Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT04787458
Status:
COMPLETED
Last Update Posted:
2021-03-08
First Post:
2021-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Abdominal Binder After Laparoscopic Cholecystectomy on Enhanced Recovery
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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-05', 'studyFirstSubmitDate': '2021-02-09', 'studyFirstSubmitQcDate': '2021-03-05', 'lastUpdatePostDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'degree of comfort', 'timeFrame': 'Until dischage, an average of 2.5 days', 'description': 'Questionnaire response options ranged from very comfortable (5) to very Questionnaire response options ranged from very comfortable (5) to very uncomfortable (0).'}, {'measure': 'postoperative pain', 'timeFrame': '12 hours after surgery', 'description': 'Subjects rated postoperative pain intensity using a visual analog scale (0-10, VAS) at 12 hours after surgery'}, {'measure': 'postoperative pain', 'timeFrame': '24 hours after surgery', 'description': 'Subjects rated postoperative pain intensity using a visual analog scale (0-10, VAS) at 24 hours after surgery'}, {'measure': 'postoperative pain', 'timeFrame': '48 hours after surgery', 'description': 'Subjects rated postoperative pain intensity using a visual analog scale (0-10, VAS) at 48 hours after surgery'}], 'secondaryOutcomes': [{'measure': 'Postoperative hospital stay', 'timeFrame': 'Until dischage, an average of 2.3 days', 'description': 'Postoperative hospital stay days to discharge'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Laparoscopy']}, 'descriptionModule': {'briefSummary': 'There have been reports that abdominal binder use after laparoscopic or open surgery affects postoperative respiratory function, walking performance, and pain but no study has evaluated binder use solely for laparoscopic cholecystectomy surgery. Therefore, the investigators performed a randomized controlled trial to evaluate the effect of abdominal binders after laparoscopic cholecystectomy by comparing postoperative outcomes in two patient groups.', 'detailedDescription': 'Abdominal binders help to prevent postoperative complications, however, their use is controversial because of a lack of evidence for their effectiveness and because they also confer disadvantages. The purpose of this randomized controlled trial was to compare the effects of abdominal binder after laparoscopic cholecystectomy on pain, degree of comfort, time until ambulation, walking ability, return of bowel function, and diet resumption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 years old\n* American Society of Anesthesiologists Physical Status classification I and II\n\nExclusion Criteria:\n\n* history of ventral hernia\n* walking disability\n* chronic obstructive respiratory disease\n* malignancy\n* chronic pain syndrome\n* open conversion\n* inability to complete the questionnaire'}, 'identificationModule': {'nctId': 'NCT04787458', 'briefTitle': 'Effect of Abdominal Binder After Laparoscopic Cholecystectomy on Enhanced Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Kangbuk Samsung Hospital'}, 'officialTitle': 'Effect of Abdominal Binder After Laparoscopic Cholecystectomy on Enhanced Recovery(ABC) : a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '202002041'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'In subjects allocated to the abdominal binder group, the abdomen binder with a standard height of 22 cm (Sejung Korea, Seoul, Republic of Korea) was applied before leaving the operating room. Subjects were carefully instructed to use the abdominal binder during at least the first 2 consecutive days and night, and to reposition the abdominal binder correctly when needed.', 'interventionNames': ['Device: abdomen binder (Sejung Korea, Seoul, Republic of Korea)']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'subjects allocated in the control group, subjects were not given any opportunity to ware an abdominal binder.'}], 'interventions': [{'name': 'abdomen binder (Sejung Korea, Seoul, Republic of Korea)', 'type': 'DEVICE', 'description': 'abdomen binder with a standard height of 22 cm (Sejung Korea, Seoul, Republic of Korea)', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kangbuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kangbuk Samsung Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hepato-biliary and pancreatic department of General Surgery, Assistant Professor', 'investigatorFullName': 'Sung Ryol Lee', 'investigatorAffiliation': 'Kangbuk Samsung Hospital'}}}}