Clinical trial NCT04538170: Neuropathic Pain After Orchidectomy and Sex Reassignment Surgery
Official title: Neuropathic Pain After Orchidectomy and Sex Reassignment Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuropathic Pain
Phantom Pain
Sex Reassignment Surgery
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 423
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: Inclusion Criteria:

* Surgery at least 6 month before data collection
* german speaking

Exclusion Criteria:

-

Primary outcomes:
measure: Incidence of Phantom Pain
timeFrame: a minimum of 6 month post-surgery up to 5 years postsurgery
Secondary outcomes:
measure: Functional Outcome
timeFrame: a minimum of 6 month post-surgery up to 5 years postsurgery
measure: Incidence of Chronic Postoperative Pain
timeFrame: a minimum of 6 month post-surgery up to 5 years postsurgery
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Tuebingen, clinic of anästhesiology and intensiv care
Study officials:
References: