Hand Assisted Versus "Pure" Laparoscopic Assisted Proctectomy for Rectal Cancer - Full Text View

Sponsored by:	Weill Medical College of Cornell University
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00651677

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

MedlinePlus related topics: Cancer Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	A Multicenter Prospective Randomized Study Comparing Hand Assisted Versus "Pure" Laparoscopic Assisted Proctectomy for Rectal Cancer

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:	September 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Hand-assisted laparoscopic proctectomy	Procedure: HAL proctectomy Hand-assisted laparoscopic proctectomy
2: Active Comparator "straight" laparoscopic proctectomy	Procedure: "straight" laparoscopic 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

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, RN	212-746-6030	kivanova@nyp.org

Locations

United States, New York
Sang Lee
New York, New York, United States, 10021

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:	Weill Medical College of Cornell University ( Sang W. Lee, MD; Assistant Professor of Surgery )
Study ID Numbers:	MITT02
Study First Received:	March 31, 2008
Last Updated:	April 9, 2008
ClinicalTrials.gov Identifier:	NCT00651677
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

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms
Gastrointestinal Neoplasms
Intestinal Diseases

Rectal cancer
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms
Rectal neoplasm

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on February 12, 2009