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Clinical Trials/NCT02997267
NCT02997267CompletedNot Applicable

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

Stanley Dudrick's Memorial Hospital2 sites in 1 country58 target enrollmentStarted: October 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
58
Locations
2
Primary Endpoint
Number of postoperative fistulas

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Number of postoperative fistulas

Time Frame: 3 months after surgery

number of patients with the fistula of the anastomosis

Secondary Outcomes

  • Timing of anticancer therapy(3 months after surgery)

Investigators

Sponsor
Stanley Dudrick's Memorial Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Stanislaw Klek

Head of the Department

Stanley Dudrick's Memorial Hospital

Study Sites (2)

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