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Completed

NCT Number: NCT04144998

Central Sensitization and Outcome of Endometriosis Surgery

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

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hôpitaux Universitaires de Genève

Geneva, 1211, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Benno Rehberg-Klug

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Oct 30, 2019
Registry last updated
Jul 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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