Preservation Versus Excision of Denonvilliers Fascia in L-PANP Surgery

Not Applicable

• Conditions: Rectal Cancer

• Registration Number: NCT02311803
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

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 incidence of urinary and sexual function disorder. PANP (pelvic autonomic nerve preservation) surgery played a role in decreasing incidence of urinary and sexual function disorder. However, 32%-44% patients still suffered from urinary and sexual function disorder when underwent open (O-PANP-TME) or laparoscopic PANP TME surgery (L-PANP-TME).

In the early stage of work, the investigators performed preservation of Denovilliers' fascia in L-PANP-TME to discuss the protection of urinary and sexual function of male mid-low rectal cancer patients. The results showed that preservation of Denovilliers' fascia in L-PANP-TME significantly decreased incidence of urinary and sexual function disorder. In order to further confirm the early work, the investigators design a randomized controlled clinical trial to compare differences in urinary and sexual function protection and long-term outcomes between preservation and excision of Denovilliers' fascia in L-PANP-TME.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-04
• Study First Submitted QC: 2014-12-04
• Study First Posted: 2014-12-08
• Study Start: 2015-02
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-26
• Last Update Posted: 2019-01-29
• Primary Completion: 2019-12
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 172

Inclusion Criteria

1. Age from over 20 to under 60 years;
2. Primary rectal adenocarcinoma confirmed pathologically by endoscopic biopsy;
3. Mid-low rectal cancer (distance from anal edge≤12cm);
4. cT1-3, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition;
5. Expected curative resection through L-PANP;
6. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale;
7. ASA (American Society of Anesthesiology) score class I, II, or III;
8. Written informed consent;
9. Urinary and sexual function normal preoperatively

Exclusion Criteria

1. Severe mental disorder;
2. History of previous pelvic surgery;
3. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging;
4. History of other malignant disease within past five years;
5. History of unstable angina or myocardial infarction within past six months;
6. History of cerebrovascular accident within past six months;
7. History of continuous systematic administration of corticosteroids within one month;
8. Contraindication of heart, brain, lung, etc dysfunction;
9. Requirement of simultaneous surgery for other disease;
10. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by rectal cancer;
11. Rectal cancer invades surrounding tissues;
12. Existence of genuine incontinence or severe stress incontinence preoperatively

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sexual function	36 months	IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function
5-year disease free survival rate	60 months
Urinary function	36 months	Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function
3-year disease free survival rate	36 months

Secondary Outcome Measures

Name	Time	Method
3-year recurrence pattern	36 months
Morbidity	36 months
3-year overall survival rate	36 months
5-year overall survival rate	60 months
Mortality	36 months
5-year recurrence pattern	60 months

Trial Locations

Locations (1)

The Third Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China