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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| extralevator APR | Experimental | 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 | Active Comparator | conventional abdominoperineal resection (APR) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| extralevator APR | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| measurement of circumferential resection margin | Measurement in millimeters (mm) of the circumferential resection margin. | 0-10 minutes post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| operative time | operative time from skin incision to skin closure | 4-6 hours |
| hospital stay | duration of hospital stay (defined as from beginning of surgery to time of discharge, measured in hours) |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberto Bergamaschi, MD, PhD | Contact | 631-444-2704 | rbergamaschi@notes.cc.sunysb.edu | |
| Eileen Finnin, RN | Contact | 631-444-5454 | efinnin@notes.cc.sunysb.edu |
| Name | Affiliation | Role |
|---|---|---|
| Roberto Bergamaschi, MD, PhD | Stony Brook University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State University Hospital Medical Center | Recruiting | Stony Brook | New York | 11794-8191 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27369739 | Derived | Bianco F, Romano G, Tsarkov P, Stanojevic G, Shroyer K, Giuratrabocchetta S, Bergamaschi R; International Rectal Cancer Study Group. Extralevator with vs nonextralevator abdominoperineal excision for rectal cancer: the RELAPe randomized controlled trial. Colorectal Dis. 2017 Feb;19(2):148-157. doi: 10.1111/codi.13436. |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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|
| APR | Procedure | standard Abdominoperineal Resection For Rectal Adenocarcinoma |
|
| from beginning of surgery through discharge, usually 4-5 days |
| estimated blood loss | estimated blood loss (ml) recorded by the anesthesiologist (not by the surgeon) | 4-6 hours |
| Stony Broook University Medical Center | Recruiting | Stony Brook | New York | 11794-8191 | United States |
|
| Stony Brook University Medical Center | Recruiting | Stony Brook | New York | 11794 | United States |
|
| Stony Brook University Medical Center | Recruiting | Stony Brook | New York | 11794 | United States |
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |