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Laparoscopy-Assisted Transanal Endoscopy Rectosigmoid Resection for Rectal Cancer

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01340755
Collaborator
(none)
5
Enrollment
1
Location
1
Arm
74
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Transanal endoscopic surgery
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pilot Study of Laparoscopy-Assisted Transanal Endoscopy Rectosigmoid Resection for Rectal Cancer
Study Start Date :
Mar 1, 2011
Actual Primary Completion Date :
May 1, 2012
Actual Study Completion Date :
May 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Transanal endoscopic surgery

Laparoscopy-assisted transanal endoscopic rectosigmoid resection

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

Outcome Measures

Primary Outcome Measures

  1. Adequacy of the total mesorectal excision based on standard guidelines on pathologic evaluation of TME specimens. [1-5 years]

Secondary Outcome Measures

  1. Incidence of 30-day perioperative complications including intraoperative, surgical postoperative, and medical postoperative complications. [1-5 years]

  2. Incidence of long-term complications [1-5 years]

  3. Oncologic outcomes in subjects receiving transanal endoscopic rectosigmoid resection [1-5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts General Hospital Boston Massachusetts United States 02114

Sponsors and Collaborators

  • Massachusetts General Hospital

Investigators

  • Principal Investigator: Patricia Sylla, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Patricia Sylla, Assistant Professor of Surgery, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01340755
Other Study ID Numbers:
  • 10-409
First Posted:
Apr 25, 2011
Last Update Posted:
Sep 6, 2017
Last Verified:
Sep 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Patricia Sylla, Assistant Professor of Surgery, Massachusetts General Hospital
Rectal cancer
Additional relevant MeSH terms:
Rectal Neoplasms

Study Results

No Results Posted as of Sep 6, 2017