Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 12:29 AM
Study NCT ID:
NCT05267860
Status:
COMPLETED
Last Update Posted:
2023-01-26
First Post:
2022-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Using Prophylactic Abdominal Drainage After Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D041881', 'term': 'Cholecystitis, Acute'}, {'id': 'D002764', 'term': 'Cholecystitis'}, {'id': 'D042883', 'term': 'Choledocholithiasis'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003137', 'term': 'Common Bile Duct Diseases'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D002769', 'term': 'Cholelithiasis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 232}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-23', 'studyFirstSubmitDate': '2022-02-21', 'studyFirstSubmitQcDate': '2022-03-02', 'lastUpdatePostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse events from the operation', 'timeFrame': 'up to 24 hours'}, {'measure': 'Mortality', 'timeFrame': 'up to 30 days'}, {'measure': 'Hospital stay', 'timeFrame': 'up to 30 days', 'description': 'Number of days, patient in hospital since admission'}], 'primaryOutcomes': [{'measure': 'Morbidity /Complications', 'timeFrame': '30 days after the operation', 'description': 'overall complication rate; graded by the Clavien- Dindo complications classification system.'}], 'secondaryOutcomes': [{'measure': 'Intraperitoneal abscess', 'timeFrame': 'up to 30 days', 'description': 'The patient will be monitored and followed up for 30 days after the surgery, and the necessary investigations will be requested to diagnose if the patient has an Intraperitoneal abscess'}, {'measure': 'Wound infection/ Surgical site infection', 'timeFrame': 'up to 30 days', 'description': 'Surgical site infection has been defined and classified as superficial incisional, deep incisional, and organ/ space\\_ surgical site infection by the Centers for Disease Control and Prevention (CDC) (Anderson 2014; Ban 2017; Berríos-Torres 2017).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prophylactic Drainage', 'Laparoscopic cholecystectomy', 'Acute cholecystitis.', 'Upper GI Surgery', 'Cholecystitis', 'Choledocholithiasis', 'Gallbladder Diseases'], 'conditions': ['Drainage', 'Laparoscopic Cholecystectomy', 'Acute Cholecystitis']}, 'referencesModule': {'references': [{'pmid': '24970306', 'type': 'BACKGROUND', 'citation': 'Antoniou S, Koch O, Antoniou G, Kohler G, Chalkiadakis G, Pointner R, Granderath F. Routine versus no drain placement after elective laparoscopic cholecystectomy: meta-analysis of randomized controlled trials. Minerva Chir. 2014 Jun;69(3):185-94.'}, {'pmid': '24000011', 'type': 'BACKGROUND', 'citation': 'Gurusamy KS, Koti R, Davidson BR. Routine abdominal drainage versus no abdominal drainage for uncomplicated laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2013 Sep 3;(9):CD006004. doi: 10.1002/14651858.CD006004.pub4.'}, {'pmid': '2042093', 'type': 'BACKGROUND', 'citation': 'Monson JR, Guillou PJ, Keane FB, Tanner WA, Brennan TG. Cholecystectomy is safer without drainage: the results of a prospective, randomized clinical trial. Surgery. 1991 Jun;109(6):740-6.'}, {'pmid': '26386402', 'type': 'BACKGROUND', 'citation': 'Wong CS, Cousins G, Duddy JC, Walsh SR. Intra-abdominal drainage for laparoscopic cholecystectomy: A systematic review and meta-analysis. Int J Surg. 2015 Nov;23(Pt A):87-96. doi: 10.1016/j.ijsu.2015.09.033. Epub 2015 Sep 18.'}, {'pmid': '39131596', 'type': 'DERIVED', 'citation': 'Arnaout AY, Kadoura L, Masri R, Nerabani Y, Atli AA, Arnaout K, Arnaout I, Bsata A, Kayali H, Mahli N, Al-Haj A, Ayoub K, Niazi A, Ghazal A; Aleppo University Hospital Team. The efficacy and safety of using prophylactic abdominal drainage after laparoscopic cholecystectomy: A randomized control trial. Health Sci Rep. 2024 Aug 8;7(8):e2284. doi: 10.1002/hsr2.2284. eCollection 2024 Aug.'}]}, 'descriptionModule': {'briefSummary': 'Investigators want to assess the safety and efficacy of using abdominal drainage with not using any drainage, by estimating different outcomes after laparoscopic cholecystectomy for different reasons. Patients are seen at the Accident and Emergency Department or in the surgical wards at Aleppo University Hospital (AUH) over 12 months period.', 'detailedDescription': 'The routine use of prophylactic drainage has become common in many hospitals around the world after cholecystectomy for different reasons. In elective surgeries, the evidence does not support the use of drainage. But in emergency laparoscopic cholecystectomy surgeries, using drainage remains controversial. Surgeons who support the use of drainage find it useful to identify the early complications of surgery and removing intra-abdominal collections, while opponents of drainage use believe that it increases the risk of wound infection. But, a systematic review and meta-analysis discussed the ineffectiveness of the routine use of the prophylactic drainage after laparoscopic cholecystectomy for acute cholecystitis and requested more randomized clinical trial studies on the subject. However, this study and others in the medical literature contain very few high-quality randomized controlled trials, hence our randomized controlled trial compares the use and non-use of drainage in patients undergoing laparoscopic cholecystectomy for different reasons.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients are seen at the Accident and Emergency Department or in the surgical wards at Aleppo University Hospital (AUH) over 12 months period.\n* Patients who undergo cholecystectomy for any reason.\n\nExclusion Criteria:\n\n* Non-cooperative patients for regular follow up.\n* Draining for therapeutic indications.'}, 'identificationModule': {'nctId': 'NCT05267860', 'briefTitle': 'The Efficacy and Safety of Using Prophylactic Abdominal Drainage After Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Aleppo'}, 'officialTitle': 'The Efficacy and Safety of Using Prophylactic Abdominal Drainage After Cholecystectomy: A Randomized Control Trial.', 'orgStudyIdInfo': {'id': 'Drainage After Cholecystectomy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with a prophylactic drain after cholecystectomy', 'interventionNames': ['Device: Prophylactic Drain']}, {'type': 'NO_INTERVENTION', 'label': 'Patients without using any prophylactic Drainage after cholecystectomy'}], 'interventions': [{'name': 'Prophylactic Drain', 'type': 'DEVICE', 'description': 'We want to put a prophylactic drain after cholecystectomy.', 'armGroupLabels': ['Patients with a prophylactic drain after cholecystectomy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aleppo', 'country': 'Syria', 'facility': 'Aleppo University Hospital', 'geoPoint': {'lat': 36.20124, 'lon': 37.16117}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'We will publish the data after publishing the research.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aleppo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ahmad Yamen Arnaout', 'investigatorAffiliation': 'University of Aleppo'}}}}