Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2025-12-25 @ 11:53 AM
Study NCT ID:
NCT04527861
Status:
RECRUITING
Last Update Posted:
2022-10-10
First Post:
2020-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oncologic Outcomes of 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'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 710}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2029-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-07', 'studyFirstSubmitDate': '2020-08-19', 'studyFirstSubmitQcDate': '2020-08-21', 'lastUpdatePostDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-year disease free survival rate', 'timeFrame': '36 months after surgery', 'description': '3-year disease free survival rate'}], 'secondaryOutcomes': [{'measure': 'Operative time', 'timeFrame': 'intraoperative', 'description': 'Operative time（minutes）'}, {'measure': 'Intraoperative blood loss', 'timeFrame': 'intraoperative', 'description': 'Estimated blood loss（milliliters，ml）'}, {'measure': 'Incision length', 'timeFrame': 'intraoperative', 'description': 'Incision length（centimeters，cm）'}, {'measure': 'Total incision length', 'timeFrame': 'intraoperative', 'description': 'The sum of all incision lengths（centimeters，cm）'}, {'measure': 'Conversion rate', 'timeFrame': 'intraoperative', 'description': 'The proportion of converted to laparotomy and added trocars（%）'}, {'measure': 'Length of stay', 'timeFrame': '1-14 days after surgery', 'description': 'The postoperative day when patients complied with the predefined discharge criteria（days after surgery）'}, {'measure': 'Postoperative recovery course', 'timeFrame': '1-14 days after surgery', 'description': 'Time to first ambulation, flatus, liquid diet and semi-liquid diet （hours after surgery）'}, {'measure': 'Early morbidity rate', 'timeFrame': '30 days after surgery', 'description': 'morbidity rate 30 days after surgery'}, {'measure': 'Pain score', 'timeFrame': '1-3 days after surgery', 'description': 'Postoperative pain is recorded using the visual analog scale (VAS) pain score （0-10 points）tool on postoperative day 1, 2, 3'}, {'measure': 'Tumor size', 'timeFrame': '14 days after surgery', 'description': 'The diameter of tumors（centimeters，cm）'}, {'measure': 'Incisal margin', 'timeFrame': '14 days after surgery', 'description': 'Length of proximal and distal margin （centimeters，cm）'}, {'measure': 'Lymph node detection', 'timeFrame': '14 days after surgery', 'description': 'Lymph nodes harvested（numbers）'}, {'measure': 'Cosmetic effect', 'timeFrame': '1 month, 6 months and 1 year after surgery', 'description': 'Assessed using a "Beauty Questionnaire" evaluating patient\'s satisfaction according to a 5-scale score, ranging from \'\'Not satisfied at all\'\' to \'\'Very satisfied\'\''}, {'measure': 'The quality of life-Core', 'timeFrame': '1 month, 6 months and 1 year after surgery', 'description': 'European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)'}, {'measure': 'The quality of life-Colorectal', 'timeFrame': '1 month, 6 months and 1 year after surgery', 'description': 'European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29 (EORTC QLQ-CR29)'}, {'measure': '5-year overall survival rate', 'timeFrame': '60 months after surgery', 'description': '5-year overall survival rate'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['single-incision laparoscopic surgery', 'conventional laparoscopic surgery', 'colorectal cancer'], 'conditions': ['Colorectal Cancer', 'Colon Cancer', 'Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '30303873', 'type': 'BACKGROUND', 'citation': 'Maggiori L, Tuech JJ, Cotte E, Lelong B, Denost Q, Karoui M, Vicaut E, Panis Y. Single-incision Laparoscopy Versus Multiport Laparoscopy for Colonic Surgery: A Multicenter, Double-blinded, Randomized Controlled Trial. Ann Surg. 2018 Nov;268(5):740-746. doi: 10.1097/SLA.0000000000002836.'}, {'pmid': '32209897', 'type': 'BACKGROUND', 'citation': 'Lee YS, Kim JH, Kim HJ, Lee SC, Kang BM, Kim CW, Lim SW, Lee SH, Kim JG. Short-term Outcomes of Single-port Versus Multiport Laparoscopic Surgery for Colon Cancer: The SIMPLE Multicenter Randomized Clinical Trial. Ann Surg. 2021 Feb 1;273(2):217-223. doi: 10.1097/SLA.0000000000003882.'}, {'pmid': '35799145', 'type': 'DERIVED', 'citation': 'Song Z, Liu K, Zhang T, Wang B, Shi Y, Jiang Y, Wang C, Chen X, Ji X, Zhao R. Oncologic outcomes of single-incision laparoscopic surgery versus conventional laparoscopic surgery for colorectal cancer (CSILS): study protocol for a multicentre, prospective, open-label, noninferiority, randomized controlled trial. BMC Cancer. 