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Diverting loop ileostomy has become routine in low anterior resection (LAR) for rectal cancer. The optimal time for stoma reversal is controversial. The aim of the present study was to compare the results after planned early (within 8–12 days) versus late (> 3 months) stoma reversal. The primary outcomes were morbidity and mortality, as measured by the Comprehensive Complication Index (CCI) within 30 days after stoma reversal, and the secondary outcomes were morbidity and mortality within 90 days after LAR. This was a multicentre trial including all patients scheduled for anterior low resection for rectal cancer with curative intent. Inclusion period was from April 2011 to December 2018. All patients were randomized 1:1 prior to surgery. Among 257 consecutive and eligible patients, a total of 214 patients were randomized: 107 patients to early stoma reversal and 107 to late reversal. A total of 68 patients were excluded for various reasons, and 146 patients completed the study, with 77 in the early reversal group and 69 in the late reversal group. The patients were asked to complete the Gastrointestinal Quality of Life Index before surgery (baseline) and at 6 and 12 months after LAR. Ostomy-related complications were evaluated by dedicated ostomy staff using the validated DET score. ClinicalTrials Identifier: NCT01865071. Fifty-three patients (69%) in the early reversal group and 60 patients (87%) in the late reversal group received the intended treatment. There were no significant differences in CCI within 90 days after index surgery with the LAR and within 30 days after stoma reversal between the two groups. There were no differences in patient-reported quality of life but significantly more stoma-related complications in the late reversal group. A total of 5 patients experienced anastomotic leakage (AL) after stoma reversal, 4 in the early reversal group and one in the late reversal group. Early and late stoma reversal showed similar outcomes in terms of overall complications and quality of life. The risk of developing anastomotic leakage after early ostomy reversal is a concern.

Background Protective stoma after rectal surgery has been associated with important complications. The most common is surgical site infection (SSI) high rates after stoma reversal reported in literature. Our study compared the rate of SSI of two skin closure techniques, linear closure, and purse string closure. Methods We carried out a single center, prospective, randomized controlled trial in the Department of Colorectal Surgery of Fondazione Policlinico Campus Bio-Medico of Rome between January 2018 through December 2021, to compare LC vs PS closure of ileostomy sites. Results A total of 117 patients (53.84% male) with a mean age of 65.68 ± 14.33 years were finally evaluated in the study. 58 patients were included in the PS group and 59 patients in the LC one. There was a marked difference in the SSI rate between the two arms of the study: 3 of 58 patients in the purse-string arm versus 11 of 59 in the control arm ( p  = 0.043). The outcome of cosmesis was also higher in PS, with a statistical significance (mean ± DS 4,01 ± 0,73 for PS group vs mean ± DS 2,38 ± 0,72 for LC group, p  < 0,001). Conclusion Our study demonstrated that the PS technique had a significantly lower incidence of stoma site SSI compared with LC technique. Our findings are in line with other randomized studies and suggest that PS closure could be considered as standard of care for wound closure after ileostomy reversal.

Purpose The objective of the current pilot trial was to evaluate whether ghost ileostomy is a safe alternative to the current standard of care in terms of a conventional loop ileostomy in patients undergoing low anterior resection with total mesorectal excision (LAR/TME) for rectal cancer. Methods This randomized controlled pilot trial included patients undergoing LAR/TME, randomly assigning them to ghost ileostomy or conventional loop ileostomy intraoperatively. Follow-up spanned 6 months, evaluating the following endpoints: comprehensive complication index (CCI), postoperative morbidity, transformation of ghost ileostomy, presence of ostomy at 6 months, Wexner score, and quality of life (EORTC QLQ-C30 & CR29). Exploratory statistical analysis based on the intention-to-treat principle was conducted. Results Recruiting 30 patients from May 2018 to September 2022, the trial was prematurely stopped due to slow recruitment. The mean CCI was comparable between groups at any point of time (at 6 months: 30.7 vs. 29.7, p = 0.889). There was no mortality and no need for creation of a terminal ostomy. Anastomotic leakage rates were similar in ghost ileostomy and loop ileostomy groups (p > 0.99). The ghost ileostomy was converted into a conventional loop ileostomy in 6 of 15 (40.0%) patients. Neither postoperative function, nor the overall quality of life showed significant differences. Conclusion Ghost ileostomy appears as a viable and safe option for selectively deciding ileostomy creation in LAR/TME for rectal cancer. However, challenges in patient selection, excluding those at high risk for anastomotic leakage, limit widespread application and call for optimization in future research. Trial-registration German Clinical Trials Register ( https://drks.de/ ): DRKS00013997; date of registration: April 9th 2018.

