Is Laparoscopic Excision for Peritoneal Endometriosis Helpful or Harmful?

Endometriosis; Peritoneum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05162794
• Other study ID #: LAPEX
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: July 1, 2026

Study information

• Verified date: November 2023
• Source: University of Aarhus
• Contact: Henrik Marschall, MSc
• Phone: +4522394563
• Email: hmars[@]psy.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis
• Endometriosis; Peritoneum

Intervention

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.
• 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.
• Medical treatment-as-usual
Patients continue their hormonal and analgesic treatment-as-usual.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Department of Obstetrics and Gynecology	Aarhus N
Denmark	Regional Hospital Herning, Department of Obstetrics and Gynecology	Herning
Denmark	Regional Hospital Horsens, Department of Obstetrics and Gynecology	Horsens	Central Jutland Region
Denmark	Regional Hospital Randers, Department of Obstetrics and Gynecology	Randers
Denmark	Regional Hospital Viborg, Department of Obstetrics and Gynecology	Viborg

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aalborg University Hospital, Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.