Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-29 @ 2:07 AM
Study NCT ID:
NCT05026268
Status:
UNKNOWN
Last Update Posted:
2021-08-30
First Post:
2021-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic 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': 2}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-23', 'studyFirstSubmitDate': '2021-08-06', 'studyFirstSubmitQcDate': '2021-08-23', 'lastUpdatePostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative complications rate', 'timeFrame': '0 to 30 days', 'description': 'The incidence and structure of postoperative complications according to the Clavien-Dindo scale (I-grade - any deviation from the normal course of the postoperative course without the need for pharmacological, surgical, endoscopic or interventional radiological interventions. drugs that are acceptable include antiemetics, antipyretics, analgesics, diuretics, and electrolytes. In addition, this grade includes a wound infection "stopped at the patient\'s bedside", V grades - Death of the patient).'}], 'secondaryOutcomes': [{'measure': 'The level of postoperative pain', 'timeFrame': '0 to 10 days', 'description': 'The level of postoperative pain with using a visual analogue pain scale: The patient assesses the postoperative pain from 0 to 10 points (0 points - no pain, 10 - unbearable pain).'}, {'measure': 'The time of activation of patients', 'timeFrame': '0 to 10 days', 'description': 'We will estimate time to verticalization of patients.'}, {'measure': 'The amount of self-help of patients', 'timeFrame': '0 to 10 days', 'description': 'We will estimate the amount of self-help of patients on the Bartel scale. Total score - 100. Indicators from 0 to 20 points correspond to complete dependence, from 21 to 60 points - severe dependence, from 61 to 90 points - moderate, from 91 to 99 life points - light dependence in everyday life.'}, {'measure': 'The time to discharge from hospital', 'timeFrame': '0 to 30 days', 'description': 'We will count days of postoperativa hospital stay.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['right colon cancer', 'laparoscopic right colectomy', 'intracorporeal anastomosis'], 'conditions': ['Colon Cancer']}, 'descriptionModule': {'briefSummary': 'This is a randomized, controlled, "non-inferiority" trial to determine the non-difference in post-operative complications rate in laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis formation.', 'detailedDescription': 'The design involves random allocation of eligible patients to laparosopic colectomy with intracorporeal or extracorporeal anastomosis.\n\nPostoperative complications in both groups will be recorded in accordance with the Clavien-Dindo classification. The level of postoperative pain will be registred according to the visual analogue pain scale (VAS). Also the investigators will study the time of activation of patients, patient self-care scope according to the Bartell scale, postoperative hospital stay will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients age is 18 years and older\n* Patients with right colon cancer\n* Informed agreement\n\nExclusion Criteria:\n\n* Carcinomatosis\n* Primary tumor stage T4b\n* Refusal of anastomosis\n* Refusal of the patient to participate in the study'}, 'identificationModule': {'nctId': 'NCT05026268', 'acronym': 'LaRCIa', 'briefTitle': 'The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'State Scientific Centre of Coloproctology, Russian Federation'}, 'officialTitle': 'The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis', 'orgStudyIdInfo': {'id': '16/21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intracorporeal anastomosis', 'description': 'A laparoscopic right colectomy will be performed according to the surgeons standard practice with the intracorporeal anastomosis performing.', 'interventionNames': ['Procedure: intracorporeal anastomosis']}, {'type': 'NO_INTERVENTION', 'label': 'extracorporeal anastomosis', 'description': 'A laparoscopic right colectomy will be performed according to the surgeons standard practice.'}], 'interventions': [{'name': 'intracorporeal anastomosis', 'type': 'PROCEDURE', 'description': 'intracorporeal stapled "side-to-side" isoperistaltic anastomosis', 'armGroupLabels': ['Intracorporeal anastomosis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Sergey Achkasov, MD', 'role': 'CONTACT'}], 'facility': 'State Scientific Centre of Coloproctology, Russian Federation', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Sergey Achkasov, MD', 'role': 'CONTACT', 'email': 'achkasovy@mail.ru', 'phone': '89036710225'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State Scientific Centre of Coloproctology, Russian Federation', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}