Early Versus Late Closure of Preventive Ileostomy

Not Applicable

Terminated

• Conditions: Ileostomy, Rectal Cancer

• Registration Number: NCT03796702
• Lead Sponsor: Vilnius University

Brief Summary

The study is designed and performed as a prospective randomized controlled single-center study. Patients who underwent rectal resection with preventive ileostomy due to rectal cancer will be included. The study investigates the effect of reversing a temporary ileostomy after 30 vs 90 days.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-01
• Primary Completion: 2018-11-30
• Study Completion: 2018-12-30
• Study First Submitted: 2018-12-30
• Study First Submitted QC: 2019-01-06
• Study First Posted: 2019-01-08
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• Patients with temporary ileostomy after rectal resection for rectal cancer
• Patients willing to participate in the study

Exclusion Criteria

• Anastomosis insufficiency detected clinically or radiologically.
• Patients, who are physically and mentally unfit to undergo surgery or to be followed-up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative morbidity	30 days after surgery	Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.

Secondary Outcome Measures

Name	Time	Method
Hospitalization time after ileostomy closure	30 days after surgery	Hospitalization time
30-days re-admission rate	30 days after surgery	Re-admission rate during 30 days after re-admission
Quality of life of patients after ileostomy closure	at 3, 6, 9 and 12 moths after surgery	Patients quality of life is assessed with EORTC QLQ-C30 questionnaires

Trial Locations

Locations (1)

National Cancer Institute; 🇱🇹 Vilnius, Lithuania