Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-27 @ 5:39 AM
Study NCT ID:
NCT01321294
Status:
COMPLETED
Last Update Posted:
2011-03-23
First Post:
2011-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Nissen Versus Toupet Fundoplication: Objective and Subjective Results of a Prospective Randomized Trial
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'lastUpdateSubmitDate': '2011-03-22', 'studyFirstSubmitDate': '2011-03-21', 'studyFirstSubmitQcDate': '2011-03-22', 'lastUpdatePostDateStruct': {'date': '2011-03-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-23', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Gastroesophageal Reflux Disease', 'Laparoscopic Antireflux Surgery']}, 'referencesModule': {'references': [{'pmid': '23361260', 'type': 'DERIVED', 'citation': 'Koch OO, Kaindlstorfer A, Antoniou SA, Luketina RR, Emmanuel K, Pointner R. Comparison of results from a randomized trial 1 year after laparoscopic Nissen and Toupet fundoplications. Surg Endosc. 2013 Jul;27(7):2383-90. doi: 10.1007/s00464-013-2803-0. Epub 2013 Jan 30.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare subjective and objective outcome and surgical "side effects" of Nissen and Toupet fundoplication performed in a single institution by only two surgeons and to compare pre and postoperative findings to healthy individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of gastroesophageal reflux disease\n* Long history of GERD symptoms\n* Persistent or recurrent symptoms despite optimal medical treatment\n* Persistent or recurrent complications of GERD\n* Reduced quality of life owing to increasing esophageal exposure to gastric juice\n* Pathological values in the preoperative evaluated functional parameters\n\nExclusion Criteria:\n\n* Previous esophageal or gastric surgery\n* Poor physical status (American Society of Anesthesiologists (ASA) scores III and IV)\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01321294', 'briefTitle': 'Laparoscopic Nissen Versus Toupet Fundoplication: Objective and Subjective Results of a Prospective Randomized Trial', 'organization': {'class': 'OTHER', 'fullName': 'General Public Hospital Zell am See'}, 'orgStudyIdInfo': {'id': 'Zell01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nissen fundoplication', 'interventionNames': ['Procedure: laparoscopic anti-reflux surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Toupet fundoplication', 'interventionNames': ['Procedure: laparoscopic anti-reflux surgery']}], 'interventions': [{'name': 'laparoscopic anti-reflux surgery', 'type': 'PROCEDURE', 'armGroupLabels': ['Nissen fundoplication', 'Toupet fundoplication']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5700', 'city': 'Zell am See', 'state': 'Salzburg', 'country': 'Austria', 'facility': 'General Public Hospital Zell am See', 'geoPoint': {'lat': 47.32306, 'lon': 12.79839}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Public Hospital Zell am See', 'class': 'OTHER'}}}}