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
Recruitment status was Recruiting
Sponsor:
Weill Medical College of Cornell University
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
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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 |
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
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 |
ClinicalTrials.gov processed this record on March 01, 2015