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Conventional Laparoscopic APR Versus Laparoscopic APR With Transabdominal Individualized Levator Transection

Primary Purpose

Rectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
LAPR
LAPR-TILT
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring laparoscopic surgery, abdominoperineal resection, rectal cancer, individualized surgery, levator muscle

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Ruijin Hospital affiliated to Shanghai Jiaotong University school of medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional LAPR

LAPR-TILT

Arm Description

Patients undergoing conventional laparoscopic abdominoperineal resection (LAPR).

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

Outcomes

Primary Outcome Measures

3-year local recurrence

Secondary Outcome Measures

3-year overall survival
3-year disease-free survival

Full Information

First Posted
June 10, 2016
Last Updated
June 21, 2016
Sponsor
Ruijin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02812628
Brief Title
Conventional Laparoscopic APR Versus Laparoscopic APR With Transabdominal Individualized Levator Transection
Official Title
Randomized Clinical Trial of Conventional Laparoscopic Abdominoperineal Resection (APR) Versus Laparoscopic APR With Transabdominal Individualized Levator Transection for Low Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
laparoscopic surgery, abdominoperineal resection, rectal cancer, individualized surgery, levator muscle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
528 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional LAPR
Arm Type
Active Comparator
Arm Description
Patients undergoing conventional laparoscopic abdominoperineal resection (LAPR).
Arm Title
LAPR-TILT
Arm Type
Experimental
Arm Description
Patients undergoing LAPR with transabdominal individualized levator transection (TILT).
Intervention Type
Procedure
Intervention Name(s)
LAPR
Intervention Description
Patients undergoing conventional LAPR, the common surgical procedure to treat low rectal cancer ≤5m from anal verge.
Intervention Type
Procedure
Intervention Name(s)
LAPR-TILT
Intervention Description
Patients undergoing LAPR-TILT, a modified APR procedure that is supposed to be safer and less invasive as compared to the LAPR.
Primary Outcome Measure Information:
Title
3-year local recurrence
Time Frame
3 years post operation
Secondary Outcome Measure Information:
Title
3-year overall survival
Time Frame
3 years post operation
Title
3-year disease-free survival
Time Frame
3 years post operation
Other Pre-specified Outcome Measures:
Title
Operative time for perineal dissection
Time Frame
1 month post operation
Title
Numbers of days to remove the urinary catheter after surgery
Time Frame
1 month post operation
Title
Circumferential Resection Margin (+) rate
Description
circumferential resection margin positive rate
Time Frame
1 month post operation
Title
Perforation rate
Description
intraoperative perforation rate
Time Frame
1 month post operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bo Feng, M.D. Ph.D
Phone
86-21-64370045
Email
fengbo2022@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Feng, Ph.D
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital affiliated to Shanghai Jiaotong University school of medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Feng, MD/PhD
Phone
86-21-64370045
Ext
664566
Email
fengbo2022@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Conventional Laparoscopic APR Versus Laparoscopic APR With Transabdominal Individualized Levator Transection

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