SafeHeal Colovac Colorectal Anastomosis Protection Device evaluation (SAFE-2) pivotal study: an international randomized controlled study to evaluate the safety and effectiveness of the Colovac Colorectal Anastomosis Protection Device.

AIM: Although proximal faecal diversion is standard of care to protect patients with high-risk colorectal anastomoses against septic complications of anastomotic leakage, it is associated with significant morbidity. The Colovac device (CD) is an intraluminal bypass device intended to avoid stoma creation in patients undergoing low anterior resection. A preliminary study (SAFE-1) completed in three European centres demonstrated 100% protection of colorectal anastomoses in 15 patients, as evidenced by the absence of faeces below the CD. This phase III trial (SAFE-2) aims to evaluate the safety and effectiveness of the CD in a larger cohort of patients undergoing curative rectal cancer resection. METHODS: SAFE-2 is a pivotal, multicentre, prospective, open-label, randomized, controlled trial. Patients will be randomized in a 1:1 ratio to either the CD arm or the diverting loop ileostomy arm, with a recruitment target of 342 patients. The co-primary endpoints are the occurrence of major postoperative complications within 12 months of index surgery and the effectiveness of the CD in reducing stoma creation rates. Data regarding quality of life and patient's acceptance and tolerance of the device will be collected. DISCUSSION: SAFE-2 is a multicentre randomized, control trial assessing the efficacy and the safety of the CD in protecting low colorectal anastomoses created during oncological resection relative to standard diverting loop ileostomy. TRIAL REGISTRATION: NCT05010850.

Temporary diverting stoma in therapy-refractory luminal colonic Crohn's disease: an alternative to immediate colorectal resection?

AIM: Creation of a diverting stoma in patients with Crohn's disease (CD) can counteract luminal inflammation. The clinical utility of a diverting stoma with the prospect of restoration of gastrointestinal continuity warrants further investigation. The aim of this work was to evaluate the long-term effects of creation of a diverting stoma on the disease course in patients with luminal colonic CD. METHOD: In this retrospective, multicentre cohort study we investigated the disease course of patients who received a diverting stoma in the biological era. Clinical characteristics, medication use and surgical course were assessed at the time of creation of the diverting stoma and during follow-up. The primary outcome was the rate of successful and lasting reestablishment of gastrointestinal continuity. RESULTS: Thirty six patients with refractory luminal CD from four institutions underwent creation of a diverting stoma. Of the overall cohort, 20 (56%) patients had their gastrointestinal continuity reestablished after initial stoma creation and 14 (39%) who had their stoma reversed remained stoma-free during a median of 3.3 years follow-up (interquartile range 2.1-6.1 years). Absence of stoma reversal was associated with the presence of proctitis (p = 0.02). Colorectal resection after creation of a diverting stoma was performed in 28 (78%) patients, with 7 (19%) having a less extensive resection and 6 (17%) having a more extensive resection compared with the surgical plan before stoma creation. CONCLUSION: A diverting stoma could potentially be an alternative to immediate definitive stoma placement in specific populations consisting of patients with luminal colonic CD, especially in the absence of proctitis.

A comparative study of stoma-related complications from diverting loop ileostomy or colostomy after colorectal surgery.

PURPOSE: Even though minor, stoma-related complications significantly impact quality of life, they are often excluded from clinical analyses that compare short-term postoperative outcomes of loop ileostomy and loop colostomy. This study compares stoma-related complications between loop ileostomy and loop colostomy after rectal resection, including minor complications, and discusses the characteristics of diverting stoma types. METHODS: A retrospective review was conducted in patients who underwent diverting stoma construction after rectal resection. Data on patient background and postoperative short-term outcomes, including stoma-related complications and morbidity after stoma closure, were collected and compared between loop ileostomy and loop colostomy groups. Morbidities of all severity grades were targeted for analysis. RESULTS: A total of 47 patients (27 loop ileostomy, 20 loop colostomy) underwent diverting stoma construction following rectal resection. Overall stoma-related complications, incidence of skin irritation, high-output stoma, and outlet obstruction were significantly higher in the loop ileostomy group but high-output stoma and outlet obstruction were absent in the loop colostomy group. Regarding morbidity after stoma closure, operation times and surgical site infections were significantly higher in the loop colostomy group while anastomotic leakage after diverting stoma closure occurred (2 cases; 15%) in the loop colostomy group but not the loop ileostomy group. CONCLUSION: Because stoma-related complications were significantly higher in the loop ileostomy group, and even these minor complications may impair QOL, early loop ileostomy closure is recommended. For loop colostomy, stoma-related morbidities are lower but post-closure leakage is a calculated risk.

Early Experience of Undertaking Robotic Assisted Total Mesorectal Excision in Rectal Resections, Avoiding a Diverting Stoma: Key eHancement of the Anastomosis for No Stoma Technique - A Case Series.

Background. Anastomotic leak is a feared complication in rectal cancer surgery, and a proximal diverting stoma to protect the rectal anastomosis is used to minimize its impact. We evaluated a novel technique that uses the da Vinci® robotic platform (Intuitive Surgical) to reinforce the colorectal anastomosis and rectal staple line with sutures, and rectal resection and assessment of the anastomotic perfusion, using our Portsmouth protocol. Methods. During robotic rectal cancer surgery, we used indocyanine green to determine the level of transection and check the vascularity of the circular anastomosis. The distal transverse staple line and circular staple line of the colorectal anastomosis were reinforced with absorbable interrupted stitches (KHANS technique - Key enHancement of the Anastomosis for No Stoma). The integrity of the colorectal/anal anastomosis was also checked using the underwater air-water leak test, with concomitant flexible sigmoidoscopy to visualize the circular staple line. Results. Fifty patients underwent total mesorectal excision for cancer. Using the KHANS technique, we avoided a diverting stoma in all cases. One patient had a radiological leak, leading to a pelvic abscess. In 56% of cases, the anastomosis was within 5 cm of the anal verge. Median length of stay was 5 (3-34) days, with two 30-day readmissions. No 90-day mortality or 30-day reoperations were observed. Conclusion. The KHANS technique appears feasible, successful, and safe in decreasing the incidence of diverting stomas in rectal resections.

Effect of the transanal drainage tube on preventing anastomotic leakage after laparoscopic surgery for rectal cancer: a systematic review and meta-analysis.

PURPOSE: Anastomotic leakage (AL) is a common postoperative complication of rectal cancer, and transanal drainage tube (TDT) efficacy is still contentious. This study aimed to evaluate the TDT effect on AL prevention. METHODS: All relevant papers were searched by using a predefined search strategy (two randomized controlled trials (RCTs), one prospective study, and four retrospective studies). Meta-analysis was conducted to estimate AL and re-operation pooled rates. RESULTS: A total of 7 studies (1556 patients) were included: No significant statistic difference was found between two groups on AL rate (odds ratio (OR) 0.61, P = 0.11) and re-operation rate (OR 0.52, P = 0.10). For subgroup analysis, significant statistic difference was found between two groups on AL rate (OR 0.29, P = 0.002) and re-operation rate (OR 0.15, P = 0.04) in patients without neoadjuvant therapy. As for patients without diverting stoma, the AL rate (OR 0.35, P = 0.002) was significantly lower than that in patients without TDT. CONCLUSIONS: TDT may reduce AL morbidity and re-operation rate for patients without high risk of AL, but may be useless for those in high-risk situations.

Ano-rectovaginal fistula after obstetrical anal sphincter injury: Diverting stoma does not improve the surgical results.

