Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2026-01-03 @ 9:34 PM
Study NCT ID:
NCT02117557
Status:
UNKNOWN
Last Update Posted:
2014-04-21
First Post:
2014-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Transumbilical Single Incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'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'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 198}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-04-17', 'studyFirstSubmitDate': '2014-04-16', 'studyFirstSubmitQcDate': '2014-04-17', 'lastUpdatePostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early morbidity rate', 'timeFrame': '30 days', 'description': 'The early morbidity rate is defined as the event observed during operation and within 30 days after surgery,'}], 'secondaryOutcomes': [{'measure': 'Operative outcomes', 'timeFrame': 'intraoperative', 'description': 'Operative time, estimated blood loss and incision length are recorded.'}, {'measure': 'Pathological outecomes', 'timeFrame': '5 days', 'description': 'Tumor size, length of proximal and distal margin and lymph nodes harvested are used to assess oncological resection.'}, {'measure': 'Postoperative recovery course', 'timeFrame': '14 days', 'description': 'Time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay are used to assess the postoperative recoverty course.'}, {'measure': 'Pain score', 'timeFrame': '14 days', 'description': 'Postoperative pain is recorded using the visual analog scale (VAS) pain score tool on postoperative day 1, 2, 3 and the day of discharge.'}, {'measure': 'Cosmetic assessment', 'timeFrame': '14 days', 'description': 'Cosmetic assessment is perform using body image scale and cosmetic scale.'}, {'measure': '3-year disease free survival rate', 'timeFrame': '36 months'}, {'measure': '5-year overall survival rate', 'timeFrame': '60 months'}, {'measure': 'Inflammatory and immune response', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Single-incision', 'Laparoscopy', 'Colorectal Cancer'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '19966617', 'type': 'BACKGROUND', 'citation': 'Bucher P, Pugin F, Morel P. Single-port access laparoscopic radical left colectomy in humans. Dis Colon Rectum. 2009 Oct;52(10):1797-801. doi: 10.1007/DCR.0b013e3181b551ce.'}, {'pmid': '20734083', 'type': 'BACKGROUND', 'citation': 'Gash KJ, Goede AC, Chambers W, Greenslade GL, Dixon AR. Laparoendoscopic single-site surgery is feasible in complex colorectal resections and could enable day case colectomy. Surg Endosc. 2011 Mar;25(3):835-40. doi: 10.1007/s00464-010-1275-8. Epub 2010 Aug 24.'}, {'pmid': '22991135', 'type': 'BACKGROUND', 'citation': 'Lim SW, Kim HJ, Kim CH, Huh JW, Kim YJ, Kim HR. Umbilical incision laparoscopic colectomy with one additional port for colorectal cancer. Tech Coloproctol. 2013 Apr;17(2):193-9. doi: 10.1007/s10151-012-0900-z. Epub 2012 Sep 19.'}, {'pmid': '23238505', 'type': 'BACKGROUND', 'citation': 'Hirano Y, Hattori M, Douden K, Shimizu S, Sato Y, Maeda K, Hashizume Y. Single-incision plus one port laparoscopic anterior resection for rectal cancer as a reduced port surgery. Scand J Surg. 2012;101(4):283-6. doi: 10.1177/145749691210100411.'}, {'pmid': '38062421', 'type': 'DERIVED', 'citation': 'Zhang X, Yuan H, Tan Z, Li G, Xu Z, Zhou J, Fu J, Wu M, Xi J, Wang Y. Long-term outcomes of single-incision plus one-port laparoscopic surgery versus conventional laparoscopic surgery for rectosigmoid cancer: a randomized controlled trial. BMC Cancer. 2023 Dec 7;23(1):1204. doi: 10.1186/s12885-023-11500-2.'}, {'pmid': '30006846', 'type': 'DERIVED', 'citation': 'Wang Y, Deng H, Mou T, Li J, Liu H, Zhou H, Li G. Short-term outcomes of single-incision plus one-port laparoscopic versus conventional laparoscopic surgery for rectosigmoid cancer: a randomized controlled trial. Surg Endosc. 2019 Mar;33(3):840-848. doi: 10.1007/s00464-018-6350-6. Epub 2018 Jul 13.'