Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:02 AM
Study NCT ID:
NCT07491003
Status:
COMPLETED
Last Update Posted:
2026-03-24
First Post:
2026-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Hiatal Hernia Repair With Mesh Cruroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006551', 'term': 'Hernia, Hiatal'}], 'ancestors': [{'id': 'D006548', 'term': 'Hernia, Diaphragmatic'}, {'id': 'D000082122', 'term': 'Internal Hernia'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-18', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of Hiatal Hernia (HH) Recurrence Rate', 'timeFrame': '6 months after the surgical procedure.', 'description': 'The primary objective is to determine the incidence of hiatal hernia recurrence following Laparoscopic Sleeve Gastrectomy (LSG) with concurrent mesh cruroplasty'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hiatal Hernia', 'Sleeve Gastrectomy']}, 'descriptionModule': {'briefSummary': "The study you're referring to explores a surgical strategy for patients undergoing Laparoscopic Sleeve Gastrectomy (LSG) who also have a Hiatal Hernia (HH). Because obesity is a major risk factor for hiatal hernias, surgeons often find these defects during bariatric procedures"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (≥18 years), Patients underwent laparoscopic sleeve gastrectomy, Intraoperative confirmation of hiatal hernia, no prior history of esophageal or gastric surgery and Patient fit for general anesthesia\n\nExclusion Criteria:\n\n* Patients with severe esophageal motility disorders, Patients with contraindications to laparoscopic surgery, Previous hiatal hernia repair, Esophageal stricture and perforation, Pregnancy or uncontrolled comorbidities, Presence of large paraesophageal hernias (\\>4 cm) with volvulus, Contraindications to laparoscopic surgery, such as severe cardiopulmonary disease and Contraindication for general anesthesia.'}, 'identificationModule': {'nctId': 'NCT07491003', 'briefTitle': 'Laparoscopic Hiatal Hernia Repair With Mesh Cruroplasty', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Laparoscopic Hiatal Hernia Repair With Mesh Cruroplasty Following Sleeve Gastrectomy: A Prospective Study', 'orgStudyIdInfo': {'id': 'Laparoscopic hiatal hernia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hernia arm represent patients with hiatal hernia', 'description': 'A single group of 20 adult patients undergoing intraoperative Hiatal Hernia (HH) repair using mesh cruroplasty during a Laparoscopic Sleeve Gastrectomy (LSG)', 'interventionNames': ['Procedure: Hiatal Hernia (HH) repair using mesh cruroplasty during a Laparoscopic Sleeve Gastrectomy (LSG)']}], 'interventions': [{'name': 'Hiatal Hernia (HH) repair using mesh cruroplasty during a Laparoscopic Sleeve Gastrectomy (LSG)', 'type': 'PROCEDURE', 'description': 'The procedure was performed laparoscopically under general anesthesia with the patient in a 30° reverse Trendelenburg position. Following pneumoperitoneum and five-trocar insertion, any adhesions from the previous Sleeve Gastrectomy (LSG) were released to expose the hiatus.\n\nDissection: The gastrohepatic ligament was divided, and the hernia sac and gastroesophageal fat pad were fully reduced into the abdomen while preserving the hepatic branch of the vagus nerve.\n\nRepair: The crural defect was closed using 2-3 interrupted non-absorbable sutures to achieve a tension-free repair.\n\nMesh Augmentation: A shaped polypropylene mesh was placed in an "onlay" fashion over the posterior crural repair, secured with endoscopic metal fixators, and covered with the remaining hernia sac flaps to protect the esophagus.\n\nClosure: After confirming hemostasis, trocars were removed and ports closed. Postoperative Management: Patients followed a standardized protocol involving gradua', 'armGroupLabels': ['hernia arm represent patients with hiatal hernia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zagazig', 'country': 'Egypt', 'facility': 'Zagazig Univeesity Hospitals', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assisstant professor', 'investigatorFullName': 'Yasser Ali Orban', 'investigatorAffiliation': 'Zagazig University'}}}}