AIM: Ano-rectovaginal fistulas (ARVF) are challenging for the surgeon. Most of the series mix aetiologies, leading to confusion with respect to the conclusion. The aim of this study was to assess the factors associated with the success of ARVF management following obstetrical anal sphincter injury (OASIS). METHODS: This retrospective multicentric study included all the patients undergoing surgery for ARVF identified by the hospital codes. Patients for whom the aetiology of ARVF was not OASIS were excluded. The major outcome measure was the success of the procedure. RESULTS: Sixty patients with treated ARVF due to OASIS were identified. The success of overall management was 91.7%. Female patients underwent a mean of 2.5 (±1.7) procedures. A diverting stoma was formed in 29 patients (48.3%) of which 26 were closed at the end of the management period (89.7%). Of the 148 surgical procedures, only 55 were successful (37.2%). The order of the procedures (OR = 1.38; 95% CI: 0.75-2.51) or the diverting stoma (OR = 1.46; 95% CI: 0.31-6.91) were not significantly associated with the success of the surgery. However, Martius flap (OR = 4.13; 95% CI: 1.1-15.54) and Musset procedures (OR = 5.79; 95% CI: 1.77-18.87) produced better results than the endorectal advancement flap (ERAF). The other procedures did not show a significant correlation with management success. CONCLUSION: A diverting stoma is not mandatory in the management of ARVF due to OASIS to improve the success of the surgical procedure. While the Martius flap procedure offers better results, the ERAF procedure may be preferred as a primary intervention in the absence of sphincter injury as it is less invasive. In cases of residual sphincter injury, the Musset procedure is most likely to be the best option.

Prophylactic transanal drainage tube placement for preventing anastomotic leakage after anterior resection for rectal cancer: A meta-analysis.

AIM: The aim was to evaluate the efficacy of transanal drainage tube (TDT) placement for preventing anastomotic leakage after low anterior resection for rectal cancer. METHOD: PubMed, the Cochrane Central Register of Controlled Trials, Embase and ClinicalTrials.gov databases were searched up to October 2021. Studies comparing outcomes following low anterior resection with or without TDT were included. The primary outcomes measured were anastomotic leakage rate, reoperation rate and anastomotic bleed rate. RESULTS: Three randomized controlled trials (RCTs) and 16 observational studies (prospective or retrospective) involving 4560 patients satisfied the basic inclusion criteria. In RCTs, a TDT was associated with no statistically significant differences in anastomotic leakage (OR = 0.67, 95% CI 0.42-1.05, P = 0.08), reduction in reoperation (OR = 0.11, 95% CI 0.03-0.51, P = 0.004) and increased anastomotic bleeding rate (OR = 2.36, 95% CI 1.11-5.01, P = 0.03). In observational studies, a TDT was associated with significant reduction in anastomotic leak (OR = 0.44, 95% CI 0.30-0.64, P < 0.0001) and reoperation (OR = 0.47, 95% CI 0.33-0.69, P < 0.0001), with no statistically significant differences in anastomotic bleeding (OR = 1.30, 95% CI 0.20-8.30, P = 0.78). CONCLUSION: In RCTs, a TDT for rectal cancer was correlated with no detectable differences in anastomotic leakage and with an increased risk of anastomotic bleeding. In observational studies, a TDT was correlated with reduction in anastomotic leakage and no detectable differences in anastomotic bleeding. Both RCTs and observational studies demonstrated a comparable reduction in reoperation rate with TDT. These data in aggregate indicated that TDTs may not show superiority but emphasized differences between RCT and observational data.

Surgical outcomes of Turnbull-Cutait delayed coloanal anastomosis with pull-through versus immediate coloanal anastomosis with diverting stoma after total mesorectal excision for low rectal cancer: a systematic review and meta-analysis.

BACKGROUND: Theoretical advantages of Turnbull-Cutait pull-through delayed coloanal anastomosis (DCAA) are a reduced risk of anastomotic leak and therefore avoidance of stoma. Gradually abandoned in favor of immediate coloanal anastomosis (ICAA) with diverting stoma, DCAA has regained popularity in recent years in reconstructive surgery for low RC, especially when combined with minimally invasive surgery (MIS). The aim of this study was to perform the first meta-analysis, exploring the safety and outcomes of DCAA compared to ICAA with protective stoma. METHODS: A systematic search of MEDLINE, EMBASE, and CENTRAL and Google Scholar databases was performed for studies published from January 2000 until December 2020. The systematic review and meta-analysis were performed according to the Cochrane Handbook for Systematic Review on Interventions recommendations and Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guidelines. RESULTS: Out of 2626 studies screened, 9 were included in the systematic review and 4 studies in the meta-analysis. Outcomes included were postoperative complications, pelvic sepsis and risk of definitive stoma. Considering postoperative complications classified as Clavien-Dindo III, no significant difference existed in the rate of postoperative morbidity between DCAA and ICAA (13% versus 21%; OR 1.17; 95% CI 0.38-3.62; p = 0.78; I2 = 20%). Patients in the DCAA group experienced a lower rate of postoperative pelvic sepsis compared with patients undergoing ICAA with diverting stoma (7% versus 14%; OR 0.37; 95% CI 0.16-0.85; p = 0.02; I2 = 0%). The risk of definitive stoma was comparable between the two groups (2% versus 2% OR 0.77; 95% CI 0.15-3.85; p = 0.75; I2 = 0%). CONCLUSIONS: According to the limited current evidence, DCAA is associated with a significant decrease in pelvic sepsis. Further prospective trials focusing on oncologic and functional outcomes are needed.

Low preoperative maximum squeezing pressure evaluated by anorectal manometry is a risk factor for non-reversal of diverting stoma.

PURPOSE: A diverting stoma is created to prevent anastomotic leakage and related complications impairing sphincteric function in rectal surgery. However, diverting stoma may be left unclosed. This study is aimed to analyze preoperative factors including anorectal manometric data associated with diverting stoma non-reversal before rectal surgery. We also addressed complications related to diverting stoma in patients undergoing surgery for rectal malignant tumor. METHODS: A total of 203 patients with rectal malignant tumor who underwent sphincter-preserving surgery with diverting stoma were retrospectively evaluated. The risk factors for non-reversal of diverting stoma were identified by univariate and multivariate analyses. For these analyses, anorectal manometric data were measured before rectal surgery. The association between stoma-related complications and other clinicopathological features was also analyzed. RESULTS: During the median follow-up of 46.4 months, 24% (49 patients) did not undergo stoma reversal. Among parameters that were available before rectal surgery, age ≥ 75 years, albumin < 3.5 g/dl, tumor size ≥ 30 mm, tumor distance from the anal verge < 4 cm, and maximum squeezing pressure (MSP) < 130 mmHg measured by anorectal manometry (ARM) were independent factors associated with stoma non-reversal. The most common stoma-related complication was peristomal skin irritation (25%). Ileostomy was the only factor associated with peristomal skin irritation. CONCLUSION: The current study demonstrated that low preoperative MSP evaluated by ARM, old age, hypoalbuminemia, and a large tumor close to the anus were predictive of diverting stoma non-reversal. Stoma site should be well deliberated when patients have the aforementioned risk factors for diverting stoma non-reversal.

Risks of anastomotic leakage in patients with colorectal cancer after operation and how to effectively avoid it. / ç›´è§†ç»“ç›´è‚ ç™Œæ‚£è€ æœ¯åŽå»åˆå£æ¼åŠå ¶é£Žé™©è§„é¿.

Despite the considerable progress in surgical level and imaging examination methods, anastomotic leakage is still the major complication after intestinal surgery with high incidence rate and mortality rate. Moreover, anastomotic leakage has become one of the serious complications threatening the postoperative life safety, prognosis and quality of life. The occurrence of anastomotic leakage involves the changes of a variety of pathophysiological factors, and is affected by intestinal microbiota, inflammation and immune system. Preoperative intestinal preparation will change the type and number of microbial population in the intestine. Intraoperative anastomotic mode and bleeding volume are also closely related to the occurrence of anastomotic leakage. In addition, the occurrence of anastomotic leakage is associated with local recurrence of colorectal cancer after surgery. Intraoperative protective stoma is confirmed to reduce the incidence of anastomotic leakage. Combined preoperative adjustment of nutritional status and inflammatory factors is important for avoiding anastomotic leakage after surgery.

The effect of a diverting stoma on morbidity and risk of permanent stoma following anastomotic leakage after low anterior resection for rectal cancer: a nationwide cohort study.

BACKGROUND: Diverting stomata (DS) have been shown to mitigate the clinical impact of anastomotic leakage (AL) but not without complications, and their routine use remains a matter of international debate. The objective of this study was to examine the association between stomata and the clinical consequences of AL. METHODS: This was a nationwide retrospective cohort study including all patients suffering from AL after low anterior resection from 2001 to 2010. RESULTS: Four thousand sixty-three patients were treated in the period of whom 581 (11.9%) developed AL. In case of AL, patients without a diverting stoma had a slightly higher 90-day mortality rate (13.5% versus 8.7%, p = 0.089). Patients suffered more complications due to AL, both surgical (52% versus 28%, p < 0.001) and non-surgical (48% versus 35%, p = 0.004) with a higher Clavien-Dindo score. Twenty percent of patients developed stoma-related complications prior to stoma reversal. Mortality related to stoma reversal was 2.4%. Factors associated with a risk of a permanent stoma were age (HR 1.04, 95% CI 1.01-1.08), blood transfusion during primary surgery (HR 2.35, 95% CI 1.16-4-78), conserved anastomosis after AL (HR 0.019, 95% CI 0.009-0.04), and a diverting stoma fashioned at the index operation (HR 0.50, 95% CI 0.26-0.97). CONCLUSION: The use of diverting stomata during low anterior resection mitigates the clinical impact of AL. However, this benefit needs to be balanced against the risk of stoma-related complications, seen in 20%, and mortality with stoma reversal (2.4%). Where practical, the decision to divert should be made pre-operatively in a multidisciplinary setting.

The possibility of a transanal tube as an alternative to diverting stoma in terms of preventing severe postoperative anastomotic leakage after laparoscopic low anterior resection.

PURPOSE: The purpose of this study was to reveal whether a transanal tube (TAT) could act as an alternative to a diverting stoma (DS) after laparoscopic low anterior resection. PATIENTS AND METHODS: A total of 89 consecutive rectal cancer patients whose tumors were located within 15 cm from the anal verge who underwent laparoscopic low anterior resection without a DS at our institution between May 12, 2015 and August 31, 2019 were included. All patients received a postoperative Gastrografin enema study (GES) through a TAT between the 3rd and 10th postoperative day. We planned two study protocols. From May 12, 2015 to March 31, 2017, we conducted a second operation including a DS construction immediately when radiological anastomotic leakage (rAL) was detected (Group A, n=46). From April 1, 2017 to August 31, 2019, we continued TAT drainage even if rAL was detected and repeated the GES weekly until the rAL was healed (Group B, n=43). RESULTS: In Group A (n=46), 14 cases of rAL were included, 11 of which underwent stoma construction. The remaining 3 patients who refused stoma construction were treated conservatively. In Group B (n=43) rAL was encountered in 10, and 7 of these patients were treated successfully by TAT continuous drainage. The rate of DS in Group B (7.0%) was significantly lower than that in Group A (23.9%) (p=0.028). CONCLUSIONS: A TAT could act as a DS to mitigate the symptoms of anastomotic leakage after laparoscopic low anterior resection.

Exploring optimal examination to detect occult anastomotic leakage after rectal resection in patients with diverting stoma.

BACKGROUND: When considering "early stoma closure", both standardized inclusion/exclusion criteria and standardized methods to assess anastomosis are necessary to reduce the risk of occult anastomotic leakage (AL). However, in the immediate postoperative period, neither have the incidence and risk factors of occult AL in patients with diverting stoma (DS) been clarified nor have methods to assess anastomosis been standardized. The aim of this study was to elucidate the incidence and risk factors of occult AL in patients who had undergone rectal resection with DS and to evaluate the significance of computed tomography (CT) following water-soluble contrast enema (CE) to detect occult anastomotic leakage. METHODS: This was a single institutional prospective observational study of patients who had undergone rectal resection with the selective use of DS between May and October 2019. Fifteen patients had undergone CE and CT to assess for AL on postoperative day (POD) 7, and CT was performed just after CE. Univariate analysis was performed to assess the relationship between preoperative variables and the incidence of occult AL on POD 7. RESULTS: The incidence of occult AL on postoperative day 7 was 6 of 15 (40%). Hand-sewn anastomosis, compared with stapled anastomosis, was a significant risk factor. Five more cases with occult AL that could not be detected with CE could be detected on CT following CE; CE alone had a 33% false-negative radiological result rate. CONCLUSIONS: Hand-sewn anastomosis appeared to be a risk factor for occult AL, and CE alone had a high false-negative radiological result rate. When considering the introduction of early stoma closure, stapled anastomosis and CT following CE could be an appropriate inclusion criterion and preoperative examination, respectively.

