Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-27 @ 2:07 PM
Study NCT ID:
NCT04879667
Status:
COMPLETED
Last Update Posted:
2021-05-10
First Post:
2021-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Management Of Refractory Gastro-cutaneous Fistula After Laparoscopic Sleeve Gastrectomy l
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "This study included patients who were admitted to investigators' center to do laparoscopic sleeve gastrectomy and complicated by gastro-cutaneous fistula . Cases were collected in the period from December 2019 to march 2021. the sample size was 30 patients divided into two equal groups. Group (1) included 15 patients managed by surgical intervention , group (2) included 15 patients managed by endoscopic intervention."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-07', 'studyFirstSubmitDate': '2021-05-05', 'studyFirstSubmitQcDate': '2021-05-07', 'lastUpdatePostDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of recurrence of fistula', 'timeFrame': 'within one week after the endoscopy'}], 'secondaryOutcomes': [{'measure': 'incidence of side effects of endoscopy', 'timeFrame': 'within one month after the endoscopy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laparoscopic Sleeve Gastrectomy'], 'conditions': ['Bariatric Surgery Candidate']}, 'referencesModule': {'references': [{'pmid': '36326931', 'type': 'DERIVED', 'citation': 'Negm S, Mousa B, Shafiq A, Abozaid M, Allah EA, Attia A, AbdelKader T, Farag A. Endoscopic management of refractory leak and gastro-cutaneous fistula after laparoscopic sleeve gastrectomy: a randomized controlled trial. Surg Endosc. 2023 Mar;37(3):2173-2181. doi: 10.1007/s00464-022-09748-z. Epub 2022 Nov 3.'}]}, 'descriptionModule': {'briefSummary': "This study included patients who were admitted to investigators' center to do laparoscopic sleeve gastrectomy and complicated by gastro-cutaneous fistula . Cases were collected in the period from December 2019 to march 2021. The study was approved by the research and Ethics committee of investigators' University .a written informed consent was obtained from all participating patients after explaining to them all the study procedures with its benefits and hazards. the work has been carried out in accordance with the code of ethics of the world medical association ( Declaration of Helsinki ) for studies involving humans .the sample size was calculated using open Epi program using the following data ; confidence interval 95% , power of test 80% , ratio of unexposed/exposed 1, percent of patients with successful management of refractory gastro-cutaneous fistula by surgical intervention 50% and those with successful management by endoscopy 99% , odds ratio 99%, and risk ratio 2 , so the calculated sample size equal 30 patients divided into two equal groups. Group (1) included 15 patients managed by surgical intervention , group (2) included 15 patients managed by endoscopic intervention.", 'detailedDescription': "This study included patients who were admitted to investigators' center to do laparoscopic sleeve gastrectomy and complicated by gastro-cutaneous fistula . Cases were collected in the period from December 2019 to march 2021. The study was approved by the research and Ethics committee of investigators' University .a written informed consent was obtained from all participating patients after explaining to them all the study procedures with its benefits and hazards. the work has been carried out in accordance with the code of ethics of the world medical association ( Declaration of Helsinki ) for studies involving humans .the sample size was calculated using open Epi program using the following data ; confidence interval 95% , power of test 80% , ratio of unexposed/exposed 1, percent of patients with successful management of refractory gastro-cutaneous fistula by surgical intervention 50% and those with successful management by endoscopy 99% , odds ratio 99%, and risk ratio 2 , so the calculated sample size equal 30 patients divided into two equal groups. Group (1) included 15 patients managed by surgical intervention , group (2) included 15 patients managed by endoscopic intervention.\n\nInclusion criteria:\n\nAny patient complicated with gastrocutaneous fistula after laparoscopic sleeve gastrectomy. patients with ASA I \\& II.\n\nExclusion criteria:\n\nAny patient complicated with gastrocutaneous fistula after laparoscopic sleeve gastrectomy and managed by conservative measures. Patients with bad general condition ASAIII.\n\nPerioperative measures:\n\nIn this randomized control trials , all patients were subjected to the followings: patients were selected by randomization method , Full history taking , Complete physical examination , laboratory investigations ( complete blood picture , liver and kidney functions , coagulation profile ) , radiological investigations ( chest x- ray , ct with oral and i.v contrast to assess if the fistula had track or not ) \\& patients were subjected to upper GI endoscopy to assess the site , size \\& cause of fistula .