Rectal Cancer
Conditions
Keywords
laparoscopic surgery, abdominoperineal resection, rectal cancer, individualized surgery, levator muscle
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.
Interventions
PROCEDURELAPR
Patients undergoing conventional LAPR, the common surgical procedure to treat low rectal cancer ≤5m from anal verge.
PROCEDURELAPR-TILT
Patients undergoing LAPR-TILT, a modified APR procedure that is supposed to be safer and less invasive as compared to the LAPR.
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year local recurrence | 3 years post operation |
Secondary
| Measure | Time frame |
|---|---|
| 3-year overall survival | 3 years post operation |
| 3-year disease-free survival | 3 years post operation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Operative time for perineal dissection | 1 month post operation | — |
| Perforation rate | 1 month post operation | intraoperative perforation rate |
| Numbers of days to remove the urinary catheter after surgery | 1 month post operation | — |
| Circumferential Resection Margin (+) rate | 1 month post operation | circumferential resection margin positive rate |
Countries
China
Contacts
Primary ContactBo Feng, M.D. Ph.D
Outcome results
None listed