Erectile Rating During the Treatment of Rectal Cancers Localized. Exploratory Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Institut Bergonié
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Proportion of Patients With Erectile Dysfunction Induced by Medical and Surgical Treatment of Rectal Cancer
Study Overview
Brief Summary
Sexual dysfunction is a common side effect of medical and surgical treatments for rectal cancer. It can manifest as ejaculation disorders or erectile dysfunction. Due to the modesty of both patients and doctors, these disorders are poorly understood and probably underestimated at present. Aim : Objectively assess the presence of erectile dysfunction induced by medical and surgical treatment of rectal cancer three months after surgery. These objective data will be obtained using the RIGISCAN® PLUS system coupled with polysomnographic recording.
Detailed Description
Sexual dysfunction is a common side effect of medical and surgical treatments for rectal cancer. It can manifest as ejaculation disorders or erectile dysfunction. Due to the modesty of both patients and doctors, these disorders are poorly understood and probably underestimated at present. After surgical treatment alone, sexual dysfunction can be observed in 40 to 90% of patients, depending on the studies and the technique used. It is the result of direct vascular and nerve damage caused during surgery. It occurs immediately after surgery. It can sometimes recover over time, up to 18 months after the operation. Pelvic radiotherapy also has side effects on sexual function. The damage is caused by alterations in microvascularization or direct nerve damage.
It develops more gradually, over a period of several weeks or months. After treatment combining radiotherapy and surgery, the risk of sexual dysfunction is significant and can affect up to 90% of patients.
In an attempt to improve these results, surgical techniques have gradually evolved towards complete resection of the mesorectum with nerve preservation. Studies published on this subject show an improvement in functional outcomes, without any deterioration in oncological outcomes. This has now become the standard surgical technique.
In the specific case of the management of neoplastic disease, it is common to observe a reactive anxiety-depression syndrome in patients. This mood disorder affects libido and sexuality. A lack of sexual activity in the postoperative period is therefore not necessarily related to iatrogenic vascular-nerve damage. In order to improve patients' quality of life, it is useful to know how to objectively diagnose post-operative erectile dysfunction. This diagnosis should make it possible to distinguish between disorders related to vascular-nervous damage and those that are part of a post-operative anxiety-depression syndrome.
An accurate diagnosis of sexual dysfunction can lead to specific treatment:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male patient.
- •Age greater than 18 years.
- •Neoplastic rectal stage ≤ T
- •Patient sexually active before diagnosis.
- •Laparoscopic surgery.
- •Medico-surgical institute Bergonié.
- •Patient information and consent for participation in the study.
Exclusion Criteria
- •Patients already treated for erectile dysfunction.
- •Absence of sexual activity before diagnosis.
- •Presence of secondary lesions at diagnosis (M +).
- •Classified T4 tumor preoperatively.
- •Surgery by laparotomy.
- •History of pelvic cancer surgery prostate or bladder.
- •History of pelvic radiotherapy (outside of the current process).
- •History of prostate or bladder neoplasia known.
- •Other neoplastic known.
- •Patient for psychological, social, family or geographical could not be treated or monitored regularly according to the criteria of the study, patient deprived of liberty or under guardianship.
Outcomes
Primary Outcomes
Proportion of Patients With Erectile Dysfunction Induced by Medical and Surgical Treatment of Rectal Cancer
Time Frame: 3 months after surgery
Erectile dysfunction is defined by the absence of normal nocturnal erections according to R/P recording (RIGISCAN® PLUS / polysomnography)
Secondary Outcomes
- Quality of Nocturnal Erections(3 years after surgery)