Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-01 @ 11:30 PM
Study NCT ID:
NCT02631967
Status:
UNKNOWN
Last Update Posted:
2017-02-15
First Post:
2015-11-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery 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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-13', 'studyFirstSubmitDate': '2015-11-29', 'studyFirstSubmitQcDate': '2015-12-15', 'lastUpdatePostDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Grade of endoscopic recurrence', 'timeFrame': '6 Months', 'description': "Severity of endoscopic recurrence (graded according to Rutgeerts' score) at the site of anastomosis at 6 months after surgery."}, {'measure': 'Surgical recurrence', 'timeFrame': 'Up to 5 years', 'description': 'Rate of patients requiring resection for anastomotic recurrence within 5 years after surgery'}], 'secondaryOutcomes': [{'measure': 'Endoscopic recurrence', 'timeFrame': '6 months up to 5 years', 'description': 'Presence of endoscopic recurrence'}, {'measure': 'Grade of endoscopic recurrence', 'timeFrame': '6 months up to 5 years', 'description': 'Severity of endoscopic recurrence at the site of anastomosis'}, {'measure': 'Clinical recurrence', 'timeFrame': 'Up to 5 years', 'description': "Presence of clinical recurrence (according to Crohn's disease activity index)"}, {'measure': 'Operating time', 'timeFrame': 'Intraoperatively', 'description': 'Duration of the operation (min)'}, {'measure': 'Anastomosis time', 'timeFrame': 'Intraoperatively', 'description': 'Time (min) required to perform the anastomosis'}, {'measure': 'Anastomotic leak', 'timeFrame': 'Up to 30 days', 'description': 'Incidence of anastomotic leak'}, {'measure': 'Surgical re-intervention', 'timeFrame': 'Up to 30 days', 'description': 'Rate of patients requiring surgical re-intervention'}, {'measure': 'Postoperative morbidity rate', 'timeFrame': 'Up to 30 days', 'description': 'Postoperative surgical (bleeding, obstruction, postoperative ileus, abdominal collection, wound infection) and medical morbidity as well as mortality will be documented and graded according to the Dindo Clavien classification'}, {'measure': 'Recovery times', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 5 days', 'description': 'Length of post-operative hospital stay, time to first flatus, time to first defecation, time to tolerance of liquid and solid diet will be documented'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Crohn disease', 'ileocecal resection', 'anastomosis', 'Kono'], 'conditions': ['Crohn Disease']}, 'referencesModule': {'references': [{'pmid': '21471760', 'type': 'BACKGROUND', 'citation': "Kono T, Ashida T, Ebisawa Y, Chisato N, Okamoto K, Katsuno H, Maeda K, Fujiya M, Kohgo Y, Furukawa H. A new antimesenteric functional end-to-end handsewn anastomosis: surgical prevention of anastomotic recurrence in Crohn's disease. Dis Colon Rectum. 2011 May;54(5):586-92. doi: 10.1007/DCR.0b013e318208b90f."}, {'pmid': '32675483', 'type': 'DERIVED', 'citation': "Luglio G, Rispo A, Imperatore N, Giglio MC, Amendola A, Tropeano FP, Peltrini R, Castiglione F, De Palma GD, Bucci L. Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease: The SuPREMe-CD Study - A Randomized Clinical Trial. Ann Surg. 2020 Aug;272(2):210-217. doi: 10.1097/SLA.0000000000003821."}]}, 'descriptionModule': {'briefSummary': "Kono and collegues have described a new anastomotic technique to restore bowel contintuity after ileocecal resection for Crohn's disease (CD).\n\nThis tecnique implies a hand-sewn ileocolic anastomosis, that involves exclusively the antimesenteric side of the bowel and that functionally acts as an end-to-end anastomosis.\n\nIn a retrospective study, the authors have shown that this anastomotic tecnique, when compared to stapled side-to-side anastomosis, significantly reduces the severity of endoscopic recurrence at 1 year after surgery and the rate of reoperation for anastomotic recurrence at 5 years after surgery.\n\nAim of this trial is to compare the outcomes of the Kono anastomosis with the ones achieved by the stapled side-to-side anastomosis, within a prospective randomized study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with Crohn's disease requiring ileocecal resection\n\nExclusion Criteria:\n\n* age \\> 75 years\n* age \\< 18 years\n* inability to give the consent to the participation in the trial\n* refusal to participate in the trial after receiving accurate information"}, 'identificationModule': {'nctId': 'NCT02631967', 'acronym': 'SuPREMeCD', 'briefTitle': "Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': "A New Anastomotic Technique After Ileocecal Resection for Crohn's Disease. Kono-s Anastomosis vs Stapled Side-to-side Anastomosis: a Randomized Controlled Trial", 'orgStudyIdInfo': {'id': '211/15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kono anastomosis', 'description': 'Patients receiving Kono anastomosis', 'interventionNames': ['Procedure: Kono anastomosis']}, {'type': 'EXPERIMENTAL', 'label': 'Stapled side-to-side anastomosis', 'description': 'Patients receiving stapled side-to-side anastomosis', 'interventionNames': ['Procedure: Stapled side-to-side anastomosis']}], 'interventions': [{'name': 'Kono anastomosis', 'type': 'PROCEDURE', 'description': 'Kono anastomosis', 'armGroupLabels': ['Kono anastomosis']}, {'name': 'Stapled side-to-side anastomosis', 'type': 'PROCEDURE', 'description': 'Stapled side-to-side anastomosis', 'armGroupLabels': ['Stapled side-to-side anastomosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80121', 'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luigi Bucci, Prof', 'role': 'CONTACT', 'email': 'luigi.bucci@unina.it', 'phone': '00390817462850'}, {'name': 'Mariano Cesare Giglio, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gaetano Luglio, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fabiana Castiglione, Prof', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Antonio Rispo, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Giovanni Domenico De Palma, Prof', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'UOC Colonproctologia Chirurgica - Dipartimento di Medicina Clinica e Chirurgia - Università degli Studi di Napoli Federico II', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}], 'centralContacts': [{'name': 'Luigi Bucci, Prof', 'role': 'CONTACT', 'email': 'luigi.bucci@unina.it', 'phone': '00390817462850'}], 'overallOfficials': [{'name': 'Luigi Bucci, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federico II University of Naples'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Luigi Bucci', 'investigatorAffiliation': 'Federico II University'}}}}