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Hand Assisted Versus "Pure" Laparoscopic Assisted Proctectomy for Rectal Cancer
A Multicenter Prospective Randomized Study Comparing Hand Assisted Versus "Pure" Laparoscopic Assisted Proctectomy for Rectal Cancer
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
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Started Apr 2011
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2008
CompletedFirst Posted
Study publicly available on registry
April 3, 2008
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJanuary 14, 2019
April 1, 2011
1.6 years
March 31, 2008
January 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
operative time
post-operative
Secondary Outcomes (3)
Adequacy of resection margins
post-operative
In-hospital mortality and morbidity
during hospitalization
urinary and sexual function
preoperative and 3-6 months postop
Study Arms (2)
HAL Proctectomy
ACTIVE COMPARATORHand-assisted laparoscopic proctectomy
SL Proctectomy
ACTIVE COMPARATOR"straight" laparoscopic proctectomy
Interventions
hand-assisted laparoscopic proctectomy
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sang Lee
New York, New York, 10021, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sang W Lee, MD
Weill Medical College of Cornell University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2008
First Posted
April 3, 2008
Study Start
April 1, 2011
Primary Completion
November 1, 2012
Study Completion
December 1, 2012
Last Updated
January 14, 2019
Record last verified: 2011-04