Surgical repair of rectovaginal fistulas: predictors of fistula closure.

INTRODUCTION AND HYPOTHESIS: We report the clinical outcome of surgical repair for rectovaginal fistula (RVF) carried out by one operative team. We also investigate the predictive factors for fistula healing. METHODS: A retrospective cohort of 63 patients underwent local surgical repair of RVF during January 2008 and December 2017 by one operative group. The clinical features of the patients were reviewed. The association between fistula closure and diverse clinical parameters, including operative method, fistula location, prior repair, and diverting stoma, was analyzed. RESULTS: Sixty-three consecutive patients underwent 80 local surgical repairs by our surgical team. Forty-five patients eventually healed after an average of 1.22 procedures. The overall success rate per procedure was 71.2%, whereas the closure rate of the first operation was 55.5% (n = 35). The etiology of the fistula did not impact on the success rate of surgical repair. The history of prior repair predicted a lower success rate on both overall procedure (RR = 0.59, 95% CI 0.41-0.85, p = 0.008) and the first repair in our institution (RR = 0.50, 95% CI 0.31-0.80, p = 0.003). There was no difference in closure rate between the stoma group and the non-stoma group. Nevertheless, among the 15 patients who underwent more than one operation in our center, a diverting stoma seemed to be necessary (10 patients healed in the stoma group and none of the patients healed in the non-stoma group, p = 0.02). CONCLUSIONS: History of prior surgical repair is a risk factor for failure. Diverting stoma did not increase the overall closure rate, but it seemed to be necessary for patients in whom the first operation failed.

Stoma rods in abdominal surgery: a systematic review and metaanalyses.

BACKGROUND: Stoma rods are used traditionally to prevent retraction of loop stomas into the abdominal cavity. However, there is very little evidence to support or refute their use. The aim of the present systematic review and metaanalysis was to assess the current data on stoma rods in loop stomas. The primary outcomes were stoma necrosis and stoma retraction. METHODS: A systematic review and metaanalyses were conducted using the preferred reporting items for systematic reviews and metaanalysis guidelines (PRISMA). The study protocol was registered prospectively on PROSPERO. An electronic search was performed by two reviewers independently using predefined search strategy and Medline. Bibliographies of selected studies were screened for additional references. RevMan was used to generate forest plots and calculate odds ratios and 95% confidence intervals (CIs). RESULTS: In total, five studies were identified that met inclusion criteria, including four randomized controlled trials. Three studies examined only ileostomies, while one included both colostomies and ileostomies, and one only examined colostomies. In total, 561 patients underwent a stoma with a rod compared to 443 without. There was a higher rate of dermatitis (rod 29.86% vs no rod 16% OR 2.65; 95% CI 1.79-3.93) and stoma necrosis (rod 7% vs no rod 1.15% OR 5.58; 95% CI 1.85-16.84) in the rod group, but there was no significant difference in stoma retraction (rod 2.28% vs no rod 3.45%; OR 0.7; 95% CI 0.32-1.54). CONCLUSIONS: Stoma rods do not reduce the incidence of stoma retraction and instead lead to increased rates of dermatitis and stoma necrosis.

The fate of preserved sphincter in rectal cancer patients.

