Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT06745505
Status:
COMPLETED
Last Update Posted:
2024-12-20
First Post:
2024-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EFFECTIVENESS of PRE-OPERATIVE BOWEL PREPARATION VS NO BOWEL PREPARATION on OUTCOMES of PEDIATRIC COLORECTAL SURGERIES
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002400', 'term': 'Cathartics'}], 'ancestors': [{'id': 'D005765', 'term': 'Gastrointestinal Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-17', 'studyFirstSubmitDate': '2024-12-17', 'studyFirstSubmitQcDate': '2024-12-17', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'No difference in surgical outcome after bowel preparation', 'timeFrame': '1 year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['effectiveness', 'pre-operative bowel preparation', 'pediatric colorectal surgery'], 'conditions': ['Colorectal Surgery', 'Pediatric', 'Bowel Preparation']}, 'descriptionModule': {'briefSummary': 'To compare the effectiveness of pre-operative bowel preparation vs no bowel preparation on outcomes of pediatric colorectal surgeries.', 'detailedDescription': 'Objective was to compare the effectiveness of pre-operative bowel preparation vs no bowel preparation on outcomes of pediatric colorectal surgeries. After approval from the ethical committee, 62 patients fulfilling the inclusion criteria were enrolled in this study from outpatient department. All participants were examined physically in person by the primary investigator. After which the patients were divided randomly into two groups A and B, 31 patients in each group. Group A patients were undergone bowel preparation while group B patients were not undergone bowel preparation. All patients were operated by a single consultant pediatric surgeon with more than 10 years of experience. Patients were called for follow up weekly till 6 weeks. Hospital stay was noted at the time of discharge. Wound infection rate was assessed till 30th post-operative day while anastomotic leak was ruled out on clinical and radiologic exam if symptoms were present. All the data of this study were analyzed in SPSS version 26. We concluded that that there is no significant difference in surgical outcomes between the group receiving the bowel preparation versus the group not receiving the bowel preparation in terms of surgical site infection rate, anastomotic leak and length of hospital stay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with congenital condition such as Hirschsprung disease, anorectal malformation requiring pull through with or without covering colostomy.\n* Patients with anorectal malformation requiring anorectoplasty with or without covering colostomy.\n* Ileostomy/colostomy acquired due to intestinal perforation, intestinal obstruction, and trauma admitted for reversal.\n* Age up to 12 years.\n* Patients of both genders.\n\nExclusion Criteria:\n\n* Any associated congenital morbid anomaly having Meningomyelocoele, Muscular dystrophy (were assessed on clinical examination)\n* Patients with behavior disorders such as autism (were assessed during psychiatric history and clinical examination)\n* Patients with behavioral disorder are difficult to counsel and follow up'}, 'identificationModule': {'nctId': 'NCT06745505', 'briefTitle': 'EFFECTIVENESS of PRE-OPERATIVE BOWEL PREPARATION VS NO BOWEL PREPARATION on OUTCOMES of PEDIATRIC COLORECTAL SURGERIES', 'organization': {'class': 'OTHER', 'fullName': 'Shaheed Zulfiqar Ali Bhutto Medical University'}, 'officialTitle': 'EFFECTIVENESS of PRE-OPERATIVE BOWEL PREPARATION VS NO BOWEL PREPARATION on OUTCOMES of PEDIATRIC COLORECTAL SURGERIES', 'orgStudyIdInfo': {'id': 'RMU-RRF-SUR002-23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Recieved Bowel Preparation', 'interventionNames': ['Procedure: Bowel Preparation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Did not receive Bowel Preparation', 'interventionNames': ['Procedure: Bowel Preparation']}], 'interventions': [{'name': 'Bowel Preparation', 'type': 'PROCEDURE', 'description': 'Group A received bowel preparation and Group B did not.', 'armGroupLabels': ['Did not receive Bowel Preparation', 'Recieved Bowel Preparation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87500', 'city': 'Rawalpindi', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Department of Pediatric Surgery, Holy Family Hospital, Rawalpindi', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}], 'overallOfficials': [{'name': 'Muhammad Salman Qamar, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rawalpindi Medical College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaheed Zulfiqar Ali Bhutto Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Holy Family Hospital, Pakistan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident Pediatric Surgery', 'investigatorFullName': 'Mansoor Ahmed', 'investigatorAffiliation': 'Shaheed Zulfiqar Ali Bhutto Medical University'}}}}