IntroductionThe objective of this study was to evaluate the impact of preoperative bowel stimulation on the development of postoperative ileus (POI) after loop ileostomy closure.MethodsThis was a multicenter, randomized controlled trial (NCT025596350) including adult (≥ 18 years old) patients who underwent elective loop ileostomy closure at 7 participating hospitals. Participants were randomly assigned (1:1) using a centralized computer-generated sequence with block randomization to either preoperative bowel stimulation or no stimulation (control group). Bowel stimulation consisted of 10 outpatient sessions within the 3 weeks prior to ileostomy closure and was performed by trained Enterostomal Therapy nurses. The primary outcome was POI, defined as an intolerance to oral food in the absence of clinical or radiological signs of obstruction, on or after postoperative day 3, that either (a) required nasogastric tube insertion; or (b) was associated with two of the following: nausea/vomiting, abdominal distension, or the absence of flatus.ResultsBetween January 2017 and November 2020, 101 patients were randomized, and 5 patients never underwent ileostomy closure; thus, 96 patients (47 stimulated vs. 49 control) were analyzed according to a modified intention-to-treat protocol. Baseline characteristics were well balanced in both groups. The incidence of POI was lower among patients randomized to stimulation (6.4% vs. 24.5%, p = 0.034; unadjusted RR: 0.26, 95% CI 0.078–0.87). Stimulated patients also had earlier median time to first flatus (2.0 days (1.0–2.0) vs. 2.0 days (2.0–3.0), p = 0.025), were more likely to pass flatus on postoperative day 1 (46.8% vs. 22.4%, p = 0.022), and had a shorter median postoperative hospital stay (3.0 days (2.0–3.5) vs. 4.0 days (2.0–6.0), p = 0.003).ConclusionsPreoperative bowel stimulation via the efferent limb of the ileostomy reduced POI after elective loop ileostomy closure.

Background The value of a bridge in loop ileostomies is debated. We aimed to evaluate whether using a bridge when creating a loop ileostomy can reduce morbidity following an ileostomy. Methods Patients who had a loop ileostomy after elective colorectal surgery from January 2016 to July 2022 were randomized in this multicenter phase 2 randomized superiority trial. The primary endpoint was the absence of postoperative stomal complications at 2 months and was assessed in a blinded fashion by a stoma therapist. Secondary endpoints were morbidity at 1 month and the STOMA-QOL score at 2 months. Results During the study period, 67 patients were randomized to the bridge group and 63 to the no-bridge group. Epidemiological and perioperative data did not differ between the two groups. The stomal complication-free rate was 76% in the bridge group and 67% in the no-bridge group ( p  = 0.3). There was no difference in the distribution of complications at 1 month according to the Clavien–Dindo score ( p  = 0.2) or the STOMA-QOL score at 2 months ( p  = 0.4) between the two groups. Conclusion The bridge does not reduce the rate of stomatal complications, nor does it appear to reduce patients’ quality of life. Trial registration number NCT02756273 (May 10, 2016).

BackgroundProphylactic ileostomy plays a critical role in the radical resection of low rectal cancer, but the incidence of stoma site incisional hernia (SSIH) after stoma closure remains high. No study has been reported in which radiomics has been used to predict SSIH. The primary aim of this study is to evaluate the safety and efficacy of biological mesh in preventing incisional hernia in patients with high-risk incisional hernia factors, as identified by image-based deep learning model, undergoing ileostomy closure surgery.Methods and analysis40 patients who need to undergo ileostomy closure and have been identified with high risk factors for SSIH by image-based deep learning model will be selected for this study. Patients will be randomly assigned equally to the prophylactic biological mesh placement group and the control group, and outcomes will be tracked via clinic review at 1 month, 3 months, 6 months and 12 months postoperatively. The outcome measures are the rate of postoperative incisional hernia, local pain, incisional infection, seroma and so on. This study demonstrates that prophylactic placement of biological mesh with ileostomy closure reduces the incidence of SSIH. Furthermore, it validates the feasibility of image-based deep learning models in predicting postoperative complications and identifying high-risk SSIH patients.Ethics and disseminationInformed consent has been obtained from all subjects. This protocol has been approved by the Ethics Committee of Renji Hospital, Shanghai Jiao Tong University School of Medicine (KY2022-087-B). The findings will be disseminated through peer-reviewed manuscripts, reports and presentations.Trial registration numberChiCTR2200064995. Registration date: October 2022. Registration authority: Chinese Clinical Trial Registry.

