical resections. A random effects-weighted inverse variance meta-analysis was performed for cell counts of natural killer (NK) cells, white blood cells (WBCs), lymphocytes, CD4+ T cells, and the CD4+/CD8+ ratio. The RoB2 tool was used to assess the risk of bias. The meta-analysis was prospectively registered in PROSPERO (CRD42021264324). A total of 14 trials including 974 participants were assessed. The LS groups showed more favorable outcomes in eight trials, with lower inflammation and less immunosuppression as indicated by higher innate and adaptive cell counts, higher NK cell activity, and higher HLA-DR expression rates compared to OS, with only one study reporting lower WBCs after OS. The meta-analysis yielded significantly higher NK cell counts at postoperative day (POD)4 (weighted mean difference (WMD) 30.80 cells/µL [19.68; 41.92], p < 0.00001) and POD6–8 (WMD 45.08 cells/µL [35.95; 54.21], p < 0.00001). Although further research is required, LS is possibly associated with less suppression of cellular immunity and lower inflammation, indicating better preservation of cellular immunity. [ABSTRACT FROM AUTHOR]

Background: The long-term outcomes after laparoscopic surgery for colon cancer remain debatable, as randomized trials have reported similar outcomes for open and laparoscopic surgery but population-based data are scarce. Thus, it is unclear whether, outside of clinical trials, laparoscopic surgery that is performed as a standard clinical treatment has detrimental effects on patients' long-term survival.Methods: This study examined a unified database of 30 German regional cancer registries for patients with colorectal cancer who were diagnosed between 2003 and 2011. Among 216,682 patients with colorectal carcinoma, we identified 37,068 patients with Union for International Cancer Control stage I-III colon carcinoma (>12 cm from the anal verge), including 3825 patients (10.38 %) who underwent laparoscopic surgery. Multivariate Cox regression analyses were also used to evaluate factors that influenced the likelihood of a patient undergoing laparoscopic surgery. Kaplan-Meier analysis with the log-rank test was used to analyse differences in short- and long-term survival outcomes after open or laparoscopic surgery.Results: Younger age, lower T-stage, and left-sided surgery were independent predictors of the patient undergoing laparoscopic surgery (all, p < 0001). The 30-day mortality rate was significantly lower for patients who underwent laparoscopic surgery for left-sided tumours (odds ratio [OR] 0.49; 95 % confidence interval [CI] 0.33-0.77). Compared to open surgery, laparoscopic surgery was a significant and independent predictor of prolonged long-term survival for right- and left-sided surgeries (right-side, OR 0.67; 95 % CI 0.56-0.82; left-sided, OR 0.70; 95 % CI 0.62-0.78).Conclusion: Our results indicate that laparoscopic surgery provides favourable outcomes even when used outside controlled trials and should be considered as a standard treatment for patients with colon cancer. [ABSTRACT FROM AUTHOR]

Background: Since 2010, laparoscopic transanal total mesorectal excision (TaTME) has been increasingly used for low and very low rectal cancer. It is supposed to improve visibility and access to the dissection planes in the pelvis. This study reports on short- and long-term outcomes of the first 100 consecutive patients treated with TaTME in a certified German colorectal cancer center. Patients and methods: Data were derived from digital patient files and official cancer registry reports for patients with TaTME tumor surgery between July 2014 and January 2020. The primary outcome was the 3-year local recurrence rate and local recurrence-free survival (LRFS). Secondary endpoints included overall survival (OAS), disease-free survival (DFS), operation time, completeness of local tumor resection, lymph node resection, and postoperative complications. The Kaplan–Meier method was employed for the survival analyses; competing risks were considered in the time-to-event analysis. Results: During the observation period, the average annual operation time decreased from 272 to 178 min. Complete local tumor resection was achieved in 97% of the procedures. Major postoperative complications (Clavien–Dindo 3–4) occurred in 11% of the cases. At a median follow-up time of 2.7 years, three patients had suffered from a local recurrence. Considering competing risks, this corresponds to a 3-year cumulative incidence rate for local recurrence of 2.2% and a 3-year LRFS of 81.9%. 3-year OAS was 82.9%, and 3-year DFS was 75.7%. Conclusion: TaTME is associated with favorable short and long-term outcomes. Since it is technically demanding, structured training programs and more research on the topic are indispensable. [ABSTRACT FROM AUTHOR]

