Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-03-03 @ 12:16 AM
Study NCT ID:
NCT03191318
Status:
COMPLETED
Last Update Posted:
2018-10-23
First Post:
2017-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Enhanced Recovery After Surgery (ERAS) Pathway With Conventional Pathway After Laparoscopic Sleeve Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-20', 'studyFirstSubmitDate': '2017-06-15', 'studyFirstSubmitQcDate': '2017-06-15', 'lastUpdatePostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital stay', 'timeFrame': '7 days', 'description': 'Postoperative hospital stay of patients'}], 'secondaryOutcomes': [{'measure': 'Pain score', 'timeFrame': 'Within 72 hours of surgery', 'description': 'Postoperative pain score'}, {'measure': 'Operative time', 'timeFrame': 'Within 24 hours, in minutes', 'description': 'Time taken to perform surgery'}, {'measure': 'Analgesic requirement', 'timeFrame': 'Within 72 hours', 'description': 'Post operative cumulative analgesic requirement'}, {'measure': 'Complication rate', 'timeFrame': 'Within 30 days', 'description': 'Post operative complications rate'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ERAS', 'Enhanced recovery after sugery in bariatric surgery', 'sleeve gastrectomy'], 'conditions': ['Morbid Obesity']}, 'referencesModule': {'references': [{'pmid': '25670530', 'type': 'BACKGROUND', 'citation': 'Pimenta GP, Capellan DA, de Aguilar-Nascimento JE. Sleeve Gastrectomy With or Without a Multimodal Perioperative Care. A Randomized Pilot Study. Obes Surg. 2015 Sep;25(9):1639-46. doi: 10.1007/s11695-015-1573-2.'}, {'pmid': '23339040', 'type': 'BACKGROUND', 'citation': 'Lemanu DP, Singh PP, Berridge K, Burr M, Birch C, Babor R, MacCormick AD, Arroll B, Hill AG. Randomized clinical trial of enhanced recovery versus standard care after laparoscopic sleeve gastrectomy. Br J Surg. 2013 Mar;100(4):482-9. doi: 10.1002/bjs.9026. Epub 2013 Jan 21.'}, {'pmid': '32291702', 'type': 'DERIVED', 'citation': 'Prabhakaran S, Misra S, Magila M, Kumar SS, Kasthuri S, Palanivelu C, Raj PP. Randomized Controlled Trial Comparing the Outcomes of Enhanced Recovery After Surgery and Standard Recovery Pathways in Laparoscopic Sleeve Gastrectomy. Obes Surg. 2020 Sep;30(9):3273-3279. doi: 10.1007/s11695-020-04585-2.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare two postoperative recovery pathways namely, enhanced recovery after surgery (ERAS) pathway and conventional recovery pathway after laparoscopic sleeve gastrectomy with respect to outcomes including hospital stay, postoperative pain and other postoperative outcomes.', 'detailedDescription': 'The Enhanced recovery after surgery (ERAS) pathway, initially introduced for colorectal surgery, is an evidence based perioperative pathway which has resulted in earlier recovery, less pain, and lower complication rates. Bariatric surgical patients, without severe co-morbidities, are good candidates for ERAS pathway, but the application of ERAS concepts has been limited in this field, specially, in Asia.\n\nAlthough the current literature shows that 2 randomized clinical trials (RCT) have been performed for application of ERAS in bariatric surgery, data is still scarce as per outcomes with respect to postoperative pain and analgesic usage. One of the RCTs has compared with historical controls and both the RCTs have not clearly defined their conventional standard pathways. In this study, the investigators have clearly defined both ERAS pathway and standard pathway leaving no ambiguity.\n\nThis study is a prospective, randomized, parallel group trial comparing ERAS pathway and standard pathway after laparoscopic sleeve gastrectomy in relation to the hospital stay, postoperative pain, complications and other perioperative parameters.\n\nThis is a single institute based trial, being conducted at GEM hospital and research centre, Coimbatore, TN, India. The trial has been approved by the GEM Hospital ethical committee.\n\nIn this trial, the investigators are planning to enroll participants with morbid obesity planned to undergo laparoscopic sleeve gastrectomy. After full assessment, informed consent, these participants will be randomised using computer generated random numbers either into ERAS pathway group or into Standard pathway group.\n\nAll the intraoperative and perioperative details with respect to anaesthetic drugs usage, intravenous fluid requirement, time to ambulation, time to oral liquids, postoperative pain score, analgesic requirement and hospital stay will be recorded in the proforma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing laparoscopic sleeve gastrectomy during this study period\n\nExclusion Criteria:\n\n* 1\\. Redo procedures 2. ASA III and above status 3. Previous major upper abdominal surgeries 4. Not willing to participate'}, 'identificationModule': {'nctId': 'NCT03191318', 'acronym': 'BARI-ERAS', 'briefTitle': 'Comparison of Enhanced Recovery After Surgery (ERAS) Pathway With Conventional Pathway After Laparoscopic Sleeve Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'GEM Hospital & Research Center'}, 'officialTitle': 'Randomized Control Trial to Compare the Outcomes of Enhanced Recovery After Surgery (ERAS) Pathway and Standard Recovery Pathway After Laparoscopic Sleeve Gastrectomy', 'orgStudyIdInfo': {'id': 'BARI-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ERAS pathway', 'description': 'Laparoscopic sleeve gastrectomy with ERAS pathway', 'interventionNames': ['Other: ERAS pathway']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard pathway', 'description': 'Laparoscopic sleeve gastrectomy with standard pathway', 'interventionNames': ['Other: Standard pathway']}], 'interventions': [{'name': 'ERAS pathway', 'type': 'OTHER', 'otherNames': ['Fast track pathway'], 'description': 'ERAS pathway after laparoscopic sleeve gastrectomy', 'armGroupLabels': ['ERAS pathway']}, {'name': 'Standard pathway', 'type': 'OTHER', 'otherNames': ['Coventional pathway'], 'description': 'Standard pathway after laparoscopic sleeve gastrectomy', 'armGroupLabels': ['Standard pathway']}]}, 'contactsLocationsModule': {'locations': [{'zip': '641045', 'city': 'Coimbatore', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Gem Hospital and Research Centre', 'geoPoint': {'lat': 11.00555, 'lon': 76.96612}}], 'overallOfficials': [{'name': 'C Palanivelu, MS, MCh', 'role': 'STUDY_CHAIR', 'affiliation': 'GEM Hospital & Research centre'}, {'name': 'P Praveen Raj, MS, DNB', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GEM Hospital and Research centre'}, {'name': 'M S Prabhakaran, DA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GEM Hospital & Research centre'}, {'name': 'Siddhartha Bhattacharya, MS, DNB, FNB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GEM Hospital & Research centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'It may be obtained by request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GEM Hospital & Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}