Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT05974358
Status:
RECRUITING
Last Update Posted:
2025-02-13
First Post:
2023-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
KONO-S Anastomosis Compared to Conventional Ileocolonic Anastomosis to Reduce Recurrence in Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective, multicenter,randomized study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 226}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2023-07-26', 'studyFirstSubmitQcDate': '2023-07-26', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'endoscopy score', 'timeFrame': 'Month 6', 'description': 'Rutgeerts endoscopy score ≥ i2 (\\>5 anastomotic lesions with passable stenosis (skip lesions); or lesions in the area of the anastomosis) at 6 months obtained by centralized double reading of filmed endoscopy.\n\nI0 no lesions\n\n* 1 \\<5 aphthous lesions in the neoterminal ileum\n* 2 \\>5 anastomotic lesions with passable stenosis (skip lesions); or lesions in the area of the anastomosis\n* 3 diffuse ileitis\n* 4 diffuse ileitis with deep ulcerations and/or Stenosis'}], 'secondaryOutcomes': [{'measure': 'Harvey-Bradshaw Index (HBI)', 'timeFrame': 'Month 6', 'description': 'Harvey-Bradshaw Index (HBI) Disease not active: \\<4 ; Mild disease activity: HBI \\>= 4 and \\<= 8 ; Moderate disease activity: HBI \\> 8 and \\<= 12 ; Severe disease activity: HBI \\> 12'}, {'measure': 'Harvey-Bradshaw Index (HBI)', 'timeFrame': 'Month 12', 'description': 'Harvey-Bradshaw Index (HBI) Disease not active: \\<4 ; Mild disease activity: HBI \\>= 4 and \\<= 8 ; Moderate disease activity: HBI \\> 8 and \\<= 12 ; Severe disease activity: HBI \\> 12'}, {'measure': 'Harvey-Bradshaw Index (HBI)', 'timeFrame': 'Month 18', 'description': 'Harvey-Bradshaw Index (HBI) Disease not active: \\<4 ; Mild disease activity: HBI \\>= 4 and \\<= 8 ; Moderate disease activity: HBI \\> 8 and \\<= 12 ; Severe disease activity: HBI \\> 12'}, {'measure': 'Harvey-Bradshaw Index (HBI)', 'timeFrame': 'Month 24', 'description': 'Harvey-Bradshaw Index (HBI) Disease not active: \\<4 ; Mild disease activity: HBI \\>= 4 and \\<= 8 ; Moderate disease activity: HBI \\> 8 and \\<= 12 ; Severe disease activity: HBI \\> 12'}, {'measure': "Crohn's Disease Activity Index (CDAI) clinical scores", 'timeFrame': 'Month 6', 'description': "Crohn's Disease Activity Index (CDAI) clinical scores The patients with CD can be divided into asymptomatic remission (CDAI \\< 150), mild-to-moderate CD (150-220), moderate-to-severe CD (220-450), and severe-fulminant disease (\\>450)."}, {'measure': "Crohn's Disease Activity Index (CDAI) clinical scores", 'timeFrame': 'Month12', 'description': "Crohn's Disease Activity Index (CDAI) clinical scores The patients with CD can be divided into asymptomatic remission (CDAI \\< 150), mild-to-moderate CD (150-220), moderate-to-severe CD (220-450), and severe-fulminant disease (\\>450)."}, {'measure': "Crohn's Disease Activity Index (CDAI) clinical scores", 'timeFrame': 'Month18', 'description': "Crohn's Disease Activity Index (CDAI) clinical scores The patients with CD can be divided into asymptomatic remission (CDAI \\< 150), mild-to-moderate CD (150-220), moderate-to-severe CD (220-450), and severe-fulminant disease (\\>450)."}, {'measure': "Crohn's Disease Activity Index (CDAI) clinical scores", 'timeFrame': 'Month24', 'description': "Crohn's Disease Activity Index (CDAI) clinical scores The patients with CD can be divided into asymptomatic remission (CDAI \\< 150), mild-to-moderate CD (150-220), moderate-to-severe CD (220-450), and severe-fulminant disease (\\>450)."}, {'measure': 'Fecal calprotectin', 'timeFrame': 'Month 6', 'description': 'Fecal calprotectin'}, {'measure': 'Fecal calprotectin', 'timeFrame': 'Month 12', 'description': 'Fecal calprotectin'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Crohn's disease", 'Kono-S anastomosis', 'conventional anastomosis', 'endoscopic recurrence'], 'conditions': ['Crohn Disease']}, 'descriptionModule': {'briefSummary': "Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) currently affecting one person in a thousand in France. It can lead to numerous digestive complications such as fistulas, abscesses or stenosis. Despite numerous therapeutic advances, the rate of patients requiring surgery remains very high, with approximately 50% requiring at least one surgical intervention at 10 years after disease diagnosis. However, surgical treatment is not curative, the postoperative recurrence rate being very high, from 65 to-90% endoscopic recurrence at 1 year. The ileocolonic anastomosis is the main site of postoperative recurrence currently defined by a Rutgeerts score (≥i2) 6 months after surgery. In 2003, Kono et al. described a new operative technique that could reduce the rate of post-operative recurrence: a termino-terminal ileocolonic anastomosis, anti-mesenteric, with a supporting column to prevent distortion and anastomotic stenosis (Kono-S anastomosis). The study showed no decrease in endoscopic recurrence rate at 1 year (83% vs 79%), but a significant decrease in surgical recurrence rate at 5 years (15% vs 0%). Recently, a randomized Italian monocenter study showed a significant decrease in endoscopic recurrence rate at 6 and 18 months (22.2% versus 62.8% and 25% versus 67.4%), as well as a decrease in clinical recurrence. The limitations of this study are its monocentric nature and the lack of centralization of the endoscopic analysis to assess the primary endpoint. This surgical technique has been performed in some centers for ileocolonic Crohn's surgery since 2020. Nevertheless, the level of evidence remains too low to establish practice recommendations. The KOALA study will be the first prospective, multicenter, randomized study comparing KONO-S anastomosis and conventional anastomosis for ileocolonicresection of Crohn's disease, with blinded and centralized evaluation of recurrence."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patient ≥ 18 years and ≤75 years\n* With Crohn's disease.\n* Requiring a first ileocolonic resection: fistulizing, abscessed, or stenosing disease or disease refractory to medical treatment.\n* Affiliated to the French social security system.\n\nExclusion Criteria:\n\n* Previous ileocolonic resection\n* Contraindication to postoperative endoscopy.\n* Anastomosis with a planned defunctioning protective stoma.\n* Emergency surgery (peritonitis).\n* Lack of consent to the study.\n* Pregnant patients.\n* Refusal to participate or inability to provide informed consent.\n* Patient under legal protection (individuals under guardianship by court order)"}, 'identificationModule': {'nctId': 'NCT05974358', 'acronym': 'KOALA', 'briefTitle': "KONO-S Anastomosis Compared to Conventional Ileocolonic Anastomosis to Reduce Recurrence in Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': "KONO-S Anastomosis Compared to Conventional Ileocolonic Anastomosis to Reduce Recurrence in Crohn's Disease: a Superiority Phase III Prospective, Randomized, Multicenter, Double-blind Trial.", 'orgStudyIdInfo': {'id': '2023/802'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kono-S group', 'description': 'Kono-S group, in which ileocolonic anastomosis will be performed following the technique described by Kono et al.', 'interventionNames': ['Procedure: Kono-S anastomosis']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'Conventional side-to-side ileocolonic anastomosis', 'interventionNames': ["Procedure: Conventional anastomosis for ileocolonicresection of Crohn's disease"]}], 'interventions': [{'name': 'Kono-S anastomosis', 'type': 'PROCEDURE', 'description': 'Kono et al. described a new operative technique that could reduce the rate of post-operative recurrence: a termino-terminal ileocolonic anastomosis, anti-mesenteric, with a supporting column to prevent distortion and anastomotic stenosis (Kono-S anastomosis).', 'armGroupLabels': ['Kono-S group']}, {'name': "Conventional anastomosis for ileocolonicresection of Crohn's disease", 'type': 'PROCEDURE', 'description': "conventional anastomosis for ileocolonicresection of Crohn's disease", 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25030', 'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Zaher LAKKIS', 'role': 'CONTACT', 'email': 'zlakkis@chu-besancon.fr'}], 'facility': 'CHu de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Bordeaux', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Benjamin FERNANDEZ', 'role': 'CONTACT', 'email': 'benjamin.fernandez@chu-bordeaux.fr'}], 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Grenoble', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bertrand TRILLING', 'role': 'CONTACT', 'email': 'btrilling@chu-grenoble.fr'}], 'facility': 'CHU de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Lille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe ZERBIB', 'role': 'CONTACT', 'email': 'philippe.zerbib@chru-lille.fr'}], 'facility': 'CHU de Lille Hopital Claude Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lyon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Eddy Cotte', 'role': 'CONTACT', 'email': 'eddy.cotte@chu-lyon.fr'}], 'facility': 'HCL-Hôpital Lyon Sud', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laura BEYER-BEJOT', 'role': 'CONTACT', 'email': 'laura.beyer@ap-hm.fr'}], 'facility': 'AP-HM Hôpital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Nancy', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Adeline GERMAIN', 'role': 'CONTACT', 'email': 'germain.adeline@gmail.com'}], 'facility': 'CHU de Nançy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'city': 'Nantes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emilie DUCHALAIS-DASSONNEVILLE', 'role': 'CONTACT', 'email': 'emilie.dassonneville@chu-nantes.fr'}], 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Léon MAGGIORI', 'role': 'CONTACT', 'email': 'leon.maggiori@aphp.fr'}], 'facility': 'Ap-HP Hopital St Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gilles MANCEAU', 'role': 'CONTACT'}], 'facility': 'AP-HP Hôpital Européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stéphane BENOIST', 'role': 'CONTACT', 'email': 'stephane.benoist@aphp.fr'}], 'facility': 'AP-HP Le Kremlin-Bicetre', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jérémie LEFEVRE', 'role': 'CONTACT', 'email': 'jeremie.lefevre@aphp.fr'}], 'facility': 'AP-HP St Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Rennes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Véronique DESFOURNEAUX', 'role': 'CONTACT', 'email': 'Veronique.desfourneaux@chu-rennes.fr'}], 'facility': 'CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Strasbourg', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Simone MANFREDELLI', 'role': 'CONTACT', 'email': 'simone.manfredelli@chru-strasbourg.fr'}], 'facility': 'CHU de Strasbourg HautePierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Toulouse', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Etienne BOUSCAIL', 'role': 'CONTACT', 'email': 'ebuscail@me.com'}], 'facility': 'CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Zaher LAKKIS', 'role': 'CONTACT', 'email': 'zlakkis@chu-besancon.fr', 'phone': '+33381218988'}, {'name': 'Astrid POZET', 'role': 'CONTACT', 'email': 'apozet@chu-besancon.fr', 'phone': '+33381218988'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}