---
title: Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy
nct_id: NCT05745909
overall_status: COMPLETED
phase: NA
sponsor: Republican Clinical Oncological Dispensary, Ministry of Health of the Republic of Bashkortostan
study_type: INTERVENTIONAL
primary_condition: Rectal Neoplasms
countries: Russia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05745909.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05745909"
ct_last_update_post_date: 2024-09-19
last_seen_at: "2026-05-12T07:23:32.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy

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

**NCT ID:** [NCT05745909](https://clinicaltrials.gov/study/NCT05745909)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 150
- **Lead Sponsor:** Republican Clinical Oncological Dispensary, Ministry of Health of the Republic of Bashkortostan
- **Conditions:** Rectal Neoplasms, Ostomy, Neoplasms
- **Start Date:** 2023-03-01
- **Completion Date:** 2024-07-30
- **CT.gov Last Update:** 2024-09-19

## Brief Summary

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

## Detailed Description

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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 79 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Loop transverse colostomy** (ACTIVE_COMPARATOR) — Laparoscopic or open low-anterior resection of the rectum with total mesorectal excision and created loop transverse colostomy
- **Loop ileostomy** (EXPERIMENTAL) — Laparoscopic or open low-anterior resection of the rectum with total mesorectal excision and created loop ileostomy

## Interventions

- **Laparoscopic or open low-anterior resection of the rectum with TME and created loop transverse colostomy** (PROCEDURE) — 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.
- **Laparoscopic or open low-anterior resection of the rectum with TME and created loop ileostomy** (PROCEDURE) — 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.

## Primary Outcomes

- **SSI** _(time frame: 60 days after surgery)_ — incidence of stoma site infections
- **Ileus** _(time frame: 60 days after surgery)_ — incidence of stoma dysfunction

## Secondary Outcomes

- **Readmission rate** _(time frame: within the first 60 days after surgery)_
- **Length of hospital stay** _(time frame: From date of surgery until the date of discharge, assessed up to 60 days)_
- **Time to stoma closure** _(time frame: within the first 6 months days after surgery)_
- **Time to first stool** _(time frame: 60 days after surgery)_
- **Time to adjuvant postoperative chemotherapy** _(time frame: within the first 2 months days after surgery)_
- **Quality of life in patients with ostomy** _(time frame: within the first 60 days after surgery)_

## Locations (1)

- Republican clinical oncological dispencery, Ufa, Bashkortostan Republic, Russia

## Recent Field Changes (last 30 days)

- `design.phases` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.republican clinical oncological dispencery|ufa|bashkortostan republic|russia` — added _(2026-05-12)_

---

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