An interventional study of LAPR and LAPR-TILT in Rectal Cancer, sponsored by Ruijin Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-06-24.
Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment
This study is designed to compare the short-term and long-term benefits between conventional laparoscopic abdominoperineal resection (APR) and laparoscopic APR with transabdominal individualized levator transection (TILT).
In the field of surgical treatment for low rectal cancer, the traditional APR is trapped by the so-called "surgical waist" and associated oncological problems, whereas the spread of extra-levator abdominoperineal resection (ELAPR) is still hindered by its high risk of wound complications and neurovascular injuries. Owing to the advancement of laparoscopic techniques, the investigators developed a laparoscopic APR with TILT procedure. During the procedure, a controlled incision of levators into the ischiorectal fat was performed transabdominally under direct vision; the meeting plane is therefore lowered and the perineal dissection is simplified without changing body position. This technique offers individualized transection of levator muscles, minimizes the risk of wound complications and prevents surgical waist to ensure oncological safety. This clinical trial is designed to evaluate the short-term and long-term benefits of this modified procedure.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 528 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients undergoing conventional laparoscopic abdominoperineal resection (LAPR).
Procedure: LAPR
Patients undergoing LAPR with transabdominal individualized levator transection (TILT).
Procedure: LAPR-TILT
Patients undergoing conventional LAPR, the common surgical procedure to treat low rectal cancer ≤5m from anal verge.
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
circumferential resection margin positive rate
Time frame: 1 month post operation
Perforation rate
intraoperative perforation rate
Time frame: 1 month post operation
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Ruijin Hospital