Hand Assisted Versus "Pure" Laparoscopic Assisted Proctectomy for Rectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Weill Medical College of Cornell University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00651677
First received: March 31, 2008
Last updated: April 18, 2011
Last verified: April 2011
  Purpose

We hypothesize that hand-assisted laparoscopy will overcome technical difficulties related to pure laparoscopic rectal surgery and allow surgeons to expand application of laparoscopic techniques to treating patients with rectal cancer. In this study, we plan to randomly assign patients diagnosed with rectal cancer to undergo either "standard" laparoscopic surgery or hand-assisted laparoscopic surgery. We will then compare both peri-operative and long-term outcomes of patients.


Condition Intervention
Rectal Cancer
Procedure: HAL proctectomy
Procedure: "straight" laparoscopic proctectomy
Procedure: Hand-assisted laparoscopic proctectomy
Procedure: SL Proctectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Prospective Randomized Study Comparing Hand Assisted Versus "Pure" Laparoscopic Assisted Proctectomy for Rectal Cancer

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • operative time [ Time Frame: post-operative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adequacy of resection margins [ Time Frame: post-operative ] [ Designated as safety issue: Yes ]
  • In-hospital mortality and morbidity [ Time Frame: during hospitalization ] [ Designated as safety issue: Yes ]
  • urinary and sexual function [ Time Frame: preoperative and 3-6 months postop ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 128
Study Start Date: April 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HAL Proctectomy
Hand-assisted laparoscopic proctectomy
Procedure: HAL proctectomy
Hand-assisted laparoscopic proctectomy
Other Name: Gelport
Procedure: Hand-assisted laparoscopic proctectomy
hand-assisted laparoscopic proctectomy
Other Name: Gelport
Active Comparator: SL Proctectomy
"straight" laparoscopic proctectomy
Procedure: "straight" laparoscopic proctectomy
"straight" laparoscopic proctectomy
Procedure: SL Proctectomy
Straight laparoscopic proctectomy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > = 18 years of age
  • Histologically proven rectal cancer
  • Inferior margin of the cancer located within 15 cm from the anal verge as determined by rigid sigmoidoscopy
  • No evidence of distant metastases
  • Childbearing age women with negative pregnancy test
  • Patient is a candidate for elective rectal resection
  • The patient, or their representative, is able to understand the study and is willing to consent to participation in the study.

Exclusion Criteria:

  • Age < 18 years of age
  • Surgically unresectable rectal cancer
  • Patients who will require APR or hand-sewn colo-anal anastomosis
  • ASA class 4 or 5
  • Patients having additional surgical procedures which may have affect recovery
  • Child bearing age women with positive pregnancy test
  • Patients with contraindication for treatment by laparoscopy
  • Patients or their representative who are unable to understand the conditions and objectives of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651677

Contacts
Contact: Sang W Lee, MD 212-746-6030 sal2013@med.cornell.edu
Contact: Koiana Trencheva, BSN,M.S. 212-746-5241 kivanova@med.cornell.edu

Locations
United States, New York
Sang Lee Recruiting
New York, New York, United States, 10021
Contact: Sang W Lee, MD    212-746-6030    sal2013@med.cornell.edu   
Contact: Malinka Velcheva, BS    212-746-5148    mav2022@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Sang W Lee, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Sang W. Lee, MD; Associate Professor of Surgery, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00651677     History of Changes
Other Study ID Numbers: MITT02
Study First Received: March 31, 2008
Last Updated: April 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
hand assisted laparoscopy
rectal cancer
short term outcomes
straight laparoscopy

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 31, 2014