Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT06362902
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction for Colon Cancer
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 37}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-08', 'studyFirstSubmitDate': '2024-04-08', 'studyFirstSubmitQcDate': '2024-04-08', 'lastUpdatePostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of postoperative complications', 'timeFrame': 'up to 30 days', 'description': 'The rate of postoperative complications = patients with any postoperative complications/all cases.'}], 'secondaryOutcomes': [{'measure': 'Operating time', 'timeFrame': 'up to 1 days', 'description': 'Operating time = The Operative time was defined as the time first skin incision was made to final skin closure'}, {'measure': 'Estimated blood loss', 'timeFrame': 'up to 1 days', 'description': 'Estimated blood loss = The sum of the blood in the suction canister (the total volume after subtracting the amount of irrigation fluid used) and the segment of increased weight of swabs used during operation phase (1 ml of blood is about weighs 1g)'}, {'measure': 'The time of first flatus', 'timeFrame': 'up to 5 days', 'description': 'The time of first flatus = The time of first flatus reported by patients'}, {'measure': 'Postoperative hospitalization', 'timeFrame': 'up to 30 days', 'description': 'Postoperative hospitalization = the number of nights from surgery to discharge'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colon cancer', 'Laparoscopic Right Hemicolectomy', 'Natural orifice specimen extraction surgery'], 'conditions': ['Colon Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the preliminary surgical outcomes of laparoscopic right hemicolectomy with transrectal specimen extraction. The hypothesis is that this type of natural orifice specimen extraction surgery (NOSES) could achieve good short-term and oncological outcomes for right colon cancer patients.', 'detailedDescription': 'This study is a prospective single-arm clinical study. 37 patients with right colon cancer undergoing laparoscopic right hemicolectomy with transrectal specimen extraction are planned to be included in the study. The purpose of this study is to investigate the preliminary surgical outcomes of laparoscopic right hemicolectomy with transrectal specimen extraction. The primary endpoint is the postoperative complications of this type of natural orifice specimen extraction surgery (NOSES). The primary hypothesis is that NOSES could reduce postoperative complications. In addition, operating time, intraoperative bleeding, post-operative recovery and quality of life (QoL) are secondary endpoints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Biopsy proven colon carcinoma;\n2. Imaging diagnosis of T1-3 colon cancer;\n3. The tumor located in the cecum, ascending colon, or colonic hepatic flexure;\n4. Maximal tumor diameter ≤5 cm;\n5. Body mass index (BMI) ≤30 kg/m2;\n6. Written informed consent;\n\nExclusion Criteria:\n\n1. Complete intestinal obstruction;\n2. Hepatitis activity and peripheral neuropathy (such as peripheral neuritis, pseudo meningitis, motor neuritis, and sensory impairment);\n3. Significant organ dysfunction or other significant diseases, including clinically relevant coronary artery disease, cardiovascular disease, or myocardial infarction within the 12 months before enrollment; severe neurological or psychiatric history; severe infection; active disseminated intravascular coagulation;\n4. Pregnancy or breastfeeding;\n5. Alcohol abuse or drug addiction;\n6. Concurrent uncontrolled medical condition;'}, 'identificationModule': {'nctId': 'NCT06362902', 'briefTitle': 'Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction for Colon Cancer', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Center, China'}, 'officialTitle': 'Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction for Colon Cancer', 'orgStudyIdInfo': {'id': 'NOSES-VIII B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction', 'description': 'STEP 1: Dissection and separation The mesentery and vessels were dissected and separated according to the principle of complete mesocolic excision.\n\nSTEP 2: Intracorporeal anastomosis An enterotomy was performed on the antimesenteric side of the ileum at the edge of the staple line. This maneuver was replicated on the transverse colic side. Subsequently, the cartridge jaw of the stapler was inserted into the transverse colon. The stapler was fired and withdrawn, and the common enterotomy was sealed by using another linear stapler.\n\nSTEP 3: Transrectal specimen extraction A longitudinal incision was made on the anterior of wall of the upper rectum. The assistant employed oval forceps to extract the specimen along with the protective sleeve through the incision in the upper rectum. After the complete extraction of the specimen, a full-layer running suturing was performed to close the incision.', 'interventionNames': ['Procedure: Laparoscopic right hemicolectomy with transrectal specimen extraction']}], 'interventions': [{'name': 'Laparoscopic right hemicolectomy with transrectal specimen extraction', 'type': 'PROCEDURE', 'description': 'Laparoscopic right hemicolectomy with transrectal specimen extraction', 'armGroupLabels': ['Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haitao Zhou, M.D.', 'role': 'CONTACT', 'email': 'zhouhaitao01745@163.com', 'phone': '+8613381167333'}, {'name': 'Yueyang Zhang, M.D.', 'role': 'CONTACT', 'email': 'yyzhang0129@163.com', 'phone': '+8613552910035'}], 'facility': 'National Cancer Center', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Zheng Xu, M.D.', 'role': 'CONTACT', 'email': '1206164395@qq.com', 'phone': '+8618800157037'}, {'name': 'Yueyang Zhang, M.D.', 'role': 'CONTACT', 'email': 'yyzhang0129@163.com', 'phone': '+8613552910035'}], 'overallOfficials': [{'name': 'Haitao Zhou, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'National Cancer Center, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Participants' data are only allowed to be used for the analysis of this study and are not authorized to be shared with other researchers."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Center, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Haitao Zhou', 'investigatorAffiliation': 'National Cancer Center, China'}}}}