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The Effect of Partial Preservation versus Complete Preservation of Denonvilliers' Fascia on Postoperative Sexual Function and Urinary Function in Male Patients with Low Rectal Cancer: a Multicenter, Prospective, Randomized Controlled Clinical Trial

The Effect of Partial Preservation versus Complete Preservation of Denonvilliers' Fascia on Postoperative Sexual Function and Urinary Function in Male Patients with Low Rectal Cancer: a Multicenter, Prospective, Randomized Controlled Clinical Trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034892
Enrollment
Unknown
Registered
2020-07-23
Start date
2020-08-01
Completion date
Unknown
Last updated
2020-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Interventions

Group 1:Partial retention of the Denonvilliers fascia
Group 2:The Denonvilliers fascia is completely retained

Sponsors

Fujian Medical University Union Hospital y
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Aged 20-75 years; 2) Male; 3) Rectal adenocarcinoma was confirmed by pathology; 4) Low rectal cancer (primary magnetic resonance MRI examination showed that the lower margin of the tumor was ?7cm from the anal margin); 5) Preoperative clinical staging was CT1-3N0-2M0 (according to AJCC-8TH TNM tumor stage); 6) Preoperative heart, lung, liver and kidney functions can be tolerated; 7) Preoperative ASA score level I-III; 8) To undergo elective TME surgery for colon-rectal or colon-anal anastomosis; 9) Normal preoperative sexual function and urine function (IIEF-5 >= 22 points;I-pss: 0-7 points); 10) Patients and their families can understand the study plan and are willing to participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) Simultaneous or heterogeneous (within 5 years) malignant tumors; 2) Patients with intestinal obstruction, intestinal perforation, intestinal bleeding and other conditions requiring emergency surgical resection; 3) Prior pelvic and urinary surgery; 4) Serious mental illness; 5) Patients with severe emphysema, interstitial pneumonia or ischemic heart disease who cannot tolerate surgery; 6) A history of unstable angina pectoris or myocardial infarction within 6 months; 7) A history of cerebral infarction or cerebral hemorrhage within 6 months; 8) A history of continuous systemic corticosteroid therapy within 1 month; 9) Need concurrent surgical treatment for other diseases; 10) Preoperative urinary incontinence or severe stress incontinence; 11) Unable to cooperate with physician to complete functional assessment; 12) Patients have contraindications in laparoscopic or robotic surgery.

Design outcomes

Primary

MeasureTime frame
Sexual function after surgery ;

Secondary

MeasureTime frame
Urination function;Postoperative complications and 30-day mortality;

Countries

China

Contacts

Public ContactChi Pan

Fujian Medical University Union Hospital

cp3169@163.com+86 13675089677

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026