Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-01-09 @ 6:01 AM
Study NCT ID:
NCT07064694
Status:
COMPLETED
Last Update Posted:
2025-07-17
First Post:
2025-07-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HyPER - Hybrid Parastomal Endoscopic Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006547', 'term': 'Hernia'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2025-07-05', 'studyFirstSubmitQcDate': '2025-07-05', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence rate of parastomal hernia', 'timeFrame': 'Up to 10 years postoperatively (mean follow-up 61 months)', 'description': 'Proportion of patients with clinically or radiologically confirmed recurrence of parastomal hernia following the HyPER procedure, as assessed during routine follow-up.'}], 'secondaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': 'Within 30 days postoperatively', 'description': 'Incidence of postoperative complications such as wound infections, seromas, bowel injury, and stoma-related issues requiring medical or surgical management.'}, {'measure': 'Patient-reported quality of life', 'timeFrame': 'Baseline and last follow-up (up to 10 years)', 'description': 'Patient-reported outcomes assessed using the Visual Analog Scale for Quality of Life (VAS-QoL), a 10-point scale ranging from 0 (worst possible health state) to 10 (best possible health state). Higher scores indicate improved physical comfort and psychosocial well-being. Preoperative and postoperative scores were collected during follow-up visits and compared.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HyPER', 'parastomal hernia', 'abdominal wall surgery', 'Hernioplasty', 'Hernia'], 'conditions': ['Parastomal Hernia']}, 'referencesModule': {'references': [{'pmid': '39123085', 'type': 'BACKGROUND', 'citation': 'Szczepkowski M, Zamkowski M, Alicja S, Piotr W, Smietanski M. Evaluating EHS parastomal hernia classification for surgical planning: a retrospective analysis of 160 consecutive cases in a single center. Hernia. 2024 Oct;28(5):1915-1923. doi: 10.1007/s10029-024-03121-w. Epub 2024 Aug 10.'}, {'pmid': '38593041', 'type': 'BACKGROUND', 'citation': 'Szczepkowski M, Przywozka-Suwala A, Ziolkowski B, Witkowski P, Perea J. Hybrid parastomal hernia endoscopic repair (HyPER): novel approach to parastomal hernia surgery. Br J Surg. 2024 Apr 3;111(4):znae092. doi: 10.1093/bjs/znae092. No abstract available.'}, {'pmid': '25960785', 'type': 'BACKGROUND', 'citation': 'Szczepkowski M, Skoneczny P, Przywozka A, Czyzewski P, Bury K. New minimally invasive technique of parastomal hernia repair - methods and review. Wideochir Inne Tech Maloinwazyjne. 2015 Apr;10(1):1-7. doi: 10.5114/wiitm.2015.50052. Epub 2015 Apr 14.'}, {'pmid': '24081460', 'type': 'BACKGROUND', 'citation': 'Smietanski M, Szczepkowski M, Alexandre JA, Berger D, Bury K, Conze J, Hansson B, Janes A, Miserez M, Mandala V, Montgomery A, Morales Conde S, Muysoms F. European Hernia Society classification of parastomal hernias. Hernia. 2014 Feb;18(1):1-6. doi: 10.1007/s10029-013-1162-z. Epub 2013 Oct 1.'}, {'pmid': '29134456', 'type': 'BACKGROUND', 'citation': 'Antoniou SA, Agresta F, Garcia Alamino JM, Berger D, Berrevoet F, Brandsma HT, Bury K, Conze J, Cuccurullo D, Dietz UA, Fortelny RH, Frei-Lanter C, Hansson B, Helgstrand F, Hotouras A, Janes A, Kroese LF, Lambrecht JR, Kyle-Leinhase I, Lopez-Cano M, Maggiori L, Mandala V, Miserez M, Montgomery A, Morales-Conde S, Prudhomme M, Rautio T, Smart N, Smietanski M, Szczepkowski M, Stabilini C, Muysoms FE. European Hernia Society guidelines on prevention and treatment of parastomal hernias. Hernia. 2018 Feb;22(1):183-198. doi: 10.1007/s10029-017-1697-5. Epub 2017 Nov 13.'}]}, 'descriptionModule': {'briefSummary': 'Retrospective single-center study analyzing long-term outcomes of Hybrid Parastomal Endoscopic Repair (HyPER) in 200 patients with symptomatic parastomal hernias, including recurrence, complications, and quality of life.', 'detailedDescription': 'This is a retrospective, single-center observational study evaluating surgical management of symptomatic parastomal hernias using a standardized Hybrid Parastomal Endoscopic Repair (HyPER) technique. The HyPER method integrates laparoscopic and open approaches to enable comprehensive dissection, mesh reinforcement, and anatomical correction, including stoma relocation and soft tissue reconstruction when indicated.\n\nAll patients were classified preoperatively according to the European Hernia Society (EHS) classification. The procedure included laparoscopic adhesiolysis, open excision of the hernia sac, and laparoscopic intraperitoneal mesh fixation. A synthetic mesh (typically DynaMesh-IPST®) was used in most cases. In selected patients, a cost-effective alternative mesh was applied using a technique referred to as the "Baldachin modification," with an omental flap interposed to prevent adhesions.\n\nThe study included adult patients with symptomatic parastomal hernias who underwent elective surgery at a tertiary referral center for abdominal wall reconstruction. Exclusion criteria involved disseminated malignancy, contraindications to laparoscopy, and severely limited life expectancy. Patients were followed up in a dedicated outpatient setting with regular clinical and imaging assessments.\n\nThe aim of this study was to evaluate feasibility, safety, and the potential for broad implementation of the HyPER technique in the surgical treatment of parastomal hernias.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Disseminated malignancy\n* Contraindications to laparoscopy\n* Severely limited life expectancy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Symptomatic parastomal hernia requiring surgical intervention\n* Eligibility for elective surgery\n* Preoperative classification using the European Hernia Society (EHS) system\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07064694', 'acronym': 'HyPER', 'briefTitle': 'HyPER - Hybrid Parastomal Endoscopic Repair', 'organization': {'class': 'OTHER', 'fullName': 'Swissmed Hospital'}, 'officialTitle': 'Hybrid Parastomal Endoscopic Repair (HyPER): Ten-Year Experience and Lessons Learned From a Single-Center Cohort of 200 Patients', 'orgStudyIdInfo': {'id': 'HyPER-200'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HyPER Procedure', 'description': 'Combined laparoscopic and open surgical technique for parastomal hernia repair, including adhesiolysis, sac excision, mesh implantation, and stoma relocation if needed.', 'interventionNames': ['Procedure: Hybrid Parastomal Endoscopic Repair (HyPER)']}], 'interventions': [{'name': 'Hybrid Parastomal Endoscopic Repair (HyPER)', 'type': 'PROCEDURE', 'description': 'Combined laparoscopic and open surgical approach involving adhesiolysis, hernia sac excision, intraperitoneal mesh fixation, and stoma revision or relocation as indicated. Standard mesh used was DynaMesh-IPST®; in selected cases, a cost-effective modification with macroporous polypropylene mesh and omental interposition was applied.', 'armGroupLabels': ['HyPER Procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01-809', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Bielański Hospital', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}]}, 'ipdSharingStatementModule': {'timeFrame': 'Beginning 6 months after publication; available for 5 years.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) that underlie the results reported in this study (including text, tables, and figures) will be made available upon reasonable request to qualified researchers whose proposed use of the data has been approved by the study team and the institutional ethics board. Data will be shared for the purpose of academic, non-commercial research only. Interested investigators should contact the corresponding author by email.', 'accessCriteria': 'Access will be granted following review and approval of a research proposal and execution of a data use agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swissmed Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical University of Gdansk', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}