NCT02435758

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 262 (actual)
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: Male
• Age: 20 Years – 71 Years
• Healthy volunteers: Not accepted

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

• Rectal Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-04-01
• Primary completion: 2020-05-06
• Completion: 2023-06-15
• First posted: 2015-05-06
• Last updated: 2023-09-21

Locations

1 site across 1 country: China