Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-28 @ 8:02 PM
Study NCT ID:
NCT07238166
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Benign Versus Malignant Causes of Intussuception in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007443', 'term': 'Intussusception'}], 'ancestors': [{'id': 'D007415', 'term': 'Intestinal Obstruction'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2025-11-16', 'studyFirstSubmitQcDate': '2025-11-16', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Operative findings', 'timeFrame': 'During intraoperative period', 'description': 'To record intraoperative findings including location of intussusception (small bowel, ileocecal, colocolic), presence of lead point, bowel viability, and type of surgical procedure'}], 'primaryOutcomes': [{'measure': 'prevalence of benign versus malignant causes', 'timeFrame': '2 weeks after surgical resection', 'description': 'Histopathological examination of resected bowel specimens will determine whether the cause of intussusception is benign (e.g., lipoma, polyp) or malignant (e.g., adenocarcinoma, lymphoma). The frequency and percentage of each category will be calculated'}], 'secondaryOutcomes': [{'measure': 'Correlation between preoperative imaging findings and histopathological results Description', 'timeFrame': 'At the time of diagnosis (preoperative period )', 'description': 'Evaluate the diagnostic accuracy of preoperative imaging (CT scan findings such as target sign, mass lesion) in predicting benign or malignant pathology'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['in adult'], 'conditions': ['Intussusception (IS)']}, 'referencesModule': {'references': [{'pmid': '33116857', 'type': 'BACKGROUND', 'citation': 'Su T, He L, Zhou T, Wu M, Guo Y, Wang Q, Jiang J, Cao X. Most Adult Intussusceptions are Caused by Tumors: A Single-Centre Analysis. Cancer Manag Res. 2020 Oct 12;12:10011-10015. doi: 10.2147/CMAR.S268921. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate adult intussecption :\n\n* Prevalence of benign vs malignant causes.\n* Distribution by anatomical type.\n* Clinical presentation patterns.\n* Diagnostic accuracy of imaging.\n* Surgical approach and outcomes.\n* Length of hospital stay, complications, recurrence', 'detailedDescription': "Intussusception is a condition characterized by the invagination of one segment of the intestine into another, leading to obstruction and potentially ischemia (1). While intussusception is relatively common in the pediatric population, it is considered a rare clinical entity in adults, accounting for only 1-5% of all cases and approximately 1% of intestinal obstructions in the adult population. The etiology, clinical presentation, and management of adult intussusception differ significantly from pediatric cases, necessitating a distinct clinical approach (2).\n\nIn contrast to children, where most cases are idiopathic, adult intussusception is commonly associated with an underlying pathological lead point. In approximately 70-90% of adult cases, a structural lesion can be identified as the cause of the intussusception (3). These lesions may be benign or malignant in nature and understanding the incidence of each is important for appropriate diagnosis and treatment planning (4).\n\nIn general, intussusceptions involving the small intestine are more likely to be caused by benign lesions such as lipomas, polyps, or Meckel's diverticulum, whereas those involving the colon have a higher likelihood of being associated with malignancy, especially primary adenocarcinoma (5).\n\nAdult intussusception poses a diagnostic challenge due to its nonspecific and often chronic symptoms, which may include intermittent abdominal pain, nausea, vomiting, gastrointestinal bleeding, or signs of partial bowel obstruction (6).\n\nThe advent of advanced imaging techniques, particularly abdominal computed tomography (CT), has improved the preoperative diagnosis of this condition (7). However, surgical exploration remains the definitive diagnostic and therapeutic modality, especially given the high probability of underlying malignancy (8).\n\nDespite advancements in diagnostic imaging and surgical techniques, there remains a lack of general agreement regarding the optimal management of adult intussusception, particularly concerning the necessity and extent of bowel resection when a benign cause is suspected (9). Moreover, data on the relative incidence of benign versus malignant causes vary widely across regions, institutions, and populations.\n\nThis study aims to evaluate adult intussecption, prevalence of benign versus malignant causes in AUH."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'a. Inclusion criteria:\n\n* Age ≥ 19 years.\n\n • Confirmed diagnosis of intussusception by: Imaging (CT , ultrasound , or barium studies) Intraoperative findings,\n * Patients managed surgically with documented follow-up and final diagnosis. b. Exclusion criteria:\n * Patients with incomplete records or lost to follow-up\n* Intussusception diagnosed radiologically but resolved spontaneously without confirmatory intervention or follow-up'}, 'identificationModule': {'nctId': 'NCT07238166', 'briefTitle': 'Benign Versus Malignant Causes of Intussuception in Adults', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Benign Versus Malignant Causes of Intussuception in Adults : A Prospective Study in Assiut University Hospital', 'orgStudyIdInfo': {'id': 'Intussusception in adult'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Adult patient with intussusception', 'description': 'Adult patient with intussusception will undergo surgical resection followed byhistopathological evaluation to determine the underlying causes ( benign or malignant )', 'interventionNames': ['Procedure: surgical resection and histopathological examination']}], 'interventions': [{'name': 'surgical resection and histopathological examination', 'type': 'PROCEDURE', 'description': 'Adult patient diagnosed with intussusception will undergo surgical resection of affected bowel segment under general anathesia . the resected specimens will be sent for histopathological evalution to determine the underlying cause , whether benign (e.g lipoma , polyp )or malignant (e.g adenocarcinama , lymphoma ). operative finding , postoperative outcome , and pathology results will be recorded and analyzed', 'armGroupLabels': ['Adult patient with intussusception']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'contacts': [{'name': 'Andrew gamal fikry, MBBCh, MSc (general surgury)', 'role': 'CONTACT', 'email': 'gamalandrew751@gmail.com', 'phone': '+201224173419'}], 'facility': 'Department of general surgury Assiut uneversity hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Andrew gamal fikry, MBBCH, MSc ( general surgury )', 'role': 'CONTACT', 'email': 'gamalandrew751@gmail.com', 'phone': '+201224173419'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Andrew gamal fikry', 'investigatorAffiliation': 'Assiut University'}}}}