Status:
UNKNOWN
Preservation Versus Excision of Denonvilliers Fascia in L-PANP Surgery
Lead Sponsor:
Third Affiliated Hospital, Sun Yat-Sen University
Conditions:
Rectal Cancer
Eligibility:
MALE
20-60 years
Phase:
NA
Brief Summary
TME (Total mesorectum excision) is the golden standard of radical resection for mid-low rectal cancer. However, the damage of pelvic autonomic nerve following with TME principle will lead to high inci...
Eligibility Criteria
Inclusion
- Age from over 20 to under 60 years;
- Primary rectal adenocarcinoma confirmed pathologically by endoscopic biopsy;
- Mid-low rectal cancer (distance from anal edge≤12cm);
- cT1-3, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition;
- Expected curative resection through L-PANP;
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale;
- ASA (American Society of Anesthesiology) score class I, II, or III;
- Written informed consent;
- Urinary and sexual function normal preoperatively
Exclusion
- Severe mental disorder;
- History of previous pelvic surgery;
- Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging;
- History of other malignant disease within past five years;
- History of unstable angina or myocardial infarction within past six months;
- History of cerebrovascular accident within past six months;
- History of continuous systematic administration of corticosteroids within one month;
- Contraindication of heart, brain, lung, etc dysfunction;
- Requirement of simultaneous surgery for other disease;
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by rectal cancer;
- Rectal cancer invades surrounding tissues;
- Existence of genuine incontinence or severe stress incontinence preoperatively
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2020
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT02311803
Start Date
February 1 2015
End Date
April 1 2020
Last Update
January 29 2019
Active Locations (1)
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1
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630