Conventional Laparoscopic APR Versus Laparoscopic APR With Transabdominal Individualized Levator Transection
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|ClinicalTrials.gov Identifier: NCT02812628|
Recruitment Status : Recruiting
First Posted : June 24, 2016
Last Update Posted : June 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Procedure: LAPR Procedure: LAPR-TILT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||528 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Randomized Clinical Trial of Conventional Laparoscopic Abdominoperineal Resection (APR) Versus Laparoscopic APR With Transabdominal Individualized Levator Transection for Low Rectal Cancer|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2022|
Active Comparator: Conventional LAPR
Patients undergoing conventional laparoscopic abdominoperineal resection (LAPR).
Patients undergoing conventional LAPR, the common surgical procedure to treat low rectal cancer ≤5m from anal verge.
Patients undergoing LAPR with transabdominal individualized levator transection (TILT).
Patients undergoing LAPR-TILT, a modified APR procedure that is supposed to be safer and less invasive as compared to the LAPR.
- 3-year local recurrence [ Time Frame: 3 years post operation ]
- 3-year overall survival [ Time Frame: 3 years post operation ]
- 3-year disease-free survival [ Time Frame: 3 years post operation ]
- Operative time for perineal dissection [ Time Frame: 1 month post operation ]
- Numbers of days to remove the urinary catheter after surgery [ Time Frame: 1 month post operation ]
- Circumferential Resection Margin (+) rate [ Time Frame: 1 month post operation ]circumferential resection margin positive rate
- Perforation rate [ Time Frame: 1 month post operation ]intraoperative perforation rate
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): NCT02812628
|Contact: Bo Feng, M.D. Ph.Demail@example.com|
|Ruijin Hospital affiliated to Shanghai Jiaotong University school of medicine||Recruiting|
|Shanghai, Shanghai, China, 200025|
|Contact: Bo Feng, MD/PhD 86-21-64370045 ext 664566 firstname.lastname@example.org|
|Principal Investigator:||Bo Feng, Ph.D||Ruijin Hospital|