PURPOSE: Sphincter-saving surgery is widely accepted operative modality to treat rectal cancer. It often requires temporary diverting stoma to avoid the complications of anastomotic failure. This study investigates the cumulative failure rate in sphincter preservation for rectal cancer and the risk factors associated with the permanent stoma. METHODS: A retrospective study on 358 patients diagnosed with primary rectal cancer from 2009 to 2013 was conducted at a single institute. Three hundred and thirty-one out of 358 patients with rectal cancer located within 12 cm from the anal verge, who underwent sphincter-preserving surgery, were included in this study. The cumulative rate for permanent stoma was calculated. Univariate and multivariate analysis were performed, comparing the patients with stoma to the ones without. RESULTS: Temporary diverting stoma was created in 223 (82%) patients. After median follow-up of 42 months, 18 patients (6.6%) persistently used temporary stoma or required re-creation of stoma. Univariate analysis revealed that BMI, tumor location below 4 cm from the anal verge, coloanal anastomosis, anastomotic leakage, and local recurrence were significantly associated with persistent use or re-formation of stoma. Multivariate analysis showed that anastomotic leakage (OR 50.3; 95% CI, 10.1-250.1; p < 0.0001) and local recurrence (OR 11.3; 95% CI, 1.61-78.5; p = 0.015) were the independent risk factors. CONCLUSION: Patients with anastomotic leakage and local recurrence are at high risk for permanent stoma. Not only should patients be fully informed of possible failure in sphincter preservation preoperatively, but also patient-oriented decision should be made on patient-tailored surgical plan.

The type of stoma matters-morbidity in patients with obstructing colorectal cancer.

PURPOSE: A loop colostomy may reduce the risk of severe intraabdominal complications in patients with obstructing colorectal cancer compared to an end colostomy. The aim of this study was to relate complications to the type of stoma, and a secondary aim was to evaluate whether the type of colostomy had an impact on time until oncological/surgical treatment. METHODS: All patients who underwent surgery and received a deviating colostomy due to obstructing colorectal cancer between January 2011 and December 2015 in five Swedish hospitals in Region Västra Götaland were included (n = 289). Patient charts were reviewed retrospectively. Patients alive in the end of 2016 were contacted and were sent a questionnaire including questions about stoma function and health-related quality of life. RESULTS: Some 289 patients were included; 147 received an end colostomy and 140 a loop colostomy. Two patients were excluded from the analysis due to missing data. There was no difference in complications at 90 days between the two groups, 44% (end colostomy) and 54% (loop colostomy) (odds ratio: 0.83 (95% CI: 0.49; 1.41). Time to start of treatment was similar in both groups. Patients with a loop colostomy had significantly higher stoma-related morbidity with retraction, prolapse, leakage and bandaging problems. No differences in quality of life were found. CONCLUSION: The hypothesis that a loop colostomy reduced complications could not be confirmed. An end colostomy should be the first choice in these patients particularly in patients who will have their colostomy for the remainder of their life to reduce stoma-related symptoms.

Multicenter analysis of risk factors for anastomotic leakage after middle and low rectal cancer resection without diverting stoma: a retrospective study of 319 consecutive patients.

PURPOSE: The purpose of this study was to evaluate the risk factors for anastomotic leakage (AL) after anterior resection for middle and low rectal cancer in order to help surgeons to decide which patients could benefit from a diverting stoma. METHODS: Data on 319 patients having a middle and low rectal cancer resection with anastomosis between May 2011 and October 2015 from two hospitals were included in the study. The analysis included the following variables: patient-related variables (gender, age, diabetes mellitus, ASA score, preoperative radiochemotherapy, body mass index, blood hemoglobin, and serum albumin level), tumor-related variables (K-ras status, distance of tumor from the anal verge, histopathologic grade, pathological T stage, pathological N stage, pathological M stage, TNM stage, and tumor size), and surgery-related variables (laparoscopic or open surgery, blood loss, and operative time). Univariate and multivariate regression analysis were carried out to identify risk factors for AL. RESULTS: The AL rate was 11.91% (38/319). Male (OR 2.898, 95% CI 1.265-6.637, p = 0.012), diabetes mellitus (OR 2.482, 95% CI 1.004-6.134, p = 0.049), K-ras mutation (OR 2.544, 95% CI 1.210-5.348, p = 0.014), distance of tumor from the anal verge (OR 3.445, 95% CI 1.631-7.279, p = 0.001), and preoperative radiochemotherapy (OR 2.790, 95% CI 1.056-7.372, p = 0.039) were independent risk factors of AL. One (2.63%) in 38 patients with AL presented with no risk factor of AL, 6 (15.8%) in 38 patients with 1 risk factor, 16 (42.1%) in 38 patients with 2 risk factors, 9 (23.7%) in 38 patients with 3 risk factors, and 6 (15.7%) in 38 patients with 4 risk factors. No patient with 5 risk factors in our study. AL rate increased with the elevated number of risk factors clustering in individuals. CONCLUSIONS: K-ras mutation is first reported to be an independent risk factor for AL after sphincter-preserving surgery without diverting stoma. A diverting stoma should be performed in sphincter-preserving surgery for middle and low rectal cancer patients with 2 or more risk factors identified in this analysis.

