Status:
NOT_YET_RECRUITING
Interest of Early Erectile Rehabilitation With Sildenafil After Radiotherapy and Proctectomy for Rectal Cancer
Lead Sponsor:
University Hospital, Rouen
Conditions:
Rectal Cancer
Eligibility:
MALE
18-70 years
Phase:
PHASE3
Brief Summary
This study aims to evaluate the efficacy of erectile rehabilitation with Sildenafil, in men treated with neoadjuvant proctectomy and radiotherapy for rectal cancer, in preventing long-term erectile dy...
Detailed Description
Colorectal cancer is the third most common cancer in men in France, after lung and prostate cancer. Proctectomy (possibly preceded by radiotherapy) is the most effective treatment for this cancer, but...
Eligibility Criteria
Inclusion
- Men aged 18 to 70
- Patients undergoing surgery for cancer of the lower or middle rectum by total removal of the mesorectum with colorectal or coloanal anastomosis after neoadjuvant radiotherapy, with normal preoperative erectile function (defined by a combined IIEF erectile function domain score of at least 22).
- Nerve-conserving surgery
- Sexually active patient without treatment for erectile function prior to surgery
- Presence of a regular sexual partner (male or female)
- Adult having read and understood the information letter and signed the consent form
- Membership of a social security scheme
Exclusion
- T4 tumor or tumor requiring extended surgery
- Patients with abnormal erectile function defined by a combined IIEF erectile function domain score of less than 22.
- History of prostate cancer
- Sleep disorders, patients taking sedatives/hypnotics
- Contraindication to SILDENAFIL EG 50 mg, film-coated tablet
- Contraindication to placebo
- Patients already treated with PDE5 inhibitors
- Patients suffering from SARS COV 2\*
- Person deprived of liberty by an administrative or judicial decision or person placed under court protection / sub-guardianship or guardianship.
- Any history of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol, or to prevent the subject from giving informed consent.
- Person participating in another drug trial.
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT06123156
Start Date
June 1 2024
End Date
May 1 2028
Last Update
November 8 2023
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