Conventional Laparoscopic APR Versus Laparoscopic APR With Transabdominal Individualized Levator Transection

Not Applicable

• Conditions: Rectal Cancer
• Interventions: Procedure: LAPR-TILT; Procedure: LAPR

• Registration Number: NCT02812628
• Lead Sponsor: Ruijin Hospital

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 Timeline

• Study Start: 2012-12
• Status Verified: 2016-06
• Study First Submitted: 2016-06-10
• Study First Submitted QC: 2016-06-21
• Last Update Submitted: 2016-06-21
• Study First Posted: 2016-06-24
• Last Update Posted: 2016-06-24
• Primary Completion: 2020-06
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 528

Inclusion Criteria

1. Patients diagnosed as having rectal cancer ≤5cm from anal verge by colonoscopy.
2. Patients undergoing elective, radial surgery with no distant metastasis.
3. Patients with Body Mass Index (BMI) between 18-30kg/m2.
4. Patients who agree to undergo standard adjuvant treatment after surgery.
5. Patients who have fully understood the aim of the trial and have signed the written informed consent.

Exclusion Criteria

1. Patients with distant metastasis, tumor infiltrating to adjacent organs, or recurrent tumors.
2. Patients undergoing emergent surgery.
3. Pregnant patients.
4. Patients with tumors other than rectal tumor.
5. Patients with severe comorbid diseases which preclude surgery.
6. Patients in bad conditions and do not ameliorate before surgery.
7. Patients undergoing other procedures to treat rectal cancer, eg. L-Dixon, L-Hartmann or Parks surgery.
8. Patients who refuse to accept standard adjuvant surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LAPR-TILT	LAPR-TILT	Patients undergoing LAPR with transabdominal individualized levator transection (TILT).
Conventional LAPR	LAPR	Patients undergoing conventional laparoscopic abdominoperineal resection (LAPR).

Primary Outcome Measures

Name	Time	Method
3-year local recurrence	3 years post operation

Secondary Outcome Measures

Name	Time	Method
3-year overall survival	3 years post operation
3-year disease-free survival	3 years post operation

Trial Locations

Locations (1)

Ruijin Hospital affiliated to Shanghai Jiaotong University school of medicine; 🇨🇳 Shanghai, Shanghai, China