The Early Closure of the Protective Ileostomy After Low Anterior Resection Enables Correct Start of Chemotherapy
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
Stanislaw Klek
Head of the Department
Stanley Dudrick's Memorial Hospital
