Clinical Trials Directory

Trials / Completed

CompletedNCT02997267

Early Closure of Protective Ileostomy in Rectal Cancer Patients

The Early Closure of the Protective Ileostomy After Low Anterior Resection Enables Correct Start of Chemotherapy

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
58 (actual)
Sponsor
Stanley Dudrick's Memorial Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREClosure of the ileostomySurgical closure of the protective ileostomy (reconnection of intestinal loops)

Timeline

Start date
2016-10-01
Primary completion
2017-03-01
Completion
2017-12-31
First posted
2016-12-20
Last updated
2018-04-03

Locations

1 site across 1 country: Poland

Source: ClinicalTrials.gov record NCT02997267. Inclusion in this directory is not an endorsement.