Laparoscopy-Assisted Transanal Endoscopy Rectosigmoid Resection for Rectal Cancer

Adenocarcinoma of the Rectum Clinical Trial

Official title:

A Pilot Study of Laparoscopy-Assisted Transanal Endoscopy Rectosigmoid Resection for Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340755
• Other study ID #: 10-409
• Status: Completed
• Phase: N/A
• First received: April 21, 2011
• Last updated: September 1, 2017
• Start date: March 2011
• Est. completion date: May 2017

Study information

• Verified date: September 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Rectum
• Rectal Neoplasms

Intervention

Procedure:
• Transanal endoscopic surgery
Laparoscopy-assisted transanal endoscopic rectosigmoid resection

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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