Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01702116 |
Recruitment Status
: Unknown
Verified April 2013 by Roberto Bergamaschi, Stony Brook University.
Recruitment status was: Recruiting
First Posted
: October 5, 2012
Last Update Posted
: April 25, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rectal Adenocarcinoma | Procedure: extralevator APR Procedure: APR | Not Applicable |
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 |
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
|
- measurement of circumferential resection margin [ Time Frame: 0-10 minutes post surgery ]Measurement in millimeters (mm) of the circumferential resection margin.
- operative time [ Time Frame: 4-6 hours ]operative time from skin incision to skin closure
- 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)
- estimated blood loss [ Time Frame: 4-6 hours ]estimated blood loss (ml) recorded by the anesthesiologist (not by the surgeon)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01702116
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 |
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 |
Principal Investigator: | Roberto Bergamaschi, MD, PhD | Stony Brook University Medical Center |
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 Key Record Dates |
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 |