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
Renmin Hospital of Wuhan University
88 participants
Nov 24, 2021
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
Inclusion Criteria6
- 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 Criteria5
- 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;
Interventions
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)
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NCT05049317