Neuropathic Pain, Phantom Pain, Sex Reassignment Surgery
Conditions
Brief summary
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?
Detailed description
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.
Interventions
BEHAVIORALpain after surgery
Sponsors
University Hospital Tuebingen
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Surgery at least 6 month before data collection * german speaking
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Phantom Pain | a minimum of 6 month post-surgery up to 5 years postsurgery | Number of patients with phantom pain of testis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Outcome | a minimum of 6 month post-surgery up to 5 years postsurgery | Number of Participants with Incontinence, Difficult Urination, Stenosis of Urethra, Spraying of Urine and/or Corrective Surgery |
| Incidence of Chronic Postoperative Pain | a minimum of 6 month post-surgery up to 5 years postsurgery | Number of patients with chronic pain after surgery and differences between the two groups |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ORC Group Orchidectomy Following Cancer Group orchidectomy following cancer
pain after surgery | 54 |
| GAC Group Sex Reassignment Surgery Group sex reassignment surgery
pain after surgery | 55 |
| Total | 109 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 104 | 210 |
Baseline characteristics
| Characteristic | GAC Group Sex Reassignment Surgery | Total | ORC Group Orchidectomy Following Cancer |
|---|---|---|---|
| Age, Continuous | 48.8 years STANDARD_DEVIATION 10.1 | 46.2 years STANDARD_DEVIATION 10.9 | 43.7 years STANDARD_DEVIATION 11.7 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Germany | 55 participants | 109 participants | 54 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 55 Participants | 109 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 54 |
| other Total, other adverse events | 0 / 55 | 0 / 54 |
| serious Total, serious adverse events | 0 / 55 | 0 / 54 |
Outcome results
Primary
Incidence of Phantom Pain
Number of patients with phantom pain of testis
Time frame: a minimum of 6 month post-surgery up to 5 years postsurgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ORC Group Orchidectomy Following Cancer | Incidence of Phantom Pain | 6 Participants |
| GAC Group Sex Reassignment Surgery | Incidence of Phantom Pain | 0 Participants |
Comparison: Preliminary work showed that approximately 25% of patients report phantom pain after orchidectomy. A difference of 20% between the GAC and ORC groups was considered relevant. Power was set to 80% and the significance level to 5%, resulting in a minimum of 40 women to be recruited, which was fulfilled.p-value: 0.013Fisher Exact
Secondary
Functional Outcome
Number of Participants with Incontinence, Difficult Urination, Stenosis of Urethra, Spraying of Urine and/or Corrective Surgery
Time frame: a minimum of 6 month post-surgery up to 5 years postsurgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ORC Group Orchidectomy Following Cancer | Functional Outcome | corrective surgery | 3 Participants |
| ORC Group Orchidectomy Following Cancer | Functional Outcome | Incontinence | 1 Participants |
| ORC Group Orchidectomy Following Cancer | Functional Outcome | difficult urination | 2 Participants |
| ORC Group Orchidectomy Following Cancer | Functional Outcome | stenosis of the urethra | 0 Participants |
| ORC Group Orchidectomy Following Cancer | Functional Outcome | spraying of urine | 0 Participants |
| GAC Group Sex Reassignment Surgery | Functional Outcome | spraying of urine | 11 Participants |
| GAC Group Sex Reassignment Surgery | Functional Outcome | stenosis of the urethra | 11 Participants |
| GAC Group Sex Reassignment Surgery | Functional Outcome | Incontinence | 7 Participants |
| GAC Group Sex Reassignment Surgery | Functional Outcome | corrective surgery | 19 Participants |
| GAC Group Sex Reassignment Surgery | Functional Outcome | difficult urination | 5 Participants |
Secondary
Incidence of Chronic Postoperative Pain
Number of patients with chronic pain after surgery and differences between the two groups
Time frame: a minimum of 6 month post-surgery up to 5 years postsurgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ORC Group Orchidectomy Following Cancer | Incidence of Chronic Postoperative Pain | 13 Participants |
| GAC Group Sex Reassignment Surgery | Incidence of Chronic Postoperative Pain | 15 Participants |