Trial Outcomes & Findings for Neuropathic Pain After Orchidectomy and Sex Reassignment Surgery (NCT NCT04538170)
NCT ID: NCT04538170
Last Updated: 2022-06-21
Results Overview
Number of patients with phantom pain of testis
Recruitment status
COMPLETED
Target enrollment
423 participants
Primary outcome timeframe
a minimum of 6 month post-surgery up to 5 years postsurgery
Results posted on
2022-06-21
Participant Flow
Participant milestones
| Measure |
(ORC) Orchiectomy Following Cancer
158 men who had undergone tumor orchidectomy between 2010 and 2014
|
(GAC) Group Sex Reassignment Surgery
265 transsexual women who had undergone surgery between 2002 and 2014
|
|---|---|---|
|
Overall Study
STARTED
|
158
|
265
|
|
Overall Study
COMPLETED
|
54
|
55
|
|
Overall Study
NOT COMPLETED
|
104
|
210
|
Reasons for withdrawal
| Measure |
(ORC) Orchiectomy Following Cancer
158 men who had undergone tumor orchidectomy between 2010 and 2014
|
(GAC) Group Sex Reassignment Surgery
265 transsexual women who had undergone surgery between 2002 and 2014
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
104
|
210
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
ORC Group Orchidectomy Following Cancer
n=54 Participants
Group orchidectomy following cancer
pain after surgery
|
GAC Group Sex Reassignment Surgery
n=55 Participants
Group sex reassignment surgery
pain after surgery
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.7 years
STANDARD_DEVIATION 11.7 • n=54 Participants
|
48.8 years
STANDARD_DEVIATION 10.1 • n=55 Participants
|
46.2 years
STANDARD_DEVIATION 10.9 • n=109 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=54 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=109 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=54 Participants
|
55 Participants
n=55 Participants
|
109 Participants
n=109 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Germany
|
54 participants
n=54 Participants
|
55 participants
n=55 Participants
|
109 participants
n=109 Participants
|
PRIMARY outcome
Timeframe: a minimum of 6 month post-surgery up to 5 years postsurgeryNumber of patients with phantom pain of testis
Outcome measures
| Measure |
ORC Group Orchidectomy Following Cancer
n=54 Participants
phantom pain of testis after surgically removal
|
GAC Group Sex Reassignment Surgery
n=55 Participants
pantom pain of testes after surgically removal
|
|---|---|---|
|
Incidence of Phantom Pain
|
6 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: a minimum of 6 month post-surgery up to 5 years postsurgeryNumber of Participants with Incontinence, Difficult Urination, Stenosis of Urethra, Spraying of Urine and/or Corrective Surgery"
Outcome measures
| Measure |
ORC Group Orchidectomy Following Cancer
n=54 Participants
phantom pain of testis after surgically removal
|
GAC Group Sex Reassignment Surgery
n=55 Participants
pantom pain of testes after surgically removal
|
|---|---|---|
|
Functional Outcome
Incontinence
|
1 Participants
|
7 Participants
|
|
Functional Outcome
difficult urination
|
2 Participants
|
5 Participants
|
|
Functional Outcome
stenosis of the urethra
|
0 Participants
|
11 Participants
|
|
Functional Outcome
spraying of urine
|
0 Participants
|
11 Participants
|
|
Functional Outcome
corrective surgery
|
3 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: a minimum of 6 month post-surgery up to 5 years postsurgeryNumber of patients with chronic pain after surgery and differences between the two groups
Outcome measures
| Measure |
ORC Group Orchidectomy Following Cancer
n=54 Participants
phantom pain of testis after surgically removal
|
GAC Group Sex Reassignment Surgery
n=55 Participants
pantom pain of testes after surgically removal
|
|---|---|---|
|
Incidence of Chronic Postoperative Pain
|
13 Participants
|
15 Participants
|
Adverse Events
GAC Gender Reassignment Surgery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ORC Patients After Inguinal Orchidectomy for Testicular Tumor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Barbara Schlisio
Department of Anaesthesiology and Intensive Care Medicine, Eberhard-Karls-University,Tuebingen, Germany
Phone: +4970712985535
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place