Endometriosis is a frequent benign disease of women in reproductive age. An infiltration of the spatium rectovaginal is rare, but if it occurs, in up to 73% the rectum is involved. If there is the indication for surgery, a partial resection of the rectum might be necessary. This can be performed by a laparoscopic approach. It is the aim of this work to describe a patient population treated for endometriosis in the spatium rectovaginal by laparoscopic surgery. A retrospective analysis of data from patients with endometriosis in rectum or sigma, which underwent a laparoscopic partial bowel resection in the years 2005–2006 at the Department of Obstetrics and Gynecology, University of Regensburg, was carried out. Between 2005 and 2006, we performed a laparoscopic partial bowel resection in six patients with endometriosis. The mean age at diagnosis was 36.1 years (range 28–50 years) and 36.5 years (range 30–50 years) at surgery. All patients were nulligravida and 50% of the patients were infertile (since 1–6 years). The interval between the onset of symptoms and surgery ranged from a few weeks up to 2.5 years. Two-thirds of the patients had endocrine treatment before surgery. Three patients had a rectum resection, one a sigma resection and two had a combined rectum- and sigma resection. The mean duration of surgery was 201 min and mean hospital stay was 8 days. We saw one post-surgery bleeding at the enteroanastomosis. In that case two erythrocyte concentrates were necessary and the bleeding was stopped by rectoscopic intervention. All follow-up coloscopies were without pathological findings. One patient had a normal delivery after IVF/ICSI treatment. If severe endometriosis needs a rectum resection then it can be done laparoscopically. This surgery should be performed in a specialized center. The duration of surgery, hospital stay and time of convalescence are short. [ABSTRACT FROM AUTHOR]

The implementation of quality of life (QoL) concepts in routine care, is still an open matter. We followed the Medical Research Council framework for complex interventions to implement a model of QoL diagnosis and therapeutic options, and investigated its effectiveness in patients with colorectal cancer. This randomised, single-blind, multicentre, clinical trial enrolled patients diagnosed with primary colorectal cancer aged 18 years or older who were surgically treated in one of four recruiting hospitals in Germany. All patients received aftercare from one of 178 coordinating practitioners (CPs) who had access to 75 healthcare professionals providing tailored therapies. QoL was measured (EORTC QLQ-C30, QLQ-CR29) in all patients after surgery (baseline) and during aftercare (3, 6, 12, 18 months). Patients were randomised (1:1) into two groups: a care pathway, including QoL-profiles consisting of 13 QoL scales plus specific therapeutic recommendations forwarded to the patient's CP or standard postoperative care adhering to the German national guideline for colorectal cancer (control). The primary endpoint was the proportion of patients in each group with a need for QoL therapy 12 months after surgery. Analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov , number NCT02321813 and closed to accrual. Between Jan 13, 2014, and Oct 28, 2015, 220 patients were enrolled and randomly assigned (n = 110 per group). At baseline (in hospital after surgery), a need for QoL therapy was diagnosed in 92/103 (89%) of intervention and 86/104 (83%) of control group patients. At 12 months (primary endpoint) the proportion of patients with a need for QoL therapy was 35/83 (42%; 95% CI 31–54%) in the intervention group versus 50/87 (57%; 95% CI: 46–68%) in the control group (p = 0·046, number needed to treat = 7; 95% CI 3–225). Patients profited from the diagnosis of QoL deficits and tailored therapeutic options in their treatment of colorectal cancer. This trial confirmed the results of a previous RCT in breast cancer patients. The implementation of QoL concepts should become standard in treatment guidelines on cancer care. Federal Ministry of Education and Research (BMBF; grant no. 01GY1339). NCT02321813. • Quality of life (QoL) may be seriously impaired in patients with colorectal cancer. • A clinical pathway with QoL diagnosis and QoL-oriented therapy was developed. • QoL diagnosis and therapy resulted in improved QoL at 12 months after surgery. • Results are compatible with a randomised trial enrolling breast cancer patients. [ABSTRACT FROM AUTHOR]

