Early Closure of Protective Ileostomy in Rectal Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ileostomy - Stoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early closure

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

Group Type EXPERIMENTAL

Closure of the ileostomy

Intervention Type PROCEDURE

Surgical closure of the protective ileostomy (reconnection of intestinal loops)

Late closure

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

Group Type ACTIVE_COMPARATOR

Closure of the ileostomy

Intervention Type PROCEDURE

Surgical closure of the protective ileostomy (reconnection of intestinal loops)

Interventions

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Closure of the ileostomy

Surgical closure of the protective ileostomy (reconnection of intestinal loops)

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No