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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Rectal Cancer	Procedure: HAL proctectomy; Procedure: "straight" laparoscopic proctectomy; Procedure: Hand-assisted laparoscopic proctectomy; Procedure: SL Proctectomy	Not Applicable

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Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	128 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Multicenter Prospective Randomized Study Comparing Hand Assisted Versus "Pure" Laparoscopic Assisted Proctectomy for Rectal Cancer
Study Start Date :	April 2011
Estimated Primary Completion Date :	November 2012
Estimated Study Completion Date :	December 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. operative time [ Time Frame: post-operative ]

Secondary Outcome Measures :

1. Adequacy of resection margins [ Time Frame: post-operative ]
2. In-hospital mortality and morbidity [ Time Frame: during hospitalization ]
3. urinary and sexual function [ Time Frame: preoperative and 3-6 months postop ]

Eligibility Criteria

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	April 3, 2008
Last Update Posted:	April 19, 2011
Last Verified:	April 2011

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