Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-02-03 @ 5:39 AM
Study NCT ID:
NCT07138235
Status:
COMPLETED
Last Update Posted:
2025-08-22
First Post:
2025-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Complications of Laparoscopic Hiatal Hernia Repair Complicated by Gastroesophageal Reflux Disease Using the ERAS Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-17', 'studyFirstSubmitDate': '2025-08-11', 'studyFirstSubmitQcDate': '2025-08-17', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'decreased complication rate and high patient satisfaction', 'timeFrame': 'October 2016 to June 2025'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['laparoscopic hiatal hernia repair,', 'ERAS protocol,', 'surgical outcomes'], 'conditions': ['Hiatal Hernia', 'Hiatal Hernia With Gastroesophageal Reflux Disease']}, 'descriptionModule': {'briefSummary': 'Nissen fundoplication with cruroraphy performed according to ERAS protocols in patients with HH complicated by GERD.', 'detailedDescription': 'The surgery was performed in accordance with the following stages. Preparation for surgery included premedication, thromboembolic prophylaxis, and intravenous administration of broad-spectrum antibiotics 30 minutes before induction of anesthesia. Patient position and approaches: the patient was on the operating table in the spinal position with the lower limbs abducted, the head was raised by 15-20° to improve visualization of the subdiaphragmatic space. Four ports were used: one 10-mm port in the umbilical region (for optics), two 5 mm ports in the right hypochondrium and epigastrium, and one 10 mm port in the left hypochondrium. Based on the analysis of early experience of laparoscopic interventions in the cardioesophageal zone, we modified the standard port technique. In particular, the rejection of the classic fan-shaped installation of five trocars turned out to be justified, since two trocars in the left hypochondrium anatomically conflict and limit the maneuverability of the instruments, also the use of an ultrasonic dissector, allowing for simultaneous coagulation and dissection of tissue, which significantly reduced the need for an additional assistant instrument. This ensured more ergonomic manipulations, reduced the duration of the operation and the need for an additional fifth port.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '106 patients with grade III-IV HH complicated by GERD, who underwent laparoscopic cruroraphy and Nissen fundoplication using the ERAS protocol.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: were clinically significant hiatal hernia complicated by GERD, confirmed endoscopically and by radiological methods, age from 18 to 80 years and ineffectiveness of drug therapy for more than 6 months.\n\n\\-\n\nExclusion Criteria: were patients who had previously undergone surgery on the upper abdominal organs and oncological diseases. All patients underwent a comprehensive preoperative examination, including general clinical and biochemical tests, ECG, endoscopy and X-ray of the esophagus, stomach and duodenum.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07138235', 'acronym': 'hiatal hernia', 'briefTitle': 'Complications of Laparoscopic Hiatal Hernia Repair Complicated by Gastroesophageal Reflux Disease Using the ERAS Protocol', 'organization': {'class': 'OTHER', 'fullName': 'Osh State University'}, 'officialTitle': 'Complications of Laparoscopic Hiatal Hernia Repair Complicated by Gastroesophageal Reflux Disease Using the ERAS Protocol', 'orgStudyIdInfo': {'id': 'Laparoscopic hiatal hernia'}}, 'armsInterventionsModule': {'interventions': [{'name': 'laparoscopic hiatal hernia repair', 'type': 'PROCEDURE', 'description': 'Intraoperative endoscopic control and the use of calibration bougies allow for increasing the accuracy of cardiac sphincter reconstruction and reducing the risk of hyper- or hypocorrection. Endoscopic equipment. The Olympus EVIS EXERA III endoscopic video system (Olympus Medical Systems Corp., Tokyo, Japan), series 190, was used for diagnostic and therapeutic endoscopic examinations.\n\nThe complex included:\n\n* CV-190 video processor with digital image magnification,\n* CLV-190 light source (xenon/LED), providing high brightness and uniformity of illumination, a high definition (HD) video monitor,\n* GIF-HQ190, GIF-H190 high-resolution series gastroscopes,\n* CF-HQ190L/I series colonoscopes (if necessary). These functions made it possible to more accurately assess the condition of the mucous membrane of the esophagus and stomach, as well as to identify pathological changes.\n\nMedications: omeprazole/esomeprazole, ondansetron, cephalosporins intravenously, metoclopramide.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Osh State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kyrgyz State Medical Academy', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, Lecturer', 'investigatorFullName': 'Zhypargul Abdullaeva', 'investigatorAffiliation': 'Osh State University'}}}}