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.
University of Aarhus
100 participants
Jan 31, 2022
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
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
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Interventions
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.
Diagnostic laparoscopy will be performed to visually confirm endometriosis in the peritoneum. However, no tissue will be excised and histology will not be performed.
Patients continue their hormonal and analgesic treatment-as-usual.
Locations(5)
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NCT05162794