Conventional Laparoscopic APR Versus Laparoscopic APR With Transabdominal Individualized Levator Transection

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02812628
• Other study ID #: MISC-APR
• Status: Recruiting
• Phase: N/A
• First received: June 10, 2016
• Last updated: June 21, 2016
• Start date: December 2012
• Est. completion date: June 2022

Study information

• Verified date: June 2016
• Source: Ruijin Hospital
• Contact: Bo Feng, M.D. Ph.D
• Phone: 86-21-64370045
• Email: fengbo2022[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 528
• Est. completion date: June 2022
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer

Intervention

Procedure:
• LAPR
Patients undergoing conventional LAPR, the common surgical procedure to treat low rectal cancer =5m from anal verge.
• LAPR-TILT
Patients undergoing LAPR-TILT, a modified APR procedure that is supposed to be safer and less invasive as compared to the LAPR.

Locations

Country	Name	City	State
China	Ruijin Hospital affiliated to Shanghai Jiaotong University school of medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Operative time for perineal dissection		1 month post operation	No
Other	Numbers of days to remove the urinary catheter after surgery		1 month post operation	No
Other	Circumferential Resection Margin (+) rate	circumferential resection margin positive rate	1 month post operation	No
Other	Perforation rate	intraoperative perforation rate	1 month post operation	No
Primary	3-year local recurrence		3 years post operation	No
Secondary	3-year overall survival		3 years post operation	No
Secondary	3-year disease-free survival		3 years post operation	No