Conventional Laparoscopic APR Versus Laparoscopic APR With Transabdominal Individualized Levator Transection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

528 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2022-06-30

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).

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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.

Conditions

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Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Conventional LAPR

Patients undergoing conventional laparoscopic abdominoperineal resection (LAPR).

Group Type ACTIVE_COMPARATOR

LAPR

Intervention Type PROCEDURE

Patients undergoing conventional LAPR, the common surgical procedure to treat low rectal cancer ≤5m from anal verge.

LAPR-TILT

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

Group Type EXPERIMENTAL

LAPR-TILT

Intervention Type PROCEDURE

Patients undergoing LAPR-TILT, a modified APR procedure that is supposed to be safer and less invasive as compared to the LAPR.

Interventions

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LAPR

Patients undergoing conventional LAPR, the common surgical procedure to treat low rectal cancer ≤5m from anal verge.

Intervention Type PROCEDURE

LAPR-TILT

Patients undergoing LAPR-TILT, a modified APR procedure that is supposed to be safer and less invasive as compared to the LAPR.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No