2022 Jul 7;22(1):743. doi: 10.1186/s12885-022-09821-9.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to investigate long-term oncologic outcomes of single-incision laparoscopic surgery (SILS) compared to conventional laparoscopic surgery (CLS) for colorectal cancer.', 'detailedDescription': 'In order to improve cosmetic effect and reduce postoperative pain, single-incision laparoscopic surgery (SILS) is attracting increasing attention. SILS is considered to be the next major advance in the progress of minimally invasive surgical approaches to colorectal disease that is more feasible in generalized use. In most previous studies, SILS for colorectal cancer was feasible and short-term safe compared to conventional laparoscopic surgery (CLS) . However, there is still controversy over its potential better cosmetic effect and less postoperative pain. Moreover, the long-term oncologic outcomes are still inconclusive as only a few studies showed long-term survival data. Up to now, most studies were limited to their retrospective nature and small samples. So more studies, especially large-scale, randomized controlled trials are needed to establish the best indications for SILS for colorectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years \\< age ≤85 years\n* Tumor located in colon and high rectum ( the lower border of the tumor is above the peritoneal reflection)\n* Pathological or highly suspected colorectal carcinoma\n* Clinically diagnosed cT1-4aN0-2 M0 lesions according to the 8th Edition of AJCC Cancer Staging Manual\n* Tumor size of 5 cm or less\n* ECOG score is 0-1\n* ASA score is Ⅰ-Ⅲ\n* Informed consent\n\nExclusion Criteria:\n\n* Body mass index (BMI) \\>35 kg/m2\n* The lower border of the tumor is located distal to the peritoneal reflection\n* Familial adenomatous polyposis (FAP)\n* Inflammatory bowel disease (IBD)\n* Multiple malignant colorectal tumors\n* Pregnant woman or lactating woman\n* Severe mental disease\n* Previous gastrointestinal surgery (except appendectomy ）\n* Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer\n* Requirement of simultaneous surgery for other disease\n* Simultaneous or metachronous multiple cancers with disease-free survival ≤ 5 years'}, 'identificationModule': {'nctId': 'NCT04527861', 'acronym': 'CSILS', 'briefTitle': 'Oncologic Outcomes of Single-incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Oncologic Outcomes of Single-incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Colorectal Cancer: A Multi-center, Prospective, Open Label, Non-inferiority, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CSILS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single-incision Laparoscopic Surgery', 'description': 'Patients with colorectal cancer undergo single-incision laparoscopic surgery.', 'interventionNames': ['Procedure: Single-incision Laparoscopic Surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Laparoscopic Surgery', 'description': 'Patients with colorectal cancer undergo conventional laparoscopic surgery（3\\~5 ports）.', 'interventionNames': ['Procedure: Conventional Laparoscopic Surgery']}], 'interventions': [{'name': 'Single-incision Laparoscopic Surgery', 'type': 'PROCEDURE', 'otherNames': ['SILS'], 'description': 'In this group，the surgery is performed through a single incision. The surgeon will adjust surgical position to expose the operative field with the help of gravity. Besides，hand over hand cross and parallel techniques are needed to achieve the SILS. All the other operative procedures are the same as conventional laparoscopic surgery.', 'armGroupLabels': ['Single-incision Laparoscopic Surgery']}, {'name': 'Conventional Laparoscopic Surgery', 'type': 'PROCEDURE', 'otherNames': ['CLS'], 'description': 'In this group，the surgery is performed through 3-5 ports according to the surgeons habits and specific conditions.', 'armGroupLabels': ['Conventional Laparoscopic Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '730050', 'city': 'Lanzhou', 'state': 'Gansu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Feng Gao, MD', 'role': 'CONTACT', 'email': 'gaof678@sohu.com'}], 'facility': 'The 940th Hospital of Joint Logistic Support Force of Chinese of