Conventional Laparoscopic APR Versus Laparoscopic APR With Transabdominal Individualized Levator Transection

June 21, 2016 updated by: Bo Feng, Ruijin Hospital

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

528

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional LAPR
Patients undergoing conventional laparoscopic abdominoperineal resection (LAPR).
Procedure: LAPR
Patients undergoing conventional LAPR, the common surgical procedure to treat low rectal cancer ≤5m from anal verge.
Experimental: LAPR-TILT
Patients undergoing LAPR with transabdominal individualized levator transection (TILT).
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time for perineal dissection
Time Frame: 1 month post operation
1 month post operation
Numbers of days to remove the urinary catheter after surgery
Time Frame: 1 month post operation
1 month post operation
Circumferential Resection Margin (+) rate
Time Frame: 1 month post operation
circumferential resection margin positive rate
1 month post operation
Perforation rate
Time Frame: 1 month post operation
intraoperative perforation rate
1 month post operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Investigators

  • Principal Investigator: Bo Feng, Ph.D, Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

June 10, 2016

First Submitted That Met QC Criteria

June 21, 2016

First Posted (Estimate)

June 24, 2016

Study Record Updates

Last Update Posted (Estimate)

June 24, 2016

Last Update Submitted That Met QC Criteria

June 21, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MISC-APR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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