Conventional Laparoscopic APR Versus Laparoscopic APR With Transabdominal Individualized Levator Transection

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Clinical Trial of Conventional Laparoscopic Abdominoperineal Resection (APR) Versus Laparoscopic APR With Transabdominal Individualized Levator Transection for Low Rectal Cancer

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: LAPR
* Procedure: LAPR-TILT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed as having rectal cancer ≤5cm from anal verge by colonoscopy. Patients undergoing elective, radial surgery with no distant metastasis. Patients with Body Mass Index (BMI) between 18-30kg/m2. Patients who agree to undergo standard adjuvant treatment after surgery. Patients who have fully understood the aim of the trial and have signed the written informed consent. Exclusion Criteria: Patients with distant metastasis, tumor infiltrating to adjacent organs, or recurrent tumors. Patients undergoing emergent surgery. Pregnant patients. Patients with tumors other than rectal tumor. Patients with severe comorbid diseases which preclude surgery. Patients in bad conditions and do not ameliorate before surgery. Patients undergoing other procedures to treat rectal cancer, eg. L-Dixon, L-Hartmann or Parks surgery. Patients who refuse to accept standard adjuvant surgery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional LAPR<br>Patients undergoing conventional laparoscopic abdominoperineal resection (LAPR). | Procedure: LAPR<br>* Patients undergoing conventional LAPR, the common surgical procedure to treat low rectal cancer ≤5m from anal verge.<br>|
| Experimental: LAPR-TILT<br>Patients undergoing LAPR with transabdominal individualized levator transection (TILT). | Procedure: LAPR-TILT<br>* Patients undergoing LAPR-TILT, a modified APR procedure that is supposed to be safer and less invasive as compared to the LAPR.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year local recurrence |  | 3 years post operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year overall survival |  | 3 years post operation | 
| 3-year disease-free survival |  | 3 years post operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic surgery, abdominoperineal resection, rectal cancer, individualized surgery, levator muscle