Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 12:46 AM
Study NCT ID:
NCT06170060
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-27
First Post:
2023-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Reflux With Sleeve Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D006551', 'term': 'Hernia, Hiatal'}, {'id': 'D004942', 'term': 'Esophagitis, Peptic'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'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'}, {'id': 'D004941', 'term': 'Esophagitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D010437', 'term': 'Peptic Ulcer'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-26', 'studyFirstSubmitDate': '2023-12-06', 'studyFirstSubmitQcDate': '2023-12-13', 'lastUpdatePostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Gastroesophageal Reflux Disease Health-Related Quality of Life Survey', 'timeFrame': '12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Reflux Disease, Gastro-Esophageal', 'Hiatal Hernia', 'Reflux Esophagitis']}, 'descriptionModule': {'briefSummary': 'In 2008, the World Health Organization (WHO) report found that 0.5-1.5 billion people aged 20 years and above suffer from overweight (body mass index (BMI) ≥ 25) and obesity (BMI ≥ 30 kg / m2) stated.\n\nWHO estimates that the number of overweight and obese people will reach 2.3 and 0.7 billion, respectively, by 2045.\n\nBariatric surgery has been developed in response to the number of obese patients living in the world and the complications caused by obesity. The most common type of bariatric surgery against obesity is Laparoscopic Sleeve Gastrectomy (LSG).\n\nAs after any surgical operation, complications may occur after Laparoscopic Sleeve Gastrectomy. Additional operations may be required to correct complications such as bleeding, anastomotic leak, gastric volvulus, infection, dyspepsia, hiatal hernia, bile and/or acid reflux.\n\nThe incidence of gastroesophageal reflux disease (GERD) is significantly increased in obese patients compared to the incidence in normal individuals. Various studies have shown that obesity causes delayed gastric emptying due to increased abdominal pressure, esophageal motility disorders, especially hypotensive lower esophageal sphincter pressure (\\<10 mm Hg), finally the development of hiatal hernia (HH), whose prevalence in the obese population is significantly higher than in non-obese patients.\n\nVarious surgical methods have been presented to prevent postoperative de-novo Gastroesophageal Reflux and de-novo Hiatal Hernia that occur after LSG. Curorrhaphy is one of these techniques that is accepted to prevent the formation or exacerbation of postoperative GERD and Hiatal Hernia.\n\nIn this surgical technique, after the diaphragmatic crura are completely exposed at the level of the lower esophageal sphincter (LES), the hiatal hernia, if present, is reduced into the abdomen. Afterwards, Z surgical sutures are applied to the diaphragmatic crura to make the diaphragmatic esophageal ring narrow enough. In this way, it is aimed to strengthen the diaphragmatic crus. Findings following cruroplasty for GERD prevention are varied. Although some authors state that the technique does not provide an advantage in preventing postoperative GERD, some studies have shown cruroplasty to be effective.\n\nIn this study, investigators aimed to show that the technique of simultaneous cruroplasty and single suture omentopexy with LSG is a treatment for GERD and HH, which are very common in obese patients, and a preventive technique for de-novo GERD seen after LSG.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obesity,\n\nExclusion Criteria:\n\n* Eating disorder or mental disorder\n* Misunderstanding of the protocol\n* Psychiatric contraindication\n* Patient participating in another interventional clinical research protocol involving a drug or medical device\n* Pregnant, breastfeeding'}, 'identificationModule': {'nctId': 'NCT06170060', 'briefTitle': 'Treatment of Reflux With Sleeve Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Aydın University'}, 'officialTitle': 'Preventing and Treating Reflux With Cruroplasty and Omentopexy After Laparoscopic Sleeve Gastrectomy', 'orgStudyIdInfo': {'id': 'IAU-YUSUFEMREALTUNDAL-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laparoscopic Sleeve Gastrectomy', 'interventionNames': ['Other: Laparoscopic Sleeve Gastrectomy']}], 'interventions': [{'name': 'Laparoscopic Sleeve Gastrectomy', 'type': 'OTHER', 'description': "Laparoscopic sleeve gastrectomy (LSG) is a surgical procedure widely used in the treatment of obesity. It's a bariatric procedure, meaning its primary aim is to induce weight loss, and it has gained popularity due to its effectiveness and relatively low complication rates compared to other bariatric surgeries.", 'armGroupLabels': ['Laparoscopic Sleeve Gastrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Küçükçekmece', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Aydin University', 'geoPoint': {'lat': 40.99104, 'lon': 28.77123}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yusuf Emre ALTUNDAL', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Yusuf Emre ALTUNDAL', 'investigatorAffiliation': 'Istanbul Aydın University'}}}}