Clinical trial NCT02812628: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Keywords: laparoscopic surgery
abdominoperineal resection
rectal cancer
individualized surgery
levator muscle
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 528
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 3-year local recurrence
timeFrame: 3 years post operation
Secondary outcomes:
measure: 3-year overall survival
timeFrame: 3 years post operation
measure: 3-year disease-free survival
timeFrame: 3 years post operation
Other outcomes:
measure: Operative time for perineal dissection
timeFrame: 1 month post operation
measure: Numbers of days to remove the urinary catheter after surgery
timeFrame: 1 month post operation
measure: Circumferential Resection Margin (+) rate
timeFrame: 1 month post operation
measure: Perforation rate
timeFrame: 1 month post operation
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital affiliated to Shanghai Jiaotong University school of medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Bo Feng, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: