RecruitingNot ApplicableNCT05049317

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

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


Sponsor

Renmin Hospital of Wuhan University

Enrollment

88 participants

Start Date

Nov 24, 2021

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how a specific type of minimally invasive rectal cancer surgery (laparoscopic total mesorectum excision) affects bladder and sexual function in men. The goal is to understand whether this surgical technique better preserves nerve function compared to older approaches. **You may be eligible if...** - You are a male between 18 and 70 years old - You have been diagnosed with rectal cancer located 6–12 cm from the anal opening - Your cancer has not spread to distant organs (stage cT1-3a, N0, M0) - Your bladder, erection, and ejaculation function are currently normal **You may NOT be eligible if...** - You have had prior major abdominal or pelvic surgery - You need emergency surgery due to cancer complications - Your cancer has spread to the pelvis or other organs - You have received radiation therapy before surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELaparoscopic 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.


Locations(1)

Yongbin Zheng

Wuhan, Hubei, China

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NCT05049317


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