Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT07167420
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-11
First Post:
2025-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RISE Ileocecal Valve Functional Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-05-21', 'size': 660889, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-09-01T09:59', 'hasProtocol': True}, {'date': '2025-07-09', 'size': 187434, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-09-01T10:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 188}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-09', 'studyFirstSubmitDate': '2025-09-01', 'studyFirstSubmitQcDate': '2025-09-09', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first formed stool after surgery (Bristol stool score < 4).', 'timeFrame': '1 week after surgery', 'description': 'According to the Bristol stool scale, stools are categorized into seven types. Since stool form is related to the duration of colonic transit, the scale can be used to assess intestinal transit time and evaluate anastomotic function. A score \\>5 is defined as diarrhea, with a score of 6 indicating mild diarrhea and a score of 7 indicating severe diarrhea.'}], 'secondaryOutcomes': [{'measure': 'Operation time', 'timeFrame': 'during the surgery'}, {'measure': 'anastomosis time', 'timeFrame': 'during surgery'}, {'measure': 'intraoperative blood loss', 'timeFrame': 'during surgery'}, {'measure': 'Complications within 30 days after surgery', 'timeFrame': '30 days after surgery', 'description': 'Surgical complications evaluation was based on the Clavien-Dindo complication scoring system.\n\nGrade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside.\n\nGrade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications.\n\nBlood transfusionsand total parenteral nutritionare also included. Grade III Requiring surgical, endoscopic or radiological intervention Grade IV Life-threatening complication (including CNS complications)\\* requiring IC/ICU-management Grade V Death of a patient'}, {'measure': 'anastomosis healing', 'timeFrame': '3 months, 6 months and 1 year after surgery', 'description': 'Colonoscopy is used to assess the healing status of an anastomosis, and to determine whether stenosis, ulcers, or other pathological changes have occurred.'}, {'measure': 'albumin level', 'timeFrame': '3 days, 1 month, 3 months, 6 months and 1 year after surgery.', 'description': 'for assessing the nutritional status.'}, {'measure': 'bile acid', 'timeFrame': '3 days, 1 month, 3 months, 6 months and 1 year after surgery', 'description': 'for assessing the nutritional status.'}, {'measure': 'VitB12', 'timeFrame': '3 days, 1 month, 3 months, 6 months and 1 year after surgery', 'description': 'for assessing the nutritional status.'}, {'measure': 'total protein', 'timeFrame': '3 days, 1 month, 3 months, 6 months and 1 year after surgery', 'description': 'for assessing the nutritional status'}, {'measure': 'EORTCQLQ-C30', 'timeFrame': 'baseline, 1 month after surgery.', 'description': 'for assessing quality of life after surgery'}, {'measure': 'EORTCQLQ-CR2930', 'timeFrame': 'baseline, 1 month after surgery.', 'description': 'for assessing quality of life after surgery'}, {'measure': 'gut microbiota', 'timeFrame': '1 month, 3 months, 6 months and 1 year after surgery.', 'description': "Analyzing the changes in gut microbiota through the patient's fecal samples."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['right-sided colon cancer', 'laparoscopic surgery', 'ileocecal valve'], 'conditions': ['Right-sided Colon Cancer']}, 'descriptionModule': {'briefSummary': 'The traditional surgical treatment for right-sided colon cancer involves the removal of an important structure, the ileocecal valve, which includes the ileocecal valve. This can lead to problems such as diarrhea and malnutrition in patients. This study reconstructs an artificial ileocecal valve through intraoperative suturing to compensate for the function of the original ileocecal valve. The control group will undergo the routine resection of the right-sided colon, including the ileocecal valve. This is a randomized controlled study. Patients enrolled will be randomly assigned to the experimental group (ileocecal valve reconstruction during surgery) or the control group (no ileocecal valve reconstruction), with no differences in other treatment procedures. After a series of follow-up observations, the research team will analyze the safety and effectiveness of the method of ileocecal valve reconstruction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects aged 18-80 years;\n* ASA score ≤ 3;\n* Patients newly diagnosed with tumors located in the appendix, ileocecal region, ascending colon, hepatic flexure of the colon, or the right one-third of the transverse colon, or those scheduled to undergo laparoscopic radical right hemicolectomy;\n* No history of other gastrointestinal diseases (except for intestinal polyps or gallstones);\n* Willing to participate in the study and sign the informed consent form;\n* Complete clinical data available.\n\nExclusion Criteria:\n\n* Presence of other malignant tumors in different organs;\n* Tumor invasion into adjacent organs;\n* Patients with concurrent infectious diseases or autoimmune diseases (e.g., Crohn's disease);\n* Patients with congenital or acquired metabolic disorders;\n* Use of antibiotics or other microbiota-altering medications within one month prior to enrollment;\n* Changes in surgical plan resulting in the resection not including the ileocecal valve."}, 'identificationModule': {'nctId': 'NCT07167420', 'briefTitle': 'RISE Ileocecal Valve Functional Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Army Medical University, China'}, 'officialTitle': 'RISE Ileocecal Valve Functional Reconstruction for the Prevention of Postoperative Intestinal Dysfunction After Robotic/Laparoscopic Right Hemicolectomy: a Single-blind, Two-arm, Multicenter Randomized Controlled Clinical Study', 'orgStudyIdInfo': {'id': 'RISE anastomosis 002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RISE anastomosis', 'description': 'After performing a conventional right hemicolectomy, an additional step is carried out in which sutures are used to artificially reconstruct an ileocecal valve structure at the ileal stump before proceeding with the ileocolic anastomosis.', 'interventionNames': ['Procedure: RISE (Revolute Insert Side-End ileocecal valve reconstruction)']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Conventional right hemicolectomy was performed, with the ileocecal valve included in the resection.'}], 'interventions': [{'name': 'RISE (Revolute Insert Side-End ileocecal valve reconstruction)', 'type': 'PROCEDURE', 'description': 'After performing a conventional right hemicolectomy, an additional step is carried out in which sutures are used to artificially reconstruct an ileocecal valve structure at the ileal stump before proceeding with the ileocolic anastomosis.', 'armGroupLabels': ['RISE anastomosis']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Weidong Xiao, MD', 'role': 'CONTACT', 'email': 'xiaoweidong@tmmu.edu.cn', 'phone': '86-13996390860'}, {'name': 'Zihan Wang, Ph.D', 'role': 'CONTACT', 'email': 'shakehanhanhan@hotmail.com', 'phone': '86-13618347369'}], 'overallOfficials': [{'name': 'Weidong Xiao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of General Surgery, Xinqiao Hospital, Army Medical University, No.183 Xinqiao Road, Chongqing, 400037, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'After the completion of this study, the data will be made public and anyone can request it by email.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Army Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of General Surgery', 'investigatorFullName': 'Weidong Xiao', 'investigatorAffiliation': 'Army Medical University, China'}}}}