Early Versus Late Closure of Preventive Ileostomy

Vilnius University86 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Ileostomy, Rectal Cancer

Interventions

DeileostomyPROCEDURE

Deileostomy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

National Cancer Institute

Vilnius, Lithuania

Outcomes

Primary Outcomes

Postoperative morbidity

Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.

Time frame: 30 days after surgery

Secondary Outcomes

Hospitalization time after ileostomy closure

Hospitalization time

Time frame: 30 days after surgery

30-days re-admission rate

Re-admission rate during 30 days after re-admission

Time frame: 30 days after surgery

Quality of life of patients after ileostomy closure

Patients quality of life is assessed with EORTC QLQ-C30 questionnaires

Time frame: at 3, 6, 9 and 12 moths after surgery

Data from ClinicalTrials.gov

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