Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-28 @ 6:04 PM
Study NCT ID:
NCT06061068
Status:
COMPLETED
Last Update Posted:
2025-05-21
First Post:
2023-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hernia Belt in Laparoscopic Inguinal Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 678}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-16', 'studyFirstSubmitDate': '2023-09-24', 'studyFirstSubmitQcDate': '2023-09-24', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hernia recurrence', 'timeFrame': '1 month,3 months,6 months and 12 months after surgery.', 'description': 'Follow up by physical examination, ultrasonography and telephone at 1 month,3 months,6 months and 12 months after surgery about the rate of hernia recurrence.'}, {'measure': 'Postoperative complications', 'timeFrame': 'Within 3 months after surgery.', 'description': 'Including seroma and hematoma development, wound infection, abdominal bloating and foreign body sensation,follow up by physical examination, ultrasonography and telephone.'}, {'measure': 'Pain score', 'timeFrame': '1 day,7 days,1 month and 3 months after surgery.', 'description': 'The visual analog scale (VAS) was adopted for pain evaluation preoperative,1 day, 7 days, 1 months and 3 months postoperatively.The scale range from 0 to 10, with 0 meaning no pain and 10 meaning the worst pain.Higher scores mean a worse outcome.'}, {'measure': 'Health-related quality of life', 'timeFrame': '1 day,7 days,1 month and 3 months after surgery.', 'description': 'The 36-item short-form health survey(SF-36) was adopted for Health-related quality of life 1 day, 7 days, 1 months and 3 months postoperatively. SF-36 consists of 36 articles, including 8 areas of physical function, physical role, physical pain, general health status, vitality, social function, emotional role and mental health.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laparoscopic inguinal hernia repair', 'Hernia belt', 'Hernia recurrence', 'Seroma Following Procedure', 'Pain, Postoperative', 'Quality of Life'], 'conditions': ['Hernia, Inguinal', 'Recurrence', 'Seroma Following Procedure', 'Pain, Postoperative', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'In this study, the investigators aimed to investigate the effect of hernia belt on postoperative complications and quality of life for patients who underwent laparoscopic inguinal hernia repair. Outcomes include hernia recurrence (patient-reported and clinical exam), postoperative complications within 3 months (seroma and hematoma development, wound infection, abdominal bloating and foreign body sensation), pain (visual analog scale,VAS), health-related quality of life (36-item short-form health survey, SF-36). Follow up by physical examination, ultrasonography and telephone.', 'detailedDescription': 'Some scholars believe that the use of hernia belts to compress the inguinal region reduces postoperative complications. According to the International Guidelines for the Management of Inguinal Hernia in Adults (2018) interpretation, the incidence of seroma after inguinal hernia repair ranges from 0.5% to 2.2%. However,there is no consensus among different research organizations and clinical staff on the use of hernia belts after laparoscopic inguinal hernia repair. In this study, the investigators aimed to investigate the effect of hernia belt on postoperative complications and quality of life for patients who underwent laparoscopic inguinal hernia repair. Outcomes include hernia recurrence (patient-reported and clinical exam), postoperative complications within 3 months (seroma and hematoma development, wound infection, abdominal bloating and foreign body sensation), pain (visual analog scale,VAS), health-related quality of life (36-item short-form health survey, SF-36). Follow up by physical examination, ultrasonography and telephone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 years or order.\n2. Primary unilateral oblique inguinal hernia, direct hernia, femoral hernia.\n3. Qualified for laparoscopic Transabdominal preperitoneal approach(TAPP) or Totally extraperitoneal(TEP).\n4. Eligible to tolerate general anesthesia.\n\nExclusion Criteria:\n\n1. Incarcerated hernia, recurrent hernia and other types of hernia.\n2. Patients presenting for obvious contraindications to surgery.\n3. Need for an open inguinal hernia repair.\n4. Difficult to follow-up or communication.\n5. Patients who are unable to give informed consent.'}, 'identificationModule': {'nctId': 'NCT06061068', 'briefTitle': 'Hernia Belt in Laparoscopic Inguinal Hernia Repair', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Nanchong Central Hospital'}, 'officialTitle': 'The Effect of Hernia Belt on Postoperative Complications and Quality of Life for Patients Who Underwent Laparoscopic Inguinal Hernia Repair:a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '20230910'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hernia belt compressing group', 'description': 'Patients were given hernia belt compression of the inguinal region after laparoscopic inguinal hernia repair surgery in the operating room. The silicone pad of the hernia belt was placed in the inguinal region of the surgical side for compression for a period of 2 weeks.', 'interventionNames': ['Procedure: Hernia belt compression']}, {'type': 'NO_INTERVENTION', 'label': 'No hernia belt compressing group', 'description': 'Patients were should not have the intervention "Hernia belt compression" .'}], 'interventions': [{'name': 'Hernia belt compression', 'type': 'PROCEDURE', 'description': 'Use the hernia belt to compress the inguinal region', 'armGroupLabels': ['Hernia belt compressing group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '637000', 'city': 'Nanchong', 'state': 'Sichuan', 'country': 'China', 'facility': 'Yunhong Tian', 'geoPoint': {'lat': 30.79508, 'lon': 106.08473}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanchong Central Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': "Guang'an People's Hospital", 'class': 'UNKNOWN'}, {'name': "Pengan County People's Hospital", 'class': 'OTHER'}, {'name': "People's Hospital of Yilong County", 'class': 'UNKNOWN'}, {'name': 'Nanbu Hospital of County Chinese Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Gastrointestinal, Colorectal and Hernia Surgery', 'investigatorFullName': 'Yunhong Tian', 'investigatorAffiliation': 'Nanchong Central Hospital'}}}}