About this trial
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
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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;
Trial design
Single group
Treatments tested in this trial
Laparoscopic FTME surgery
Procedure/SurgeryNerve 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.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of sexual dysfunction
The 5-item version of the International Index of Erectile Function (IIEF-5) and ejaculation function are used to assess sexual function. the IIEF-5 total score ranged from 1 to 25, with a lower score indicating more severe erectile dysfunction, male sexual dysfunction was defined as the IIEF-5 score ≤11points. Ejaculation function was classified as: Grade I, normal ejaculation; Grade II: retrograde ejaculation; Grade III: anejaculation, and ejaculation dysfunction was identified as ejaculation function of grade II/III.
Incidence of urinary dysfunction
The International Prostate Symptom Score (IPSS) are used to assess urinary function. the IIEF-5 total score ranged from 0 to 35, with a higher score indicating more severe erectile dysfunction,moderate-to-severe urinary dysfunction was defined as the IPSS score \>8 points.
Secondary outcomes
Morbidity
incidence of postoperatvie complications
Mortality
incidence of postoperatvie deaths
3-year overall survival rate
3-year overall survival rate
3-year disease free survival rate
3-year disease free survival rate
Sponsors and contacts
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