Background: Rectal cancer is frequent in Germany and worldwide. Several studies have assessed laparoscopic surgery as a treatment option and most have shown favorable results. However, long-term oncologic safety remains a controversial issue.Methods: The current dataset derives from 30 clinical cancer registries in Germany and includes 16,378 patients diagnosed with rectal cancer between 2007 and 2016. Outcomes were 90-day mortality, overall survival (OS), local recurrence-free survival (RFS) and relative survival of patients treated with either open or laparoscopic surgery. Multivariable logistic regression was used to evaluate factors that affected the probability of a patient undergoing laparoscopic surgery as well as to evaluate short-term mortality. OS and RFS were analyzed by Kaplan-Meier plots and multivariable Cox regression conducted separately for UICC stages I-III, tumor location, and sex as well as by propensity score matching followed by univariable and multivariable survival analysis.Results: Of 16,378 patients, 4540 (27.7%) underwent laparoscopic surgery, a trend which increased during the observation period. Patients undergoing laparoscopy attained better results for 90-day mortality (odds ratio, OR 0.658, 95% confidence interval, CI 0.526-0.822). The 5-year OS rate in the laparoscopic group was 82.6%, vs. 76.6% in the open surgery group, with a hazard ratio (HR) of 0.819 in multivariable Cox regression (95% CI 0.747-0.899, p < 0.001). The laparoscopic group showed a better 5-year RFS, with 81.8 vs. 74.3% and HR 0.770 (95% CI 0.705-0.842, p < 0.001). The 5-year relative survival rates were also in favor of laparoscopy, with 93.1 vs. 88.4% (p = 0.012).Conclusion: Laparoscopic surgery for rectal cancer can be performed safely and, according to this study, is associated with an oncological outcome superior to that of the open procedure. Therefore, in the absence of individual contraindications, it should be considered as a standard approach. [ABSTRACT FROM AUTHOR]

Introduction: Rectal cancer is a frequently diagnosed tumor worldwide. Various studies have shown the noninferiority or even slight superiority of laparoscopic resection. However, there is no clear recommendation on whether age should influence the choice of surgical approach. Materials and methods: This study compared outcomes of laparoscopic and open surgery in rectal cancer patients. Perioperative mortality and 5-year overall, relative, and recurrence-free survival rates were analyzed separately for three age groups. Data originate from 30 regional German cancer registries that cover approximately one quarter of the German population. All primary nonmetastatic rectal adenocarcinoma cases with surgery between 2005 and 2014 were eligible for inclusion. To compare survival rates, Kaplan–Meier analysis, a relative survival model, and multivariable Cox regression were used; a sensitivity analysis assessed bias by exclusion. Results: Ten thousand seven hundred fifty-four patients were included in the analysis. The mean laparoscopy rate was 23.0% and increased over time. Analysis of 30-day postoperative mortality rates revealed advantages for laparoscopically treated patients, although the significance level was not reached in any age group. Regarding 5-year overall survival, laparoscopy generally seems to be the superior approach, whereas for recurrence-free survival, an age-dependent gradient in effect size was observed: with a hazard ratio (HR) of 0.703 for laparoscopy, patients under 60 years benefitted more from the minimally invasive approach than older patients (septuagenarians, HR 0.923). Conclusion: Laparoscopy shows similar results to the open approach in terms of postoperative survival in all age groups. Concerning long-term outcomes, younger patients benefitted most from the minimally invasive approach. [ABSTRACT FROM AUTHOR]

Background: Over 20 years after the introduction of laparoscopic surgery for colon cancer, many surgeons still prefer the open approach. Whereas randomized controlled trials (RCTs) have proven the oncologic safety of laparoscopy, long-term data depicting daily clinical routine are scarce.Methods: This population-based cohort study compares 5-year overall, relative, and recurrence-free survival rates after laparoscopic and open colon carcinoma surgery. Data derive from an independent German cancer registry encompassing all tumor patients within a political district of 1.1 million inhabitants. The final analysis included 2669 patients with major elective resection of primary non-metastatic colonic adenocarcinoma between January 1, 2004 and December 31, 2013. Survival rates were compared using Kaplan-Meier analyses, relative survival models, and multivariate Cox regression. Sensitivity analysis quantified selection bias.Results: The proportion of laparoscopic procedures increased from 9.7 to 25.8% in 2011 and dropped again to 15.8% at the end of observation period. Laparoscopy patients were younger, had a lower tumor stage, and were more likely to receive postoperative chemotherapy. Overall, relative, and recurrence-free survival was significantly superior or equivalent in Kaplan-Meier analysis (5-year overall survival rate open vs. laparoscopic: 69.0 vs. 80.2%, p < 0.001). The superiority of laparoscopy mostly remained stable after adjusting for confounders, although significance was only reached in T1-3 patients without lymph node metastases (overall survival: hazard ratio (HR) 0.654; 95% confidence interval (CI) 0.446-0.958; p = 0.029).Conclusion: Laparoscopy is a safe and promising alternative to the open approach in daily clinic practice. These favorable outcomes require future confirmation by high-quality studies outside the setting of RTCs. [ABSTRACT FROM AUTHOR]

