Clinical trial NCT01340755: Laparoscopy-Assisted Transanal Endoscopy Rectosigmoid Resection for Rectal Cancer
Official title: A Pilot Study of Laparoscopy-Assisted Transanal Endoscopy Rectosigmoid Resection for Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenocarcinoma of the Rectum
Keywords: Rectal cancer
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2011-04-25
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adequacy of the total mesorectal excision based on standard guidelines on pathologic evaluation of TME specimens.
timeFrame: 1-5 years
Secondary outcomes:
measure: Incidence of 30-day perioperative complications including intraoperative, surgical postoperative, and medical postoperative complications.
timeFrame: 1-5 years
measure: Incidence of long-term complications
timeFrame: 1-5 years
measure: Oncologic outcomes in subjects receiving transanal endoscopic rectosigmoid resection
timeFrame: 1-5 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Patricia Sylla, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.