Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-02-20 @ 3:22 AM
Study NCT ID:
NCT05106660
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
2021-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ambulatory 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': 1554}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-03', 'studyFirstSubmitDate': '2021-10-13', 'studyFirstSubmitQcDate': '2021-11-03', 'lastUpdatePostDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Readmission', 'timeFrame': 'up to 12 months after surgery', 'description': 'Readmission to hospital after discharge'}, {'measure': 'Number of patients undergoing reoperative or revisional surgical or endoscopic intervention', 'timeFrame': 'up to 12 months', 'description': 'Number of participants who underwent abdominal surgery or endoscopy for sleeve gastrectomy related complications'}, {'measure': 'Hospital Transfer', 'timeFrame': 'up to 16 hours', 'description': 'Transfer of patient in Ambulatory LSG group to hospital for postop stay'}, {'measure': 'Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0', 'timeFrame': 'within 30 days', 'description': 'Number of participants who experienced postoperative complications (e.g. bleeding, staple line leaks, surgical site infection, etc...)'}, {'measure': 'Mortality', 'timeFrame': 'up to 30 days', 'description': 'Postoperative 30-day mortality rate'}], 'secondaryOutcomes': [{'measure': 'Weight loss', 'timeFrame': '3 months, 6 months, and 1 year', 'description': 'Weight difference between baseline and follow-up visits in kilograms. Weight measured using validated, calibrated scale with minimal clothing.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sleeve gastrectomy', 'ambulatory surgery', 'day case surgery'], 'conditions': ['Obesity, Morbid']}, 'descriptionModule': {'briefSummary': 'In the era of laparoscopic surgery, day case procedures are increasingly practiced around the world, however, day case bariatric surgery remains a controversial issue due to lack of sufficient evidence evaluating its safety. Laparoscopic sleeve gastrectomy (LSG) is currently the most popular bariatric surgery performed worldwide, and the standard is 1-2 days postop stay. However, the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery released guidelines in 2016 that allowed LSG in ambulatory surgery centers for low acuity patients. In the present trial, investigators will compare the safety and feasibility of same day discharge vs next day discharge in a large group of patients undergoing laparoscopic sleeve gastrectomy.', 'detailedDescription': 'This is a 2-group, randomized, open label clinical trial patients who will be recruited at an ASC to undergo LSG with same-day discharge, termed Ambulatory Surgery Center LSG (ASC LSG) or LSG with conventional hospitalization and next day discharge (CH LSG). The study will recruit participants between December 2018 and December 2020. Data collected will include including age, body mass index (BMI), operative time, recovery room time, hospital stay, readmission, follow up visits, ASC visits, adverse events, and re-operation rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 18 and 65 years\n2. Body mass index \\<60\n3. American Anesthesiologists Association classification ≤III\n4. Commitment to stay within close proximity to the ambulatory surgery center for 4 days after surgery\n\nExclusion Criteria:\n\n1. High risk for thromboembolic disease\n2. Has a history of major open abdominal surgery\n3. Bleeding disorders\n4. Heart disease\n5. Pulmonary hypertension\n6. Uncontrolled type 2 diabetes\n7. Severe obstructive sleep apnea\n8. Chronic obstructive pulmonary disease'}, 'identificationModule': {'nctId': 'NCT05106660', 'acronym': 'DAYSLEEVE', 'briefTitle': 'Ambulatory Laparoscopic Sleeve Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'King Saud University'}, 'officialTitle': 'Safety and Efficacy of Same Day vs Next Day Discharge Post Sleeve Gastrectomy', 'orgStudyIdInfo': {'id': 'NYASCLSG001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ambulatory Care Laparoscopic sleeve gastrectomy', 'description': 'Laparoscopic sleeve gastrectomy as ambulatory care procedure with same-day discharge', 'interventionNames': ['Procedure: Ambulatory Laparoscopic Sleeve Gastrectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Next Day Discharge Laparoscopic sleeve gastrectomy', 'description': 'Laparoscopic sleeve gastrectomy with next day discharge', 'interventionNames': ['Procedure: Conventional Laparoscopic Sleeve Gastrectomy']}], 'interventions': [{'name': 'Ambulatory Laparoscopic Sleeve Gastrectomy', 'type': 'PROCEDURE', 'description': 'Same-day discharge', 'armGroupLabels': ['Ambulatory Care Laparoscopic sleeve gastrectomy']}, {'name': 'Conventional Laparoscopic Sleeve Gastrectomy', 'type': 'PROCEDURE', 'description': 'Next-day discharge', 'armGroupLabels': ['Next Day Discharge Laparoscopic sleeve gastrectomy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'New You Medical Center', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'overallOfficials': [{'name': 'Aayed Alqahtani, MD FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New You Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Saud University', 'class': 'OTHER'}, 'collaborators': [{'name': 'New You Medical Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'Aayed Alqahtani', 'investigatorAffiliation': 'King Saud University'}}}}