Hand Assisted Versus "Pure" Laparoscopic Assisted Proctectomy for Rectal Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00651677 |
Recruitment Status :
Withdrawn
(funding issues)
First Posted : April 3, 2008
Last Update Posted : January 14, 2019
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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 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 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 |
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 |
- operative time [ Time Frame: post-operative ]
- Adequacy of resection margins [ Time Frame: post-operative ]
- In-hospital mortality and morbidity [ Time Frame: during hospitalization ]
- urinary and sexual function [ Time Frame: preoperative and 3-6 months postop ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00651677
United States, New York | |
Sang Lee | |
New York, New York, United States, 10021 |
Principal Investigator: | Sang W Lee, MD | Weill Medical College of Cornell University |
Responsible Party: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT00651677 |
Other Study ID Numbers: |
MITT02 |
First Posted: | April 3, 2008 Key Record Dates |
Last Update Posted: | January 14, 2019 |
Last Verified: | April 2011 |
hand assisted laparoscopy rectal cancer short term outcomes straight laparoscopy |
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases |