NCT05049317Recruiting
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
Source: ClinicalTrials.gov · Last updated 1 Nov 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 88 (estimated)
- First submitted
- 10 Sept 2021
- Start date
- Nov 2021
- Primary completion date
- Sept 2022
- Lead sponsor
- Renmin Hospital of Wuhan University
- Diseases
- Colorectal cancer
- NCT number
- NCT05049317
What you commit to
- Study type: Interventional
- Planned participants: 88
- From Nov 2021 to the primary completion date, Sept 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Neoadjuvant radiotherapy or chemoradiotherapy;
Other illness
- History of abdominal and pelvic major surgery;
- Emergency surgery is needed due to the complication (bleeding, obstruction, or perforation) caused by rectal cancer;
Other
- Pelvic or distant metastasis;
- No sexual life;
Who the study is looking for
- 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;
Age in the registry: 18 years to 70 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yongbin Zheng Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.