Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00238381
Status:
COMPLETED
Last Update Posted:
2019-05-15
First Post:
2005-10-12
Brief Title:
Rectal Reconstruction in Treating Patients Who Are Undergoing Surgery for Rectal Cancer
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
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
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20528 | None | None | None |