Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-28 @ 12:07 AM
Study NCT ID:
NCT06800534
Status:
RECRUITING
Last Update Posted:
2025-01-30
First Post:
2025-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perineal and Abdominal Reconstruction: a Comparison of Reconstructive Methodologies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2025-01-09', 'studyFirstSubmitQcDate': '2025-01-28', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical Success', 'timeFrame': 'From the first patient enrolled to the 50th patient, an average of 2 years', 'description': 'Technical success is assessed by the number of reinterventions after 1 year from the treatment and the number of major complications.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgery']}, 'descriptionModule': {'briefSummary': 'The different reconstructive methods (V-Y flap, lotus flap, gracilis muscle flap, TRAM flap) will be compared with the complications that occurred following the surgery, so as to define which reconstructive methods have led to fewer complications and in which categories of patients.', 'detailedDescription': 'he study is of a non-interventional observational nature. It involves the collection of patient data in pseudonymous form from preoperative and postoperative assessments in accordance with daily clinical practice and normally performed for proper patient management.\n\nThe data recorded in the study are obtained from the medical records of patients who are normally accessed by the doctors of the operating unit during daily practice.\n\nAfter having performed a meticulous collection of the basic data of the patients (gender, age, remote pathological history, recent pathological history, type of demolitive and reconstructive surgery performed), the different reconstructive methods (V-Y flap, lotus flap, gracilis muscle flap, TRAM flap) will be compared with the complications that occurred following the surgery, so as to define which reconstructive methods have led to fewer complications and in which categories of patients.\n\nThe complications are assessed through the retrospective analysis of the outpatient reports that are normally drawn up during the usual follow-up outpatient visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patient population consists of subjects affected by rectal or vulvar neoplasia or chronic inflammatory bowel disease and subjected to demolition surgery at the General Surgery Unit of the IRCCS Azienda Ospedaliero-Universitaria di Bologna and related reconstruction (performed by the Plastic Surgery Unit of the IRCCS Azienda Ospedaliero-Universitaria di Bologna) in the period between 01/01/2011 and 31/12/2021.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing pelvic-perineal amputations for oncological disease or chronic inflammatory diseases whose surgical treatment required the collaboration of the plastic surgeon\n* Patients with complications in the abdominal or pelvic-perineal region of surgical relevance and requiring reconstruction (enteric fistulas, abdominal wall defects)\n* Age greater than or equal to 18 years\n* Acquisition of written informed consent\n\nExclusion Criteria:\n\n* Incomplete or missing data.'}, 'identificationModule': {'nctId': 'NCT06800534', 'acronym': 'PLAST-GEN-1', 'briefTitle': 'Perineal and Abdominal Reconstruction: a Comparison of Reconstructive Methodologies', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Perineal and Abdominal Reconstruction: a Comparison of Reconstructive Methodologies', 'orgStudyIdInfo': {'id': 'PLAST-GEN-1'}}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marco Pignatti, MD', 'role': 'CONTACT', 'email': 'marco.pignatti@unibo.it', 'phone': '+390512143614'}], 'facility': "IRCCS AOU di Bologna Policlinico di Sant'Orsola", 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Marco Pignatti, MD', 'role': 'CONTACT', 'email': 'marco.pignatti@unibo.it', 'phone': '+390512143614'}], 'overallOfficials': [{'name': 'Marco Pignatti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}