Evaluation of the SafeHeal Colovac+ anastomosis protection device after low anterior resection for rectal cancer: the safe anastomosis feasibility evaluation (SAFE) 2019 trial.

BACKGROUND: Protective ileostomy (PI) is the current standard of care to protect the anastomosis after low anterior resection (LAR) for rectal cancer, but is associated with significant morbidity. Colovac is an anastomosis protection device designed to shield the anastomosis from fecal content. A second version (Colovac+) was developed to limit the migration risk during the implantation period. The objective of this clinical trial was to evaluate the preliminary efficacy and safety of the Colovac+. METHODS: This was a prospective, multicenter, pilot study aiming to enroll 15 patients undergoing LAR with Colovac+ placement. After 10 days, a CT scan was performed to evaluate the anastomosis and the Colovac+ was retrieved endoscopically. During the 10-day implantation and 3-month follow-up period, we collected data regarding predefined efficacy and safety endpoints. The primary endpoint was the rate of major (Clavien-Dindo III-V) postoperative complications related to the Colovac+ or LAR procedure. RESULTS: A total of 25 patients were included (68% male), of whom 15 were consecutively treated with the Colovac+ and Vacuum Loss Alert System. The Colovac+ was successfully implanted in all 15 patients. No major discomfort was reported during the implantation period. The endoscopic retrieval was performed in 14/15 (93%) patients. The overall major postoperative morbidity rate was 40%, but none of the reported complications were related to the Colovac+. A device migration occurred in 2 (13%) patients, but these were not associated with AL or stoma conversion. Overall, Colovac+ provided effective fecal diversion in all 15 patients and was able to avoid the PI in 11/15 (73%) patients. CONCLUSIONS: Colovac+ provides a safe and effective protection of the anastomosis after LAR, and avoids the PI in the majority (73%) of patients. The improved design reduces the overall migration rate and limits the clinical impact of a migration.

Risk factors of acute renal failure in patients with protective ileostomy after rectal cancer surgery.

BACKGROUND: Despite the potential benefits of protective ileostomy in rectal surgery, diverting loop ileostomy construction is not free of specific medical consequences implying unplanned hospital readmissions. The most common reason for readmission in these patients is a dehydration with a prevalence of acute renal failure (ARF) of 20%. The objective of this study was to establish the predictive factors of ARF in patients with protective ileostomy after surgery for rectal cancer from a bicentric study. METHODS: we conducted a bicentric retrospective cohort study to identify the risk factor of ARF. This study was carried out on 277 patients operated for rectal cancer with necessity of a protective ileostomy during the study period. ARF was measured at any endpoint between ileostomy creation and reversal. Multiple logistic regressions were performed to identify independent risk factors. RESULTS: A total of 277 patients were included, and 18% (n = 50) were readmitted for ARF. In multivariate logistic regression, increased age (OR 1.02, p = 0.01), Psychiatric diseases (OR 4.33, p = 0.014), Angiotensin II receptor blockers (OR 5.15, p < 0.001) and the ASA score ≥ 3 (OR 9.5, p < 0.001) were significantly associated with ARF. CONCLUSION: Acute renal failure is a prevalent and significant event in the postoperative course of ileostomy patients. Patients at risk should be risk stratified before discharge and targeted for intensive preventive measures.

Protective ileostomy creation after anterior resection of the rectum: Shared decision-making or still subjective?

AIM: The choice of whether to perform protective ileostomy (PI) after anterior resection (AR) is mainly guided by risk factors (RFs) responsible for the development of anastomotic leakage (AL). However, clear guidelines about PI creation are still lacking in the literature and this is often decided according to the surgeon's preferences, experiences or feelings. This qualitative study aims to investigate, by an open-ended question survey, the individual surgeon's decision-making process regarding PI creation after elective AR. METHOD: Fifty four colorectal surgeons took part in an electronic survey to answer the questions and describe what usually led their decision to perform PI. A content analysis was used to code the answers. To classify answers, five dichotomous categories (In favour/Against PI, Listed/Unlisted RFs, Typical/Atypical, Emotions/Non-emotions, Personal experience/No personal experience) have been developed. RESULTS: Overall, 76% of surgeons were in favour of PI creation and 88% considered listed RFs in the question of whether to perform PI. Atypical answers were reported in 10% of cases. Emotions and personal experience influenced surgeons' decision-making process in 22% and 49% of cases, respectively. The most frequently considered RFs were the distance of the anastomosis from the anal verge (96%), neoadjuvant chemoradiotherapy (88%), a positive intraoperative leak test (65%), blood loss (37%) and immunosuppression therapy (35%). CONCLUSION: The indications to perform PI following rectal cancer surgery lack standardization and evidence-based guidelines are required to inform practice. Until then, expert opinion can be helpful to assist the decision-making process in patients who have undergone AR for adenocarcinoma.

Hidden ileostomy as a rescue procedure in major colorectal surgeries: a novel technique to prevent re-laparotomy in anastomotic leak cases.

BACKGROUND: Anastomotic leak is a major cause of morbidity and mortality of patients worldwide, and it has remained stable over the last years. Routine construction of protective ileostomy is associated with stoma and negatively affects patients' quality of life. Developing another technique to minimize those drawbacks with at least the same clinical success can help patients with anastomotic leak. We present the novel technique "Hidden Ileostomy" as an alternative to protective ileostomy that can achieve that balance. MATERIALS AND METHODS: Eight patients presented to our department underwent the novel technique "Hidden Ileostomy" as a rescue procedure for different reasons. The associated risk factors and clinical scenarios, together with the follow-up data, are presented. RESULTS: For the eight cases in this study, one patient was ASA grade 1, 3 patients were classified as ASA grade 2, and 4 were grade 3. The mean ± SD operative time and blood loss were 196.3 ± 16.4 min and 325 ± 204.6 ml, respectively. The hidden ileostomy was removed after an average of 8 days. Only Case 6 reported an anastomotic leak on a postoperative day 10. CONCLUSION: A hidden ileostomy is an alternative and feasible technique in selected cases in colorectal surgery. This technique could be adopted in our practice instead of routine instruction of ileostomy, especially in the equivocal anastomosis.

[Protective colostomy and protective ileostomy for the prevention of anastomotic leak in patients with rectal cancer after neoadjuvant chemoradiotherapy and radical surgery].

Objective: To investigate whether protective colostomy and protective ileostomy have different impact on anastomotic leak for rectal cancer patients after neoadjuvant chemoradiotherapy (nCRT) and radical surgery. Methods: A retrospectively cohort study was conducted. Inclusion criteria: (1) Standard neoadjuvant therapy before operation; (2) Laparoscopic rectal cancer radical resection was performed; (3) During the operation, the protective enterostomy was performed including transverse colostomy and ileostomy; (4) The patients were followed up regularly; (5) Clinical data was complete. Exclusion criteria: (1) Colostomy and radical resection of rectal cancer were not performed at the same time; (2) Intestinal anastomosis is not included in the operation, such as abdominoperineal resection; (3) Rectal cancer had distant metastasis or multiple primary colorectal cancer. Finally 208 patients were included in this study. They suffered from rectal cancer and underwent protective stoma in radical surgery after nCRT at our hospital from January 2014 to December 2018. There were 148 males and 60 females with age of (60.5±11.1) years. They were divided into protective transverse colostomy group (n=148) and protective ileostomy group (n=60). The main follow up information included whether the patient has anastomotic leak and the type of leak according to ISREC Grading standard. Besides, stoma opening time, stoma flow, postoperative hospital stay, stoma related complications and postoperative intestinal flora were also collected. Results: A total of 28 cases(13.5%) suffered from anastomotic leak and 26 (92.9%) of them happened in the early stage after surgery (less than 30 days) . As for these early-stage leak, ISREC Grade A happened in 11 cases(42.3%), grade B in 15 cases(57.7%) and no grade C occurred. There was no significant difference in the incidence [12.8% (19/148) vs. 15.0% (9/60) , χ(2)=0.171, P=0.679] or type [Grade A: 5.4%(8/147) vs. 5.1%(3/59); Grade B: 6.8%(10/147) vs. 8.5%(5/59), Z=0.019, P=1.000] of anastomotic leak between the transverse colostomy group and ileostomy group (P>0.05), as well as operation time, postoperative hospital stay, drainage tube removal time or stoma reduction time (P>0.05). There were 10 cases (6.8%) and 24 cases (40.0%) suffering from intestinal flora imbalance in protective transverse colostomy and protective ileostomy group, respectively (χ(2)=34.503, P<0.001). Five cases (8.3%) suffered from renal function injury in the protective ileostomy group, while protective colostomy had no such concern (P=0.002). The incidence of peristomal dermatitis in the protective colostomy group was significantly lower than that in the protective ileostomy group [12.8% (9/148) vs. 33.3%(20/60), χ(2)=11.722, P=0.001]. Conclusions: It is equally feasible and effective for rectal cancer patients after nCRT to carry out protective transverse colostomy or ileostomy in radical surgery. However, we should pay more attention to protective ileostomy patients, as they are at high risk of intestinal flora imbalance, renal function injury and peristomal dermatitis.

