NCT04144998

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2022

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

2.3 years

First QC Date

October 28, 2019

Last Update Submit

July 20, 2022

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • other subscales of the endometriosis health profile EHP-30

    6 months

Interventions

central sensitization inventory (questionnaire)DIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients scheduled for elective endometriosis surgery

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires de Genève

Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Benno Rehberg-Klug, Principal Investigator

Study Record Dates

First Submitted

October 28, 2019

First Posted

October 30, 2019

Study Start

October 1, 2019

Primary Completion

December 31, 2021

Study Completion

June 13, 2022

Last Updated

July 21, 2022

Record last verified: 2022-07

Locations

CH(1)