Is Laparoscopic Excision for Peritoneal Endometriosis Helpful or Harmful?

NCT05162794 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-11-15

No results posted yet for this study

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

Interventions

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

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

Medical treatment-as-usual

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

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER
  • Aalborg University Hospital

    collaborator OTHER
  • University of Aarhus

    lead OTHER

Principal Investigators

  • Axel Forman, PhD, MD · Aarhus University, Aarhus University Hospital, Denmark

  • Henrik Marschall, MSc · University of Aarhus

  • Dorthe K Thomsen, PhD · University of Aarhus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2026-01-01
Completion
2026-07-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05162794 on ClinicalTrials.gov