Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Transanal Endoscopic Rectosigmoid Resection with Laparoscopic Assistance was developed at Massachusetts General Hospital and performed successfully to remove cancer of the lower rectum. Based on the outcomes, the research doctors believe that this investigational surgery may be as safe and effective as standard laparoscopic or open surgery performed to remove rectal cancer, may facilitate the operation and reduce the size of the abdominal incisions. In this research study, the investigators are looking to see if this investigational procedure is a safe and effective approach to remove rectal cancer of the mid and lower rectum.
Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. At the end of the procedure, the rectum will be removed though the anus, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transanal endoscopic surgery | Experimental | Laparoscopy-assisted transanal endoscopic rectosigmoid resection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transanal endoscopic surgery | Procedure | Laparoscopy-assisted transanal endoscopic rectosigmoid resection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adequacy of the total mesorectal excision based on standard guidelines on pathologic evaluation of TME specimens. | 1-5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of 30-day perioperative complications including intraoperative, surgical postoperative, and medical postoperative complications. | 1-5 years | |
| Incidence of long-term complications | 1-5 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Patricia Sylla, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23572214 | Result | Sylla P, Bordeianou LG, Berger D, Han KS, Lauwers GY, Sahani DV, Sbeih MA, Lacy AM, Rattner DW. A pilot study of natural orifice transanal endoscopic total mesorectal excision with laparoscopic assistance for rectal cancer. Surg Endosc. 2013 Sep;27(9):3396-405. doi: 10.1007/s00464-013-2922-7. Epub 2013 Apr 10. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000067368 | Transanal Endoscopic Surgery |
| ID | Term |
|---|---|
| D057605 | Natural Orifice Endoscopic Surgery |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Oncologic outcomes in subjects receiving transanal endoscopic rectosigmoid resection | 1-5 years |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003933 | Diagnosis |
| D011351 | Proctoscopy |
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |