Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT06928220
Status:
COMPLETED
Last Update Posted:
2025-04-15
First Post:
2021-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Manual Versus Mechanical Intestinal Suturing on the Incidence of Postoperative Complications Following Cystectomy With Ileal Conduit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D045823', 'term': 'Ileus'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D007415', 'term': 'Intestinal Obstruction'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015653', 'term': 'Cystectomy'}, {'id': 'D014547', 'term': 'Urinary Diversion'}], 'ancestors': [{'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-04-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2021-01-18', 'studyFirstSubmitQcDate': '2025-04-07', 'lastUpdatePostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Demonstrate the superiority of manual intestinal suturing versus mechanical suturing, defined as a lower incidence of postoperative digestive complications in patients undergoing radical cystectomy with ileal conduit.', 'timeFrame': '1 year', 'description': 'Compare the incidence of gastrointestinal complications according to the type of suturing used in the creation of the ileo-ileal anastomosis in patients undergoing radical cystectomy with ileal conduit during the hospital admission period and at one-year follow-up.'}], 'secondaryOutcomes': [{'measure': 'To evaluate the predictive factors of postoperative complications.', 'timeFrame': '1 year', 'description': 'Identify the predictive factors of postoperative complications during hospital admission and at one-year follow-up, both overall and according to the type of suturing.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bladder Cancer', 'Cystectomy', 'hand sewn anastamosis', 'stapled anastamosis', 'intestinal complications'], 'conditions': ['Bladder Cancer', 'Anastomosis; Complications', 'Ileus Paralytic']}, 'descriptionModule': {'briefSummary': 'Impact of Manual Versus Mechanical Intestinal Suturing on the Incidence and Management of Postoperative Complications in Patients Undergoing Radical Cystectomy with Ileal Conduit.', 'detailedDescription': "Currently, no specific trial compares hand-sewn intestinal anastomosis with mechanical stapled anastomosis in patients undergoing radical cystectomy with ileal conduit.\n\nAt Fundació Puigvert, approximately one hundred radical cystectomies with ileal conduit are performed annually. Due to the lack of evidence regarding the superiority of either intestinal anastomosis technique, the decision to use hand-sewn versus stapled anastomosis depends on the surgeon's expertise, without considering the potential impact of each technique on postoperative complication rates, surgical time, or functional outcomes.\n\nCurrently, no well-designed surgical trials demonstrate differences between hand-sewn and mechanical stapled anastomosis in radical cystectomy regarding intraoperative and postoperative complications. For this reason, the investigators will conduct a trial to assess the impact of each anastomosis technique"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who consents to participate and signs the informed consent.\n* Patient candidate for radical open cystectomy and ileal conduit.\n\nExclusion Criteria:\n\n* Patient who is unable to complete the study questionnaires.\n* Patient who has a life expectancy of less than 1 year.\n* Candidate patients for other urinary diversions other than ileal conduit as a first option\n* Candidate patients for laparoscopic or robotic cystectomy..'}, 'identificationModule': {'nctId': 'NCT06928220', 'acronym': 'CIMMIS', 'briefTitle': 'The Impact of Manual Versus Mechanical Intestinal Suturing on the Incidence of Postoperative Complications Following Cystectomy With Ileal Conduit', 'organization': {'class': 'OTHER', 'fullName': 'Fundacio Puigvert'}, 'officialTitle': 'A Single-Center, Prospective, Randomized Clinical Trial Investigating the Impact of Manual Versus Mechanical Intestinal Suturing on the Incidence and Management of Postoperative Complications in Patients Undergoing Radical Cystectomy With Ileal Conduit.', 'orgStudyIdInfo': {'id': '181184'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Manual anastamosis', 'description': 'Intestinal anastamosis will be performed manually', 'interventionNames': ['Procedure: cystectomy with ileal conduit, using manual bowel anastomosis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mechanical anastamosis', 'description': 'Intestinal anastamosis will be performed using stapling device', 'interventionNames': ['Procedure: cystectomy with ileal conduit, using mechanical bowel anastomosis']}], 'interventions': [{'name': 'cystectomy with ileal conduit, using mechanical bowel anastomosis', 'type': 'PROCEDURE', 'description': 'An ileal conduit will be the new storage area for urine once the bladder is removed.\n\nGIA Device will be used to perform bowel anastomosis', 'armGroupLabels': ['Mechanical anastamosis']}, {'name': 'cystectomy with ileal conduit, using manual bowel anastomosis', 'type': 'PROCEDURE', 'description': 'An ileal conduit will be the new storage area for urine once the bladder is removed.\n\nVycryl suture will be used to perform manual bowel anastomosis', 'armGroupLabels': ['Manual anastamosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08025', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Fundacio Puigvert', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacio Puigvert', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant surgeon', 'investigatorFullName': 'Pavel Gavrilov', 'investigatorAffiliation': 'Fundacio Puigvert'}}}}