Background: An increasing number of rectal carcinoma resections in Germany and worldwide are performed laparoscopically. The recently published COLOR II trial demonstrated the oncologic safety of this surgical approach. It remains unclear whether these findings can be transferred to clinical practice.Patients and Methods: This population-based retrospective cohort study aimed to evaluate 5-year overall, relative, disease-free, and local recurrence-free survival of rectal cancer patients treated by open surgery and laparoscopy. Data from a southern German region of 1.1 million inhabitants were collected by an official clinical cancer registry. All primary non-metastatic rectal adenocarcinoma cases with surgery between 2004 and 2013 were eligible for inclusion. To compare survival rates, Kaplan-Meier analyses, relative survival models, and multivariate Cox regression were applied; a sensitivity analysis assessed bias by exclusion.Results: Finally, 1507 patients with a median follow-up time of 7.1 years were included. Of these patients, 28.4% underwent laparoscopic procedures, with an increasing rate over time. Patients with tumors of the upper or middle rectum, younger patients, and patients of specialized colorectal cancer centers were more likely to undergo laparoscopy. After 5 years, 80.4% of laparoscopy patients were still alive, compared to 68.6% in the open group (p < 0.001). Moreover, laparoscopy was associated with superior local recurrence-free survival rates. This advantage was also significant in multivariate analysis (HR 0.70, 95% CI 0.52-0.92).Conclusion: Laparoscopic rectal cancer surgery can be considered safe in daily clinical practice. This should be confirmed by future studies outside the setting of randomized trials. [ABSTRACT FROM AUTHOR]

Background: Laparoscopic surgery offers patients with rectal cancer short-term benefits and similar survival rates as open surgery. However, selecting patients who are suitable candidates for laparoscopic surgery is essential to prevent intra-operative conversion from laparoscopic to open surgery. Clinical and pathological variables were studied among patients who had converted laparoscopic surgeries within the COLOR II trial to improve patient selection for laparoscopic rectal cancer surgery.Methods: Between January 20, 2004, and May 4, 2010, 1044 patients with rectal cancer enrolled in the COLOR II trial and were randomized to either laparoscopic or open surgery. Of 693 patients who had laparoscopic surgery, 114 (16 %) were converted to open surgery. Predictive factors were studied using multivariate analyses, and morbidity and mortality rates were determined.Results: Factors correlating with conversion were as follows: age above 65 years (OR 1.9; 95 % CI 1.2-3.0: p = 0.003), BMI greater than 25 (OR 2.7; 95 % CI 1.7-4.3: p < 0.001), and tumor location more than 5 cm from the anal verge (OR 0.5; CI 0.3-0.9). Gender was not significantly related to conversion (p = 0.14). In the converted group, blood loss was greater (p < 0.001) and operating time was longer (p = 0.028) compared with the non-converted laparoscopies. Hospital stay did not differ (p = 0.06). Converted procedures were followed by more postoperative complications compared with laparoscopic or open surgery (p = 0.041 and p = 0.042, respectively). Mortality was similar in the laparoscopic and converted groups.Conclusions: Age above 65 years, BMI greater than 25, and tumor location between 5 and 15 cm from the anal verge were risk factors for conversion of laparoscopic to open surgery in patients with rectal cancer. [ABSTRACT FROM AUTHOR]

