Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2013 by Stony Brook University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Stony Brook University
Information provided by (Responsible Party):
Roberto Bergamaschi, Stony Brook University
ClinicalTrials.gov Identifier:
NCT01702116
First received: August 11, 2011
Last updated: April 23, 2013
Last verified: April 2013
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Purpose
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 | Intervention |
|---|---|
|
Rectal Adenocarcinoma |
Procedure: extralevator APR Procedure: APR |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Multicenter Randomized Controlled Trial, Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma |
Further study details as provided by Stony Brook University:
Primary Outcome Measures:
- measurement of circumferential resection margin [ Time Frame: 0-10 minutes post surgery ] [ Designated as safety issue: No ]Measurement in millimeters (mm) of the circumferential resection margin.
Secondary Outcome Measures:
- operative time [ Time Frame: 4-6 hours ] [ Designated as safety issue: No ]operative time from skin incision to skin closure
- hospital stay [ Time Frame: from beginning of surgery through discharge, usually 4-5 days ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]estimated blood loss (ml) recorded by the anesthesiologist (not by the surgeon)
| Estimated Enrollment: | 34 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01702116
Please refer to this study by its ClinicalTrials.gov identifier: NCT01702116
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
| 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 |
| Study First Received: | August 11, 2011 |
| Last Updated: | April 23, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on September 29, 2016