Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy

Study Overview
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Brief Summary
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The purpose of this study is to determine which stoma creation technique is preferable after low anterior resection of the rectum.

Detailed Description
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The investigators enroll patients with a histologically confirmed diagnosis of primary rectal cancer with or without prior chemoradiotherapy who were hospitalized at the Ufa Republican Clinical Oncology Center from February 2023 to February 2024. All patients undergo planned laparoscopic or open low-anterior resection of the rectum with total mesorectal excision. Patients are randomized into 2 groups in a 1:1 ratio. In the first group, a loop transverse colostomy is created, and in the second group, a loop ileostomy is created. The stoma exit sites are marked in advance the day before the surgery. The bowels are prepared by mechanical means (a polyethylene glycol-based laxative with a cleansing enema) according to a standard procedure before the surgery. Standardized stoma creation techniques are used. The resected parts are collected through a separate access. Patients are followed up for 60 days after surgery. The sample size should be 124 patients to reach statistical significance (α = 0.05, study power 80%, confidence interval (CI) = 95%.). Considering possible losses during the study, the number of patients was increased to 130. The investigators hypothesis is that the loop ileostomy group has a 20% higher incidence of stoma dysfunction but a 20% lower incidence of SSI (stoma site infections) compared to the loop colostomy group.

Official Title
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Randomized Single Center Clinical Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy in Patients After Major Anterior Resections

Conditions
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Rectal Neoplasms, Ostomy, Neoplasms

Intervention / Treatment
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* Procedure: Laparoscopic or open low-anterior resection of the rectum with TME and created loop transverse colostomy
* Procedure: Laparoscopic or open low-anterior resection of the rectum with TME and created loop ileostomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed adenocarcinoma of the rectum (stages 1-3 according to MRI) ECOG status 0-2, ASA≤3. At least 18 years of age Written informed consent Exclusion Criteria: Emergency surgery; Previously formed stoma; Stage 4 disease; Obstructive resection of the rectum; Patients older than 79 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Loop transverse colostomy<br>Laparoscopic or open low-anterior resection of the rectum with total mesorectal excision and created loop transverse colostomy | Procedure: Laparoscopic or open low-anterior resection of the rectum with TME and created loop transverse colostomy<br>* The loop transverse colostomy is matured without torsion using a plastic retainer. The stoma protrudes 2-3 cm. The loop of the transverse colon is sutured with interrupted sutures using an absorbable 3/0 polyglactin suture without piercing the intestinal wall. The intestinal lumen is opened through a transverse incision on the antimesenteric border.<br>|
| Experimental: Loop ileostomy<br>Laparoscopic or open low-anterior resection of the rectum with total mesorectal excision and created loop ileostomy | Procedure: Laparoscopic or open low-anterior resection of the rectum with TME and created loop ileostomy<br>* The loop ileostomy is matured 25-30 cm from the ileocecal angle without torsion and without a retainer, so that stoma protrudes 2-3 cm. The loop of the ileum is sutured with interrupted sutures using an absorbable 3/0 polyglactin suture without piercing the intestinal wall. The intestinal lumen is opened through a transverse incision on the antimesenteric border.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SSI | incidence of stoma site infections | 60 days after surgery | 
| Ileus | incidence of stoma dysfunction | 60 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission rate | readmission rate | within the first 60 days after surgery | 
| Length of hospital stay | the number of days from surgery to discharge | From date of surgery until the date of discharge, assessed up to 60 days | 
| Time to stoma closure | the number of days from surgery to stoma closure | within the first 6 months days after surgery | 
| Time to first stool | the occurrence of anything other than serous-hemorrhagic contents in the colostomy bag | 60 days after surgery | 
| Time to adjuvant postoperative chemotherapy | the number of days from surgery to hospitalization for first chemotherapy | within the first 2 months days after surgery | 
| Quality of life in patients with ostomy | estimated using EORTC QLQ-CR29 | within the first 60 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low anterior resection, Rectal cancer, Loop transverse colostomy, Loop ileostomy, Stoma site infections