Early Closure of Protective Ileostomy in Rectal Cancer Patients

Not Applicable

Completed

• Conditions: Ileostomy - Stoma
• Interventions: Procedure: Closure of the ileostomy

• Registration Number: NCT02997267
• Lead Sponsor: Stanley Dudrick's Memorial Hospital

Brief Summary

The aim of the study was to compare the restoration of the GI tract by the closure of protective ileostomy after low anterior resection for rectal cancer after 14 days and more than 3 months.

Detailed Description

The closure of the protective ileostomy created during the low anterior resection for rectal cancer to protect the colo-rectal anastomosis is inevitable to restore the continuity of the gastrointestinal tract. It usually takes place several months after the primary surgery, because the patients starts chemotherapy and cannot undergo the procedure during the therapy. It results in the relative low quality of life of the patient, as well as often leads to complications. Therefore, it seem reasonable to close the stoma as soon as possible to take the burden off patient.

It is well known that the healing process of the anastomosis runs in the three phases, but only two first are crucial for the clinical result. The second takes place between 5th and 14th postoperative day. Therefore it should be possible to perform successful restoration of the GI tract already after two weeks after operation, and not after many moths.

The aim of the study was to compare the restoration of the GI tract after 14 days and more than 3 months, so to compare the traditional and early strategy.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-12-05
• Study First Submitted QC: 2016-12-19
• Study First Posted: 2016-12-20
• Primary Completion: 2017-03
• Study Completion: 2017-12-31
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-31
• Last Update Posted: 2018-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• more than 18 year old
• the presence of the protective ileostomy created during the low anterior resection to protect the colo-rectal anastomosis

Exclusion Criteria

• the presence of the protective ileostomy created during any other procedure than the low anterior resection to protect the colo-rectal anastomosis
• age < 18 yo

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Late closure	Closure of the ileostomy	Closure of the ileostomy more than 90 days after the primary operation, in which it was created.
Early closure	Closure of the ileostomy	Closure of the ileostomy 14 days after the primary operation, in which it was created.

Primary Outcome Measures

Name	Time	Method
Number of postoperative fistulas	3 months after surgery	number of patients with the fistula of the anastomosis

Secondary Outcome Measures

Name	Time	Method
Timing of anticancer therapy	3 months after surgery	Time to the beginning of adiuvant chemotherapy

Trial Locations

Locations (1)

Stanley Dudrick's Memorial Hospital; 🇵🇱 Skawina, Poland