Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2026-01-14 @ 2:44 AM
Study NCT ID:
NCT02812628
Status:
UNKNOWN
Last Update Posted:
2016-06-24
First Post:
2016-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conventional Laparoscopic APR Versus Laparoscopic APR With Transabdominal Individualized Levator Transection
Sponsor:
Ruijin Hospital
Organization:
Study Overview
Official Title:
Randomized Clinical Trial of Conventional Laparoscopic Abdominoperineal Resection (APR) Versus Laparoscopic APR With Transabdominal Individualized Levator Transection for Low Rectal Cancer
Status:
UNKNOWN
Status Verified Date:
2016-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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).
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: