An interventional study of Laparoscopy with excision and Laparoscopy without excision in Endometriosis; Peritoneum, sponsored by University of Aarhus. Recruiting at 5 sites in Denmark. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-11-15.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
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.
901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.
This study's planned enrollment of 100 is above the median of 64 across 525 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Laparoscopy with excision · Other: Medical treatment-as-usual
Other: Laparoscopy without excision · Other: Medical treatment-as-usual
Other: Medical treatment-as-usual
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.
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.
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.
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.
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.
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.
Worst pelvic pain measured using NRS
Worst pelvic pain intensity and unpleasantness 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.
Pain frequency measured using weekly count
Pain frequency will be measured using a weekly count, ranging from 0 days of pain to 7 days of pain.
Time frame: Change from pre-randomization to 1, 3 and 6 months post-randomization.
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.
Plan to share: Yes — When participant inclusion has ended, data can be shared in accordance with the ICJME guidelines, if relevant research objectives are provided. Data sharing will require approval from the Central Denmark Region and the Danish Data Protection Agency, and the requesting party shall cover any fees associated with data sharing. Requests for data can be addressed to af@clin.au.dk.
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University of Aarhus