Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma

Not Applicable

• Conditions: Rectal Adenocarcinoma
• Interventions: Procedure: extralevator APR; Procedure: APR

• Registration Number: NCT01702116
• Lead Sponsor: Stony Brook University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-08-11
• Study First Submitted QC: 2012-10-04
• Study First Posted: 2012-10-05
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-23
• Last Update Posted: 2013-04-25
• Primary Completion: 2013-07
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Resectable, histologically proven primary adenocarcinoma of the low rectum with internal and/or external sphincter muscle involvement. Staged as follows prior to neoadjuvant chemoradiation:
• Stage T3 or T4 at MRI
• N0-2 at MRI
• M0 at CT scan
• Patient must undergo long term neoadjuvant chemoradiation: 20 fractions of radiation over ≥5 weeks: total of 50-60 Gy, and chemotherapeutic agents

Exclusion Criteria

• Squamous cell carcinoma
• Adenocarcinoma Stage T1-2, any N
• T4 with one of the following:

with pelvic side wall involvement requiring sacrectomy requiring prostatectomy (partial or total) Distant metastasis (M1) Unresectable primary rectal cancer or Inability to complete R0 resection. Recurrent rectal cancer Previous pelvic malignancy Inability to sign informed consent Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
extralevator APR	extralevator APR	This is a modified and more extensive procedure that is used 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.
standard APR	APR	conventional abdominoperineal resection (APR)

Primary Outcome Measures

Name	Time	Method
measurement of circumferential resection margin	0-10 minutes post surgery	Measurement in millimeters (mm) of the circumferential resection margin.

Secondary Outcome Measures

Name	Time	Method
operative time	4-6 hours	operative time from skin incision to skin closure
hospital stay	from beginning of surgery through discharge, usually 4-5 days	duration of hospital stay (defined as from beginning of surgery to time of discharge, measured in hours)
estimated blood loss	4-6 hours	estimated blood loss (ml) recorded by the anesthesiologist (not by the surgeon)

Trial Locations

Locations (3)

State University Hospital Medical Center; 🇺🇸 Stony Brook, New York, United States

Stony Broook University Medical Center; 🇺🇸 Stony Brook, New York, United States

Stony Brook University Medical Center; 🇺🇸 Stony Brook, New York, United States