Background: The incidence of anal abscess and fistula is relatively high, and the condition is most common in young men. Methods: This is a revised version of the German S3 guidelines first published in 2011. It is based on a systematic review of pertinent literature. Results: Cryptoglandular abscesses and fistulas usually originate in the proctodeal glands of the intersphincteric space. Classification depends on their relation to the anal sphincter. Patient history and clinical examination are diagnostically sufficient in order to establish the indication for surgery. Further examinations (endosonography, MRI) should be considered in complex abscesses or fistulas. The goal of surgery for an abscess is thorough drainage of the focus of infection while preserving the sphincter muscles. The risk of abscess recurrence or secondary fistula formation is low overall. However, they may result from insufficient drainage. Primary fistulotomy should only be performed in case of superficial fistulas. Moreover, it should be done by experienced surgeons. In case of unclear findings or high fistulas, repair should take place in a second procedure. Anal fistulas can be treated only by surgical intervention with one of the following operations: laying open, seton drainage, plastic surgical reconstruction with suturing of the sphincter (flap, sphincter repair, LIFT), and occlusion with biomaterials. Only superficial fistulas should be laid open. The risk of postoperative incontinence is directly related to the thickness of the sphincter muscle that is divided. All high anal fistulas should be treated with a sphincter-saving procedure. The various plastic surgical reconstructive procedures all yield roughly the same results. Occlusion with biomaterial results in lower cure rate. Conclusion: In this revision of the German S3 guidelines, instructions for diagnosis and treatment of anal abscess and fistula are described based on a review of current literature. [ABSTRACT FROM AUTHOR]

Background: Recent studies demonstrated favorable short- and mid-term results after laparoscopic surgery for rectal cancer. However, long-term results from large series are lacking. The present study analyses long-term results of laparoscopic rectal cancer surgery from a large-volume center. Methods: From January 1998 until March 2005, 225 patients underwent laparoscopic rectal resection due to carcinoma at the Medical Centre of the University of Regensburg. From 224 patients, a follow-up over 10 years was performed using the data of the Tumour Centre of the University of Regensburg. The data were analysed using oncological data (tumour recurrence) as well as overall survival. In addition, the effect of conversion to open resection on overall survival was analysed. Results: With a median of 10 years at follow-up, the overall and disease-free survival was 50.5 and 50.1 %, respectively. Local recurrence of all patients was 5.8 % and none of the converted patients was within this group. The median time interval for the development of local recurrence was 30 months. Six of the 13 patients with local recurrence (46.1 %) had received neoadjuvant radiochemotherapy before surgery. Patients with a conversion to open surgery had primarily a significantly worse outcome than patients resected completely laparoscopically ( p = 0.003). However, this difference was no longer apparent using a multivariant analysis (hazard ratio 1.221; p = 0.478). Conclusions: Overall survival and local recurrence rate of patients undergoing laparoscopic resection of rectal cancer are comparable to open surgery. However, in our analysis, patients undergoing laparoscopic anterior resection had a higher survival rate compared with patients with abdominoperineal resection. [ABSTRACT FROM AUTHOR]

Background: This study aimed to evaluate the implementation of a joystick-controlled camera holder (Soloassist; Actormed, Barbing, Germany) in laparoscopic cholecystectomy as so-called solo-surgery compared with the standard operation. Methods: Of the 123 patients included in this study, 63 underwent laparoscopic cholecystectomy using the Soloassist system and were compared with 60 patients who underwent laparoscopic cholecystectomy with human assistance. The two groups did not differ significantly in terms of age, sex, body mass index, or American Society of Anesthesiology classification. The surgeons were divided into those highly experienced and those experienced with the new camera holder. The operation times were measured, including setup and dismantling of the system. The assessment also included complications, postoperative hospital stay, measurement of human resources in terms of personnel/minutes/operation, and subjective evaluation of the camera-guiding device by the surgeons. Results: The hospital stay and operation-related complications were not enhanced in the Soloassist group. The differences in core operation time ( p = 0.008) and total operating time ( p = 0.001) significantly favored the human assistant. Whereas the absolute duration of surgery was longer, the relative operating time (in personnel/minutes/operation) was significantly shorter ( p < 0.001). In 4.8 % of the cases, the operation could not be performed completely with the camera-holding device. Clinically relevant postoperative complications did not occur. The experience of the surgeons did not differ significantly. The subjective evaluation regarding handling, image quality, effort, and satisfaction demonstrated high acceptance of the Soloassist system. Conclusions: The camera-guiding device can be implemented without increased complications. The Soloassist system is safe and can be operated even by colleagues without system experience. All the surgeons rated their satisfaction with the system as very good to excellent. Although the operating times were longer than with the standard camera guidance, the absolute overall staff time was reduced. [ABSTRACT FROM AUTHOR]

