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Laparoscopy-Assisted Transanal Endoscopy Rectosigmoid Resection for Rectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01340755
Recruitment Status : Completed
First Posted : April 25, 2011
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
Patricia Sylla, Massachusetts General Hospital

Study Description
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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
Adenocarcinoma of the Rectum Procedure: Transanal endoscopic surgery Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : March 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Adequacy of the total mesorectal excision based on standard guidelines on pathologic evaluation of TME specimens. [ Time Frame: 1-5 years ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01340755


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Patricia Sylla, MD Massachusetts General Hospital
More Information
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Publications of Results:

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Responsible Party: Patricia Sylla, Assistant Professor of Surgery, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01340755    
Other Study ID Numbers: 10-409
First Posted: April 25, 2011    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Patricia Sylla, Massachusetts General Hospital:
Rectal cancer
Additional relevant MeSH terms:
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Rectal Neoplasms
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases