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Multicenter Study on Preservation Versus Excision of Denonvilliers Fascia in L-PANP Surgery

NCT02435758 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 262

Last updated 2023-09-21

No results posted yet for this study

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 multicenter 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

Interventions

PROCEDURE

Preservation of Denonvilliers Fascia during L-PANP surgery

In this group, the patients accept L-PANP surgery, as well as preservation of Denonvilliers Fascia

Sponsors & Collaborators

  • Sixth Affiliated Hospital, Sun Yat-sen University

    collaborator OTHER

  • Nanfang Hospital, Southern Medical University

    collaborator OTHER

  • Third Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
71 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2020-05-06
Completion
2023-06-15

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02435758 on ClinicalTrials.gov