Is Laparoscopic Excision for Peritoneal Endometriosis Helpful or Harmful?

Not Applicable

Recruiting

• Conditions: Endometriosis; Peritoneum
• Interventions: Other: Laparoscopy with excision; Other: Laparoscopy without excision; Other: Medical treatment-as-usual

• Registration Number: NCT05162794
• Lead Sponsor: University of Aarhus

Brief Summary

The trial seeks to test effect of laparoscopic excision of peritoneal endometriosis on pelvic pain. Data will also be gathered on quality of life and neuropathic pain. Patients will be randomized to one of three groups: 1) laparoscopy with excision of endometrial tissue, 2) laparoscopy without excision of endometrial tissue and 3) waiting list control.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-17
• Study First Submitted QC: 2021-12-06
• Study First Posted: 2021-12-17
• Study Start: 2022-01-31
• Status Verified: 2023-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2026-01-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Adult (≥ 18 years) with suspected peritoneal endometriosis undergoing elective surgery for pain relief
• Pain intensity ≥ 5 on Numeric Rating Scale (NRS) in the four weeks prior to giving consent

Exclusion Criteria

• Other known conditions/diseases that may cause pelvic pain
• Diagnosed personality disorder, schizophrenia or treatment with anti-psychotics
• Planned pregnancy during study period
• Women who cannot read or speak Danish

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Surgery	Laparoscopy with excision	-
Active Surgery	Medical treatment-as-usual	-
Diagnostic Surgery	Laparoscopy without excision	-
Diagnostic Surgery	Medical treatment-as-usual	-
No-surgery control	Medical treatment-as-usual	-

Primary Outcome Measures

Name	Time	Method
Pelvic pain measured using NRS	Change from pre-randomization to 1, 3 and 6 months post-randomization.	Pelvic pain intensity (sensory) and unpleasantness (affective) will be measured on 11-point Numeric Rating Scales (0 = no pain to 10 = worst pain imaginable) weekly.

Secondary Outcome Measures

Name	Time	Method
Work ability measured using "Work Ability Index"	Change from pre-randomization to 1, 3 and 6 months post-randomization.	Work ability is measured using the "Work Ability Index" short questionnaire.
Neuropathic pain symptoms (assessed) measured using quantitative sensory testing	Change from pre-randomization to 6 months post-randomization.	Neuropathic pain symptoms (assessed) is measured using a quantitative sensory testing battery. Allodynia, pinprick and pressure pain thresholds are measured.
Neuropathic pain symptoms (patient-reported) measured using painDETECT	Change from pre-randomization to 1, 3 and 6 months post-randomization.	Neuropathic pain symptoms (patient-reported) is measured using the validated painDETECT questionnaire.
Health-related Quality of Life measured using Endometriosis Health Profile-30	Change from pre-randomization to 1, 3 and 6 months post-randomization.	Quality of Life will be measured using the validated and patient-generated, endometriosis-specific questionnaire "Endometriosis Health Profile 30", consisting of 30 questions rated on Likert scales.
Pain frequency measured using weekly count	Change from pre-randomization to 1, 3 and 6 months post-randomization.	Pain frequency will be measured using a weekly count, ranging from 0 days of pain to 7 days of pain.
Worst pelvic pain measured using NRS	Change from pre-randomization to 1, 3 and 6 months post-randomization.	Worst pelvic pain intensity and unpleasantness will be measured on 11-point Numeric Rating Scales (0 = no pain to 10 = worst pain imaginable) weekly.

Trial Locations

Locations (5)

Regional Hospital Horsens, Department of Obstetrics and Gynecology; 🇩🇰 Horsens, Central Jutland Region, Denmark

Aarhus University Hospital, Department of Obstetrics and Gynecology; 🇩🇰 Aarhus N, Denmark

Regional Hospital Herning, Department of Obstetrics and Gynecology; 🇩🇰 Herning, Denmark

Regional Hospital Viborg, Department of Obstetrics and Gynecology; 🇩🇰 Viborg, Denmark

Regional Hospital Randers, Department of Obstetrics and Gynecology; 🇩🇰 Randers, Denmark