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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| Aalborg University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Surgery | Other |
| |
| Diagnostic Surgery | Other |
| |
| No-surgery control | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopy with excision | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from pre-randomization to 1, 3 and 6 months post-randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from pre-randomization to 1, 3 and 6 months post-randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from pre-randomization to 1, 3 and 6 months post-randomization. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Henrik Marschall, MSc | Contact | +4522394563 | hmars@psy.au.dk |
| Name | Affiliation | Role |
|---|---|---|
| Axel Forman, PhD, MD | Aarhus University, Aarhus University Hospital, Denmark | Study Director |
| Henrik Marschall, MSc | University of Aarhus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Hospital Horsens, Department of Obstetrics and Gynecology | Recruiting | Horsens | Central Jutland | DK-8700 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36328387 | Derived | Marschall H, Forman A, Lunde SJ, Kesmodel US, Hansen KE, Vase L. Is laparoscopic excision for superficial peritoneal endometriosis helpful or harmful? Protocol for a double-blinded, randomised, placebo-controlled, three-armed surgical trial. BMJ Open. 2022 Nov 3;12(11):e062808. doi: 10.1136/bmjopen-2022-062808. |
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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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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Laparoscopy without excision | Other | Diagnostic 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 | Patients continue their hormonal and analgesic treatment-as-usual. |
|
| Neuropathic pain symptoms (patient-reported) measured using painDETECT | Neuropathic pain symptoms (patient-reported) is measured using the validated painDETECT questionnaire. | 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. | 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. | 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. | 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. | Change from pre-randomization to 1, 3 and 6 months post-randomization. |
| Dorthe K Thomsen, PhD |
| University of Aarhus |
| Study Chair |
| Aarhus University Hospital, Department of Obstetrics and Gynecology | Recruiting | Aarhus N | DK-8200 | Denmark |
| Regional Hospital Herning, Department of Obstetrics and Gynecology | Recruiting | Herning | DK-7400 | Denmark |
| Regional Hospital Randers, Department of Obstetrics and Gynecology | Recruiting | Randers | DK-8930 | Denmark |
| Regional Hospital Viborg, Department of Obstetrics and Gynecology | Recruiting | Viborg | DK-8800 | Denmark |
| D000091662 | Genital Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |