Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT05841069
Status:
UNKNOWN
Last Update Posted:
2023-05-03
First Post:
2023-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Short and Prolonged Conservative Treatment in Patients With Adhesive Intestinal Obstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072700', 'term': 'Conservative Treatment'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking is expected due to the nature of interventions'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter controlled randomized prospective study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-21', 'studyFirstSubmitDate': '2023-04-11', 'studyFirstSubmitQcDate': '2023-04-21', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non-operative treatment success', 'timeFrame': '72 hours', 'description': 'Frequency of non-operative intestinal obstruction resolution'}], 'secondaryOutcomes': [{'measure': 'Overall mortality', 'timeFrame': 'up to 30 days', 'description': 'Number of patients, died during hospitalization'}, {'measure': 'Postoperative complications', 'timeFrame': 'up to 30 days', 'description': 'Number and variety of postoperative complications in patients, who underwent surgery'}, {'measure': 'Resectional interventions', 'timeFrame': 'up to 30 days', 'description': 'Number of patients, who underwent surgery, including small bowel resection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute adhesive intestinal obstruction, conservative treatment'], 'conditions': ['Small Bowel Obstruction', 'Small Bowel Adhesion']}, 'descriptionModule': {'briefSummary': 'This study will compare the results of 24 h conservative treatment and N h conservative treatment of adhesive small bowel obstruction (where N = 72 h minus duration of intestinal obstruction).', 'detailedDescription': 'Patients with acute adhesive intestinal obstruction, who dont need an emergency operation, will be given water insoluble contrast per os and randomized into two groups - early and delayed surgery. The first group will receive conservative treatment within no more than 24 h. Duration of non-operative treatment in second group will be 72 h minus duration of intestinal obstruction, based on the onset of symptoms. In both groups surgery will be performed if contrast will not reach colon in mentioned terms or clinical deterioration signs will appear. The results of 24 h conservative treatment and N h conservative treatment (where N = 72 h minus duration of intestinal obstruction) will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with acute intestinal obstruction\n\nExclusion Criteria:\n\n* pregnancy;\n* peritonitis or strangulation, revealed during primary examination;\n* early acute small bowel obstruction (presence of anamnestic surgical intervention within 6 month)'}, 'identificationModule': {'nctId': 'NCT05841069', 'briefTitle': 'Short and Prolonged Conservative Treatment in Patients With Adhesive Intestinal Obstruction', 'organization': {'class': 'OTHER', 'fullName': 'North-Western State Medical University named after I.I.Mechnikov'}, 'officialTitle': 'Multicenter Controlled Randomized Prospective Study of the Comparative Efficacy of Early and Delayed Surgical Interventions in Patients With Acute Adhesive Intestinal Obstruction', 'orgStudyIdInfo': {'id': '24121989'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Short conservative treatment', 'description': 'Conservative treatment will be performed within no more than 24 h. Surgery will be performed in the absence of contrast in colon according to X-ray examination and if signs of clinical degradation will appear.', 'interventionNames': ['Procedure: Adhesiolysis', 'Radiation: X-ray examination', 'Procedure: Conservative treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Prolonged conservative treatment', 'description': 'Conservative treatment will be performed within N h, where N = 72 h minus duration of acute intestinal obstruction. Surgery will be performed in the absence of contrast in colon according to X-ray examination and if signs of clinical degradation will appear.', 'interventionNames': ['Procedure: Adhesiolysis', 'Radiation: X-ray examination', 'Procedure: Conservative treatment']}], 'interventions': [{'name': 'Adhesiolysis', 'type': 'PROCEDURE', 'description': 'Median laparotomy with subsequent detection of intestinal obstruction cause and adhesiolysis.', 'armGroupLabels': ['Prolonged conservative treatment', 'Short conservative treatment']}, {'name': 'X-ray examination', 'type': 'RADIATION', 'description': 'Plain X-ray of abdomen (1-4 times) with water insoluble contrast.', 'armGroupLabels': ['Prolonged conservative treatment', 'Short conservative treatment']}, {'name': 'Conservative treatment', 'type': 'PROCEDURE', 'description': 'A set of measures aimed at non-operative resolution of acute intestinal obstruction - nasogastric tube, infusion therapy.', 'armGroupLabels': ['Prolonged conservative treatment', 'Short conservative treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Mikhail A Protchenkov, PhD', 'role': 'CONTACT'}], 'facility': '26 City Hospital', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Badri V Sigua, MD', 'role': 'CONTACT', 'email': 'dr.sigua@gmail.com', 'phone': '+79111979343'}], 'facility': 'North-Western State Medical University named after I. I. Mechnikov', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Aleksei V Osipov, MD', 'role': 'CONTACT', 'email': 'osipov@emergency.spb.ru', 'phone': '+79219338603'}], 'facility': 'Saint-Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Pavel A Kotkov, PhD', 'role': 'CONTACT', 'email': 'kotkovdr@mail.ru', 'phone': '+79062619231'}], 'facility': 'The City Hospital of the Holy Martyr Elizabeth', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}], 'centralContacts': [{'name': 'Pavel A Kotkov, PhD', 'role': 'CONTACT', 'email': 'kotkovdr@mail.ru', 'phone': '+79062619231'}, {'name': 'Badri V Sigua, MD', 'role': 'CONTACT', 'email': 'dr.sigua@gmail.com', 'phone': '+79111979343'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'North-Western State Medical University named after I.I.Mechnikov', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, surgery department assistant', 'investigatorFullName': 'Kotkov Pavel', 'investigatorAffiliation': 'North-Western State Medical University named after I.I.Mechnikov'}}}}