Neuropathic Pain After Orchidectomy and Sex Reassignment Surgery

NCT04538170 | Completed Results

• 1 other identifier: 611/2013BO2
• Study Type: observational
• Target: 423
• Locations: 1 country
• Sites: 1

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?

Conditions

Neuropathic Pain; Phantom Pain; Sex Reassignment Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Functional Outcome

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

• Incidence of Chronic Postoperative Pain

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

Study Arms (2)

ORC

Group orchidectomy following cancer

Behavioral: pain after surgery

GAC

Group sex reassignment surgery

Behavioral: pain after surgery

Interventions

pain after surgery BEHAVIORAL

GAC; ORC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Tuebingen, clinic of anästhesiology and intensiv care

Tübingen, 72074, Germany

Location

MeSH Terms

Conditions

Neuralgia; Phantom Limb

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Pain, Postoperative; Postoperative Complications; Pathologic Processes

Limitations and Caveats

The response rate could influence the result. One reason could be the large period of time between the operation and data collection

Results Point of Contact

• Title: Dr. Barbara Schlisio
• Organization: Department of Anaesthesiology and Intensive Care Medicine, Eberhard-Karls-University,Tuebingen, Germany

barbara.schlisio@med.uni-tuebingen.de

+4970712985535

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: September 4, 2020
• Study Start: September 1, 2014
• Primary Completion: August 8, 2017
• Study Completion: July 1, 2019
• Last Updated: June 21, 2022
• Results First Posted: June 21, 2022

Record last verified: 2014-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)