Postoperative Ileus after Stimulation with Probiotics before Ileostomy Closure.

Loop ileostomy closure after colorectal surgery is often associated with Postoperative ileus, with an incidence between 13-20%. The aim of this study is to evaluate the efficacy and safety of preoperative stimulation of the efferent loop with probiotics prior to ileostomy closure in patients operated on for colorectal carcinoma. For this, a prospective, randomized, double-blind, controlled study is designed. All patients who underwent surgery for colorectal carcinoma with loop ileostomy were included. Randomized and divided into two groups, 34 cases and 35 controls were included in the study. Postoperative ileus, the need for nasogastric tube insertion, the time required to begin tolerating a diet, restoration of bowel function, and duration of hospital stay were evaluated. The incidence of Postoperative ileus was similar in both groups, 9/34 patients stimulated with probiotics and 10/35 in the control group (CG) with a p = 0.192. The comparative analysis showed a direct relationship between Postoperative ileus after oncological surgery and Postoperative ileus after reconstruction surgery, independently of stimulation. Postoperative ileus after closure ileostomy is independent of stimulation of the ileostomy with probiotics through the efferent loop. There seem to be a relationship between Postoperative ileus after reconstruction and the previous existence of Postoperative ileus after colorectal cancer surgery.

Protective colostomy and protective ileostomy for the prevention of anastomotic leak in patients with rectal cancer after neoadjuvant chemoradiotherapy and radical surgery / 中华胃肠外科杂志

Objective: To investigate whether protective colostomy and protective ileostomy have different impact on anastomotic leak for rectal cancer patients after neoadjuvant chemoradiotherapy (nCRT) and radical surgery. Methods: A retrospectively cohort study was conducted. Inclusion criteria: (1) Standard neoadjuvant therapy before operation; (2) Laparoscopic rectal cancer radical resection was performed; (3) During the operation, the protective enterostomy was performed including transverse colostomy and ileostomy; (4) The patients were followed up regularly; (5) Clinical data was complete. Exclusion criteria: (1) Colostomy and radical resection of rectal cancer were not performed at the same time; (2) Intestinal anastomosis is not included in the operation, such as abdominoperineal resection; (3) Rectal cancer had distant metastasis or multiple primary colorectal cancer. Finally 208 patients were included in this study. They suffered from rectal cancer and underwent protective stoma in radical surgery after nCRT at our hospital from January 2014 to December 2018. There were 148 males and 60 females with age of (60.5±11.1) years. They were divided into protective transverse colostomy group (n=148) and protective ileostomy group (n=60). The main follow up information included whether the patient has anastomotic leak and the type of leak according to ISREC Grading standard. Besides, stoma opening time, stoma flow, postoperative hospital stay, stoma related complications and postoperative intestinal flora were also collected. Results: A total of 28 cases(13.5%) suffered from anastomotic leak and 26 (92.9%) of them happened in the early stage after surgery (less than 30 days) . As for these early-stage leak, ISREC Grade A happened in 11 cases(42.3%), grade B in 15 cases(57.7%) and no grade C occurred. There was no significant difference in the incidence [12.8% (19/148) vs. 15.0% (9/60) , χ(2)=0.171, P=0.679] or type [Grade A: 5.4%(8/147) vs. 5.1%(3/59); Grade B: 6.8%(10/147) vs. 8.5%(5/59), Z=0.019, P=1.000] of anastomotic leak between the transverse colostomy group and ileostomy group (P>0.05), as well as operation time, postoperative hospital stay, drainage tube removal time or stoma reduction time (P>0.05). There were 10 cases (6.8%) and 24 cases (40.0%) suffering from intestinal flora imbalance in protective transverse colostomy and protective ileostomy group, respectively (χ(2)=34.503, P<0.001). Five cases (8.3%) suffered from renal function injury in the protective ileostomy group, while protective colostomy had no such concern (P=0.002). The incidence of peristomal dermatitis in the protective colostomy group was significantly lower than that in the protective ileostomy group [12.8% (9/148) vs. 33.3%(20/60), χ(2)=11.722, P=0.001]. Conclusions: It is equally feasible and effective for rectal cancer patients after nCRT to carry out protective transverse colostomy or ileostomy in radical surgery. However, we should pay more attention to protective ileostomy patients, as they are at high risk of intestinal flora imbalance, renal function injury and peristomal dermatitis.

Protective ileostomy does not prevent anastomotic leakage after anterior resection of rectal cancer.

OBJECTIVE: To explore whether protective ileostomy is beneficial in preventing anastomotic leakage after anterior resection of rectal cancer. METHODS: A total of 347 patients underwent anterior resection of rectal cancer in our hospital. Ninety-five patients were treated with protective ileostomy (treatment group), and 252 patients were not (control group). The incidences of anastomotic leakage and permanent stoma were compared between the two groups. RESULTS: The overall incidences of anastomotic leakage were 6.32% (6/95) and 8.73% (22/252) in the treatment group and control group, respectively. In the cohort of patients who underwent neoadjuvant radiotherapy, the incidence of anastomotic leakage was 5.88% (2/34) and 12.0% (3/25) in the treatment group and control group, respectively. Logistic regression showed that the incidence of anastomotic leakage was not statistically significant. However, diabetes and the anastomotic height significantly affected the occurrence of anastomotic leakage. The permanent stoma rate was 6.42% (6/95) and 5.95% (15/252) in the treatment group and control group, respectively. CONCLUSION: Protective ileostomy did not show a significant advantage in reducing the incidence of postoperative anastomotic leakage in patients with rectal cancer, and it may lead to a permanent stoma.

Diverting ileostomy in laparoscopic rectal cancer surgery: high price of protection.

BACKGROUND: Anastomotic leakage presents the most feared complication after low anterior resection (LAR). A proximal diversion of the gastrointestinal tract is recommended to avoid septic complications of anastomotic leakage. The aim of the present study was to evaluate the benefits and risks of diverting ileostomy (DI) created during laparoscopic LAR because of low rectal cancer. METHODS: This was a retrospective clinical cohort study conducted to assess outcomes of laparoscopic LAR with/without DI in a single institution within a 6-year period. RESULTS: In total, 151 patients were enrolled in the study (73 patients without DI, 78 patients with DI). There were no significant differences between both groups regarding demographic and clinical features. Overall 30-day morbidity rates were significantly lower in patients without DI (23.3 vs. 42.3 %, P = 0.013). Symptomatic anastomotic leakage occurred more frequently in patients without DI (9.6 vs. 2.5 %, P = 0.090); surgical intervention was needed in 6.8 % of patients without DI. Post-operative hospital stay was significantly longer in the group of patients with DI (11.3 ± 8.5 vs. 8.1 ± 6.9 days, P = 0.013). Stoma-related complications occurred in 42 of 78 (53.8 %) patients with DI; some patients had more than one complication. Acute surgery was needed in 9 patients (11.5 %) because of DI-related complications. Small bowel obstruction due to DI semi-rotation around its longitudinal axis was seen in 3 patients (3.8 %) and presents a distinct complication of DI laparoscopic construction. The mean interval between LAR and DI reversal was more than 8 months; only 19.2 % of patients were reversed without delay (≤4 months). Morbidity after DI reversal was 16.6 %; re-laparotomy was necessary in 2.5 % of patients. CONCLUSIONS: The present study indicates that DI protects low rectal anastomosis from septic complications at a cost of many stoma-related complications, substantial risk of acute surgery necessity and long stoma periods coupled with decreased quality of life.

Presentation and management of rectovaginal fistulas after delivery.

INTRODUCTION: Obstetric trauma leading to rectovaginal fistula (RVF) formation results from perineal laceration and/or from prolonged ischemia and necrosis following obstructed labor. Due to modern obstetric care fistulas are rare in industrialized countries. METHODS: Patients undergoing surgery for a RVF between January 2005 and December 2014 at the Department of Obstetrics and Gynecology, Tuebingen, Germany, were identified and their records were reviewed retrospectively. RESULTS: Of 48 patients, 13 developed RVF of obstetric etiology. Parity ranged from 2 to 4. RVF repair was performed in all patients using a transvaginal approach: fistula excision and multilayer closure (7 of 13) with Martius flap interposition (1 of 7) and sphincteroplasty (5 of 13). One RVF closed spontaneously. Due to significant destruction of the anal canal, large RVF and RVF recurrence, 4 of the 13 patients needed a temporary protective ileostomy. Fistula closure was achieved in 12 of 13 patients. CONCLUSION: The choice of RVF repair should be tailored to the underlying pathology and type of repair done previously and the patient's wishes.

