Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-03-06 @ 9:21 AM
Study NCT ID:
NCT04109105
Status:
UNKNOWN
Last Update Posted:
2019-10-02
First Post:
2019-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study for the Efficacy and Security Analysis in the Protection of Ileocolic Anastomosis Conducted in Laparoscopic Right Hemicolectomy Because of Colon Cancer, Using a NHS-PEG Coated Collagen Patch.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D057868', 'term': 'Anastomotic Leak'}], '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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-30', 'studyFirstSubmitDate': '2019-09-27', 'studyFirstSubmitQcDate': '2019-09-27', 'lastUpdatePostDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness and security analysis in the prevention of anastomosis leakage through the protection of ileocolic anastomosis with NHS-PEG coated collagen patch.', 'timeFrame': 'Up to 30 days after the surgery', 'description': 'Ileocolic anastomosis leakage existence of evidence and seriousness.'}], 'secondaryOutcomes': [{'measure': 'Analysis of the percentage of leaks in the ileocolic anastomosis reinforced with NHS-PEG coated collagen patch.', 'timeFrame': 'Up to 30 days after the surgery', 'description': 'Percentage of leaks that occur in the ileocolic anastomosis after being reinforced with NHS-PEG coated collagen patch.'}, {'measure': 'Number of complications related to anastomotic leakage in patients with ileocolic anastomosis reinforced with NHS-PEG coated collagen patch.', 'timeFrame': 'Up to 30 days after the surgery', 'description': 'Number and type of complications due to the anastomotic leakage in patients with ileocolic anastomosis reinforced with NHS-PEG coated collagen patch.'}, {'measure': 'Number of surgical repetitions.', 'timeFrame': 'Up to 30 days after the surgery', 'description': 'Number of following surgeries that the patient has to undergo due to the failure of the collagen patch ileocolic anastomosis protection.'}, {'measure': 'Number of hospital readmissions.', 'timeFrame': 'Up to 30 days after the surgery', 'description': 'Number of times that the patient has to be rehospitalized due to the failure of the collagen patch ileocolic anastomosis protection.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colon neoplasia', 'Ascendant colon', 'Surgical anastomosis', 'Anastomotic leak', 'Collagen', 'Polyethylene glycol', 'Hemopatch'], 'conditions': ['Adenocarcinoma Colon']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to analyse the effectiveness and security in the prevention of anastomotic leakage by protecting the ileocolic anastomosis with a reabsorbable NHS-PEG collagen patch.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing a programmed right laparoscopic hemicolectomy for right colon adenocarcinoma with curative intention at the Virgen Macarena University Hospital during the necessary period of time to achieve the proposed number of patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years old.\n* Ability to understand and make their own decision to participate in the study.\n* Pre-surgery right colon adenocarcinoma pathological diagnosis.\n* Patient with a mechanic, intra or extracorporeal ileocolic anastomosis.\n\nExclusion Criteria:\n\n* Urgent intervention.\n* Simultaneous colon cancer.\n* M1 pre-surgery staging.'}, 'identificationModule': {'nctId': 'NCT04109105', 'acronym': 'ANASTOPATCH', 'briefTitle': 'Study for the Efficacy and Security Analysis in the Protection of Ileocolic Anastomosis Conducted in Laparoscopic Right Hemicolectomy Because of Colon Cancer, Using a NHS-PEG Coated Collagen Patch.', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Pública Andaluza para la gestión de la Investigación en Sevilla'}, 'officialTitle': 'Prospective Pilot Study for the Efficacy and Security Analysis in the Protection of Ileocolic Anastomosis Conducted in Laparoscopic Right Hemicolectomy Because of Colon Cancer, Using a Using a NHS-PEG (N-hydroxysuccinimide Functionalized Polyethylene Glycol) Coated Collagen Patch.', 'orgStudyIdInfo': {'id': 'FIS-HEMOPATCH-2018-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NHS-PEG coated collagen patch cohort', 'description': 'Patients diagnosed of colon adenocarcinoma that have ileocolic anastomosis after undergoing a laparoscopic right hemicolectomy surgery.', 'interventionNames': ['Other: NHS-PEG coated collagen patch']}], 'interventions': [{'name': 'NHS-PEG coated collagen patch', 'type': 'OTHER', 'otherNames': ['Hemopatch'], 'description': 'Analysis of the number and seriousness of leaks in the ileocolic anastomosis after using a NHS-PEG coated collagen patch reinforcement.', 'armGroupLabels': ['NHS-PEG coated collagen patch cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41009', 'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan Carlos Gómez Rosado', 'role': 'CONTACT', 'email': 'juanc.gomez.rosado.sspa@juntadeandalucia.es', 'phone': '955 00 80 00'}], 'facility': 'Hospital Universitario Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'centralContacts': [{'name': 'Juan Carlos Gómez Rosado', 'role': 'CONTACT', 'email': 'juanc.gomez.rosado.sspa@juntadeandalucia.es', 'phone': '955 00 80 00'}], 'overallOfficials': [{'name': 'Juan Carlos Gómez Rosado', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Virgen Macarena'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Pública Andaluza para la gestión de la Investigación en Sevilla', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}