PLA', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'zip': '110004', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Zhang, MD', 'role': 'CONTACT', 'email': 'haojiubujian1203@sina.com'}], 'facility': 'Shengjing Hospital', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '110801', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qingtong Zhang, MD', 'role': 'CONTACT', 'email': '2690960111@qq.com'}], 'facility': 'Liaoning Tumor Hospital & Institute', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '250021', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoqiao Zhang, MD', 'role': 'CONTACT', 'email': 'xqz@vip.163.com'}], 'facility': 'Shandong Provincial Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '610083', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lin Zhang, MD', 'role': 'CONTACT', 'email': 'flysky8026@aliyun.com'}], 'facility': 'The General Hospital of Western Theater Command', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '310014', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shiliang Tu, MD', 'role': 'CONTACT', 'email': 'yuanhang1981@126.com'}], 'facility': "Zhejiang Provincial People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '200032', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ye Xu, MD', 'role': 'CONTACT', 'email': 'xu_shirley021@163.com'}], 'facility': 'Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200120', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chun Song, MD', 'role': 'CONTACT', 'email': 'chunsong163@163.com'}], 'facility': 'Dongfang Hospital Affiliated to Tongji University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200127', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Zhou, MD', 'role': 'CONTACT', 'email': 'renjizhouhong@163.com'}], 'facility': 'RenJi Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200438', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liqiang Hao, MD', 'role': 'CONTACT', 'email': 'hao_liqiang@139.com'}], 'facility': 'Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '201801', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kun Liu, MD', 'role': 'CONTACT', 'email': 'lookiere@126.com', 'phone': '+8618121263082'}], 'facility': 'Ruijin Hospital, Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Ren Zhao, MD, PHD', 'role': 'CONTACT', 'email': 'zhaorensurgeon@aliyun.com', 'phone': '+8618917762018'}, {'name': 'Kun Liu, MD', 'role': 'CONTACT', 'email': 'lookiere@126.com', 'phone': '+8618121263082'}], 'overallOfficials': [{'name': 'Ren Zhao, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospitlal , Shanghai Jiaotong University School of Medicine'}, {'name': 'Chun Song, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dongfang Hospital Affiliated to Tongji University'}, {'name': 'Ye Xu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shanghai Cancer Center'}, {'name': 'Liqiang Hao, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Changhai Hospital'}, {'name': 'Hong Zhang, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shengjing Hospital'}, {'name': 'Hong Zhou, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'RenJi Hospital'}, {'name': 'Qingtong Zhang, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Liaoning Cancer Hospital & Institute'}, {'name': 'Shiliang Tu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Zhejiang Provincial People's Hospital"}, {'name': 'Xiaoqiao Zhang, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shandong Provincial Hospital'}, {'name': 'Lin Zhang, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The General Hospital of Western Theater Command'}, {'name': 'Feng Gao, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The 940th Hospital of Joint Logistic Support Force of Chinese of PLA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dongfang Hospital Affiliated to Tongji University', 'class': 'OTHER'}, {'name': 'Fudan University', 'class': 'OTHER'}, {'name': 'Changhai Hospital', 'class': 'OTHER'}, {'name': 'Shengjing Hospital', 'class': 'OTHER'}, {'name': 'RenJi Hospital', 'class': 'OTHER'}, {'name': 'Liaoning Cancer Hospital & Institute', 'class': 'OTHER'}, {'name': "Zhejiang Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'Shandong Provincial Hospital', 'class': 'OTHER_GOV'}, {'name': 'The General Hospital of Western Theater Command', 'class': 'OTHER'}, {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physicion', 'investigatorFullName': 'Zhao Ren', 'investigatorAffiliation': 'Ruijin Hospital'}}}}