Is Laparoscopic Excision for Peritoneal Endometriosis Helpful or Harmful?
ConditionEndometriosis; Peritoneum
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorUniversity of Aarhus
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Laparoscopy with excision
Other interventionDiagnostic laparoscopy will be performed to visually confirm endometriosis in the peritoneum. Then, the relevant tissue will be excised and a histology will be performed.
Laparoscopy without excision
Other interventionDiagnostic laparoscopy will be performed to visually confirm endometriosis in the peritoneum. However, no tissue will be excised and histology will not be performed.
Medical treatment-as-usual
Other interventionPatients continue their hormonal and analgesic treatment-as-usual.
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: Active SurgeryOther 2 interventions
Group B: Diagnostic SurgeryOther 2 interventions
Group C: No-surgery controlOther 1 intervention
Trial outcomes
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.
Time frame
Change from pre-randomization to 1, 3 and 6 months post-randomization.Secondary outcomes
1
Health-related Quality of Life measured using Endometriosis Health Profile-30
Quality of Life will be measured using the validated and patient-generated, endometriosis-specific questionnaire "Endometriosis Health Profile 30", consisting of 30 questions rated on Likert scales.
Time frame
Change from pre-randomization to 1, 3 and 6 months post-randomization.2
Neuropathic pain symptoms (patient-reported) measured using painDETECT
Neuropathic pain symptoms (patient-reported) is measured using the validated painDETECT questionnaire.
Time frame
Change from pre-randomization to 1, 3 and 6 months post-randomization.3
Neuropathic pain symptoms (assessed) measured using quantitative sensory testing
Neuropathic pain symptoms (assessed) is measured using a quantitative sensory testing battery. Allodynia, pinprick and pressure pain thresholds are measured.
Time frame
Change from pre-randomization to 6 months post-randomization.4
Work ability measured using "Work Ability Index"
Work ability is measured using the "Work Ability Index" short questionnaire.
Time frame
Change from pre-randomization to 1, 3 and 6 months post-randomization.Other outcomes
1
Widespread pain measured using body map
Widespread pain will be measured using a body map. At each measurement point, participants will rate the areas where they experience pain.
Time frame
Change from pre-randomization to 1, 3 and 6 months post-randomization.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Aarhus
Lead sponsor
Aarhus University Hospital
Collaborator
Aalborg University Hospital
Collaborator
Source ClinicalTrials.gov