Investigating urinary and sexual function after laparoscopic surgery for rectal cancer
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
This study is testing if a specific type of laparoscopic surgery for rectal cancer can help men keep their urinary and sexual function after the operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Male |
| Sponsor | Renmin Hospital of Wuhan University Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05049317 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the protective effects of laparoscopic functional total mesorectum excision (FTME) on urinary and sexual function in male patients with mid-low rectal cancer. It is a prospective, single-arm, multicenter, uncontrolled clinical study involving 88 eligible subjects. Participants will undergo laparoscopic FTME surgery, and their demographic information, surgical details, postoperative outcomes, and follow-up data will be collected and analyzed. The study seeks to provide higher-level evidence regarding the benefits of this surgical approach in preserving nerve function.
Who should consider this trial
Good fit: Ideal candidates are males aged 18-70 with mid-low rectal cancer and normal urinary and sexual function.
Not a fit: Patients with a history of major abdominal or pelvic surgery or those requiring emergency surgery due to complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved urinary and sexual function outcomes for male patients undergoing surgery for rectal cancer.
How similar studies have performed: Previous studies have indicated potential benefits of nerve plane-oriented surgical techniques, but this specific approach is being evaluated for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Wuhan, Hubei
- Yongbin Zheng — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Yongbin Zheng, M.D,Ph.D — Renmin Hospital of Wuhan University
- Study coordinator: Yongbin Zheng, M.D,Ph.D
- Email: yongbinzheng@whu.edu.cn
- Phone: 13871189698
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.