Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-27 @ 5:34 AM
Study NCT ID:
NCT05034692
Status:
RECRUITING
Last Update Posted:
2022-10-24
First Post:
2021-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of Overlap Method to Digestive Tract Reconstruction of Totally Laparoscopic Left Colectomy
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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-20', 'studyFirstSubmitDate': '2021-02-06', 'studyFirstSubmitQcDate': '2021-08-29', 'lastUpdatePostDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of early complications', 'timeFrame': 'one month after surgery', 'description': 'According to Clavein Dindo grading standards（The scale is divided into four levels, with the minimum（Ⅰ） and the maximum（Ⅳ） level. The higher the level that more severe symptoms.）, the incidence of complications within one month after surgery, such as incision infection, bleeding, anastomotic leakage, ileus, etc., was counted'}], 'secondaryOutcomes': [{'measure': 'anastomotic orifice stricture and torsion', 'timeFrame': 'one month after surgery', 'description': 'According to results of intestinal barium contrast, colonoscopy and clinical symptoms to judgment'}, {'measure': 'the time of first flatus', 'timeFrame': 'one month after surgery', 'description': 'Observation of patients exhaust on days after operation'}, {'measure': 'the time of first defecation', 'timeFrame': 'one month after surgery', 'description': 'Observation of patients bowl movement on days after operation'}, {'measure': 'the time of first oral feeding', 'timeFrame': 'one month after surgery', 'description': 'Observation of patients oral intake on days after operation'}, {'measure': 'postoperative hospitalization days', 'timeFrame': 'one month after surgery', 'description': 'Observation of patients hospitalization duration on days post-surgery'}, {'measure': 'the incision length and cosmetic', 'timeFrame': 'one month after surgery', 'description': 'Comparing length and cosmetic of two groups measuring with metric'}, {'measure': 'pain score', 'timeFrame': 'postoperative 6 hours, the first day and the third day', 'description': 'Estimate for pain of subject By Visual Analog Scale for Pain (VAS Pain，The scale is divided into four levels, with the minimum（1 score） and the maximum（10 score） level. The higher the level that more severe pain.)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colon Neoplasm']}, 'descriptionModule': {'briefSummary': 'Objective:The comparison between total laparoscopic colectomy with intracorporeal anastomosis by overlap method and laparoscopic-assisted colectomy with extracorporeal anastomosis for colon cancer surgery.\n\nCondition or disease：Left colon cancer Intervention/treatment： Procedure:Intracorporeal left colectomy Overlap anastomosis Procedure: Extracorporeal left colectomy convention anastomosis', 'detailedDescription': 'This a simple randomized, single-center, single-blind, randomized controlled trial study.The patients were randomly divided into experimental groups and control groups by computer.The perioperative recovery data, complications and oncology index of total laparoscopic colectomy with intracorporeal anastomosis and laparoscopic-assisted colectomy with extracorporeal anastomosis would be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA\\<3 classification\n* 18kg/m2≤BMI≤30kg/m2\n* Neoplasm staging is T1-4a, N0-2, M0\n* No previous history of abdominal surgery\n* No previous history of neoplasm chemoradiotherapy\n* No status of ileus, bowel obstruction and active hemorrhage of the digestive tract\n\nExclusion Criteria:\n\n* Age\\<18 years or \\>75 years\n* ASA≥3 classification\n* BMI\\<18kg/m2 or BMI\\>30kg/m2\n* Neoplasm staging is T4b or M1 Underwent chemoradiotherapy Appeared status of ileus,bowel perforation or active hemorrhage of digestive tract Patients with pregnant'}, 'identificationModule': {'nctId': 'NCT05034692', 'briefTitle': 'Application of Overlap Method to Digestive Tract Reconstruction of Totally Laparoscopic Left Colectomy', 'organization': {'class': 'OTHER', 'fullName': 'Tang-Du Hospital'}, 'officialTitle': 'Application of Overlap Method to Digestive Tract Reconstruction of Totally Laparoscopic Left Colectomy', 'orgStudyIdInfo': {'id': 'K202012-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Overlap group', 'description': 'Total laparoscopic with intracorporeal anastomosis by overlap method', 'interventionNames': ['Procedure: Total laparoscopic with intracorporeal anastomosis by overlap method']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional group', 'description': 'Laparoscopic-assisted colectomy with extracorporeal anastomosis', 'interventionNames': ['Procedure: Laparoscopic-assisted colectomy with extracorporeal anastomosis']}], 'interventions': [{'name': 'Total laparoscopic with intracorporeal anastomosis by overlap method', 'type': 'PROCEDURE', 'description': 'After the intestinal canal was dissociated and vascularized, the intestinal canal was nuded and cut off, and the distal and proximal intestinal canals were overlapped by 6 cm', 'armGroupLabels': ['Overlap group']}, {'name': 'Laparoscopic-assisted colectomy with extracorporeal anastomosis', 'type': 'PROCEDURE', 'description': 'After the corresponding colon and blood vessels were dissociated and treated, the carbon dioxide pneumoperitoneum was removed. The appropriate length of the incision was cut at the corresponding position of the abdomen, and the incision protector was placed. The tumor was lifted together with the free intestinal canal to the outside of the abdomen. The intestinal canals at the quasi-dismembered sites on both sides of the tumor were nuded, and the colon-colon functional end-to-end anastomosis was performed.', 'armGroupLabels': ['Traditional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710000', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wang Nan, Doctor', 'role': 'CONTACT', 'email': 'wangnandoc@163.com', 'phone': '0086-029-84778829'}, {'name': 'Nan Wang, Master', 'role': 'CONTACT', 'email': '1620544187@qq.com', 'phone': '0086-029-84717400'}], 'facility': 'General Surgery Gastrointestinal Department，Tang-Du of Fourth Military Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Nan Wang, Doctor', 'role': 'CONTACT', 'email': 'wangnandoc@163.com', 'phone': '0086-029-84778829'}, {'name': 'Nan Wang, Master', 'role': 'CONTACT', 'email': '1620544187@qq.com', 'phone': '0086-029-84717400'}], 'overallOfficials': [{'name': 'Wang Nan, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'General surgery ,Tang Du of Fourth Military Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tang-Du Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}