Adenocarcinoma of the Rectum Clinical Trial
Official title:
A Pilot Study of Laparoscopy-Assisted Transanal Endoscopy Rectosigmoid Resection for Rectal Cancer
Verified date | September 2017 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 5 |
Est. completion date | May 2017 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Biopsy-proven adenocarcinoma of the rectum - Eligible to undergo standard open or laparoscopic low anterior resection with a temporary diverting stoma - Node negative (N0), T1 (high risk features), T2 and T3 rectal cancer on pelvic MRI - Closest distance between tumor edge and mesorectal fascia 5mm or more based on pelvic MRI - Rectal cancer located 4-12 cm from the anal verge - ECOG performance status 2 or less Exclusion Criteria: - Metastasis - Obstructing rectal cancer - Synchronous colon cancer - T3 rectal cancer not treated preoperatively with full-course chemoradiation - Pregnant or breast-feeding - Receiving any other study agents - Fecal incontinence - History of prior colorectal cancer - History of inflammatory bowel disease - History of pelvic radiation - Prior pelvic surgery or multiple abdominal procedures - BMI > 30 - Large uterine fibroids - Uncontrolled intercurrent illness - Other malignancies diagnosed within the previous year, except basal cell cancer |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
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):339 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adequacy of the total mesorectal excision based on standard guidelines on pathologic evaluation of TME specimens. | 1-5 years | ||
Secondary | Incidence of 30-day perioperative complications including intraoperative, surgical postoperative, and medical postoperative complications. | 1-5 years | ||
Secondary | Incidence of long-term complications | 1-5 years | ||
Secondary | Oncologic outcomes in subjects receiving transanal endoscopic rectosigmoid resection | 1-5 years |
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