Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-02-21 @ 5:09 PM
Study NCT ID:
NCT02574702
Status:
COMPLETED
Last Update Posted:
2019-04-18
First Post:
2013-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial to Reduce Wound Infection With Contralateral Drainage in Loop Ileostomy Closure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-17', 'studyFirstSubmitDate': '2013-03-18', 'studyFirstSubmitQcDate': '2015-10-12', 'lastUpdatePostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with surgical site infection after ileostomy closure depending if there is or not a penrose drainage application', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Number of patients with hematoma after ileostomy closure surgery', 'timeFrame': '30 days'}, {'measure': 'Number of patients with seroma after ileostomy closure surgery', 'timeFrame': '30 days'}, {'measure': 'Number of patients with anastomotic leak after ileostomy colsure surgery', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['superficial surgical site infection', 'loop ileostomy', 'Ileostomy closure'], 'conditions': ['Surgical Wound Infection']}, 'referencesModule': {'references': [{'pmid': '30824960', 'type': 'DERIVED', 'citation': 'Serracant A, Serra-Aracil X, Mora-Lopez L, Pallisera-Lloveras A, Serra-Pla S, Zarate-Pinedo A, Navarro-Soto S. The Effectiveness of Contralateral Drainage in Reducing Superficial Incisional Surgical Site Infection in Loop Ileostomy Closure: Prospective, Randomized Controlled Trial. World J Surg. 2019 Jul;43(7):1692-1699. doi: 10.1007/s00268-019-04972-6.'}]}, 'descriptionModule': {'briefSummary': '1. Introduction:\n\n The most common complication of loop ileostomies closure for rectal cancer patients undergoing a low anterior rectum resection, is the superficial surgical site infection (incidence 2-40%). There are various techniques related to closing loop ileostomy. In a retrospective study at our center, the investigators objectify that superficial surgical site infection rate was reduced by more than a half by the application of a contralateral drainage (Penrose ®) in primary loop ileostomy closure.\n2. Objectives and Hypothesis:\n\n Hypothesis: The application of a contralateral drainage (Penrose ®) in primary loop ileostomy closure (in carriers of loop ileostomy by a low anterior rectum resection for rectal cancer) reduces the superficial surgical site infection.\n\n Main objective: To reduce the rate of superficial surgical site infection by the application of a contralateral drainage (Penrose ®) in surgical wound of primary loop ileostomy closure.\n3. Methodology:\n\nProspective and randomized clinical trial on the effectiveness of contralateral Penrose® drainage implementation in those patients that have a primary loop ileostomy (by low anterior rectum resection) closure to be able to know if the investigators can reduce the superficial surgical site infection rate. Monitorization until 30 days after surgery', 'detailedDescription': '1. Introduction:\n\n The most common complication of loop ileostomies closure for rectal cancer patients undergoing a low anterior rectum resection, is the superficial surgical site infection (incidence 2-40%). In the literature there are various techniques related to closing loop ileostomy that try to reduce the rate of infections recorded. In a retrospective study at our center, the investigators objectify that superficial surgical site infection rate was reduced by more than a half by the application of a contralateral drainage (Penrose ®) in primary loop ileostomy closure.\n2. Objectives and Hypothesis:\n\n Hypothesis: The application of a contralateral drainage (Penrose ®) in primary loop ileostomy closure (in carriers of loop ileostomy by a low anterior rectum resection for rectal cancer) reduces the superficial surgical site infection.\n\n Main objective: To reduce the rate of superficial surgical site infection by the application of a contralateral drainage (Penrose ®) in surgical wound of primary loop ileostomy closure.\n\n Secondary objectives:\n * Identify risk factors associated with superficial surgical site infection in relation to a primary loop ileostomy closure (with or without drainage).\n * Reducing hospital stay and care at home.\n3. Methodology:\n\nProspective and randomized clinical trial on the effectiveness of contralateral Penrose® drainage implementation in those patients that have a primary loop ileostomy (by low anterior rectum resection) closure to be able to know if the investigators can reduce the superficial surgical site infection rate.\n\nIt will be used a simple randomization. To assess the occurrence of superficial incisional infection, the investigators will be monitoring patients till 30 days after surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient carrying loop ileostomy due to low anterior resection for rectal cancer.\n* Over 18 years.\n* Surgery scheduled.\n* Informed consent signed.\n\nExclusion Criteria:\n\nPatients with terminal ileostomy.\n\n* Patients with loop ileostomy different from any surgery of rectal cancer.\n* To require another surgical procedure added.\n* Urgent surgery.\n* Patient refusal to participate in the study.'}, 'identificationModule': {'nctId': 'NCT02574702', 'briefTitle': 'Trial to Reduce Wound Infection With Contralateral Drainage in Loop Ileostomy Closure', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': 'Prospective Randomized Controlled Trial to Reduce the Superficial Surgical Site Infection Due to a Contralateral Drainage Application in Loop Ileostomy Closure', 'orgStudyIdInfo': {'id': 'ILEOS-ISS_2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Patients with primary loop ileostomy closure without drainage of the surgical wound'}, {'type': 'EXPERIMENTAL', 'label': 'Drainage Group', 'description': 'Patients with the application of a contralateral drainage (Penrose ®) in surgical wound of primary loop ileostomy closure.\n\nIntervention: application of a contralateral drainage in surgical wound closure.', 'interventionNames': ['Procedure: application of a contralateral drainage (Penrose ® device)']}], 'interventions': [{'name': 'application of a contralateral drainage (Penrose ® device)', 'type': 'PROCEDURE', 'description': 'application of a contralateral drainage (Penrose ®) in surgical wound of primary loop ileostomy closure', 'armGroupLabels': ['Drainage Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitario Parc Tauli de Sabadell', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}], 'overallOfficials': [{'name': 'Xavier Serra-Aracil, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Parc Tauli de Sabadell'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Xavier Serra-Aracil', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}