Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Rectal Adenocarcinoma	Procedure: extralevator APR; Procedure: APR	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	34 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Multicenter Randomized Controlled Trial, Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma
Study Start Date :	July 2011
Estimated Primary Completion Date :	July 2013
Estimated Study Completion Date :	July 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 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.	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.
Active Comparator: standard APR; conventional abdominoperineal resection (APR)	Procedure: APR; standard Abdominoperineal Resection For Rectal Adenocarcinoma

Outcome Measures

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Primary Outcome Measures :

1. measurement of circumferential resection margin [ Time Frame: 0-10 minutes post surgery ]
   Measurement in millimeters (mm) of the circumferential resection margin.

Secondary Outcome Measures :

1. operative time [ Time Frame: 4-6 hours ]
   operative time from skin incision to skin closure
2. hospital stay [ Time Frame: 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)
3. estimated blood loss [ Time Frame: 4-6 hours ]
   estimated blood loss (ml) recorded by the anesthesiologist (not by the surgeon)

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Roberto Bergamaschi, MD, PhD	631-444-2704	rbergamaschi@notes.cc.sunysb.edu
Contact: Eileen Finnin, RN	631-444-5454	efinnin@notes.cc.sunysb.edu

Locations

United States, New York
State University Hospital Medical Center	Recruiting
Stony Brook, New York, United States, 11794-8191
Contact: Roberto Bergamaschi, MD, PhD 631-444-2704 rbergamaschi@notes.cc.sunysb.edu
Contact: Paula Denoya, MD 631-444-3431 pdenoya@notes.cc.sunysb.edu
Sub-Investigator: Paula Denoya, MD
Stony Broook University Medical Center	Recruiting
Stony Brook, New York, United States, 11794-8191
Contact: Roberto Bergamaschi, MD, PhD 631-444-2704 rbergamaschi@notes.cc.sunysb.edu
Contact: Paula Denoya, MD 631-444-3431 pdenoya@notes.cc.sunysb.edu
Sub-Investigator: Paula Denoya, MD
Sub-Investigator: Kenneth Shroyer, MD
Stony Brook University Medical Center	Recruiting
Stony Brook, New York, United States, 11794
Contact: Roberto Bergamaschi, MD, PhD 631-444-2704 rbergamaschi@notes.cc.sunysb.edu
Principal Investigator: Roberto Bergamaschi, MD, PhD
Sub-Investigator: Paula Denoya, MD
Sub-Investigator: Sami Khan, MD
Sub-Investigator: Meenakshi Singh, MD
Sub-Investigator: Kenneth Shroyer, MD
Stony Brook University Medical Center	Recruiting
Stony Brook, New York, United States, 11794
Contact: Roberto Bergamaschi, MD, PhD 631-444-2704 rbergamaschi@notes.cc.sunysb.edu
Principal Investigator: Roberto Bergamaschi, MD, PhD
Sub-Investigator: Paula Denoya, MD
Sub-Investigator: Sami Khan, MD
Sub-Investigator: Meenakshi Singh, MD

Sponsors and Collaborators

Stony Brook University

Investigators

Principal Investigator:	Roberto Bergamaschi, MD, PhD	Stony Brook University Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Roberto Bergamaschi, Professor and Chief, Colon and Rectal Surgery, Stony Brook University
ClinicalTrials.gov Identifier:	NCT01702116 History of Changes
Other Study ID Numbers:	APR2011
First Posted:	October 5, 2012
Last Update Posted:	April 25, 2013
Last Verified:	April 2013

Keywords provided by Roberto Bergamaschi, Stony Brook University:

rectal adenocarcinoma; Standard APR; Extralevator APR

Additional relevant MeSH terms:

Adenocarcinoma; Rectal Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms	Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases