Early Closure of Protective Ileostomy in Rectal Cancer Patients (ECPIS)

Stanley Dudrick's Memorial Hospital

Status: Completed

Conditions: Ileostomy - Stoma

Treatments: Procedure: Closure of the ileostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02997267

Zespolenia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Early closure

Experimental group

Description:

Closure of the ileostomy 14 days after the primary operation, in which it was created.

Treatment:

Procedure: Closure of the ileostomy

Late closure

Active Comparator group

Description:

Closure of the ileostomy more than 90 days after the primary operation, in which it was created.

Treatment:

Procedure: Closure of the ileostomy