Central Sensitization and Outcome of Endometriosis Surgery

Overview

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

Full Title of Study: “Substudy on Central Sensitization and Outcome of Endometriosis Surgery of the PROMPT Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 1, 2020

Interventions

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Benno Rehberg-Klug
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Benno Rehberg-Klug, Dr. Benno Rehberg-Klug, Principal Investigator – University Hospital, Geneva
  • Overall Contact(s)
    • Benno Rehberg-Klug, MD, +41 (0)22 372 33 11, benno.rehberg-klug@hcuge.ch

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