Multicenter Study on Postoperative Urinary and Sexual Function During Laparoscopic Functional Total Mesorectum Excision

NCT05049317 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2021-11-01

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Laparoscopic FTME surgery

Nerve plane was defined as the overlying tiny membranous tissue including the nerves, the adipose tissue and the extremely tiny capillaries around the nerve. Following the TME principles, the surgical procedure of FTME was guided by the nerve plane and dissected between the proper fascia of the rectum and nerve plane (the first gap), which could ensure completeness of the nerve plane and the proper fascia of the rectum.

Sponsors & Collaborators

  • Renmin Hospital of Wuhan University

    lead OTHER

Principal Investigators

  • Yongbin Zheng, M.D,Ph.D · Renmin Hospital of Wuhan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-24
Primary Completion
2022-09-24
Completion
2028-09-24

Countries

  • China

Study Locations

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Entities

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 NCT05049317 on ClinicalTrials.gov