Laparoscopy-Assisted Transanal Endoscopy Rectosigmoid Resection for Rectal Cancer

September 1, 2017 updated by: Patricia Sylla, Massachusetts General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transanal endoscopic surgery
Laparoscopy-assisted transanal endoscopic rectosigmoid resection
Procedure: Transanal endoscopic surgery
Laparoscopy-assisted transanal endoscopic rectosigmoid resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adequacy of the total mesorectal excision based on standard guidelines on pathologic evaluation of TME specimens.
Time Frame: 1-5 years
1-5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of 30-day perioperative complications including intraoperative, surgical postoperative, and medical postoperative complications.
Time Frame: 1-5 years
1-5 years
Incidence of long-term complications
Time Frame: 1-5 years
1-5 years
Oncologic outcomes in subjects receiving transanal endoscopic rectosigmoid resection
Time Frame: 1-5 years
1-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

April 21, 2011

First Submitted That Met QC Criteria

April 21, 2011

First Posted (Estimate)

April 25, 2011

Study Record Updates

Last Update Posted (Actual)

September 6, 2017

Last Update Submitted That Met QC Criteria

September 1, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-409

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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