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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
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.
Regional Hospital Horsens, Department of Obstetrics and Gynecology
Horsens, Central Jutland, Denmark
RECRUITINGAarhus University Hospital, Department of Obstetrics and Gynecology
Aarhus N, Denmark
RECRUITINGRegional Hospital Herning, Department of Obstetrics and Gynecology
Herning, Denmark
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.
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Regional Hospital Randers, Department of Obstetrics and Gynecology
Randers, Denmark
RECRUITINGRegional Hospital Viborg, Department of Obstetrics and Gynecology
Viborg, Denmark
RECRUITINGTime 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.