Summary: Background: Laparoscopic surgery as an alternative to open surgery in patients with rectal cancer has not yet been shown to be oncologically safe. The aim in the COlorectal cancer Laparoscopic or Open Resection (COLOR II) trial was to compare laparoscopic and open surgery in patients with rectal cancer. Methods: A non-inferiority phase 3 trial was undertaken at 30 centres and hospitals in eight countries. Patients (aged ≥18 years) with rectal cancer within 15 cm from the anal verge without evidence of distant metastases were randomly assigned to either laparoscopic or open surgery in a 2:1 ratio, stratified by centre, location of tumour, and preoperative radiotherapy. The study was not masked. Secondary (short-term) outcomes—including operative findings, complications, mortality, and results at pathological examination—are reported here. Analysis was by modified intention to treat, excluding those patients with post-randomisation exclusion criteria and for whom data were not available. This study is registered with ClinicalTrials.gov, number NCT00297791. Findings: The study was undertaken between Jan 20, 2004, and May 4, 2010. 1103 patients were randomly assigned to the laparoscopic (n=739) and open surgery groups (n=364), and 1044 were eligible for analyses (699 and 345, respectively). Patients in the laparoscopic surgery group lost less blood than did those in the open surgery group (median 200 mL [IQR 100–400] vs 400 mL [200–700], p<0·0001); however, laparoscopic procedures took longer (240 min [184–300] vs 188 min [150–240]; p<0·0001). In the laparoscopic surgery group, bowel function returned sooner (2·0 days [1·0–3·0] vs 3·0 days [2·0–4·0]; p<0·0001) and hospital stay was shorter (8·0 days [6·0–13·0] vs 9·0 days [7·0–14·0]; p=0·036). Macroscopically, completeness of the resection was not different between groups (589 [88%] of 666 vs 303 [92%] of 331; p=0·250). Positive circumferential resection margin (<2 mm) was noted in 56 (10%) of 588 patients in the laparoscopic surgery group and 30 (10%) of 300 in the open surgery group (p=0·850). Median tumour distance to distal resection margin did not differ significantly between the groups (3·0 cm [IQR 2·0–4·8] vs 3·0 cm [1·8–5·0], respectively; p=0·676). In the laparoscopic and open surgery groups, morbidity (278 [40%] of 697 vs 128 [37%] of 345, respectively; p=0·424) and mortality (eight [1%] of 699 vs six [2%] of 345, respectively; p=0·409) within 28 days after surgery were similar. Interpretation: In selected patients with rectal cancer treated by skilled surgeons, laparoscopic surgery resulted in similar safety, resection margins, and completeness of resection to that of open surgery, and recovery was improved after laparoscopic surgery. Results for the primary endpoint—locoregional recurrence—are expected by the end of 2013. Funding: Ethicon Endo-Surgery Europe, Swedish Cancer Foundation, West Gothia Region, Sahlgrenska University Hospital. [Copyright &y& Elsevier]

Background: The incidence of anal abscess is relatively high, and the condition is most common in young men. Methods: A systematic review of the literature was undertaken. Results: This abscess usually originates in the proctodeal glands of the intersphincteric space. A distinction is made between subanodermal, intersphincteric, ischioanal, and supralevator abscesses. The patient history and clinical examination are diagnostically sufficient to establish the indication for surgery. Further examinations (endosonography, MRI) should be considered in recurrent abscesses or supralevator abscesses. The timing of the surgical intervention is primarily determined by the patient's symptoms, and acute abscess is generally an indication for emergency treatment. Anal abscesses are treated surgically. The type of access (transrectal or perianal) depends on the abscess location. The goal of surgery is thorough drainage of the focus of infection while preserving the sphincter muscles. The wound should be rinsed regularly (using tap water). The use of local antiseptics is associated with a risk of cytotoxicity. Antibiotic treatment is only necessary in exceptional cases. Intraoperative fistula exploration should be conducted with extreme care if at all; no requirement to detect fistula should be imposed. The risk of abscess recurrence or secondary fistula formation is low overall, but they can result from insufficient drainage. Primary fistulotomy should only be performed in case of superficial fistulas and by experienced surgeons. In case of unclear findings or high fistulas, repair should take place in a second procedure. Conclusion: In this clinical S3 guideline, instructions for diagnosis and treatment of anal abscess are described for the first time in Germany. [ABSTRACT FROM AUTHOR]

