A Prospective, Multicenter Clinical Study of Preservative Effect on Postoperative Urinary and Sexual Function During Laparoscopic Functional Total Mesorectum Excision for Male Rectal Cancer Patients

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Urinary and sexual dysfunctions are among the most common complications in rectal cancer surgery. The aim of this study was to investigate the protective effect of laparoscopic functional total mesorectum excision (FTME) on urinary and sexual function in male patients with mid-low rectal cancer. This is a prospective, single-arm, multicenter, uncontrolled, clinical study in 88 eligible subjects with mid-low rectal cancer. After informed consent, eligible patients will be performed laparoscopic FTME surgery. Patients' demographic, operative detail, postoperative outcomes and follow-up will be recorded prospectively.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

⁃ Male, 18-70 years of age, informed consent;

⁃ Tumors from anal edge 6 \

• 12 cm (measured by rigid proctoscope);

⁃ Rectal cancer confirmed pathologically by endoscopic biopsy;

⁃ Preoperative cT1-3aN0M0 stage (ESMO, 2013);

⁃ Ro resection is expected;

⁃ Normal urinary function, normal erection function and ejaculation function grading as I level;

Locations
Other Locations
China
Yongbin Zheng
RECRUITING
Wuhan
Contact Information
Primary
Yongbin Zheng, M.D,Ph.D
yongbinzheng@whu.edu.cn
13871189698
Time Frame
Start Date: 2021-11-24
Estimated Completion Date: 2028-09-24
Participants
Target number of participants: 88
Treatments
Experimental: FTME group
Participants will undergo laparoscopic FTME surgery.
Related Therapeutic Areas
Sponsors
Leads: Renmin Hospital of Wuhan University

This content was sourced from clinicaltrials.gov