Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-05-19 @ 12:53 PM
Study NCT ID:
NCT05942833
Status:
RECRUITING
Last Update Posted:
2025-09-05
First Post:
2023-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life in Acute Complicated and Chronic Recurrent Left-sided Diverticulitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004238', 'term': 'Diverticulitis'}], 'ancestors': [{'id': 'D000076385', 'term': 'Diverticular Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective, randomized controlled'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 136}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2023-06-07', 'studyFirstSubmitQcDate': '2023-07-04', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastrointestinal Quality of Life Index', 'timeFrame': 'Up to 18 weeks', 'description': 'Quality of Life'}], 'secondaryOutcomes': [{'measure': 'SF-36 score (Short form score)', 'timeFrame': 'Up to 18 weeks', 'description': 'physical and mental health summary scores (0-100), the higher the better'}, {'measure': 'Low anterior resection syndrome score', 'timeFrame': 'Up to 18 weeks', 'description': 'points (0-40), the lower the better'}, {'measure': 'Anastomosis insufficiency', 'timeFrame': 'Up to 18 weeks', 'description': 'yes/no'}, {'measure': 'Intraoperative complication', 'timeFrame': 'Up to 18 weeks', 'description': 'bleeding, ureter harming (yes/no)'}, {'measure': 'Exitus', 'timeFrame': 'Up to 18 weeks', 'description': 'yes/no'}, {'measure': 'Length of stay (sum of days in hospital until end of study)', 'timeFrame': 'Up to 18 weeks', 'description': 'days'}, {'measure': 'Earlier readmission due to recurrence while waiting for surgery', 'timeFrame': 'Up to 18 weeks', 'description': 'Only in Group B'}, {'measure': 'Postoperative complication', 'timeFrame': 'Up to 18 weeks', 'description': 'pneumonia, urinary tract infection (yes/no)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Recurrent diverticulitis', 'Quality of life', 'Acute complicated Diverticulitis', 'Early resection', 'Elective resection'], 'conditions': ['Diverticulitis of Sigmoid']}, 'descriptionModule': {'briefSummary': 'Patients presenting in hospital with symptoms of acute diverticulitis. Acute inflammation of the left-sided colon is confirmed with CT scan or ultrasound in experienced centers and diagnosis is defined according to the "Classification of Diverticular Disease (CDD)". CDD Type 2a, 2b and 3b will be included and then randomized in two groups. Group A will get an early left hemicolectomy 7 to 10 days after admission and initial antibiotic therapy and/or drainage of the abscess. Group B is designated for an elective resection 6 to 8 weeks after dismissal at the earliest and initial conservative treatment and/or after drainage of the abscess. Six weeks after the operation patients of Group A will be asked for their present quality of life with a standardized scoring system (Gastrointestinal Quality of Life Index = GIQLI; Short-form 36 Score = SF-36 Score; Low anterior resection syndrome = LARS Score). Group B (elective resection) will be asked at their readmission prior to elective surgery is done. This survey package will be repeated again 6 to 8 weeks later in both groups. Primary endpoints will be the two GIQLI at the said examination times. Secondary endpoints will be SF-36 score, LARS-score, GIQLI-Domains, anastomosis insufficiency and other complications, mortality and length of hospital stay. Comparisons between the groups are made at the said examination times but also 6-8 weeks after the operation.', 'detailedDescription': "Primary endpoints:\n\nGastrointestinal Quality of Life Index (GIQLI)\n\nSecondary endpoints:\n\nSF-36 score (physical and mental health summary scores), LARS score, GIQLI-domains, anastomosis insufficiency and other complications, exitus and length of hospital stay\n\nTreatment strategy:\n\nA patient is coming into the hospital with acute symptoms of diverticulitis. The diagnosis must then be confirmed either with ultrasound or with a CT scan. After confirmation the patient is asked to be part of the study. At that point of time the patient does not know his randomization. After the patient's approval and signed consent the patients will bei informed about the further procedure and the appointment of surgery. Questionnaires will now be filled out and antibiotical treatment starts. If necessary a radiological intervention (drainage) is performed.\n\nIs the patient is randomized into Group A he will get early left hemicolectomy immediately up to a maximum of 2 days after 7-10 days lasting initial conservative or interventional treatment (e.g: antibiotics, analgesics, drainage). If the patient is in Group B he will receive an elective left hemicolectomy 6 to 8 weeks after 7-10 days lasting initial conservative or interventional treatment (e.g: antibiotics, analgesics, drainage).\n\nReassessment of the questionnaires will bei done in both groups. Group A will be asked 6-8 after surgery and again 6-8 weeks after the second reassessment.