Central Sensitization and Outcome of Endometriosis Surgery

• Sponsor: Benno Rehberg-Klug (Other)
• Overall Status: Completed
• CT.gov ID: NCT04144998
• Collaborator: (none)
• Enrollment: 71
• Location: 1
• Actual Duration (Months): 32.4
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Diagnostic Test: central sensitization inventory (questionnaire)

Study Design

• Study Type: Observational
• Actual Enrollment: 71 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Substudy on Central Sensitization and Outcome of Endometriosis Surgery of the PROMPT Study
• Actual Study Start Date: Oct 1, 2019
• Actual Primary Completion Date: Dec 31, 2021
• Actual Study Completion Date: Jun 13, 2022

Outcome Measures

Primary Outcome Measures

1. endometriosis health profile EHP-30 pain subscale [6 months]

   Pain subscale of the questionnaire "endometriosis health profile" EHP-30, scale from 0-100, higher values indicate worse health status

Secondary Outcome Measures

1. other subscales of the endometriosis health profile EHP-30 [6 months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpitaux Universitaires de Genève	Geneva		Switzerland	1211

Sponsors and Collaborators

• Benno Rehberg-Klug

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Benno Rehberg-Klug, Dr. Benno Rehberg-Klug, Principal Investigator, University Hospital, Geneva
• ClinicalTrials.gov Identifier: NCT04144998
• Other Study ID Numbers: EndoPROMPT
• First Posted: Oct 30, 2019
• Last Update Posted: Jul 21, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Endometriosis

Study Results

No Results Posted as of Jul 21, 2022