Conventional Laparoscopic APR Versus Laparoscopic APR With Transabdominal Individualized Levator Transection

Shanghai Jiao Tong University

Status: Unknown

Conditions: Rectal Cancer

Treatments: Procedure: LAPR-TILT; Procedure: LAPR

Study type: Interventional

Funder types: Other

Identifiers

NCT02812628

MISC-APR

Details and patient eligibility

About

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).

Full 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.

Enrollment: 528 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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528 participants in 2 patient groups

Conventional LAPR

Active Comparator group

Description:

Patients undergoing conventional laparoscopic abdominoperineal resection (LAPR).

Treatment:

Procedure: LAPR

LAPR-TILT

Experimental group

Description:

Patients undergoing LAPR with transabdominal individualized levator transection (TILT).

Treatment:

Procedure: LAPR-TILT