NCT02165800

Multicenter Study on Laparoscopic Versus Open PANP-TME for Male Mid-low Rectal Cancer Patients

Multicenter Study on Outcomes and Protection of Urinary and Sexual Function of Laparoscopic Versus Open PANP-TME for Male Mid-low Rectal Cancer Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 667 (estimated)
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: Male
• Age: 20 Years – 60 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. Open PANP (pelvic autonomic nerve preservation) TME 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 PANP TME surgery (O-PANP-TME). Laparoscopy-assisted TME surgery (L-TME) is applied wildly nowadays. In the early stage of work, we performed laparoscopy-assisted PANP TME surgery (L-PANP-TME) to discuss the protection of urinary and sexual function of male mid-low rectal cancer patients. The results showed that L-PANP-TME significantly decreased incidence of urinary and sexual function disorder. In order to further confirm our early work, we design a multiple-center randomized controlled clinical trial to compare differences in urinary and sexual function protection and long-term outcomes between L-PANP-TME and O-PANP-TME.

Conditions

• Rectum Neoplasms

Interventions

Type	Name	Description
PROCEDURE	L-PANP-TME
PROCEDURE	O-PANP-TME

Timeline

• Start date: 2014-01-01
• Primary completion: 2019-12-01
• Completion: 2023-12-01
• First posted: 2014-06-18
• Last updated: 2018-04-26

Locations

1 site across 1 country: China