Central Sensitization and Outcome of Endometriosis Surgery

July 20, 2022 updated by: Benno Rehberg-Klug

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

71

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1211
        • Hôpitaux Universitaires de Genève

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

patients scheduled for elective endometriosis surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
endometriosis health profile EHP-30 pain subscale
Time Frame: 6 months
Pain subscale of the questionnaire "endometriosis health profile" EHP-30, scale from 0-100, higher values indicate worse health status
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
other subscales of the endometriosis health profile EHP-30
Time Frame: 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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benno Rehberg-Klug

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

June 13, 2022

Study Registration Dates

First Submitted

October 28, 2019

First Submitted That Met QC Criteria

October 28, 2019

First Posted (Actual)

October 30, 2019

Study Record Updates

Last Update Posted (Actual)

July 21, 2022

Last Update Submitted That Met QC Criteria

July 20, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EndoPROMPT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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