Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-05 @ 1:35 PM
Study NCT ID:
NCT05923151
Status:
COMPLETED
Last Update Posted:
2023-06-28
First Post:
2023-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Cranial-caudal Mixed Medial Approach for Laparoscopic Right Hemicolectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-19', 'studyFirstSubmitDate': '2023-06-09', 'studyFirstSubmitQcDate': '2023-06-19', 'lastUpdatePostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of lymph nodes cleaned', 'timeFrame': '3-5 days after surgery', 'description': 'Number of lymph node dissection'}, {'measure': 'Anastomotic leakage', 'timeFrame': 'Within 30 days after surgery', 'description': 'Positive bacterial culture in peritoneal drainage fluid'}, {'measure': 'Liver failure', 'timeFrame': 'Within 30 days after surgery', 'description': 'ASL and ALT indicators in liver function examination'}, {'measure': 'Renal failure', 'timeFrame': 'Within 30 days after surgery', 'description': 'BUN and Cr indicators in renal function examination'}], 'primaryOutcomes': [{'measure': 'The operative time', 'timeFrame': 'Surgery start (skin incision time) - Surgery end (suture incision end time)', 'description': 'The length of operative time'}], 'secondaryOutcomes': [{'measure': 'Intraoperative blood loss', 'timeFrame': 'Surgery start (skin incision time) - Surgery end (suture incision end time)', 'description': 'Measurement by gauze transfusion weighing method: soaked 32cm × A 20cm sized gauze loses approximately 30ml of blood; Soak 36cm × A 36cm sized gauze loses approximately 50ml of blood.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intraoperative Blood Loss', 'Postoperative Complications', 'Pathology']}, 'descriptionModule': {'briefSummary': 'To explore the feasibility and effectiveness of the cranial-caudal mixed medial approach in laparoscopic right hemicolectomy with complete mesocolic excision. Laparoscopic right hemicolectomy using the cranial-caudal mixed medial approach is safe and feasible, can shorten the operation time, reduce the risk of intraoperative bleeding, and has good clinical results.', 'detailedDescription': "The data of patients undergoing laparoscopic right hemicolectomy performed in the same surgical group of gastrointestinal surgery at Northern Jiangsu People's Hospital from February 2017 to June 2022 were retrospectively analyzed. According to different surgical approaches, patients were divided into the cranial-caudal mixed medial approach group and the medial approach group.\n\nIntraoperative and postoperative data were collected. Intraoperative data is obtained through surgical records and pathological reports, including total operation time, Laparoscopic procedure time, Intraoperative blood loss, sample length, number of lymph nodes collected, and number of positive lymph nodes. Postoperative data includes exhaust time, liquid intake time, postoperative hospitalization and complications. Among them, complications are short-term postoperative complications (surgical related complications, non-surgical related complications) within the first 30 days after surgery (or throughout the hospitalization period, if more than 30 days, and are classified according to the Clavien-Dindo classification method.\n\nTo explore the feasibility and effectiveness of the cranial-caudal mixed medial approach in laparoscopic right hemicolectomy with complete mesocolic excision."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age range: 18-70 years old\n* Right colon cancer confirmed by colonoscopy and pathological diagnosis\n* Single primary tumor without distal metastasis\n* Laparoscopic operation\n\nExclusion Criteria:\n\n* Age below 18 and above 70 years old\n* Patients who need urgent surgery\n* Persons with a history of malignant tumors\n* Multiple primary tumors or distant metastases'}, 'identificationModule': {'nctId': 'NCT05923151', 'briefTitle': 'The Cranial-caudal Mixed Medial Approach for Laparoscopic Right Hemicolectomy', 'organization': {'class': 'OTHER', 'fullName': "Subei People's Hospital of Jiangsu Province"}, 'officialTitle': 'Techniques and Advantages of the Cranial-caudal Mixed Medial Approach for Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision', 'orgStudyIdInfo': {'id': 'SubeiH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The cranial-caudal mixed medial approach group', 'description': '75 patients were diagnosed with right colon cancer and underwent the cranial-caudal mixed medial approach for laparoscopic right hemicolectomy with complete mesocolic excision.', 'interventionNames': ['Procedure: The cranial-caudal mixed medial approach']}, {'type': 'OTHER', 'label': 'the medial approach group', 'description': '73 patients were diagnosed with right colon cancer and underwent the medial approach for laparoscopic right hemicolectomy with complete mesocolic excision.', 'interventionNames': ['Procedure: The cranial-caudal mixed medial approach']}], 'interventions': [{'name': 'The cranial-caudal mixed medial approach', 'type': 'PROCEDURE', 'description': 'Expose the fusion fascia of Transverse colon mesocolon and stomach, and cut the gastrocolic ligament. The mesentery of Transverse colon was dissociated from the medial side to the lateral side along the gastroepiploic vessels to expose the branches of Henle\'s trunk and the right colon vessels. The dorsal mesentery of the small intestine is cut along the "yellow white line", and free cephalically along the Toldt space to separate the posterior space of the Ascending colon and the anterior space of the pancreas and duodenum behind the Transverse colon. The right colon blood vessels were dissected along SMV from the projection of ileocolic blood vessels, and the blood vessels were cut off by high ligation, and the lymph nodes at the root of Mesentery were cleared. Through a small incision in the middle of the abdomen, the right colon and mesentery were completely removed to complete digestive tract reconstruction.', 'armGroupLabels': ['The cranial-caudal mixed medial approach group', 'the medial approach group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '225000', 'city': 'Yangzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': "Subei People's Hospital", 'geoPoint': {'lat': 32.39722, 'lon': 119.43583}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jie Wang', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yangzhou University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jie Wang', 'investigatorAffiliation': "Subei People's Hospital of Jiangsu Province"}}}}