Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-01-11 @ 10:57 PM
Study NCT ID:
NCT06538402
Status:
RECRUITING
Last Update Posted:
2025-07-09
First Post:
2024-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ten Versus Fifteen Centimeter Pouch in IPAA Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D011125', 'term': 'Adenomatous Polyposis Coli'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D018256', 'term': 'Adenomatous Polyps'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D044483', 'term': 'Intestinal Polyposis'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2038-07-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-04', 'studyFirstSubmitDate': '2024-08-01', 'studyFirstSubmitQcDate': '2024-08-01', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pouch dysfunction score', 'timeFrame': '1, 3, 5 and 10 years after surgery', 'description': 'Ranges from 0 to 7.5, where a low score indicates good bowel function will little to no impact on quality of life'}], 'secondaryOutcomes': [{'measure': 'Short Inflammatory Bowel Disease Questionnaire', 'timeFrame': '1, 3, 5 and 10 years after surgery', 'description': 'Consists of 10 questions with a total score range from 10 (poor health-related quality of life) to 70 (good health-related quality of life)'}, {'measure': 'Short-form (SF)-36', 'timeFrame': '1, 3, 5 and 10 years after surgery', 'description': 'Consists of questions relating to 8 domains of life with a total score ranging from 0-100, with lower numbers indicating worse health status'}, {'measure': 'Postoperative complications using the Comprehensive Complication Index (CCI)', 'timeFrame': '90 days after surgery', 'description': 'The CCI is a continuous scale, where each postoperative complication as defined by Clavien-Dindo is assigned a weigth based on its severity. A total summarized score taking all complications into account is thus generated.'}, {'measure': 'Pouch failure', 'timeFrame': '1, 3, 5 and 10 years after surgery', 'description': 'Hazard ratio of pouch failure defined as an intended permanent ileostomy with or without pouch excision'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ileal pouch-anal anastomosis', 'ulcerative colitis', 'familial adenomatous polyposis', 'randomized controlled trial', 'pouch function', 'quality of life', 'complications'], 'conditions': ['Ulcerative Colitis', 'Familial Adenomatous Polyposis']}, 'descriptionModule': {'briefSummary': 'The aim of this randomized controlled trial is to compare outcome after construction of an ileal (J-shaped) reservoir of 10 versus 15 centimeters in primary ileal pouch-anal anastomosis surgery.', 'detailedDescription': 'The primary aim of this randomized controlled trial is to compare functional outcome in terms of bowel function correlated with quality of life for patients who undergo primary ileal pouch-anal anastomosis surgery with an ileal (J-shaped) reservoir length of either 10 cm or 15 cm.\n\nSecondary aims include health-related quality of life measures and postoperative complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing ileal pouch-anal anastomosis (IPAA) for ulcerative colitis or familial adenomatous polyposis (FAP) (implying a normal sphincter function as judged by history and clinical examination)\n* Signed informed consent\n* Able to perform both a small (10 cm) and medium-size (15 cm) pouch with adequate reach and no tension as determined subjectively by the surgeon intraoperatively'}, 'identificationModule': {'nctId': 'NCT06538402', 'acronym': 'TESTIMONY', 'briefTitle': 'Ten Versus Fifteen Centimeter Pouch in IPAA Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Ileal Reservoir Length and Functional Outcome in Ileal Pouch-anal Anastomosis', 'orgStudyIdInfo': {'id': 'OP_2227'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '10 cm', 'description': 'Ileal reservoir length of 10 cm', 'interventionNames': ['Procedure: 10 cm pouch']}, {'type': 'ACTIVE_COMPARATOR', 'label': '15 cm', 'description': 'Ileal reservoir length of 15 cm', 'interventionNames': ['Procedure: 15 cm pouch']}], 'interventions': [{'name': '10 cm pouch', 'type': 'PROCEDURE', 'description': 'A 10 cm pouch will be constructed', 'armGroupLabels': ['10 cm']}, {'name': '15 cm pouch', 'type': 'PROCEDURE', 'description': 'A 15 cm pouch will be constructed', 'armGroupLabels': ['15 cm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aarhus', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Sanne Harsløf, MD PhD', 'role': 'CONTACT', 'email': 'sanne.harslof@rm.dk'}], 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'city': 'Hvidovre', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Frederik Rønne Pachler, MD PhD', 'role': 'CONTACT', 'email': 'fpachler@gmail.com'}], 'facility': 'Hvidovre Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'centralContacts': [{'name': 'Anders Mark-Christensen, MD, PhD', 'role': 'CONTACT', 'email': 'anders.mark.christensen2@rsyd.dk', 'phone': '+45 51236691'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}