Increased postoperative complications after protective ileostomy closure delay: An institutional study.

AIM: To study the morbidity and complications associated to ileostomy reversal in colorectal surgery patients, and if these are related to the time of closure. METHODS: A retrospective analysis of 93 patients, who had undergone elective ileostomy closure between 2009 and 2013 was performed. Demographic, clinical and surgical variables were reviewed for analysis. All complications were recorded, and classified according to the Clavien-Dindo Classification. Statistical univariate and multivariate analysis was performed, setting a P value of 0.05 for significance. RESULTS: The patients had a mean age of 60.3 years, 58% male. The main procedure for ileostomy creation was rectal cancer (56%), and 37% had received preoperative chemo-radiotherapy. The average delay from creation to closure of the ileostomy was 10.3 mo. Postoperative complications occurred in 40% of the patients, with 1% mortality. The most frequent were ileus (13%) and wound infection (13%). Pseudomembranous colitis appeared in 4%. Increased postoperative complications were associated with delay in ileostomy closure (P = 0.041). Male patients had more complications (P = 0.042), mainly wound infections (P = 0.007). Pseudomembranous colitis was also associated with the delay in ileostomy closure (P = 0.003). End-to-end intestinal anastomosis without resection was significantly associated with postoperative ileus (P = 0.037). CONCLUSION: Although closure of a protective ileostomy is a fairly common surgical procedure, it has a high rate of complications, and this must be taken into account when the indication is made. The delay in stoma closure can increase the rate of complications in general, and specifically wound infections and colitis.

Routine barium enema prior to closure of defunctioning ileostomy is not necessary.

PURPOSE: The use of barium enemas to confirm the anastomotic integrity prior to ileostomy closure is still controversial. The purpose of the study was to determine the utility of routine contrast enema prior to ileostomy closure and its impact on patient management in patients with a low pelvic anastomosis. METHODS: One hundred forty-five patients had a temporary loop ileostomy constructed to protect a low colorectal or coloanal anastomosis following low anterior resection for rectal cancer. All patients were evaluated by physical examination, proctoscopy, and barium enema prior to ileostomy closure. RESULTS: The median time from ileostomy creation to closure was 8 months. Five (3.5%) of the 144 patients were found to have clinically relevant strictures at the colorectal anastomosis on routine barium enema. One patient (0.7%) showed anastomotic leak on their barium enema. Overall, 141 patients (97.9%) had an uncomplicated postoperative course. Postoperative complication occurred in three patients (2.1%). None of them showed abnormal barium enema finding, which suggested that routine contrast enema examination did not predict postoperative complication. CONCLUSION: Routine barium enema evaluation of low pelvic anastomoses before loop ileostomy closure did not provide any additional information for postoperative colorectal anastomotic complication.

Routine barium enema prior to closure of defunctioning ileostomy is not necessary / 대한외과학회지

PURPOSE: The use of barium enemas to confirm the anastomotic integrity prior to ileostomy closure is still controversial. The purpose of the study was to determine the utility of routine contrast enema prior to ileostomy closure and its impact on patient management in patients with a low pelvic anastomosis. METHODS: One hundred forty-five patients had a temporary loop ileostomy constructed to protect a low colorectal or coloanal anastomosis following low anterior resection for rectal cancer. All patients were evaluated by physical examination, proctoscopy, and barium enema prior to ileostomy closure. RESULTS: The median time from ileostomy creation to closure was 8 months. Five (3.5%) of the 144 patients were found to have clinically relevant strictures at the colorectal anastomosis on routine barium enema. One patient (0.7%) showed anastomotic leak on their barium enema. Overall, 141 patients (97.9%) had an uncomplicated postoperative course. Postoperative complication occurred in three patients (2.1%). None of them showed abnormal barium enema finding, which suggested that routine contrast enema examination did not predict postoperative complication. CONCLUSION: Routine barium enema evaluation of low pelvic anastomoses before loop ileostomy closure did not provide any additional information for postoperative colorectal anastomotic complication.