Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-27 @ 11:24 PM
Study NCT ID:
NCT05162794
Status:
RECRUITING
Last Update Posted:
2024-11-15
First Post:
2021-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is Laparoscopic Excision for Peritoneal Endometriosis Helpful or Harmful?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D017699', 'term': 'Pelvic Pain'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010535', 'term': 'Laparoscopy'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-13', 'studyFirstSubmitDate': '2021-11-17', 'studyFirstSubmitQcDate': '2021-12-06', 'lastUpdatePostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Widespread pain measured using body map', 'timeFrame': 'Change from pre-randomization to 1, 3 and 6 months post-randomization.', 'description': 'Widespread pain will be measured using a body map. At each measurement point, participants will rate the areas where they experience pain.'}], 'primaryOutcomes': [{'measure': 'Pelvic pain measured using NRS', 'timeFrame': 'Change from pre-randomization to 1, 3 and 6 months post-randomization.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Health-related Quality of Life measured using Endometriosis Health Profile-30', 'timeFrame': 'Change from pre-randomization to 1, 3 and 6 months post-randomization.', 'description': '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.'}, {'measure': 'Neuropathic pain symptoms (patient-reported) measured using painDETECT', 'timeFrame': 'Change from pre-randomization to 1, 3 and 6 months post-randomization.', 'description': 'Neuropathic pain symptoms (patient-reported) is measured using the validated painDETECT questionnaire.'}, {'measure': 'Neuropathic pain symptoms (assessed) measured using quantitative sensory testing', 'timeFrame': 'Change from pre-randomization to 6 months post-randomization.', 'description': 'Neuropathic pain symptoms (assessed) is measured using a quantitative sensory testing battery. Allodynia, pinprick and pressure pain thresholds are measured.'}, {'measure': 'Work ability measured using "Work Ability Index"', 'timeFrame': 'Change from pre-randomization to 1, 3 and 6 months post-randomization.', 'description': 'Work ability is measured using the "Work Ability Index" short questionnaire.'}, {'measure': 'Worst pelvic pain measured using NRS', 'timeFrame': 'Change from pre-randomization to 1, 3 and 6 months post-randomization.', 'description': 'Worst pelvic pain intensity and unpleasantness will be measured on 11-point Numeric Rating Scales (0 = no pain to 10 = worst pain imaginable) weekly.'}, {'measure': 'Pain frequency measured using weekly count', 'timeFrame': 'Change from pre-randomization to 1, 3 and 6 months post-randomization.', 'description': 'Pain frequency will be measured using a weekly count, ranging from 0 days of pain to 7 days of pain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pelvic pain', 'Quality of life', 'Post-surgical neuropathic pain', 'Endometriosis surgery'], 'conditions': ['Endometriosis; Peritoneum']}, 'referencesModule': {'references': [{'pmid': '36328387', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (≥ 18 years) with suspected peritoneal endometriosis undergoing elective surgery for pain relief\n* Pain intensity ≥ 5 on Numeric Rating Scale (NRS) in the four weeks prior to giving consent\n\nExclusion Criteria:\n\n* Other known conditions/diseases that may cause pelvic pain\n* Diagnosed personality disorder, schizophrenia or treatment with anti-psychotics\n* Planned pregnancy during study period\n* Women who cannot read or speak Danish'}, 'identificationModule': {'nctId': 'NCT05162794', 'briefTitle': 'Is Laparoscopic Excision for Peritoneal Endometriosis Helpful or Harmful?', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Is Laparoscopic Excision for Peritoneal Endometriosis Helpful or Harmful: A Double-blind, Randomized, Controlled, Three-armed Surgical Trial.', 'orgStudyIdInfo': {'id': 'LAPEX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Active Surgery', 'interventionNames': ['Other: Laparoscopy with excision', 'Other: Medical treatment-as-usual']}, {'type': 'OTHER', 'label': 'Diagnostic Surgery', 'interventionNames': ['Other: Laparoscopy without excision', 'Other: Medical treatment-as-usual']}, {'type': 'OTHER', 'label': 'No-surgery control', 'interventionNames': ['Other: Medical treatment-as-usual']}], 'interventions': [{'name': 'Laparoscopy with excision', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Active Surgery']}, {'name': 'Laparoscopy without excision', 'type': 'OTHER', 'description': 'Diagnostic laparoscopy will be performed to visually confirm endometriosis in the peritoneum. However, no tissue will be excised and histology will not be performed.', 'armGroupLabels': ['Diagnostic Surgery']}, {'name': 'Medical treatment-as-usual', 'type': 'OTHER', 'description': 'Patients continue their hormonal and analgesic treatment-as-usual.', 'armGroupLabels': ['Active Surgery', 'Diagnostic Surgery', 'No-surgery control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-8700', 'city': 'Horsens', 'state': 'Central Jutland', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'Regional Hospital Horsens, Department of Obstetrics and Gynecology', 'geoPoint': {'lat': 55.86066, 'lon': 9.85034}}, {'zip': 'DK-8200', 'city': 'Aarhus N', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'Aarhus University Hospital, Department of Obstetrics and Gynecology', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}, {'zip': 'DK-7400', 'city': 'Herning', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'Regional Hospital Herning, Department of Obstetrics and Gynecology', 'geoPoint': {'lat': 56.13615, 'lon': 8.97662}}, {'zip': 'DK-8930', 'city': 'Randers', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'Regional Hospital Randers, Department of Obstetrics and Gynecology', 'geoPoint': {'lat': 56.4607, 'lon': 10.03639}}, {'zip': 'DK-8800', 'city': 'Viborg', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'Regional Hospital Viborg, Department of Obstetrics and Gynecology', 'geoPoint': {'lat': 56.45319, 'lon': 9.40201}}], 'centralContacts': [{'name': 'Henrik Marschall, MSc', 'role': 'CONTACT', 'email': 'hmars@psy.au.dk', 'phone': '+4522394563'}], 'overallOfficials': [{'name': 'Axel Forman, PhD, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aarhus University, Aarhus University Hospital, Denmark'}, {'name': 'Henrik Marschall, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Aarhus'}, {'name': 'Dorthe K Thomsen, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Aarhus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'Aalborg University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}