PReventive cOlostomy vs Ileostomy in Low anTErior reCTal Resection

NCT04357171 | Completed DMC

• 1 other identifier: 5
• Study Type: interventional
• Target: 202
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rectal Cancer

Keywords

colostomy; ileostomy; rectal cancer; low anterior resection

Outcome Measures

Primary Outcomes (1)

• The rate of readmissions due to severe dehydratation

  The percentage of patients who were readmitted to the hospital due to dehydration, that could not be managed in outhospital setting

  6 weeks

Secondary Outcomes (5)

• Early postoperative complications rate

  30 days after the initial procedure

• Late postoperative complications rate

  starting on 31st day and within 6 months in late postoperative period after the initial procedure

• Overall quality of life

  6 and 12 months after the initial procedure

• Time with stoma

  5 years

• The rate of early postoperative complications after stoma closure operation

  3 months after stoma closure

Study Arms (2)

Ileostomy

ACTIVE COMPARATOR

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

Procedure: Low anterior resection with protective loop ileostomy

Colostomy

ACTIVE COMPARATOR

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

Procedure: Low anterior resection with protective loop transverse colostomy

Interventions

Low anterior resection with protective loop ileostomy 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.

Ileostomy

Low anterior resection with protective loop transverse colostomy 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.

Colostomy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Russian Society of Colorectal Surgeons: lead

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Petr Tsarkov

  Clinic of Colorectal and Minimally Invasive Surgery

  PRINCIPAL INVESTIGATOR

• Inna Tulina

  Clinic of Colorectal and Minimally Invasive Surgery

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 22, 2020
• Study Start: January 14, 2012
• Primary Completion: February 2, 2020
• Study Completion: February 2, 2020
• Last Updated: April 22, 2020

Record last verified: 2020-04