Neuropathic Pain After Orchidectomy and Sex Reassignment Surgery

Neuropathic Pain Clinical Trial

— NPASRS  

Official title:

Neuropathic Pain After Orchidectomy and Sex Reassignment Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04538170
• Other study ID #: 611/2013BO2
• Status: Completed
• Start date: September 1, 2014
• Est. completion date: July 1, 2019

Study information

• Verified date: August 2014
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 423
• Est. completion date: July 1, 2019
• Est. primary completion date: August 8, 2017
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Surgery at least 6 month before data collection

• german speaking

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Phantom Limb
• Phantom Pain
• Sex Reassignment Surgery

Intervention

Behavioral:
• pain after surgery

Locations

Country	Name	City	State
Germany	University Tuebingen, clinic of anästhesiology and intensiv care	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Phantom Pain	Number of patients with phantom pain of testis	a minimum of 6 month post-surgery up to 5 years postsurgery
Secondary	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
Secondary	Incidence of Chronic Postoperative Pain	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