Is Laparoscopic Excision for Peritoneal Endometriosis Helpful or Harmful?

NCT05162794 | Recruiting

• 1 other identifier: LAPEX
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

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.

Conditions

Endometriosis; Peritoneum

Keywords

Pelvic pain; Quality of life; Post-surgical neuropathic pain; Endometriosis surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Health-related Quality of Life measured using Endometriosis Health Profile-30

  Change from pre-randomization to 1, 3 and 6 months post-randomization.

• Neuropathic pain symptoms (patient-reported) measured using painDETECT

  Change from pre-randomization to 1, 3 and 6 months post-randomization.

• Neuropathic pain symptoms (assessed) measured using quantitative sensory testing

  Change from pre-randomization to 6 months post-randomization.

• Work ability measured using "Work Ability Index"

  Change from pre-randomization to 1, 3 and 6 months post-randomization.

• Worst pelvic pain measured using NRS

  Change from pre-randomization to 1, 3 and 6 months post-randomization.

Other Outcomes (1)

• Widespread pain measured using body map

  Change from pre-randomization to 1, 3 and 6 months post-randomization.

Study Arms (3)

Active Surgery

OTHER

Other: Laparoscopy with excision; Other: Medical treatment-as-usual

Diagnostic Surgery

OTHER

Other: Laparoscopy without excision; Other: Medical treatment-as-usual

No-surgery control

OTHER

Other: Medical treatment-as-usual

Interventions

Laparoscopy with excision OTHER

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.

Active Surgery

Laparoscopy without excision OTHER

Diagnostic laparoscopy will be performed to visually confirm endometriosis in the peritoneum. However, no tissue will be excised and histology will not be performed.

Diagnostic Surgery

Medical treatment-as-usual OTHER

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

Active Surgery; Diagnostic Surgery; No-surgery control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• Aalborg University Hospital: collaborator

Study Sites (5)

Regional Hospital Horsens, Department of Obstetrics and Gynecology

Horsens, Central Jutland, DK-8700, Denmark

RECRUITING

Aarhus University Hospital, Department of Obstetrics and Gynecology

Aarhus N, DK-8200, Denmark

RECRUITING

Regional Hospital Herning, Department of Obstetrics and Gynecology

Herning, DK-7400, Denmark

RECRUITING

Regional Hospital Randers, Department of Obstetrics and Gynecology

Randers, DK-8930, Denmark

RECRUITING

Regional Hospital Viborg, Department of Obstetrics and Gynecology

Viborg, DK-8800, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 36328387 DERIVED

MeSH Terms

Conditions

Endometriosis; Pelvic Pain

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Axel Forman, PhD, MD

  Aarhus University, Aarhus University Hospital, Denmark

  STUDY DIRECTOR

• Henrik Marschall, MSc

  University of Aarhus

  PRINCIPAL INVESTIGATOR

• Dorthe K Thomsen, PhD

  University of Aarhus

  STUDY CHAIR

Central Study Contacts

Henrik Marschall, MSc

CONTACT

+4522394563; hmars@psy.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 17, 2021
• Study Start: January 31, 2022
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 15, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

DK (5)