Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-28 @ 6:24 PM
Study NCT ID:
NCT00382850
Status:
COMPLETED
Last Update Posted:
2018-08-01
First Post:
2006-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial Comparing Open and Laparoscopic Nissen Fundoplication in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018662', 'term': 'Fundoplication'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2010-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-30', 'studyFirstSubmitDate': '2006-09-29', 'studyFirstSubmitQcDate': '2006-09-29', 'lastUpdatePostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative length of stay', 'timeFrame': '0 to 14days', 'description': 'days in hospital'}, {'measure': 'postoperative narcotic pain medication requirements', 'timeFrame': '0 to 14 days', 'description': 'days requiring narcotics for pain relief'}, {'measure': 'length of time to tolerating full feeds prior to discharge', 'timeFrame': '0 to 7 days', 'description': 'days after surgery before feeding begins'}], 'secondaryOutcomes': [{'measure': 'intraoperative complication rates', 'timeFrame': 'duration of procedure', 'description': 'complications of procedure'}, {'measure': 'wrap failure and need for subsequent reoperation', 'timeFrame': 'up to 2 yrs', 'description': 'operative failure'}, {'measure': 'need for continued medical therapy for GER', 'timeFrame': 'up to 2 yrs', 'description': 'symptomatic reflux requiring medication'}, {'measure': 'death', 'timeFrame': 'up to 2 years', 'description': 'death'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nissen fundoplication', 'gastroesophageal reflux'], 'conditions': ['Gastroesophageal Reflux']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether short- and long-term outcomes are different between open and laparoscopic Nissen fundoplication performed in children younger than 2 years of age.', 'detailedDescription': 'Nissen fundoplication is a commonly performed procedure in infants and children with gastroesophageal reflux and a variety of other medical conditions including respiratory compromise, severe neurologic impairment, failure to thrive and swallowing dysfunction. Randomized controlled trials in adults have shown that laparoscopic fundoplication is a safe procedure that results in lower morbidity, shorter hospital length of stay and similar 5-year recurrence rates when compared to an open procedure. The aim of this study is to compare laparoscopic and open Nissen fundoplication in children less than 2 years of age.\n\nChildren younger than 2 years of age presenting for Nissen fundoplication will be randomized to either a laparoscopic or an open procedure. Patients who have already undergone anti-reflux surgery or whose hospitalization is anticipated to be prolonged by an unrelated illness will be excluded. All procedures will be performed at a single institution by two surgeons who will perform both the open and laparoscopic procedures.\n\nA total of 68 patients will be needed (34 in each group) to detect a 20% difference in length of stay at a significance level of p \\< 0.05 and power of 80%. Patients will be followed for up to 2 years postoperatively. Variables to be compared between the two groups will include age, gender, presence of neurologic impairment, presence and specification of any congenital abnormalities, total operative time, total dose of narcotic analgesia required, postoperative day on which the patient tolerated full feedings, postoperative and total lengths of stay as well as the occurrence of postoperative complications (including wound infection and the need for immediate reoperation). The primary outcomes analyzed will be length of stay and amount of narcotic analgesia required. Longer-term outcomes including persistent GERD, wrap failure and need for reoperation within 24 months of the initial procedure also will be determined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical or radiographic diagnosis of gastroesophageal reflux\n* age less than 2 years (24 months) at the time of surgery\n\nExclusion Criteria:\n\n* prior fundoplication procedure\n* concomitant need for an intraabdominal procedure (except gastrostomy tube placement)\n* esophageal dysmotility\n* hospitalization expected to be prolonged due to a concurrent illness actively being treated (e.g. congenital heart disease requiring surgical repair during the same hospitalization)'}, 'identificationModule': {'nctId': 'NCT00382850', 'briefTitle': 'Clinical Trial Comparing Open and Laparoscopic Nissen Fundoplication in Children', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Randomized Controlled Trial of Laparoscopic Compared to Open Nissen Fundoplication in Children Younger Than 2 Years of Age', 'orgStudyIdInfo': {'id': '05-08-01-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'open nissen fundoplication', 'description': 'open repair through surgical midline incision', 'interventionNames': ['Procedure: Nissen fundoplication']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'laparoscopic nissen fundoplication', 'description': 'use of laparoscope to do repair', 'interventionNames': ['Procedure: Nissen fundoplication']}], 'interventions': [{'name': 'Nissen fundoplication', 'type': 'PROCEDURE', 'armGroupLabels': ['laparoscopic nissen fundoplication', 'open nissen fundoplication']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Paul M Colombani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}