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Efficacy and safety of postoperative early oral sildenafil for the prevention of erectile dysfunction after laparoscopic total mesorectal excision of rectal cancer: study protocol for a randomized controlled trial

Efficacy and safety of postoperative early oral sildenafil for the prevention of erectile dysfunction after laparoscopic total mesorectal excision of rectal cancer: study protocol for a randomized controlled trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015080
Enrollment
Unknown
Registered
2018-03-06
Start date
2018-07-01
Completion date
Unknown
Last updated
2018-03-12

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

Conditions

erectile dysfunction after laparoscopic total mesorectal excision of rectal cancer

Interventions

Experience group:oral sildenafil afer operation
control group:oral placebo after operation

Sponsors

The Second Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Tumor has invaded surrounded organs and tissues, which could not be resected, or has distant metastasis; 2. Patients with severe respiratory insufficiency, circulatory disease or malfunction of liver and kidney; 3. Patients with Heart disease (Coronary heart disease, myocardial infarction, arrhythmia, etc); 4. patients with taking nitrates; 5. patients with a history of spontaneous erectile erection; 6. patients with visual interference; 7. patients with drepanocytosis or coagulation diaorders.

Exclusion criteria

Exclusion criteria: 1. patients who not meet the criteria of inclusion; 2. patients with severe pelvic autonomic nerves damage during operation; 3. subjects take other interventions which will influence the outcome of the test; 4. Researchers think that subjects should terminate the test from a medical point of view; 5. patients require to terminate and withdraw from the test.

Design outcomes

Secondary

MeasureTime frame
The changes of pre- and postoperative erectile function, ESV and PSV.;The intraoperative and postoperative complication.;The side effects of sildenafil tablet.;

Primary

MeasureTime frame
The incidence of erectile dysfunction at 12 months after laparoscopic total mesorectal excision of rectal cancer.;

Countries

China

Contacts

Public ContactZhenhong Zou

The Second Affiliated Hospital, Nanchang University

1025377834@qq.com+86 13767991650

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026