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OpenTrials
Completed

NCT Number: NCT04538170

Neuropathic Pain After Orchidectomy and Sex Reassignment Surgery

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?

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

pain after surgery

Behavioral

Primary outcomes

  1. Incidence of Phantom Pain

    Time frame: a minimum of 6 month post-surgery up to 5 years postsurgery

    Number of patients with phantom pain of testis

Secondary outcomes

  1. Functional Outcome

    Time frame: 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"

  2. Incidence of Chronic Postoperative Pain

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Acronym: NPASRS

Important dates

Study start
2014
Primary completion
2017
Study completion
2019
First posted
Sep 4, 2020
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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