Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-02 @ 9:21 AM
Study NCT ID:
NCT06578767
Status:
RECRUITING
Last Update Posted:
2024-10-10
First Post:
2024-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decompression of Pudendal and Inferior Cluneal Nerves Using Robot-assisted Laparoscopy for Entrapment Neuralgias : the X-DECO Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060545', 'term': 'Pudendal Neuralgia'}], 'ancestors': [{'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-07', 'studyFirstSubmitDate': '2024-08-05', 'studyFirstSubmitQcDate': '2024-08-28', 'lastUpdatePostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the efficacy of the surgical technique on pain experience related to pudendal and inferior cluneal chronic entrapment neuralgias, using a composite criteria (Numeric pain scale, time seated, PGIC score)', 'timeFrame': 'Pré-operatively, 2 days, 4 months, 1 year after surgery', 'description': 'Numeric pain scale (0 "no pain" to 10 "maximal pain"), time seated (\\> 30 min,\\> 60min or unlimited) Patients\' Global Impression of Change (PGIC) scale (1 "very hightly improved" to 7 "very hightly worsened") are combined to create a composite criteria (significant improvement to complete improvement)'}], 'secondaryOutcomes': [{'measure': 'Report all complications during the follow-up', 'timeFrame': '2 days, 4 months, 1 year after surgery', 'description': 'Complications are evaluated with Clavien-Dindo classification (Grade I to V(death))'}, {'measure': 'Evaluate the effect of the surgical technique on anxiety', 'timeFrame': 'Pré-operatively, 2 days, 4 months, 1 year after surgery', 'description': 'Anxiety is evaluated with STAI (State Trait Anxiety Inventory-form) (anxious personality since STAI score 51 for women, and score 61 for men)'}, {'measure': 'Evaluate the effect of the surgical technique on depression', 'timeFrame': 'Pré-operatively, 2 days, 4 months, 1 year after surgery', 'description': 'Depression is evaluated with Beck inventory (mild to moderate depression since score 10, moderate depression since score 19, severe depression since score 30)'}, {'measure': 'Evaluate the effect of the surgical technique on post-traumatic stress syndrome', 'timeFrame': 'Pré-operatively, 2 days, 4 months, 1 year after surgery', 'description': 'Post-traumatic stress syndrome is evaluated with PCL-5 (post-traumatic stress disorder checklist with a PTSD since score 38'}, {'measure': 'Evaluate the impact on quality of life', 'timeFrame': 'Pré-operatively, 2 days, 4 months, 1 year after surgery', 'description': 'Quality of life is evaluated with SF-36 (36-item Short Form Health Survey)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pudendal', 'inferior cluneal', 'robot', 'surgery', 'decompression', 'neurolysis', 'laparoscopy'], 'conditions': ['Pudendal Neuralgia']}, 'descriptionModule': {'briefSummary': 'The objective of our study is to evaluate the efficacy of the laparoscopic robot-assited approach after 1 year of follow-up, on pain experience, and anxiety, depression, post-traumatic stress syndrome and quality of life.', 'detailedDescription': 'Pudendal and inferior cluneal neuralgias are responsible for chronic pelvic perineal pain. The compression of both of the nerves are thought to be associated in approximately 25% of the pudendal neuralgias. The failure of the isolated pudendal decompression led in the early 2000s to the identification of an entrapment syndrome of the posterior femoral cutaneous nerve and its inferior cluneal branche around the ischial tuberosity. This subsequent neuralgia affects the posterior part of the perineum, lower buttock, and the posterior part of the thigh, without any associated neuro-vegetative symptoms, unlike in pudendal neuralgia. In case of failure of the medical treatment, the open trans-gluteal decompression was proposed as a gold standard. However, this technique remains invasive and requires a long recovery. In a previous study, the investigators demonstrated the feasibility of double decompression via a minimally invasive robot-assisted laparoscopic approach, and described a 4-step technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This cohort study is a pilot study to evaluate decompression of pudendal and inferior cluneal nerves using robot-assisted laparoscopy for entrapment neuralgias', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years old\n* Patients presenting a pudendal and inferior cluneal entrapment neuralgia with 5 positive"Nantes criteria", and failure of the medical treatment\n* Patient having given consent after reading the information note\n\nExclusion Criteria:\n\n* Absence of any "Nantes criteria",\n* Patient non suitable for surgery/general anesthesia'}, 'identificationModule': {'nctId': 'NCT06578767', 'acronym': 'X-DECO', 'briefTitle': 'Decompression of Pudendal and Inferior Cluneal Nerves Using Robot-assisted Laparoscopy for Entrapment Neuralgias : the X-DECO Study', 'organization': {'class': 'OTHER', 'fullName': 'UBOSGA'}, 'officialTitle': 'Decompression of Pudendal and Inferior Cluneal Nerves Using Robot-assisted Laparoscopy for Entrapment Neuralgias: Results After 1 Year of Follow-up (the X-DECO Study)', 'orgStudyIdInfo': {'id': 'CERU_2024-034'}}, 'contactsLocationsModule': {'locations': [{'zip': '33000', 'city': 'Bordeaux', 'state': 'Gironde', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier Celhay, MD', 'role': 'CONTACT', 'email': 'celhay.ubsg33@gmail.com', 'phone': '+33(0)5 56 11 61 44'}, {'name': 'Alexandra Dupire', 'role': 'CONTACT', 'email': 'arc.ubosga@gmail.com', 'phone': '+33(0)6 07 87 05 56'}, {'name': 'Olivier Celhay, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UBOSGA', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'centralContacts': [{'name': 'Olivier Celhay, M.D', 'role': 'CONTACT', 'email': 'celhay.ubsg33@gmail.com', 'phone': '+33(0)5 56 11 61 44'}], 'overallOfficials': [{'name': 'Olivier Celhay, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UBOSGA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UBOSGA', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}