Endometriosis; Peritoneum
Conditions
Keywords
Pelvic pain, Quality of life, Post-surgical neuropathic pain, Endometriosis surgery
Brief 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.
Interventions
OTHERLaparoscopy with excision
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.
OTHERLaparoscopy without excision
Diagnostic laparoscopy will be performed to visually confirm endometriosis in the peritoneum. However, no tissue will be excised and histology will not be performed.
OTHERMedical treatment-as-usual
Patients continue their hormonal and analgesic treatment-as-usual.
Sponsors
Aarhus University Hospital
Aalborg University Hospital
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic pain measured using NRS | Change from pre-randomization to 1, 3 and 6 months post-randomization. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related Quality of Life measured using Endometriosis Health Profile-30 | Change from pre-randomization to 1, 3 and 6 months post-randomization. | 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. |
| Neuropathic pain symptoms (patient-reported) measured using painDETECT | Change from pre-randomization to 1, 3 and 6 months post-randomization. | Neuropathic pain symptoms (patient-reported) is measured using the validated painDETECT questionnaire. |
| Neuropathic pain symptoms (assessed) measured using quantitative sensory testing | Change from pre-randomization to 6 months post-randomization. | Neuropathic pain symptoms (assessed) is measured using a quantitative sensory testing battery. Allodynia, pinprick and pressure pain thresholds are measured. |
| Worst pelvic pain measured using NRS | Change from pre-randomization to 1, 3 and 6 months post-randomization. | Worst pelvic pain intensity and unpleasantness will be measured on 11-point Numeric Rating Scales (0 = no pain to 10 = worst pain imaginable) weekly. |
| Pain frequency measured using weekly count | Change from pre-randomization to 1, 3 and 6 months post-randomization. | Pain frequency will be measured using a weekly count, ranging from 0 days of pain to 7 days of pain. |
| Work ability measured using Work Ability Index | Change from pre-randomization to 1, 3 and 6 months post-randomization. | Work ability is measured using the Work Ability Index short questionnaire. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Widespread pain measured using body map | Change from pre-randomization to 1, 3 and 6 months post-randomization. | Widespread pain will be measured using a body map. At each measurement point, participants will rate the areas where they experience pain. |
Countries
Denmark
Contacts
Primary ContactHenrik Marschall, MSc
Outcome results
None listed