\n\nendoscopic techniques : we performed upper GI endoscopy to all cases first to assess the site , size and cause of fistula . we used stents , clips , sutures and ballon dilatation to close the fistula according to size , site and cause of fistula.if the fistula had no track that was proved by CT with oral \\& I.V contrast , we used the endoscopic stent. if the fistula had track that was proved by CT with oral \\& I.V contrast , we used the OVASCO clip , endo suturing or ballon. Combined maneuvers may be used like ballon dilation and clipping or ballon dilatation and suturing if there was distal narrowing.\n\nFollow up after endoscopy and discharge from the hospital:\n\nWe examined the patients clinically, made routine laboratory investigations , made follow up ct with oral and i.v contrast \\& patients were subjected to upper GI endoscopy. The patients were followed up for one week, two weeks and one month, 6months post operatively.\n\nStatistical analysis:\n\nThe collected data were analyzed by computer using Statistical Package of Social Services version 22 (SPSS), Data were represented in tables and graphs, Continuous Quantitative variables e.g. age were expressed as the mean ± SD \\& (range), and categorical qualitative variables were expressed as absolute frequencies (number) \\& relative frequencies (percentage).\n\nSuitable statistical tests of significance were used after checked for normality. Categorical data were cross tabulated and analyzed by the Chi-square test or Fisher's Exact Test; Continuous data were evaluated by student t- test. The results were considered statistically significant when the significant probability was less than 0.05 (P \\< 0.05). P-value \\< 0.001 was considered highly statistically significant (HS), and P-value ≥ 0.05 was considered statistically insignificant (NS)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient complicated with gastrocutaneous fistula after laparoscopic sleeve gastrectomy.\n* patients with ASA I \\& II.\n\nExclusion Criteria:\n\n* Any patient complicated with gastrocutaneous fistula after laparoscopic sleeve gastrectomy and managed by conservative measures.\n* Patients with bad general condition ASAIII.'}, 'identificationModule': {'nctId': 'NCT04879667', 'briefTitle': 'Endoscopic Management Of Refractory Gastro-cutaneous Fistula After Laparoscopic Sleeve Gastrectomy l', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Endoscopic Management Of Refractory Gastro-cutaneous Fistula After Laparoscopic Sleeve Gastrectomy ; A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'Zagazig University Hospitalis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'group (1)', 'description': 'surgical management of gastrocutaneous fistula after laparoscopic sleeve gatrectomy by surgical exploration'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group (2)', 'description': 'we performed upper GI endoscopy to all cases first to assess the site , size and cause of fistula . we used stents , clips , sutures and ballon dilatation to close the fistula according to size , site and cause of fistula.if the fistula had no track that was proved by CT with oral \\& I.V contrast , we used the endoscopic stent. if the fistula had track that was proved by CT with oral \\& I.V contrast , we used the OVASCO clip , endo suturing or ballon. Combined maneuvers may be used like ballon dilation and clipping or ballon dilatation and suturing if there was distal narrowing.', 'interventionNames': ['Procedure: endoscopic management of gastrocutaneous fistula after laparoscopic sleeve gastrectomy']}], 'interventions': [{'name': 'endoscopic management of gastrocutaneous fistula after laparoscopic sleeve gastrectomy', 'type': 'PROCEDURE', 'description': 'we performed upper GI endoscopy to all cases first to assess the site , size and cause of fistula . we used stents , clips , sutures and ballon dilatation to close the fistula according to size , site and cause of fistula.if the fistula had no track that was proved by CT with oral \\& I.V contrast , we used the endoscopic stent. if the fistula had track that was proved by CT with oral \\& I.V contrast , we used the OVASCO clip , endo suturing or ballon. Combined maneuvers may be used like ballon dilation and clipping or ballon dilatation and suturing if there was distal narrowing.', 'armGroupLabels': ['group (2)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zagazig', 'country': 'Egypt', 'facility': 'Zagazig University Hospitals', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'overallOfficials': [{'name': 'Said Mohamed Negm, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ZAGAZIG UNIVERSITY HOSPITALS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of general surgery', 'investigatorFullName': 'Said Mohamed Said Abdou Negm', 'investigatorAffiliation': 'Zagazig University'}}}}