Early Versus Late Closure of Preventive Ileostomy

Vilnius University

Status: Terminated

Conditions: Ileostomy, Rectal Cancer

Treatments: Procedure: Deileostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03796702

1

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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86 participants in 2 patient groups

Early closure of preventive ileostomy

Experimental group

Description:

A preventive ileostomy is closed 30 days after the primary surgery

Treatment:

Procedure: Deileostomy

Late closure of preventive ileostomy

Experimental group

Description:

A preventive ileostomy is closed 90 days after the primary surgery

Treatment:

Procedure: Deileostomy