NCT01702116

Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma

Multicenter Randomized Controlled Trial, Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Stony Brook University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study that compares two types of surgery for rectal cancer. There are two procedures that can be used during this surgery, conventional abdominal resection (APR) and extended (or extralevator) APR. The investigators are doing this research to see whether the extralevator APR increases the likelihood that the edge of the tissue that is removed will be more likely to be free from cancer cells compared with the conventional APR surgery. At this time there is no evidence that one type of procedure is better at this than the other. The objective of this research is to determine whether extralevator APR is more likely to have clean margins (free of cancer) compared to the standard APR surgery.

Conditions

• Rectal Adenocarcinoma

Interventions

Type	Name	Description
PROCEDURE	extralevator APR	Extralevator Abdominoperineal Resection For Rectal Adenocarcinoma. The aim of this modified and more extensive procedure is to remove the levator muscle en bloc with the anal canal and the mesorectum, creating a more "cylindrical" specimen, so that the amount of tissue removed around the tumor will be larger, thereby reducing the probability that the CRM will be positive.
PROCEDURE	APR	standard Abdominoperineal Resection For Rectal Adenocarcinoma

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2012-10-05
• Last updated: 2013-04-25

Locations

4 sites across 1 country: United States