Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-31 @ 12:21 AM
Study NCT ID:
NCT06796595
Status:
RECRUITING
Last Update Posted:
2025-01-28
First Post:
2025-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Medical Program to Optimize Nerve Regeneration After Robot-assisted Laparoscopic Neurolyses of Pudendal and/or Inferior Cluneal Nerves for Chronic Neuralgias: Results After 1-year Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060545', 'term': 'Pudendal Neuralgia'}, {'id': 'D009437', 'term': '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': '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': '2025-01-23', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2025-01-22', 'studyFirstSubmitQcDate': '2025-01-27', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the 1-year effectiveness of a perioperative medical program on the characteristics of neuropathic pain related to postoperative neurapraxia, following robot-assisted laparoscopic neurolyses of the pudendal and inferior cluneal nerves', 'timeFrame': 'Pré-operatively, and then post-operatively : every day the first month, then once a week until the 4th month then at 1 year year after surgery', 'description': 'Numeric pain scale (0 "no pain" to 10 "maximal pain")'}], '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': {'conditions': ['Pudendal Neuralgia', 'Neuralgia']}, 'descriptionModule': {'briefSummary': 'Pudendal and inferior cluneal neuralgias are responsible for chronic pelvicperineal pain. These two neuralgias are associated in approximately 25% of cases. In the event of failure of first-line multimodal medical treatment, a mini-invasive robot-assisted laparoscopic decompression can be proposed. These surgeries carry the risk of neurapraxia, leading to a temporary increase in neuropathic pain and numbness in the nerve sensitive area, a motoric or neurovegetative disturbance (pudendal).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This cohort study is a pilot study to evaluate the 1-year effectiveness of a perioperative medical program on the characteristics of neuropathic pain related to postoperative neurapraxia, following robot-assisted laparoscopic neurolyses of the pudendal and inferior cluneal nerves', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years old\n* Patients presenting a pudendal and/or inferior cluneal neuralgias with failure of the medical treatment\n* Patient having given consent after reading the information note\n\nExclusion Criteria:\n\n* Inoperable patients (contraindications to anesthesia or surgery) surgical contraindications)\n* Person deprived of liberty or under guardianship\n* Person under court protection\n* Pregnant or breast-feeding woman\n* Minors'}, 'identificationModule': {'nctId': 'NCT06796595', 'acronym': 'REGEN', 'briefTitle': 'Perioperative Medical Program to Optimize Nerve Regeneration After Robot-assisted Laparoscopic Neurolyses of Pudendal and/or Inferior Cluneal Nerves for Chronic Neuralgias: Results After 1-year Follow-up', 'organization': {'class': 'OTHER', 'fullName': 'UBOSGA'}, 'officialTitle': 'Perioperative Medical Program to Optimize Nerve Regeneration After Robot-assisted Laparoscopic Neurolyses of Pudendal and/or Inferior Cluneal Nerves for Chronic Neuralgias: Results After 1-year Follow-up', 'orgStudyIdInfo': {'id': 'UBOSGA 2025/01'}}, 'contactsLocationsModule': {'locations': [{'zip': '33000', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier CELHAY', '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', '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'}, {'name': 'Alexandra Dupire', 'role': 'CONTACT', 'email': 'arc.ubosga@gmail.com', 'phone': '+33(0)6 07 87 05 56'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UBOSGA', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}