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Phantom pain is associated with cortical reorganization after amputation. This phenomenon should not play a role in transsexual women, since the cortical representation of the male sex organs is presumably altered. The study investigates the incidence of phantom pain in this patient population.
For this study the following question should be investigated:
Is the incidence of phantom pain and local chronic postsurgical pain lower in sex reassignment surgery from male to female compared to inguinal tumor orchidectomy?
Phantom pain is a common and much studied phenomenon after amputation.The loss of visceral organs is also associated with phantom pain. Under entirely different conditions than the removal of a tumorous testicle, sex reassignment surgery from male to female sex occurs in transsexual women. In this operation, parts of the penis and both testicles are removed and a plastic surgical transformation is made into a female genital.The surgical trauma is greater compared to an orchidectomy.
The sex reassignment surgery is expressly desired, the amputated tissues are rejected or perceived as not belonging to the patient's own body and thus do not appear as a loss. The group of patients with tumor orchidectomy acts as a control group.
In addition to the incidence of phantom pain and chronic local postoperative pain in comparison between the two groups, the secondary objectives of the study were defined as the occurrence of phantom pain, the type of pain and the intensity of pain.
Two patient groups were compared, the group after sex reassignment surgery (GAC) and the group after inguinal orchidectomy for testicular tumor (ORC).
A total of 265 transgender women were written to, 46 of whom had undergone surgery in Tübingen and 219 in Munich. The operations took place between 2002 and 2014.
For the group of patients after orchidectomy, 158 men who had undergone surgery in Tuebingen between 2010 and 2014 were contacted by letter.
The pseudonymization was done with a combination of letters and numbers, which were created with a key generator program.
The patients received a questionnaire divided into several categories, these categories were questions on demography, pre- and postoperative pain as well as phantom pain, pain processing, quality of life, sex life and urological questions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ORC | Group orchidectomy following cancer |
| |
| GAC | Group sex reassignment surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pain after surgery | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Phantom Pain | Number of patients with phantom pain of testis | a minimum of 6 month post-surgery up to 5 years postsurgery |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Outcome | Number of Participants with Incontinence, Difficult Urination, Stenosis of Urethra, Spraying of Urine and/or Corrective Surgery" | a minimum of 6 month post-surgery up to 5 years postsurgery |
| Incidence of Chronic Postoperative Pain |
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Inclusion Criteria:
Exclusion Criteria:
-
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Patients after surgery (orcidectomy and sex resignment surgery in the universtiy hospital of Tuebingen Department of Urology and the Hospital of Munich Bogenhausen Department of Urology
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Tuebingen, clinic of anästhesiology and intensiv care | Tübingen | 72074 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | (ORC) Orchiectomy Following Cancer | 158 men who had undergone tumor orchidectomy between 2010 and 2014 |
| FG001 | (GAC) Group Sex Reassignment Surgery | 265 transsexual women who had undergone surgery between 2002 and 2014 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ORC Group Orchidectomy Following Cancer | Group orchidectomy following cancer pain after surgery |
| BG001 | GAC Group Sex Reassignment Surgery | Group sex reassignment surgery pain after surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Incidence of Phantom Pain | Number of patients with phantom pain of testis | Posted | Count of Participants | Participants | a minimum of 6 month post-surgery up to 5 years postsurgery |
|
|
a minimum of 6 month post-surgery up to 5 years postsurgery
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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 | GAC Gender Reassignment Surgery | 55 transsexual women who had undergone gender reassignment surgery answer a questionnaire |
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The response rate could influence the result. One reason could be the large period of time between the operation and data collection
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Barbara Schlisio | Department of Anaesthesiology and Intensive Care Medicine, Eberhard-Karls-University,Tuebingen, Germany | +4970712985535 | barbara.schlisio@med.uni-tuebingen.de |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 23, 2013 | Apr 28, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010591 | Phantom Limb |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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Number of patients with chronic pain after surgery and differences between the two groups
| a minimum of 6 month post-surgery up to 5 years postsurgery |
| BG002 | Total | Total of all reporting groups |
| 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 |
|
| Participants |
|
|
|
| Secondary | Functional Outcome | Number of Participants with Incontinence, Difficult Urination, Stenosis of Urethra, Spraying of Urine and/or Corrective Surgery" | Posted | Count of Participants | Participants | a minimum of 6 month post-surgery up to 5 years postsurgery |
|
|
|
| Secondary | Incidence of Chronic Postoperative Pain | Number of patients with chronic pain after surgery and differences between the two groups | Posted | Count of Participants | Participants | a minimum of 6 month post-surgery up to 5 years postsurgery |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | ORC Patients After Inguinal Orchidectomy for Testicular Tumor | 54 patients after inguinal orchidectomy for testicular tumor, answer a questionnaire | 0 | 54 | 0 | 54 | 0 | 54 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| stenosis of the urethra |
|
| spraying of urine |
|
| corrective surgery |
|