Multicenter Study on Postoperative Urinary and Sexual Function During Laparoscopic Functional Total Mesorectum Excision

ConditionRectal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-70
SponsorRenmin Hospital of Wuhan University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Laparoscopic FTME surgery

    Procedure/Surgery

    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.

Treatment groups

88 Participants
are divided into 1 treatment group
Group A: FTME groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months
2

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.

Time frame
3 months

Secondary outcomes

1

Morbidity

incidence of postoperatvie complications

Time frame
30 days
2

Mortality

incidence of postoperatvie deaths

Time frame
30 days
3

3-year overall survival rate

3-year overall survival rate

Time frame
36 months
4

3-year disease free survival rate

3-year disease free survival rate

Time frame
36 months

Other outcomes

Sponsors and contacts

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