}, {'pmid': '26620555', 'type': 'DERIVED', 'citation': 'Wang Y, Liu R, Zhang Z, Xue Q, Yan J, Yu J, Liu H, Zhao L, Mou T, Deng H, Li G. A safety study of transumbilical single incision versus conventional laparoscopic surgery for colorectal cancer: study protocol for a randomized controlled trial. Trials. 2015 Nov 30;16:539. doi: 10.1186/s13063-015-1067-5.'}]}, 'descriptionModule': {'briefSummary': "* Compared with traditional open colectomy, laparoscopic surgery is associated with less pain, earlier recovery, and better cosmetic outcome, and its short- and long-term oncologic outcomes have been demonstrated.\n* In experienced surgeons' hands, single incision laparoscopic surgery is increasingly performed for colorectal disease, and even for malignant lesion because of its reduced incision-associated morbidity and scarring.\n* However, the safety and efficacy of single incision laparoscopic surgery for colorectal cancer has not yet been evaluated. Thus, the prospective randomized trial comparing single incision versus conventional laparoscopic surgery for colorectal cancer is needed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years \\< age \\< 80 years\n* Tumor located in rectosigmoid (defined as 10- to 30-cm from the anal verge)\n* Pathological rectosigmoid carcinoma\n* Preoperative T stage ranging from T1 to T4a according to the 7th Edition of AJCC Cancer Staging Manual\n* Tumor size of 5 cm or less; 6) ECOG score is 0-1\n* ASA socre is Ⅰ-Ⅲ\n* Informed consent\n\nExclusion Criteria:\n\n* Body mass index (BMI) \\>30 kg/m2\n* Pregnant woman or lactating woman\n* Severe mental disease\n* Previous abdominal surgery\n* Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer\n* Requirement of simultaneous surgery for other disease'}, 'identificationModule': {'nctId': 'NCT02117557', 'briefTitle': 'Safety Study of Transumbilical Single Incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'A Prospective Randomized Controlled Trial Comparing Transumbilical Single Incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer', 'orgStudyIdInfo': {'id': 'NFGS-SILS-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single incision laparoscopic surgery', 'description': 'Transumbilical single incision laparoscopic surgery will be performed for patients in this group.And addition of only one trocar through the stoma for drainage tube is allowed.', 'interventionNames': ['Procedure: Single incision laparoscopic surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional laparoscopic surgery', 'description': 'Conventional laparoscopic surgery for colorectal cancer will be performed for patients in this group.', 'interventionNames': ['Procedure: Conventional laparoscopic surgery']}], 'interventions': [{'name': 'Single incision laparoscopic surgery', 'type': 'PROCEDURE', 'otherNames': ['SILS'], 'armGroupLabels': ['Single incision laparoscopic surgery']}, {'name': 'Conventional laparoscopic surgery', 'type': 'PROCEDURE', 'otherNames': ['CLS'], 'armGroupLabels': ['Conventional laparoscopic surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510-515', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guoxin Li, M.D.,PH.D.', 'role': 'CONTACT', 'email': 'gzliguoxin@163.com', 'phone': '+86-138-0277-1450'}, {'name': 'Guoxin Li, M.D.,PH.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yanan Wang, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Haijun Deng, M.D.,PH.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Qi Xue, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Nanfang Hospital, Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Guoxin Li, M.D., PH.D.', 'role': 'CONTACT', 'email': 'gzliguoxin@163.com', 'phone': '+86-138-0277-1450'}, {'name': 'Yanan Wang, M.D.', 'role': 'CONTACT', 'email': 'wyn8116@163.com', 'phone': '+86-150-1875-3181'}], 'overallOfficials': [{'name': 'Guoxin Li, M.D., PH.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanfang Hospital, Southern Medical University, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guoxin Li', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'M.D., Ph.D.', 'investigatorFullName': 'Guoxin Li', 'investigatorAffiliation': 'Nanfang Hospital, Southern Medical University'}}}}