RecruitingNot ApplicableNCT05162794

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.


Sponsor

University of Aarhus

Enrollment

100 participants

Start Date

Jan 31, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria2

  • 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 Criteria4

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERLaparoscopy 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.

OTHERLaparoscopy 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.

OTHERMedical treatment-as-usual

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


Locations(5)

Regional Hospital Horsens, Department of Obstetrics and Gynecology

Horsens, Central Jutland, Denmark

Aarhus University Hospital, Department of Obstetrics and Gynecology

Aarhus N, Denmark

Regional Hospital Herning, Department of Obstetrics and Gynecology

Herning, Denmark

Regional Hospital Randers, Department of Obstetrics and Gynecology

Randers, Denmark

Regional Hospital Viborg, Department of Obstetrics and Gynecology

Viborg, Denmark

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05162794


Related Trials