Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-25 @ 2:00 PM
Study NCT ID:
NCT07148492
Status:
RECRUITING
Last Update Posted:
2025-08-29
First Post:
2025-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antireflux Suture In One Anastomsis Gastric Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], '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': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 316}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-28', 'studyFirstSubmitDate': '2025-08-23', 'studyFirstSubmitQcDate': '2025-08-28', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reflux disease', 'timeFrame': '3 months and 6 months postoperatively', 'description': 'The incidence of gastroesophageal reflux will be measured after surgery'}], 'secondaryOutcomes': [{'measure': 'Postoperative vomiting', 'timeFrame': 'At 3 months and 6 months postoperatively', 'description': 'Incidence of postoperative vomiting will be measured'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Reflux Disease, Gastro-Esophageal', 'Vomiting, Postoperative']}, 'descriptionModule': {'briefSummary': 'To prevent refulx symptoms in a type of bariatric surgery, a suture is taken.there is no enough evidence in support of or against the suture. our study aims to compare the symptoms of patients in whom the suture is taken and in those in whom it is not.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing one anastomosis gastric bypass surgery\n\nExclusion Criteria:\n\n* Non consenting individuals'}, 'identificationModule': {'nctId': 'NCT07148492', 'briefTitle': 'Antireflux Suture In One Anastomsis Gastric Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Khyber Teaching Hospital'}, 'officialTitle': 'Antireflux Suture In Laparoscopic One Anastomsis Gastric Bypass Surgery, A Randomised Control Trial', 'orgStudyIdInfo': {'id': '528/DME/KMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Antireflux suture group', 'description': 'This group consist of patients in whom antireflux suture is taken', 'interventionNames': ['Procedure: Antireflux suture']}, {'type': 'EXPERIMENTAL', 'label': 'No Antireflux suture', 'description': 'This group consist of patients in whom no antireflux suture is taken', 'interventionNames': ['Procedure: No Antireflux suture']}], 'interventions': [{'name': 'Antireflux suture', 'type': 'PROCEDURE', 'description': 'Antireflux suture will be taken in this intervention group', 'armGroupLabels': ['Antireflux suture group']}, {'name': 'No Antireflux suture', 'type': 'PROCEDURE', 'description': 'Antireflux suture will not be taken in this intervention group', 'armGroupLabels': ['No Antireflux suture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Peshawar', 'state': 'Khyberpukhtunkhwa', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Saeed Sarwar, MBBS', 'role': 'CONTACT', 'email': 'saeedkmc2020@gmail.com', 'phone': '+923420973863'}], 'facility': 'Khyber teaching hospital', 'geoPoint': {'lat': 34.008, 'lon': 71.57849}}], 'centralContacts': [{'name': 'Saeed Sarwar, MBBS', 'role': 'CONTACT', 'email': 'saeedkmc2020@gmail.com', 'phone': '+923420973863'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Patients privacy may be breached'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Khyber Teaching Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Dr Saeed Sarwar', 'investigatorAffiliation': 'Khyber Teaching Hospital'}}}}