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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.
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:
intracavernosal injections of prostaglandins are the standard treatment, but phosphodiesterase 5 inhibitors can also be used. For these reasons, it is necessary to develop a method for evaluating objective erectile dysfunction after resection.
The Rigiscan Plus device is a commercially available measurement tool that has received CE certification.
It can be used to assess several parameters of erection: rigidity, intensity, and duration. This measuring device has been validated for the assessment of erectile dysfunction, and normal values have been established in healthy subjects.
Combining these two tests makes it possible to assess the presence or absence of erections during REM sleep and to objectively diagnose erectile dysfunction:
in the presence of decreased libido, nocturnal erections are preserved, whereas they are impaired following vascular-nervous damage. Recording nocturnal erections is useful for assessing erectile dysfunction after rectal surgery in two ways. Preoperatively, it provides objective confirmation that the patient has spontaneous erections of good quality. Postoperatively, recording allows confirmation that the autonomic nervous system required for erection has been preserved. It is an objective examination that is independent of the patient's libido, which is often impaired by the treatment of a neoplastic disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with localized rectal cancer | Other | Assessment (at night) of erctile dysfunction using R/P recording (RIGISCAN® PLUS / polysomonography) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluation of erectile dysfunction | Other | Assessment (at night) of erctile dysfunction using R/P recording (RIGISCAN® PLUS / polysomonography) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Erectile Dysfunction Induced by Medical and Surgical Treatment of Rectal Cancer | Erectile dysfunction is defined by the absence of normal nocturnal erections according to R/P recording (RIGISCAN® PLUS / polysomnography) | 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Nocturnal Erections | Erections are assessed according to R/P recording (RIGISCAN® PLUS / polysomnography). Erectile function will be described and categorized into 4 distinct stages:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| EVRARD Serge, PU-PH | Institut Bergonié | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonié | Bordeaux | Aquitaine | 33000 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Localized Rectal Cancer | Assessment (at night) of erctile dysfunction using R/P recording (RIGISCAN® PLUS / polysomonography) Evaluation of erectile dysfunction: Assessment (at night) of erctile dysfunction using R/P recording (RIGISCAN® PLUS / polysomonography) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Localized Rectal Cancer | Assessment (at night) of erctile dysfunction using R/P recording (RIGISCAN® PLUS / polysomonography) Evaluation of erectile dysfunction: Assessment (at night) of erctile dysfunction using R/P recording (RIGISCAN® PLUS / polysomonography) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients With Erectile Dysfunction Induced by Medical and Surgical Treatment of Rectal Cancer | Erectile dysfunction is defined by the absence of normal nocturnal erections according to R/P recording (RIGISCAN® PLUS / polysomnography) | Participants with R/P recording (RIGISCAN® PLUS / polysomnography) performed | Posted | Count of Participants | Participants | 3 months after surgery |
|
3 months
Other [Not Including Serious] Adverse Events were not monitored/assessed for this prospective observational study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Localized Rectal Cancer | Assessment (at night) of erectile dysfunction using R/P recording (RIGISCAN® PLUS / polysomonography) Evaluation of erectile dysfunction: Assessment (at night) of erectile dysfunction using R/P recording (RIGISCAN® PLUS / polysomonography) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Simone Mathoulin-Pélissier, Director of Clinical Trials Unit | Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR | +33 5 56 33 33 33 | s.mathoulin@bordeaux.unicancer.fr |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| 3 years after surgery |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Quality of Nocturnal Erections | Erections are assessed according to R/P recording (RIGISCAN® PLUS / polysomnography). Erectile function will be described and categorized into 4 distinct stages:
| Participants with available R/P recording (RIGISCAN® PLUS / polysomnography). | Posted | Count of Participants | Participants | 3 years after surgery |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 0 |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| Absence of erections |
|