Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-02-23 @ 4:54 AM
Study NCT ID:
NCT01670851
Status:
COMPLETED
Last Update Posted:
2015-12-08
First Post:
2012-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perineal Reconstruction Following eLAPE and Simultaneous Stoma Sublay Reinforcement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-07', 'studyFirstSubmitDate': '2012-08-19', 'studyFirstSubmitQcDate': '2012-08-21', 'lastUpdatePostDateStruct': {'date': '2015-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perineal wound healing', 'timeFrame': '12 months', 'description': 'Perineal wound healing will be assessed using the Southamptom Wound Scoring System and perineal pain assessed using a visual analogue scale (VAS) daily during hospital stay and then POD 7, 30 and months 3, 6 and 12.'}], 'secondaryOutcomes': [{'measure': 'Incidence of perineal herniation', 'timeFrame': '24 months', 'description': 'Incidence of perineal hernia'}, {'measure': 'Incidence of parastomal hernia', 'timeFrame': '24 months', 'description': 'Stoma will be assessed for herniation at Months 3, 6, 12 and 24'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['eLAPE,', 'perineum,', 'pelvic floor reconstruction'], 'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multicenter, single arm, observational pilot study to assess the clinical outcomes of Strattice Reconstructive Tissue Matrix for perineal reconstruction following eLAPE and simultaneous stoma reinforcement.', 'detailedDescription': 'About 40 subjects will be enrolled from 4 centers over approx 24 months. Subjects will all be undergoing extralevator abdominoperineal excision with concomitant ostomy creation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with low rectal carcinoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary cancers undergoing curative surgery (R0)\n* Life expectancy \\> 2 yrs\n* Neoadjuvant radiotherapy with or without chemotherapy\n\nExclusion Criteria:\n\n* Pelvic extenteration or extended resections\n* Previously irradiated patients (i.e. radiation therapy for a previous cancer)\n* Co-morbidities of: systemic infection, chronic liver failure, chronic renal failure, HIV, Hepatitis C, other advanced/metastatic cancer, collagen disorder\n* sensitivity to porcine derived products or polysorbate'}, 'identificationModule': {'nctId': 'NCT01670851', 'acronym': 'PRESSUR', 'briefTitle': 'Perineal Reconstruction Following eLAPE and Simultaneous Stoma Sublay Reinforcement', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals, Leicester'}, 'officialTitle': 'Perineal Reconstruction Following Extralevator Abdominoperineal Excision of Rectum and Simultaneous Stoma Sublay Reinforcement', 'orgStudyIdInfo': {'id': 'ISIS.11.01.06.BS/SC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Strattice', 'description': 'eLAPE', 'interventionNames': ['Device: Strattice']}], 'interventions': [{'name': 'Strattice', 'type': 'DEVICE', 'description': 'Perineal reconstruction and stoma reinforcement with Strattice', 'armGroupLabels': ['Strattice']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Slagelse', 'country': 'Denmark', 'facility': 'Slagelse Hospital', 'geoPoint': {'lat': 55.40276, 'lon': 11.35459}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': 'LE5 4PW', 'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'University Hospitals Leicester', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}], 'overallOfficials': [{'name': 'Baljit Singh, FRCS, FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Leicester, UK'}, {'name': 'Sanjay Chaudhri, FRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Leicester, UK'}, {'name': 'Per J Nilsson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}, {'name': 'Pierre J Maina, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Slagelse Hospital, Denmark'}, {'name': 'W Bemelman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Academic Medical Center, Amsterdam, Netherlands'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals, Leicester', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska University Hospital', 'class': 'OTHER'}, {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, {'name': 'Slagelse Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}