Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-02-20 @ 6:20 PM
Study NCT ID:
NCT03754751
Status:
COMPLETED
Last Update Posted:
2021-01-15
First Post:
2018-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhanced Recovery in Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D041881', 'term': 'Cholecystitis, Acute'}, {'id': 'D002764', 'term': 'Cholecystitis'}], 'ancestors': [{'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017081', 'term': 'Cholecystectomy, Laparoscopic'}], 'ancestors': [{'id': 'D002763', 'term': 'Cholecystectomy'}, {'id': 'D001662', 'term': 'Biliary Tract Surgical Procedures'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D010535', 'term': 'Laparoscopy'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 189}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-14', 'studyFirstSubmitDate': '2018-11-21', 'studyFirstSubmitQcDate': '2018-11-26', 'lastUpdatePostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative length of stay (pLOS)', 'timeFrame': '30 days', 'description': 'Time interval measured from the end of the surgery until the moment of discharge from the hospital, measured in days'}], 'secondaryOutcomes': [{'measure': 'Complication rate', 'timeFrame': '30 days', 'description': 'Number of patients who develop postoperative complications (surgical site infections, intraabdominal organ-specific infection, postoperative ileus) in relation to the total number of patients, measured in percentage'}, {'measure': 'Readmission rate', 'timeFrame': '30 days', 'description': 'Number of patients with readmission to the hospital after discharge in relation to the total number of patients, measured as a percentage'}, {'measure': 'Postoperative pain', 'timeFrame': '24 hours', 'description': 'Level of postoperative pain syndrome measured with a visual analog scale in centimeters'}, {'measure': 'Shoulder pain incidence', 'timeFrame': '24 hours', 'description': 'Quantity of patients who developed shoulder pain after surgery in relation to the total number of patients, measured as a percentage'}, {'measure': 'Shoulder pain level', 'timeFrame': '24 hours', 'description': 'Level of shoulder pain syndrome measured with a visual analog scale in centimeters'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['enhanced recovery', 'intraperitoneal anesthesia', 'low pressure pneumoperitoneum', 'cholecystitis', 'in-hospital stay', 'laparoscopic cholecystectomy'], 'conditions': ['Acute Cholecystitis', 'Gangrenous Cholecystitis']}, 'descriptionModule': {'briefSummary': 'The study assesses the impact of the modified enhanced recovery protocol on the results of surgical treatment of patients with acute cholecystitis.', 'detailedDescription': 'Laparoscopic cholecystectomy (LC) is the most common surgical procedures in the world. Elective LC is commonly performed as one-day surgery, while in an emergency setting of acute cholecystitis the in-hospital stay averages 4.5 days. Causes of prolonged rehabilitation period are often associated with severe pain syndrome, dyspepsia and postoperative complications. The complications rate after LC is about 6% and has no tendency to decrease. The implementation of enhanced recovery after surgery (ERAS) programs may potentially reduce stress-associated complications and improve the quality of rehabilitation. A few retrospective studies examined their advantages and setbacks in the treatment of acute cholecystitis with encouraging results. The aim of this randomized control study is to evaluate the modified ERAS program for patients with acute cholecystitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Grade I and II acute cholecystitis according to Tokyo Guidelines 2013 classification (TG13)\n* ASA I and II.\n\nExclusion Criteria:\n\n* Severe acute cholecystitis (Grade III on TG13);\n* Patient's refusal to participate;\n* The language barrier;\n* Transfer to the intensive care unit after surgery;\n* ASA class ≥ III;\n* Conversion to open procedure;\n* Biliary hypertension detected during preoperative examination or intraoperatively."}, 'identificationModule': {'nctId': 'NCT03754751', 'acronym': 'ERLAC', 'briefTitle': 'Enhanced Recovery in Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Pirogov Russian National Research Medical University'}, 'officialTitle': 'Modified Enhanced Recovery Program in Patients With Acute Cholecystitis Undergoing Laparoscopic Cholecystectomy: Prospective Randomized Trial', 'orgStudyIdInfo': {'id': 'ERLAC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modified ERAS program group', 'description': 'Laparoscopic cholecystectomy with the implementation of modified ERAS program', 'interventionNames': ['Procedure: Laparoscopic cholecystectomy with the implementation of modified ERAS program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional care group', 'description': 'Laparoscopic cholecystectomy with standard perioperative treatment', 'interventionNames': ['Procedure: Laparoscopic cholecystectomy with standard perioperative treatment']}], 'interventions': [{'name': 'Laparoscopic cholecystectomy with the implementation of modified ERAS program', 'type': 'PROCEDURE', 'description': 'Preoperative Crystalloid isotonic solutions and antibiotic prophylaxis 30 min prior to surgery.\n\n1\\) Patient informing and brochure\n\nSurgery Cholecystectomy using monopolar by experienced surgeons under general anesthesia\n\n1. Low-pressure pneumoperitoneum (8-9 mmHg)\n2. Trocar wound and intraabdominal anesthesia with 0.25% ropivacaine\n3. PONV prophylaxis in patients of risk\n\nPostoperative care\n\n1. Early mobilization (2 h after surgery)\n2. Early fluid intake (2 h after surgery)\n3. Early liquid food (6 h after surgery) Antibiotics for 3-5 d for patients with complicated cholecystitis (TG13 2). The postoperative pain level evaluation in rest by VAS in 0 h (immediately after awakening), 6 h and 24 h postop. The postoperative analgesic modality "on demand": Ketorolac 30 mg for patients with VAS pain level ≥ 5 cm. Antiemetics in dyspepsia. No iv infusions postoperatively. Intestinal peristalsis evaluation by auscultation every 2 h after surgery', 'armGroupLabels': ['Modified ERAS program group']}, {'name': 'Laparoscopic cholecystectomy with standard perioperative treatment', 'type': 'PROCEDURE', 'description': 'Preoperative Crystalloid isotonic solutions and antibiotic prophylaxis 30 min prior to surgery.\n\n1\\) Patient oral informing. No brochure\n\nSurgery Cholecystectomy using monopolar by experienced surgeons under general anesthesia\n\n1. Standard CO2 pressure (12-14 mmHg)\n2. No additional anesthesia\n\nPostoperative care\n\n1. Mobilization in 4-6 h after surgery\n2. Fluid intake in 6 hours\n3. Liquid food intake in 12 hours Antibiotics for 3-5 d for patients with complicated cholecystitis (TG13 2). The postoperative pain level evaluation in rest by VAS in 0 h (immediately after awakening), 6 h and 24 h postop. The postoperative analgesic modality "on demand": Ketorolac 30 mg for patients with VAS pain level ≥ 5 cm. Antiemetics in dyspepsia. No iv infusions postoperatively. Intestinal peristalsis evaluation by auscultation every 2 h after surgery', 'armGroupLabels': ['Conventional care group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '115569', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Taras Nechay', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Alexander Sazhin, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Pirogov Russian National Research Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pirogov Russian National Research Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}