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Potsdam Carpal Tunnel Syndrome Sex Study

Organizational Data

DRKS-ID:
DRKS00032657
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2023-09-18
Last update in DRKS:
2024-03-18
Registration type:
Retrospective

Acronym/abbreviation of the study

Pots-CTS-Sex

URL of the study

https://www.evb-gesundheit.de/klinikumevb/neurochirurgie/forschung-und-lehre#c7583

Brief summary in lay language

We study and compare the sexual limitations experienced by individuals undergoing surgery for carpal tunnel syndrome. Additionally, we aim to explore how the patients' self-confidence can impact the outcomes.

Brief summary in scientific language

Quantification and comparison of sexual activity limitations, as well as an investigation into the influence of self-efficacy in patients undergoing carpal tunnel syndrome surgery.

Health condition or problem studied

ICD10:
G56.0 - Carpal tunnel syndrome
Healthy volunteers:
No

Interventions, Observational Groups

Arm 1:
Patients with CTS (carpal tunnel syndrome) undergoing carpal tunnel release surgery The Boston Carpal Tunnel Questionnaire and sexual activity are assessed at the following points in time: - time point 0 (pre-op) - time point 1 (3 weeks post-op) - time point 2 (3 months post-op)

Endpoints

Primary outcome:
Sexual limitations in patients after carpal tunnel release surgery. The severity of symptoms and functional status change will be assessed using the classification system developed by Keilani MY et al. Continuous variables will be analyzed for statistical significance using the Kruskal-Wallis test, and categorical variables will be assessed using the Chi-square test.
Secondary outcome:
The impact of patient self-efficacy, according to Schwarzer, on the surgical outcomes of carpal tunnel release.

Study Design

Purpose:
Prognosis
Retrospective/prospective:
Prospective
Study type:
Non-interventional
Longitudinal/cross-sectional:
Longitudinal study
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • Medical center Ernst von Bergmann Klinikum Potsdam

Recruitment period and number of participants

Planned study start date:
2023-08-01
Actual study start date:
2023-09-13
Planned study completion date:
2025-09-30
Actual Study Completion Date:
No Entry
Target Sample Size:
100
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
All patients aged >18 years with clinically indicated carpal tunnel syndrome surgery, who are physically and mentally capable of completing the study questionnaires.

Exclusion Criteria

Minors, patients lacking the capacity for understanding and informed consent, as well as the inability to complete the study questionnaires.

Addresses

Primary Sponsor

Klinikum Ernst von Bergmann
Dr. med. Holger Joswig
14467 Potsdam
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Klinikum Ernst von Bergmann Potsdam
Dr. med. Holger Joswig
Charlottenstraße 72
14467 Potsdam
Germany
Telephone:
+4933124137953
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Klinikum Ernst von Bergmann Potsdam
Dr. med. Holger Joswig
Charlottenstraße 72
14467 Potsdam
Germany
Telephone:
+4933124137953
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Klinikum Ernst von Bergmann Potsdam
Dr. med. Holger Joswig
Charlottenstraße 72
14467 Potsdam
Germany
Telephone:
+4933124137953
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Ernst von Bergmann Klinikum Potsdam
Charlottenstraße 72
14467 Potsdam
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethikkommission der Landesärztekammer Brandenburg
Dreifertstr. 12
03044 Cottbus
Germany
Telephone:
+49-355-78010151/-152
Fax:
No Entry
Contact per E-Mail
URL:
http://laekb.de/www/website/PublicNavigation/arzt/ethikkommission/

Vote of leading Ethics Committee

Date of ethics committee application:
2023-09-07
Ethics committee number:
2023-97-BO-ff
Vote of the Ethics Committee:
Approved
Date of the vote:
2023-09-12

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry