PReventive cOlostomy vs Ileostomy in Low anTErior reCTal Resection

NCT ID: NCT04357171

Last Updated: 2020-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-14
• Study Completion Date: 2020-02-02

Brief 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.

Detailed Description

Modern surgery for the rectal cancer is featured by sphincter-preserving operations. It is proved that colorectal anastomosis leakage is severe and, in some cases, lethal complication that reduces quality of life of patients and increases the risk of disease reccurence.

The presence of preventive stoma is an effective way to avoid this complication that is why it's included to treatment protocols for the middle and low ampullary rectal cancers is undisputed by the most of surgeons. However, the type of preventive stoma is under discussion yet and remains to be an urgent issue.

The majority of large meta-analyzes demonstrates that preventive ileostomy is used more often for the protection of low colorectal anastomoses. In the western countries the preferred method is double barreled ileostomy due to more rapid formation and closure, as well as due to lower rate of stoma-related morbidity.

In Russia and CIS countries the double-barreled transverse colostomy is a preferred method of defuction of low colorectal anastomosis due to lower rate of electrolytic disorders and related hospital admissions, along with series of unproven advantages.

Presented study will allow to reveal the early and late postoperative morbidity rate and the related hospital re-admissions in real-life clinical practice of Russia from the standpoints of evidence- based medicine, to define indications and contraindications for each type of "low" colorectal anastomosis protection with the least risk for the patient.

Conditions

Rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ileostomy

Loop protective ileostomy as a defunction mean after low anterior resection with D3 lymphnode dissection

Group Type: ACTIVE_COMPARATOR

Low anterior resection with protective loop ileostomy

Intervention Type: PROCEDURE

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.

Colostomy

Loop protective transverse colostomy as a defunction mean after low anterior resection with D3 lymphnode dissection

Group Type: ACTIVE_COMPARATOR

Low anterior resection with protective loop transverse colostomy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Mid- and low rectal cancer
• Age ≧ 18
• TME
• ASA ≦ 3
• No previous stoma formation
• Informed consent for participation

Exclusion Criteria

• Patients lost during the follow-up
• Refusal of the patient from further participation in the study
• Inability of stoma formation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Russian Society of Colorectal Surgeons

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Petr Tsarkov

Role: PRINCIPAL_INVESTIGATOR

Clinic of Colorectal and Minimally Invasive Surgery

Inna Tulina

Role: STUDY_CHAIR

Clinic of Colorectal and Minimally Invasive Surgery

Other Identifiers

5

Identifier Type: -

Identifier Source: org_study_id