\n\nGroup B will be asked 6-8 weeks after discharge (directly before surgery) and again 6-8 weeks after surgery.\n\nThe aim of the study is to evaluate the outcome and quality of life in patients receiving early surgery versus elective resection of the left-sided colon in acute complicated diverticulitis and chronic recurrent diverticulitis with acute exacerbation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent to participate in the study\n* CDD Type 2a, 2b: acute complicated left-sided diverticulitis\n* CDD Type 3b: relapsing diverticulitis without complications (\\>2 episodes within 2 years)\n* Acute presentation\n* Inflammation located in the left-sided colon\n* Inflammation is CT proven or ultrasound confirmed from experienced radiologists\n\nExclusion Criteria:\n\n* \\< 18 years\n* Pregnancy\n* BMI \\> 55kg/m2\n* Current colorectal carcinoma in the left-sided colon\n* Oral and/or intravenous corticosteroid\n* Ongoing chemotherapy\n* Status post left hemicolectomy\n* Patients who cannot take care of themselves at home or are unable to follow instructions\n* Patients who are not fit for surgery (anesthesia, expert knowledge from specialists) and will not benefit from surgery'}, 'identificationModule': {'nctId': 'NCT05942833', 'acronym': 'DATE', 'briefTitle': 'Quality of Life in Acute Complicated and Chronic Recurrent Left-sided Diverticulitis', 'organization': {'class': 'OTHER', 'fullName': 'Kepler University Hospital'}, 'officialTitle': 'DATE Trial: Outcomes and Quality of Life in Patients With Early Versus Elective Resection in Acute Complicated and Chronic Recurrent Left-sided Diverticulitis', 'orgStudyIdInfo': {'id': '1203/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (Early)', 'description': 'Early left hemicolectomy immediately up to a maximum of 2 days after 7-10 days lasting initial conservative or interventional treatment (e.g: antibiotics, analgesics, drainage) and CT scan/ultrasound proven left-sided colonic diverticulitis', 'interventionNames': ['Procedure: Sigmoid resection']}, {'type': 'OTHER', 'label': 'Group B (Late)', 'description': 'Elective left hemicolectomy 6 to 8 weeks after 7-10 days lasting initial conservative or interventional treatment (e.g: antibiotics, analgesics, drainage) and CT scan/ultrasound proven left-sided colonic diverticulitis', 'interventionNames': ['Procedure: Sigmoid resection']}], 'interventions': [{'name': 'Sigmoid resection', 'type': 'PROCEDURE', 'description': 'Timing of sigmoid resection', 'armGroupLabels': ['Group A (Early)', 'Group B (Late)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4020', 'city': 'Linz', 'state': 'Austria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Matthias Biebl, Dr.', 'role': 'CONTACT', 'email': 'matthias.biebl@ordensklinikum.at', 'phone': '+43 (0)732-7677 - 7300'}, {'name': 'Christoph Schwaiger-Hengstschläger, Dr.', 'role': 'CONTACT', 'phone': '+43 (0)732-7677 - 7300'}], 'facility': 'Ordensklinikum Elisabethinen Linz', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '4010', 'city': 'Linz', 'state': 'Upper Austria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Matthias Biebl, Dr.', 'role': 'CONTACT', 'email': 'matthias.biebl@ordensklinikum.at', 'phone': '+43 (0)732-7677 - 7300'}, {'name': 'Gerd Pressl, Dr.', 'role': 'CONTACT', 'email': 'gerd.pressl@ordensklinikum.at', 'phone': '+43 732 7677 - 7300'}], 'facility': 'Krankenhaus Barmherzige Schwestern Linz', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '4020', 'city': 'Linz', 'state': 'Upper Austria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Sandra Raab, Dr.', 'role': 'CONTACT', 'email': 'sandra.raab@kepleruniklinikum.at', 'phone': '+43 (0)5 7680 83 - 78470'}, {'name': 'Andreas Shamiyeh, Dr.', 'role': 'CONTACT', 'email': 'andreas.shamiyeh@kepleruniklinikum.at', 'phone': '+43 (0)5 7680 83 - 2133'}], 'facility': 'Kepler University Hospital', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '68167', 'city': 'Mannheim', 'state': 'Mannheim', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Steffen Seyfried, PD MD', 'role': 'CONTACT', 'email': 'steffen.seyfried@umm.de', 'phone': '+49 621 383-4864'}, {'name': 'Christoph Reißfelder, Prof. MD', 'role': 'CONTACT', 'email': 'christoph.reißfelder@umm.de', 'phone': '+49 621 383-4864'}], 'facility': 'Universitätsklinikum Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}], 'centralContacts': [{'name': 'Sandra Raab, Dr.', 'role': 'CONTACT', 'email': 'sandra.raab@kepleruniklinikum.at', 'phone': '+43 (0)5 7680 83 - 78470'}, {'name': 'Andreas Shamiyeh, Dr.', 'role': 'CONTACT', 'email': 'andreas.shamiyeh@kepleruniklinikum.at', 'phone': '+43 (0)5 7680 83 - 2133'}], 'overallOfficials': [{'name': 'Andreas Shamiyeh, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kepler University Hospital Linz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kepler University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Krankenhaus Barmherzige Schwestern Linz', 'class': 'OTHER'}, {'name': 'Elisabethinen Hospital', 'class': 'OTHER'}, {'name': 'Universitätsmedizin Mannheim', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}