Multicenter Study on Postoperative Urinary and Sexual Function During Laparoscopic Functional Total Mesorectum Excision
Recruiting · NCT05049317 · Interventional (participants receive a specific treatment) · Lead sponsor: Renmin Hospital of Wuhan University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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;
Exclusion criteria
- History of abdominal and pelvic major surgery;
- Emergency surgery is needed due to the complication (bleeding, obstruction, or perforation) caused by rectal cancer;
- Pelvic or distant metastasis;
- Neoadjuvant radiotherapy or chemoradiotherapy;
- No sexual life;
Where it is running
1 location listed.
- Yongbin Zheng - Wuhan, Hubei, China