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Laparoscopy-Assisted Transanal Endoscopy Rectosigmoid Resection for Rectal Cancer

Primary Purpose

Adenocarcinoma of the Rectum

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transanal endoscopic surgery
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Rectum focused on measuring Rectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transanal endoscopic surgery

Arm Description

Laparoscopy-assisted transanal endoscopic rectosigmoid resection

Outcomes

Primary Outcome Measures

Adequacy of the total mesorectal excision based on standard guidelines on pathologic evaluation of TME specimens.

Secondary Outcome Measures

Incidence of 30-day perioperative complications including intraoperative, surgical postoperative, and medical postoperative complications.
Incidence of long-term complications
Oncologic outcomes in subjects receiving transanal endoscopic rectosigmoid resection

Full Information

First Posted
April 21, 2011
Last Updated
September 1, 2017
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01340755
Brief Title
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

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Rectum
Keywords
Rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transanal endoscopic surgery
Arm Type
Experimental
Arm Description
Laparoscopy-assisted transanal endoscopic rectosigmoid resection
Intervention Type
Procedure
Intervention Name(s)
Transanal endoscopic surgery
Intervention Description
Laparoscopy-assisted transanal endoscopic rectosigmoid resection
Primary Outcome Measure Information:
Title
Adequacy of the total mesorectal excision based on standard guidelines on pathologic evaluation of TME specimens.
Time Frame
1-5 years
Secondary Outcome Measure Information:
Title
Incidence of 30-day perioperative complications including intraoperative, surgical postoperative, and medical postoperative complications.
Time Frame
1-5 years
Title
Incidence of long-term complications
Time Frame
1-5 years
Title
Oncologic outcomes in subjects receiving transanal endoscopic rectosigmoid resection
Time Frame
1-5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Sylla, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23572214
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.
Results Reference
result

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Laparoscopy-Assisted Transanal Endoscopy Rectosigmoid Resection for Rectal Cancer

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