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Recruiting NCT05049317

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

Trial Parameters

Condition Rectal Cancer
Sponsor Renmin Hospital of Wuhan University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 88
Sex MALE
Min Age 18 Years
Max Age 70 Years
Start Date 2021-11-24
Completion 2022-09-24
Interventions
Laparoscopic FTME surgery

Brief 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 Criteria

Inclusion Criteria: 1. Male, 18-70 years of age, informed consent; 2. Tumors from anal edge 6 \~ 12 cm (measured by rigid proctoscope); 3. Rectal cancer confirmed pathologically by endoscopic biopsy; 4. Preoperative cT1-3aN0M0 stage (ESMO, 2013); 5. Ro resection is expected; 6. Normal urinary function, normal erection function and ejaculation function grading as I level; Exclusion Criteria: 1. History of abdominal and pelvic major surgery; 2. Emergency surgery is needed due to the complication (bleeding, obstruction, or perforation) caused by rectal cancer; 3. Pelvic or distant metastasis; 4. Neoadjuvant radiotherapy or chemoradiotherapy; 5. No sexual life;

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