Introduction: Lynch syndrome as the most common hereditary colorectal cancer syndrome and the most common cause of hereditary endometrial cancer is characterized by an autosomal dominant inheritance with a penetrance of 85-90%. The molecular genetic underlying mechanism is a mutation in one of the mismatch repair genes. Methods: In order to identify patients with Lynch syndrome, a nuclear family history should be ascertained and matched with the Amsterdam criteria. A different approach for identification is the adherence to Bethesda criteria and subsequent testing for microsatellite instability. In patients with unstable tumors as an indicator for mismatch repair deficiency, genetic counseling and mutation analysis are warranted. For families fulfilling the Amsterdam criteria, intensified screening is recommended, even if a pathogenic mutation is not identified. Results: Individuals from families with a proven pathogenic mutation that are tested negative are at normal population risk for cancers and may be dismissed from intensified surveillance. Prophylactic surgery in high-risk individuals without neoplasia is not generally recommended. At the time of a colon primary, however, extended surgery should be discussed in the light of a high rate of metachronous cancers. The worries of impairing functional results have now been evaluated in the light of quality of life in a large international cohort. Interestingly, extended (prophylactic) surgery does not lead to inferior quality of life with equal perioperative risks. Conclusions: Therefore, taking the risk reduction into account, extended surgery at the time of the first colon primary should at least be discussed, if not recommended. Also, prophylactic hysterectomy and bilateral oophorectomy at the time of a colorectal primary should be recommended if family planning has been completed. [ABSTRACT FROM AUTHOR]

Background and Aim: Severe acute pancreatitis is characterized by lipase-induced peripancreatic fat cell necrosis. Because adipocytes secret several highly active molecules, the aim of the present study was to investigate the hypothesis that adipocytokines could serve as potential markers predicting peripancreatic necrosis and severity in acute pancreatitis. Methods: A total of 23 patients (11 females, 12 males) with acute pancreatitis were included and a computed tomography (CT) examination was available in 20 patients. Balthazar score, Schröder score, pancreatic necrosis score, Ranson score and APACHE II score were calculated, correlated with biochemical parameters and analyzed using receiver-operator characteristics (ROC) analysis. Adipocytokine serum levels were measured daily by enzyme-linked immunosorbent assay (ELISA) over 10 days after admission. Results: Resistin and leptin were significantly elevated in patients with severe pancreatitis and were correlated with a radiological scoring system for extrapancreatic necrosis. Whereas resistin correlated positively with clinical scoring systems, time until discharge and the need for interventions, leptin was correlated positively with C-reactive protein (CRP) levels. Resistin levels measured on the day of admittance had a positive predictive value of 93.3% (cut-off: >6.95 ng/mL) in predicting a Schröder score >3. Conclusion: Resistin, and to a lesser extent leptin, but not adiponectin levels are novel potential markers for extrapancreatic necrosis and severity of acute pancreatitis and should therefore be tested in larger cohorts of patients. [ABSTRACT FROM AUTHOR]

The article, "Laparoscopic and open surgery in rectal cancer patients in Germany: short and long‑term results of a large 10-year population-based cohort," written by Valentin Schnitzbauer, Michael Gerken, Stefan Benz, Vinzenz Völkel,, Teresa Draeger, Alois Fürst, and Monika Klinkhammer-Schalke was originally published electronically on the publisher's internet portal (currently SpringerLink) on 30 May 2019 without open access. With the author(s)' decision to opt for Open Choice the copyright of the article changed on September 18, 2019 to © The Author(s) [Year] and the article is forthwith distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits use, duplication, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit original author(s) and the source, provide a link to the Creative Commons licence and indicate if changes were made. [ABSTRACT FROM AUTHOR]