Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-26 @ 2:16 AM
Study NCT ID:
NCT01520857
Status:
COMPLETED
Last Update Posted:
2017-03-16
First Post:
2012-01-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spinal Versus General Anesthesia for Transabdominal Preperitoneal (TAPP) Repair of Inguinal Hernia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-15', 'studyFirstSubmitDate': '2012-01-19', 'studyFirstSubmitQcDate': '2012-01-25', 'lastUpdatePostDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative opioid consumption', 'timeFrame': 'Every 8 hours', 'description': 'The total dose of morphine was calculated as mg and administered by PCA pump'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': 'Every 8 hrs', 'description': 'NRS = numeric rating scale 0-10 mm (0=no pain to 10= worst imaginable pain)'}, {'measure': 'Side- effects', 'timeFrame': 'Every 8 hrs', 'description': 'To determine the occurrence of side effects such as postoperative nausea,vomiting, itching, headache, shoulder pain, urinary retention, etc'}, {'measure': 'Hospital stay', 'timeFrame': 'Patients will be followed for the duration of hospital stay'}, {'measure': 'Patient satisfaction', 'timeFrame': '2 weeks after the operation'}, {'measure': 'Chronic Pain', 'timeFrame': '12 months after the operation'}, {'measure': 'Quality of life', 'timeFrame': '6 months after the operation', 'description': 'SF 36 questionnaire'}, {'measure': 'Complications', 'timeFrame': '1 year', 'description': 'seroma, hematoma, infection, recurrence of hernia, etc'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Laparoscopic inguinal hernia repair', 'TAPP', 'Spinal Anesthesia', 'General Anesthesia'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess whether spinal anesthesia is superior to the standard general anesthesia or not for patients undergoing transabdominal preperitoneal inguinal hernia repair (TAPP).', 'detailedDescription': 'Anesthesia for laparoscopic procedures, including transabdominal preperitoneal inguinal hernia repair(TAPP) is synonymous with general anesthesia because of the adverse effects of the CO2 pneumoperitoneum on the awake patient, and regional anesthesia is preferred only in patients where general anesthesia is contraindicated. Α pilot study of our hospital has recently shown the feasibility to perform successfully and safely transabdominal preperitoneal inguinal hernia repair with low pressure CO2 pneumoperitoneum under spinal anesthesia.After this pilot study and based on previous experience in regional anesthesia for laparoscopic procedures, we designed a controlled randomized trial in order to compare spinal anesthesia with the standard general anesthesia for patients undergoing transabdominal preperitoneal inguinal hernia repair (TAPP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA physical status I-III\n* BMI ≤ 35\n* Age ≥ 18\n* Normal coagulation profile\n\nExclusion Criteria:\n\n* Non-reducible/obstructed hernias\n* Previous open surgery in the lower abdomen\n* Contraindication for pneumoperitoneum\n* Contraindication for spinal or/and general anesthesia\n* History of chronic pain or daily intake of analgesics\n* Psychiatric disorders\n* Inability of patients to use PCA pump'}, 'identificationModule': {'nctId': 'NCT01520857', 'briefTitle': 'Spinal Versus General Anesthesia for Transabdominal Preperitoneal (TAPP) Repair of Inguinal Hernia', 'organization': {'class': 'OTHER', 'fullName': 'Larissa University Hospital'}, 'officialTitle': 'A Controlled Randomized Trial Comparing Spinal Versus General Anesthesia for Transabdominal Preperitoneal (TAPP) Repair of Inguinal Hernia', 'orgStudyIdInfo': {'id': 'UTH5535/12/11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Spinal anesthesia', 'description': 'Transabdominal Preperitoneal repair of inguinal hernia. spinal anesthesia', 'interventionNames': ['Procedure: Transabdominal Preperitoneal repair of inguinal hernia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'General Anesthesia', 'description': 'Transabdominal Preperitoneal repair of inguinal hernia. general anesthesia', 'interventionNames': ['Procedure: Transabdominal Preperitoneal repair of inguinal hernia']}], 'interventions': [{'name': 'Transabdominal Preperitoneal repair of inguinal hernia', 'type': 'PROCEDURE', 'description': 'Transabdominal Preperitoneal (TAPP) repair of inguinal hernia using CO2 pneumoperitoneum under spinal anesthesia', 'armGroupLabels': ['Spinal anesthesia']}, {'name': 'Transabdominal Preperitoneal repair of inguinal hernia', 'type': 'PROCEDURE', 'description': 'Transabdominal Preperitoneal (TAPP) repair of inguinal hernia using CO2 pneumoperitoneum under general anesthesia', 'armGroupLabels': ['General Anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41100', 'city': 'Larissa', 'country': 'Greece', 'facility': 'University Hospital of Larissa', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}], 'overallOfficials': [{'name': 'Chamaidi Sarakatsianou, RN,MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Larissa'}, {'name': 'George Tzovaras, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital of Larissa'}, {'name': 'George Tzovaras, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital of Larissa'}, {'name': 'Stavroula Georgopoulou, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital of Larissa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Larissa University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Thessaly', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'RN,MSc', 'investigatorFullName': 'Chamaidi Sarakatsianou', 'investigatorAffiliation': 'Larissa University Hospital'}}}}