Is Laparoscopic Excision for Peritoneal Endometriosis Helpful or Harmful?

Is Laparoscopic Excision for Peritoneal Endometriosis Helpful or Harmful: A Double-blind, Randomized, Controlled, Three-armed Surgical Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Endometriosis; Peritoneum
• Intervention / Treatment: Other: Laparoscopy with excision; Other: Medical treatment-as-usual; Other: Laparoscopy without excision

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Henrik Marschall, MSc; Phone Number: +4522394563; Email: hmars@psy.au.dk

Study Locations

• Denmark
  • Aarhus N, Denmark, DK-8200
    • Recruiting
    • Aarhus University Hospital, Department of Obstetrics and Gynecology
  • Herning, Denmark, DK-7400
    • Recruiting
    • Regional Hospital Herning, Department of Obstetrics and Gynecology
  • Randers, Denmark, DK-8930
    • Recruiting
    • Regional Hospital Randers, Department of Obstetrics and Gynecology
  • Viborg, Denmark, DK-8800
    • Recruiting
    • Regional Hospital Viborg, Department of Obstetrics and Gynecology
  • Central Jutland Region
    • Horsens, Central Jutland Region, Denmark, DK-8700
      • Recruiting
      • Regional Hospital Horsens, Department of Obstetrics and Gynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Active Surgery	Other: Laparoscopy with excision; Diagnostic laparoscopy will be performed to visually confirm endometriosis in the peritoneum. Then, the relevant tissue will be excised and a histology will be performed.; Other: Medical treatment-as-usual; Patients continue their hormonal and analgesic treatment-as-usual.
Other: Diagnostic Surgery	Other: Medical treatment-as-usual; Patients continue their hormonal and analgesic treatment-as-usual.; Other: Laparoscopy without excision; Diagnostic laparoscopy will be performed to visually confirm endometriosis in the peritoneum. However, no tissue will be excised and histology will not be performed.
Other: No-surgery control	Other: Medical treatment-as-usual; Patients continue their hormonal and analgesic treatment-as-usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic pain measured using NRS	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.	Change from pre-randomization to 1, 3 and 6 months post-randomization.

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Widespread pain measured using body map	Widespread pain will be measured using a body map. At each measurement point, participants will rate the areas where they experience pain.	Change from pre-randomization to 1, 3 and 6 months post-randomization.

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital; Aalborg University Hospital
• Investigators: Study Director: Axel Forman, PhD, MD, Aarhus University, Aarhus University Hospital, Denmark; Principal Investigator: Henrik Marschall, MSc, University of Aarhus; Study Chair: Dorthe K Thomsen, PhD, University of Aarhus

Publications and helpful links

General Publications

• Marschall H, Forman A, Lunde SJ, Kesmodel US, Hansen KE, Vase L. Is laparoscopic excision for superficial peritoneal endometriosis helpful or harmful? Protocol for a double-blinded, randomised, placebo-controlled, three-armed surgical trial. BMJ Open. 2022 Nov 3;12(11):e062808. doi: 10.1136/bmjopen-2022-062808.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2022
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: November 17, 2021
• First Submitted That Met QC Criteria: December 6, 2021
• First Posted (Actual): December 17, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Quality of life; Pelvic pain; Endometriosis surgery; Post-surgical neuropathic pain
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: LAPEX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: When participant inclusion has ended, data can be shared in accordance with the ICJME guidelines, if relevant research objectives are provided. Data sharing will require approval from the Central Denmark Region and the Danish Data Protection Agency, and the requesting party shall cover any fees associated with data sharing. Requests for data can be addressed to af@clin.au.dk.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No