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

History of Changes

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:

MedlinePlus related topics: Cancer

Genetic and Rare Diseases Information Center resources: Rectal Neoplasm

U.S. FDA Resources

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

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Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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


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 September 26, 2016

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