Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-29 @ 5:56 AM
Study NCT ID:
NCT07094594
Status:
COMPLETED
Last Update Posted:
2025-08-03
First Post:
2025-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ARES Trial: Approach to Resection and Evaluation in Severe Diverticulitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043963', 'term': 'Diverticulosis, Colonic'}], 'ancestors': [{'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 578}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2025-07-22', 'studyFirstSubmitQcDate': '2025-07-29', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ostomy closure', 'timeFrame': '24 mounths', 'description': 'The primary endpoint was ostomy closure within 24 months, defined as the successful reversal of the stoma. This outcome was chosen as a measure of complete care, reflecting the restoration of bowel continuity and functionality.'}], 'secondaryOutcomes': [{'measure': 'Quality of life, assessed using validated tools such as the SF-36', 'timeFrame': '24 months', 'description': 'Quality of life will be evaluated using the Short Form Health Survey (SF-36), a validated questionnaire assessing physical and mental health. The SF-36 score ranges from 0 to 100, with higher scores indicating better quality of life across its domains (physical functioning, role limitations, pain, general health, vitality, social functioning, and mental health).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diverticular disease of colon', 'Hartmann', 'loop ileostomies'], 'conditions': ['Diverticular Disease of Colon', 'Colostomy - Stoma', 'Loop Ileostomies']}, 'descriptionModule': {'briefSummary': 'This observational study was conducted across five surgical centers in Italy, including both academic and community hospitals, from January 2017 to December 2022. The study aimed to evaluate outcomes in patients with acute perforated sigmoid diverticulitis classified as Hinchey Stage III or IV. All consecutive patients aged 18 years or older who presented with acute perforated sigmoid diverticulitis and underwent emergency colonic resection were included. Patients were excluded if they had Hinchey Stage I or II diverticulitis, postoperative confirmation of malignancy, or underwent laparoscopic surgery. This approach ensured a well-defined patient cohort for consistent and reliable analysis.', 'detailedDescription': "This multicenter, prospective observational study evaluated clinical outcomes in adult patients with acute perforated sigmoid diverticulitis classified as Hinchey Stage III or IV, who underwent emergency open colonic resection in five surgical centers in Italy. The study period extended from January 2017 to December 2022 and involved both academic and community hospitals, providing a representative overview of real-world surgical practice.\n\nAll consecutive patients aged 18 years or older with a clinical and radiological diagnosis of Hinchey III-IV perforated sigmoid diverticulitis were considered for inclusion. Eligible patients were required to be clinically stable at presentation, enabling them to undergo either primary anastomosis with diverting loop ileostomy or Hartmann's procedure , based on surgeon judgment and intraoperative findings.\n\nExclusion criteria included:\n\n* Hinchey Stage I or II diverticulitis\n* Postoperative confirmation of malignancy as the primary cause of the perforation\n* Laparoscopic procedures instead of open resections\n* Patients with severe hemodynamic instability, septic shock, or uncontrolled sepsis The primary objective was to compare short- and long-term outcomes between primary anastomosis with diverting loop ileostomy and Hartmann's procedure, including postoperative morbidity and mortality, quality of life, stoma reversal rates, and hospital readmissions. Secondary endpoints included surgical site infections, length of hospital stay, and long-term complications such as parastomal hernia.\n\nThis structured design ensured a well-defined and homogeneous study cohort for outcome comparison, allowing for the generation of meaningful real-world evidence on the optimal surgical management of complicated diverticulitis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study population consists of adult patients (≥18 years) who presented with acute perforated sigmoid diverticulitis (PSD) classified as Hinchey Stage III or IV and underwent emergency open colonic resection. All participants were clinically stable at the time of surgery and were eligible to receive either primary anastomosis with diverting loop ileostomy (PADLI) or Hartmann's procedure (HP).\n\nPatients with Hinchey Stage I-II diverticulitis, postoperative confirmation of malignancy, laparoscopic surgery, or hemodynamic instability were excluded to ensure a well-defined and homogeneous study cohort for consistent outcome analysis.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults aged ≥18 years\n* Clinical diagnosis of perforated sigmoid diverticulitis (Hinchey Stage III or IV)\n* Clinically stable and suitable for undergoing emergency colonic resection\n* Eligible to receive either primary anastomosis with diverting loop ileostomy or Hartmann's procedure\n* Informed consent provided by the patient or a legal surrogate\n\nExclusion Criteria:\n\nHinchey Stage I or II diverticulitis\n\n* Postoperative confirmation of malignancy as the primary cause of perforation\n* Laparoscopic surgery instead of open colonic resection\n* Unstable patients with severe sepsis, septic shock, or significant hemodynamic compromise"}, 'identificationModule': {'nctId': 'NCT07094594', 'acronym': 'ARES', 'briefTitle': 'ARES Trial: Approach to Resection and Evaluation in Severe Diverticulitis', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Sanitaria Locale Napoli 2 Nord'}, 'officialTitle': "Comparing Hartmann's Procedure and Primary Resection With Anastomosis in Hinchey III-IV Diverticulitis: Focus on Ostomy Closure and Long-Term Outcomes", 'orgStudyIdInfo': {'id': '20251107'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Hartmann's Procedure Hartmann's Procedure (HP)", 'description': "Hartmann's Procedure (Hartmann's Procedure (HP)): Segmental resection of the sigmoid colon with the creation of an end colostomy."}, {'label': 'Primary Anastomosis and Diverting Loop Ileostomy (PADLI)', 'description': 'Primary Anastomosis and Diverting Loop Ileostomy (PADLI): Segmental resection followed by end-to-end anastomosis, protected by a diverting loop ileostomy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared. The decision not to share IPD is based on institutional policies and ethical considerations related to patient confidentiality and data protection. Additionally, no data-sharing infrastructure has been established within the current study protocol, and there are no plans at this time to develop such a framework.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Sanitaria Locale Napoli 2 Nord', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Francesco Pizza', 'investigatorAffiliation': 'Azienda Sanitaria Locale Napoli 2 Nord'}}}}