Clinical trial NCT05745909: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Neoplasms
Ostomy
Neoplasms
Keywords: Rectal cancer
Low anterior resection
Loop transverse colostomy
Loop ileostomy
Stoma site infections
Lead sponsor: Republican Clinical Oncological Dispensary, Ministry of Health of the Republic of Bashkortostan
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 criteria: 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

Primary outcomes:
measure: SSI
timeFrame: 60 days after surgery
measure: Ileus
timeFrame: 60 days after surgery
Secondary outcomes:
measure: Readmission rate
timeFrame: within the first 60 days after surgery
measure: Length of hospital stay
timeFrame: From date of surgery until the date of discharge, assessed up to 60 days
measure: Time to stoma closure
timeFrame: within the first 6 months days after surgery
measure: Time to first stool
timeFrame: 60 days after surgery
measure: Time to adjuvant postoperative chemotherapy
timeFrame: within the first 2 months days after surgery
measure: Quality of life in patients with ostomy
timeFrame: within the first 60 days after surgery
Other outcomes:
Locations:
city: Ufa
country: Russian Federation
facility: Republican clinical oncological dispencery
state: Republic Of Bashkortostan
Study officials:
References: