Is Laparoscopic Excision for Peritoneal Endometriosis Helpful or Harmful?

University of Aarhus

Status: Enrolling

Conditions: Endometriosis; Peritoneum

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05162794

LAPEX

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 3 patient groups

Active Surgery

Other group

Treatment:

Other: Laparoscopy with excision

Other: Medical treatment-as-usual

Diagnostic Surgery

Other group

Treatment:

Other: Laparoscopy without excision

Other: Medical treatment-as-usual

No-surgery control

Other group

Treatment:

Other: Medical treatment-as-usual