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PReventive cOlostomy vs Ileostomy in Low anTErior reCTal Resection

NCT04357171 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2020-04-22

No results posted yet for this study

Summary

The type of preventive intestinal stoma (colostomy/ileostomy) after low anterior rectal resection rectum is still a debate.

This study purpose is to demonstrate that preventive loop ileostomy is characterized by a higher readmission rate caused by dehydration, in comparison with the loop colostomy.

Conditions

Interventions

PROCEDURE

Low anterior resection with protective loop ileostomy

Nerve-sparing paraaortic lymph node dissection is performed. The inferior mesenteric artery is divided at 1-2 cm from its origin from the aorta or right below left colic artery. Nerve-sparing total mesorectal excision is performed. Side-to-end sigmoido-rectal anastomosis is created. A loop defunctioning ileostomy is performed.

PROCEDURE

Low anterior resection with protective loop transverse colostomy

Nerve-sparing paraaortic lymph node dissection is performed. The inferior mesenteric artery is divided at 1-2 cm from its origin from the aorta or right below left colic artery. Nerve-sparing total mesorectal excision is performed. Side-to-end sigmoido-rectal anastomosis is created. A loop defunctioning transverse colostomy is performed.

Sponsors & Collaborators

  • Russian Society of Colorectal Surgeons

    lead OTHER

Principal Investigators

  • Petr Tsarkov · Clinic of Colorectal and Minimally Invasive Surgery

  • Inna Tulina · Clinic of Colorectal and Minimally Invasive Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-14
Primary Completion
2020-02-02
Completion
2020-02-02

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04357171 on ClinicalTrials.gov