Preservation Versus Excision of Denonvilliers Fascia in L-PANP Surgery

NCT ID: NCT02311803

Last Updated: 2019-01-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2020-04-30

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.

Conditions

Rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Preservation of Denonvilliers Fascia

Preservation of Denonvilliers Fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery for male mid-low rectal cancer patients

Group Type: EXPERIMENTAL

Preservation of Denonvilliers Fascia

Intervention Type: PROCEDURE

In this group, patients accepte L-PANP surgery without excision of Denonvilliers Fascia

Excision of Denonvilliers Fascia

Excision of Denonvilliers Fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery for male mid-low rectal cancer patients

Group Type: ACTIVE_COMPARATOR

Excision of Denonvilliers Fascia

Intervention Type: PROCEDURE

In this group, patients accepte L-PANP surgery with excision of Denonvilliers Fascia

Interventions

Preservation of Denonvilliers Fascia

In this group, patients accepte L-PANP surgery without excision of Denonvilliers Fascia

Intervention Type: PROCEDURE

Excision of Denonvilliers Fascia

In this group, patients accepte L-PANP surgery with excision of Denonvilliers Fascia

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Hongbo Wei

Assistant to the Dean

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Hongbo Wei, M.D., Ph.D.

Role: primary

8613760660785

Other Identifiers

PED-PANP001

Identifier Type: -

Identifier Source: org_study_id