High stoma prevalence and stoma reversal complications following anterior resection for rectal cancer: a population-based multicentre study.

AIM: Fashioning a defunctioning stoma is common when performing an anterior resection for rectal cancer in order to avoid and mitigate the consequences of an anastomotic leakage. We investigated the permanent stoma prevalence, factors influencing stoma outcome and complication rates following stoma reversal surgery. METHOD: Patients who had undergone an anterior resection for rectal cancer between 2007 and 2013 in the northern healthcare region were identified using the Swedish Colorectal Cancer Registry and were followed until the end of 2014 regarding stoma outcome. Data were retrieved by a review of medical records. Multiple logistic regression was used to evaluate predefined risk factors for stoma permanence. Risk factors for non-reversal of a defunctioning stoma were also analysed, using Cox proportional-hazards regression. RESULTS: A total of 316 patients who underwent anterior resection were included, of whom 274 (87%) were defunctioned primarily. At the end of the follow-up period 24% had a permanent stoma, and 9% of patients who underwent reversal of a stoma experienced major complications requiring a return to theatre, need for intensive care or mortality. Anastomotic leakage and tumour Stage IV were significant risk factors for stoma permanence. In this series, partial mesorectal excision correlated with a stoma-free outcome. Non-reversal was considerably more prevalent among patients with leakage and Stage IV; Stage III patients at first had a decreased reversal rate, which increased after the initial year of surgery. CONCLUSION: Stoma permanence is common after anterior resection, while anastomotic leakage and advanced tumour stage decrease the chances of a stoma-free outcome. Stoma reversal surgery entails a significant risk of major complications.

Radiation-induced rectovaginal fistulas in locally advanced gynaecological malignancies-new patients, old problem?

PURPOSE: Radiation-induced rectovaginal fistula (RI-RVF) is a chronic and serious condition with a significant influence on quality of life. The aim of this study is to evaluate the results of surgical treatment of rectovaginal fistulas of patients previously undergoing radiotherapy. METHODS: Fifty patients treated in the Gynaecological Radiotherapy Unit for gynaecologic malignancy and in the Department of General and Colorectal Surgery for RI-RVF between 2003 and 2013 were enrolled into a prospectively maintained database and underwent regular follow-up examinations in an outpatient clinic, during which surgical outcomes were assessed. RESULTS: Median age was 60 years (range 40-84 years). Cervical cancer was the most common cause of radiotherapy. Median time of fistula development after radiotherapy was 20 months (range 5-240 months). In 48 (96%) patients, only faecal diversion could be performed, while two patients underwent rectal resection. The fistula healed in six patients. Factors that correlated with fistula healing were a distance from the anal verge above 7 cm (p = 0.007 OR 18 95%CI 2.2609-14.3062) and creation of loop ileostomy (p = 0.08 OR 17 95%CI 1.2818-23.9701), whereas a prolonged course of radiotherapy of more than 6 weeks (p = 0.047) correlated negatively. In multivariate analysis, only distance from the anal verge remained significant (p = 0.031 OR 2.35 95%CI 1.0422-5.2924). CONCLUSIONS: The treatment of radiation-induced rectovaginal fistulas needs to be tailored individually to each patient. Faecal diversion remains the simplest and safest method of treating RI-RVF, especially in the group of patients who cannot undergo complicated surgical procedures, and offers acceptable quality of life.