BackgroundEarly ileostomy closure (EIC), ≤ 2 weeks from creation, is a relatively new practice. Multiple studies have demonstrated that this approach is safe, feasible, and cost-effective. Despite the demonstrated benefits, this is neither routine practice, nor has it been studied, in North America. This study aimed to assess patient and surgeon perspectives about EIC.MethodsA mixed-methods, cross-sectional study of patients and surgeons was performed. Rectal cancer survivors from a single institution who underwent restorative proctectomy with diverting loop ileostomy and subsequent closure within the last 5 years were contacted. North American surgeons with high rectal cancer volumes (> 20 cases/year) were included. Surveys (patients) and semi-structured interviews (surgeons) were conducted. Analysis employed descriptive statistics and thematic analysis, respectively.ResultsForty-eight patients were surveyed (mean age 65.1 ± 11.8 years; 54.2% male). Stoma closure occurred after a median of 7.7 months (IQR 4.8–10.9) and 50.0% (24) found it “difficult” or “very difficult” to live with their stoma. Patients considered improvement in quality of life and quicker return to normal function the most important advantages of EIC, whereas the idea of two operations in two weeks being too taxing on the body was deemed the biggest disadvantage. Most patients (35, 72.9%) would have opted for EIC. Surgeon interviews (15) revealed 4 overarching themes: (1) there are many benefits to EIC; (2) specific patient characteristics would make EIC an appropriate option; (3) many barriers to implementing EIC exist; and (4) many logistical hurdles need to be addressed for successful implementation. Most surgeons (12, 80.0%) would “definitely want to participate” in a North American randomized-controlled trial (RCT) on EIC for rectal cancer patients.ConclusionsImplementing EIC poses many logistical challenges. Both patients and surgeons are interested in further exploring EIC and believe it warrants a North American RCT to motivate a change in practice.

IntroductionLoop ileostomy and loop colostomy are both used to form a protective stoma after anterior resection. Evidence regarding which of these two procedures is superior is lacking. Furthermore, no studies comparing changes in the microbiome after loop ileostomy or loop colostomy exist.Methods and analysisThis multicentre, open-label, superiority, individually randomised controlled trial will include patients who undergo anterior rectal resection with primary anastomosis with a protective stoma. The exclusion criteria are patients who already have a stoma, technical inability to create either type of stoma, aged <18 years and inadequate cooperation. Patients scheduled for anterior rectal resection will be randomised intraoperatively in a 1:1 ratio to undergo either loop ileostomy or loop colostomy. The primary outcome is cumulative stoma-related adverse events within 60 days after primary surgery, measured using the Comprehensive Complication Index (CCI). Secondary outcomes include all postoperative complications (measured using the CCI), number of hospital-free days within 30 days after primary surgery, quality of life at 2 months (measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires-Core 30 and Colorectal 29), complications within 30 days after stoma closure (measured using the CCI) and kidney function (measured using estimated glomerular filtration rate) at 1 year. Tertiary outcomes are survival, kidney function and number of stoma site hernias at 5 years. The sample size was calculated to detect a mean difference of five CCI points between groups, resulting in a final sample size of 350 patients. Microbiome samples will be collected from the faeces and mucous membrane from patients in Helsinki University Hospital.Ethics and disseminationThe Ethics Committee of Helsinki University Hospital approved the study (approval number 4579/2024). The findings will be disseminated in peer-reviewed academic journals.Trial registrationClinicalTrials.gov, NCT06650085, registered on 20 August 2024. Protocol version: Version 3.0, dated 17 April 2025.

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.

BackgroundLaparoscopic ileostomy closure with intracorporeal anastomosis offers potential advantages over open reversal with extracorporeal anastomosis, including earlier return of bowel function and reduced postoperative pain. In this study, we aim to compare the outcome and cost of laparoscopic ileostomy reversal (utilizing either intracorporeal or extracorporeal anastomosis) with open ileostomy reversal.MethodsA retrospective review of sequential patients undergoing elective loop ileostomy reversal between 2013 and 2016 at a single, high-volume institution was performed. Patients were stratified on the basis of operative approach: open reversal, laparoscopic-assisted reversal with extracorporeal anastomosis (LE), and laparoscopic reversal with intracorporeal anastomosis (LI). Linear and logistic regressions were utilized to perform multivariate analysis and determine risk-adjusted outcomes.ResultsOf 132 sequential cases of loop ileostomy reversal, 50 (38%) underwent open, 49 (37%) underwent LE, and 33 (22%) underwent LI. Demographic data and preoperative comorbidities were similar between the three cohorts. Median length of stay was significantly shorter for LI (52.1 h, p < 0.05) compared to open (69.0 h) and LE (69.6 h). After risk-adjusted analysis, length of stay was significant shorter in LI compared to LE (GM 0.78, 95% CI 0.64–0.93, p < 0.01) and open reversal (GM 0.78, 95% CI 0.66–0.93, p < 0.01). Risk-adjusted 30-day morbidity rates were similar for LI compared to LE (OR 0.43, 95% CI 0.081–2.33, p = 0.33) and open reversal (OR 0.53, 95% CI 0.09–3.125, p = 0.48). Median in-hospital direct cost was similar for LI ( $6575.00), LE ($ 6722.50), and open reversal ($6181.00).ConclusionLaparoscopic ileostomy reversal with intracorporeal anastomosis was associated with shorter length of stay without increased overall direct cost. The technique of laparoscopic ileostomy reversal warrants continued study in a randomized clinical trial.