Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2026-03-02 @ 4:49 PM
Study NCT ID:
NCT02855333
Status:
COMPLETED
Last Update Posted:
2016-08-04
First Post:
2016-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility, Safety and QoL After Merendino Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-03', 'studyFirstSubmitDate': '2016-07-13', 'studyFirstSubmitQcDate': '2016-08-03', 'lastUpdatePostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life (QoL)', 'timeFrame': 'up to 10 years after surgery', 'description': 'EORTC QLQ-C30 and QLQ-OES24 questionnaire (global health status item, functional and symptom scale items)'}], 'secondaryOutcomes': [{'measure': 'Intraoperative complications', 'timeFrame': 'up to 1 day after surgery', 'description': 'Blood loss (ml), requirement for blood transfusion (units), operation time (min)'}, {'measure': 'Postoperative complications', 'timeFrame': 'up to 100 days after surgery', 'description': 'Morbidity (re-intervention rate, re-operation rate), in-hospital mortality'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Merendino procedure', 'Feasibility, Safety and QoL of the Merendino procedure'], 'conditions': ['Benign or Early Malignant Lesion of the Distal Esophagus or Gastro-esophageal Junction Requiring Surgical Resection']}, 'referencesModule': {'references': [{'pmid': '25189438', 'type': 'BACKGROUND', 'citation': "Zapletal C, Lorenz D. Quality of life after surgical treatment of early Barrett's cancer: a prospective comparison of the Ivor-Lewis resection versus the modified Merendino resection. A statistical hint: reply. World J Surg. 2014 Nov;38(11):3034. doi: 10.1007/s00268-014-2723-8. No abstract available."}, {'pmid': '25123190', 'type': 'BACKGROUND', 'citation': "Gotzky K, Jahne J. [Quality of life after operation for early Barrett's cancer: a prospective comparison of Ivor Lewis resection versus modified Merendino resection]. Chirurg. 2014 Sep;85(9):822. doi: 10.1007/s00104-014-2856-1. No abstract available. German."}, {'pmid': '24791672', 'type': 'BACKGROUND', 'citation': "Mangano A, Lianos GD, Rausei S, Boni L, Dionigi G. Quality of life after surgical treatment of early Barrett's cancer: a prospective comparison of the Ivor-Lewis resection versus the modified Merendino resection. A statistical hint. World J Surg. 2014 Nov;38(11):3033. doi: 10.1007/s00268-014-2624-x. No abstract available."}, {'pmid': '24378548', 'type': 'BACKGROUND', 'citation': "Zapletal Ch, Heesen Ch, Origer J, Pauthner M, Pech O, Ell Ch, Lorenz D. Quality of life after surgical treatment of early Barrett's cancer: a prospective comparison of the Ivor-Lewis resection versus the modified Merendino resection. World J Surg. 2014 Jun;38(6):1444-52. doi: 10.1007/s00268-013-2410-1."}, {'pmid': '18989696', 'type': 'BACKGROUND', 'citation': "Holscher AH, Vallbohmer D, Gutschow C, Bollschweiler E. Reflux esophagitis, high-grade neoplasia, and early Barrett's carcinoma-what is the place of the Merendino procedure? Langenbecks Arch Surg. 2009 May;394(3):417-24. doi: 10.1007/s00423-008-0429-9. Epub 2008 Nov 7."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to analyse retrospectively the early postoperative and functional outcome of patients (pts) after Merendino procedure for benign or early malignant lesions of the distal part of the esophagus or the gastroesophageal junction.', 'detailedDescription': "Between 2004 and 2013, 14 pts had transhiatal resection of median 8 (6-10) cm of distal esophagus including the gastroesophageal junction. Locoregional lymphadenectomy was performed in all patients with (suspected) early adenocarcinoma. In case of vagus nerve resection, pyloromyectomy and cholecystectomy were done. A pediculated isoperistaltic jejunal segment of 15-18 cm length was interponed between esophageal stump and remaining stomach by end-to-side anastomoses. At least one postoperative contrast examination of the anastomoses was done in all pts. Quality of life was assessed by using the EORTC QLQ-OES18 survey, recording patients' general activity and condition and specific gastrointestinal symptoms."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who underwent Merendino procedure between 08/2004 and 02/2013 at the Kantonal Hospital of Baselland, Liestal (Switzerland) were included into the Merendino (MER) group. Considering indication for surgery, age, ASA score, and co-morbidities, patients who underwent gastrectomy during the same period were matched for control (CON) group.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* alive\n* MER or CON procedure\n* informed consent\n* CON patients were matched according to diagnosis, Age and ASA score\n\nExclusion Criteria:\n\n* withdrawal of informed consent\n* legal incapacity\n* limitations in mental state or medical condition precluding questioning (only QoL data)'}, 'identificationModule': {'nctId': 'NCT02855333', 'acronym': 'MER', 'briefTitle': 'Feasibility, Safety and QoL After Merendino Procedure', 'organization': {'class': 'OTHER', 'fullName': 'Kantonsspital Liestal'}, 'officialTitle': 'The Merendino Procedure for Benign or Early Malignant Lesions of the Distal Esophagus/Gastroesophageal Junction is Feasible, Safe and Provides Good QoL', 'orgStudyIdInfo': {'id': 'KLiestal'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Merendino Group (MER)', 'description': 'Patients who underwent merendino procedure for benign or early malignant lesions of the distal esophagus/gastroesophageal junction Perioperative data and EORTC and QLQ-C30 / QLQ-OES24 questionnaire', 'interventionNames': ['Other: EORTC and QLQ-C30 / QLQ-OES24 questionnaire']}, {'label': 'Control Group (CON)', 'description': 'Patients who underwent alternative surgery for benign or early malignant lesions of the distal esophagus/gastroesophageal junction Perioperative data and EORTC and QLQ-C30 / QLQ-OES24 questionnaire', 'interventionNames': ['Other: EORTC and QLQ-C30 / QLQ-OES24 questionnaire']}], 'interventions': [{'name': 'EORTC and QLQ-C30 / QLQ-OES24 questionnaire', 'type': 'OTHER', 'description': 'EORTC and QLQ-C30 / QLQ-OES24 questionnaire was sent to patients to asses QoL after MER or CON procedure', 'armGroupLabels': ['Control Group (CON)', 'Merendino Group (MER)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4410', 'city': 'Liestal', 'state': 'Basel-Landschaft', 'country': 'Switzerland', 'facility': 'Kantonsspital Baselland, Liestal', 'geoPoint': {'lat': 47.48455, 'lon': 7.73446}}], 'overallOfficials': [{'name': 'Christoph A Maurer, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hirslanden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kantonsspital Liestal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}