Central Sensitization and Outcome of Endometriosis Surgery

Endometriosis Clinical Trial

Official title:

Substudy on Central Sensitization and Outcome of Endometriosis Surgery of the PROMPT Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04144998
• Other study ID #: EndoPROMPT
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: June 13, 2022

Study information

• Verified date: July 2022
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will evaluate whether the degree of central sensitization as measured by the questionnaire "central sensitization inventory CSI" is related to the outcome of surgical endometriosis treatment

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: June 13, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary surgery because of pelvic/abdominal pain under suspected diagnosis of and with the aim to confirm endometriosis

• Elective abdominal surgery in women with pelvic/abdominal pain and confirmed endometriosis

Exclusion Criteria:

• Patient is unable to give consent

• Cognitive impairment

• Patient outcomes questionnaire is not available in a language that the patient knows.

• Secondary surgery due to complications

• Endometriosis Surgery due to infertility

Related Conditions & MeSH terms

• Endometriosis

Intervention

Diagnostic Test:
• central sensitization inventory (questionnaire)
T.G. Mayer, R. Neblett, H. Cohen, et al. The development and psychometric validation of the central sensitization inventory Pain Pract, 12 (2012), pp. 276-285

Locations

Country	Name	City	State
Switzerland	Hôpitaux Universitaires de Genève	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Benno Rehberg-Klug

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endometriosis health profile EHP-30 pain subscale	Pain subscale of the questionnaire "endometriosis health profile" EHP-30, scale from 0-100, higher values indicate worse health status	6 months
Secondary	other subscales of the endometriosis health profile EHP-30	control and powerlessness scale, emotional well-being scale, social support scale, self-image scale, all scales from 0-100, higher values indicate worse health status	6 months