Trials / Completed
CompletedNCT00238381
Rectal Reconstruction in Treating Patients Who Are Undergoing Surgery for Rectal Cancer
Clinical Function After Total Mesorectal Excision and Rectal Replacement. A Prospective Randomized Trial Comparing Side-to-End Anastomosis, Colon-J-Pouch and Straight Coloanal Anastomosis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 336 (actual)
- Sponsor
- Swiss Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Rectal reconstruction after surgery to treat rectal cancer may help patients keep some of their bowel function. It is not yet known which method of rectal reconstruction is most effective after surgery. PURPOSE: This randomized phase III trial is studying three different methods of rectal reconstruction to compare how well they work in treating patients who are undergoing surgery for rectal cancer.
Detailed description
This is a randomized, multicenter study. Patients are stratified according to participating center, gender, distance of the distal tumor margin from the dentate line (\> 5 cm vs ≤ 5 cm), age (\< 70 vs ≥ 70), neoadjuvant chemoradiotherapy (yes vs no), and distant metastasis (M0 vs M1). Patients are randomized to 1 of 3 treatment arms.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | 5 cm colon-J-pouch | 5 cm colon-J-pouch with/without temporary protective ileostomy |
| PROCEDURE | side-to-end anastomosis | side-to-end anastomosis with/without temporary protective ileostomy |
| PROCEDURE | straight coloanal anastomosis | straight coloanal anastomosis with/without temporary protective ileostomy |
Timeline
- Start date
- 2005-07-01
- Primary completion
- 2014-05-01
- Completion
- 2016-08-01
- First posted
- 2005-10-13
- Last updated
- 2019-05-15
Locations
18 sites across 2 countries: Germany, Switzerland
Source: ClinicalTrials.gov record NCT00238381. Inclusion in this directory is not an endorsement.