Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-24 @ 2:17 AM
Study NCT ID:
NCT06753968
Status:
COMPLETED
Last Update Posted:
2024-12-31
First Post:
2024-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Natural Orifice Specimen Extraction Surgery (NOSES) in Treating Right-sided 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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 349}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-22', 'studyFirstSubmitDate': '2024-12-22', 'studyFirstSubmitQcDate': '2024-12-22', 'lastUpdatePostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'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)'}], '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': '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', 'totallly laparoscopic right hemicolectomy', 'natural orifice specimen extraction surgery'], 'conditions': ['Colon Cancer']}, 'referencesModule': {'references': [{'pmid': '31362128', 'type': 'RESULT', 'citation': 'Li XW, Wang CY, Zhang JJ, Ge Z, Lin XH, Hu JH. Short-term efficacy of transvaginal specimen extraction for right colon cancer based on propensity score matching: A retrospective cohort study. Int J Surg. 2019 Dec;72:102-108. doi: 10.1016/j.ijsu.2019.07.025. Epub 2019 Jul 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the short-term and long-term outcomes between natural orifice specimen extraction surgery (NOSES) and totally laparoscopic right hemicolectomy (TLRH). The hypothesis is that NOSES could achieve good short-term and oncological outcomes for right colon cancer patients.', 'detailedDescription': 'This study is a retrospective clinical study. We reviewed collected data from all patients who underwent laparoscopic curative resection for stage I-III right-sided colon cancer between January 2018 and January 2023. A total of consecutive 115 patients who underwent laparoscopic resection with transvaginal or transrectal specimen extraction were identified as the NOSES group. To establish a comparative cohort, 234 patients who underwent totally laparoscopic right hemicolectomy (TLRH) during the same period were selected. The purpose of this study is to investigate the short-term and long-term outcomes between NOSES and TLRH. The hypothesis is that NOSES could promote postoperative recovery, reduce incision-related complications with comaprable long-term oncological outcomes when compared with TLRH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 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. 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': 'NCT06753968', 'briefTitle': 'The Role of Natural Orifice Specimen Extraction Surgery (NOSES) in Treating Right-sided Colon Cancer', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Center, China'}, 'officialTitle': 'The Role of Natural Orifice Specimen Extraction Surgery (NOSES) in Treating Right-sided Colon Cancer', 'orgStudyIdInfo': {'id': 'NOSES for right hemicolectomy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laparoscopic Right Hemicolectomy With Transrectal/transvaginal Specimen Extraction (NOSES)', 'description': 'The NOSES group employs two distinct methods for specimen extraction, both of which have been thoroughly outlined in previous studies. The first method, transvaginal extraction, begins with the irrigation and disinfection of the vagina, followed by a transverse incision in the posterior fornix. The assistant then utilizes oval forceps to carefully extract the specimen bag through the incision, which is subsequently closed with continuous full-thickness sutures, using barbed sutures to ensure secure closure. The second method, transrectal extraction, similarly begins with irrigation of the rectum using a dilute iodine solution, followed by a longitudinal incision along the anterior wall of the upper rectum. The specimen, along with the protective sleeve, is then removed using oval forceps, and the incision is closed with a continuous full-layer running suture once the specimen has been completely extracted.', 'interventionNames': ['Procedure: Laparoscopic Right Hemicolectomy With Transrectal/transvaginal Specimen Extraction (NOSES)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Totally Laparoscopic Right Hemicolectomy (TLRH)', 'description': 'Totally Laparoscopic Right Hemicolectomy (TLRH), which involves performing intracorporeal anastomosis and specimen extraction through a small abdominal incision, enhances the benefits of minimally invasive surgery In the TLRH group, following the stapled side-to-side anastomosis, a small horizontal incision is made about 2 to 3 cm above the symphysis pubis, at the junction of the pubic hairline, to allow for specimen removal.', 'interventionNames': ['Procedure: Totally laparoscopic right hemicolectomy (TLRH)']}], 'interventions': [{'name': 'Laparoscopic Right Hemicolectomy With Transrectal/transvaginal Specimen Extraction (NOSES)', 'type': 'PROCEDURE', 'description': 'Transvaginal extraction, begins with the irrigation and disinfection of the vagina, followed by a transverse incision in the posterior fornix. The assistant then utilizes oval forceps to carefully extract the specimen bag through the incision, which is subsequently closed with continuous full-thickness sutures, using barbed sutures to ensure secure closure. Similarly, transrectal extraction begins with irrigation of the rectum using a dilute iodine solution, followed by a longitudinal incision along the anterior wall of the upper rectum. The specimen, along with the protective sleeve, is then removed using oval forceps, and the incision is closed with a continuous full-layer running suture once the specimen has been completely extracted.', 'armGroupLabels': ['Laparoscopic Right Hemicolectomy With Transrectal/transvaginal Specimen Extraction (NOSES)']}, {'name': 'Totally laparoscopic right hemicolectomy (TLRH)', 'type': 'PROCEDURE', 'description': 'Totally laparoscopic right hemicolectomy (TLRH), which involves performing intracorporeal anastomosis and specimen extraction through a small abdominal incision, further enhances the benefits of minimally invasive surgery. In the TLRH group, following the stapled side-to-side anastomosis, a small horizontal incision is made about 2 to 3 cm above the symphysis pubis, at the junction of the pubic hairline, to allow for specimen removal.', 'armGroupLabels': ['Totally Laparoscopic Right Hemicolectomy (TLRH)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'National Cancer Center, Beijing, Beijing 100000', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, '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': 'Professor Haitao Zhou', 'investigatorFullName': 'Haitao Zhou', 'investigatorAffiliation': 'National Cancer Center, China'}}}}