Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-03-05 @ 12:49 AM
Study NCT ID:
NCT03151733
Status:
COMPLETED
Last Update Posted:
2024-12-10
First Post:
2017-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Incision Laparoscopic Colorectal Surgery
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-07', 'studyFirstSubmitDate': '2017-03-20', 'studyFirstSubmitQcDate': '2017-05-10', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early morbidity rate', 'timeFrame': '30 days', 'description': 'morbidity rate 30 days after surgery'}], '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': 'Lymph node detection', 'timeFrame': '14 days after surgery', 'description': 'Lymph nodes harvested（numbers）'}, {'measure': 'Incisal margin', 'timeFrame': '14 days after surgery', 'description': 'Length of proximal and distal margin （centimeters，cm）'}, {'measure': 'Tumor size', 'timeFrame': '14 days after surgery', 'description': 'The diameter of tumors（centimeters，cm）'}, {'measure': 'Length of stay', 'timeFrame': '1-14 days after surgery', 'description': 'Duration of hospital stay（days after surgery）'}, {'measure': 'Postoperative recovery course', 'timeFrame': '1-14 days after surgery', 'description': 'Time to first ambulation, flatus, liquid diet and soft diet （hours 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 and the day of discharge'}, {'measure': '3-year disease free survival rate', 'timeFrame': '36 months after surgery', 'description': '3-year disease free survival rate'}, {'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': ['SILS', 'colorectal cancer'], 'conditions': ['Laparoscopic Colorectal Surgery']}, 'referencesModule': {'references': [{'pmid': '27478914', 'type': 'RESULT', 'citation': 'Aldeghaither S, Zubaidi A, Alkhayal K, Al-Obaid O. Single-incision laparoscopic colorectal surgery: a report of 33 cases in Saudi Arabia. Ann Saudi Med. 2016 Jul-Aug;36(4):282-7. doi: 10.5144/0256-4947.2016.282.'}, {'pmid': '34760706', 'type': 'DERIVED', 'citation': 'Song Z, Liu K, Li Y, Shi Y, Jiang Y, Wang C, Chen X, Zhang T, Ji X, Zhao R. Short-Term Outcomes of Single-Incision Laparoscopic Surgery for Colorectal Cancer: A Single-Center, Open-Label, Non-Inferiority, Randomized Clinical Trial. Front Oncol. 2021 Oct 25;11:762147. doi: 10.3389/fonc.2021.762147. eCollection 2021.'}, {'pmid': '30043168', 'type': 'DERIVED', 'citation': 'Song Z, Li Y, Liu K, Jiang Y, Shi Y, Ji X, Zhang T, Wu H, Shi Y, Zhao R. Clinical and oncologic outcomes of single-incision laparoscopic surgery for right colon cancer: a propensity score matching analysis. Surg Endosc. 2019 Apr;33(4):1117-1123. doi: 10.1007/s00464-018-6370-2. Epub 2018 Jul 24.'}]}, 'descriptionModule': {'briefSummary': 'Single incision laparoscopic surgery (SILS) is the further development of the concept of minimally invasive surgery for colorectal cancer,which rapidly developed in the field of colorectal surgery. Through the development of single hole laparoscopic colorectal cancer radical surgery and clinical study and follow up accordingly, evaluating the feasibility, surgical effectiveness and economy help to promote the popularization and application of single hole laparoscopic techniques in the field.', 'detailedDescription': 'The patients with colorectal cancer will randomly divided into single incision laparoscopic surgery group and conditional laparoscopic surgery group. The operation time, blood loss, the incidence of lymph node , the number of postoperative complications, the gastrointestinal function recovery time, postoperative hospital stay，the number of local recurrence and distant metastasis, survival rate and the total cost of hospitalization will be evaluated to confirm the feasibility of single incision laparoscopic surgery is effective and economical. It is worthy of clinical application.'}, '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 colon and high rectum ( the lower border of the tumor is above the peritoneal reflection)\n* Pathological colorectal carcinoma\n* Clinically diagnosed cT1-4aN0-2 M0 lesions according to the 7th 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) \\>30 kg/m2\n* The lower border of the tumor is located distal to the peritoneal reflection\n* Pregnant woman or lactating woman\n* Severe mental disease\n* Previous abdominal surgery（except appendectomy and cholecystotomy）\n* Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer\n* Requirement of simultaneous surgery for other disease'}, 'identificationModule': {'nctId': 'NCT03151733', 'acronym': 'SILCS', 'briefTitle': 'Single Incision Laparoscopic Colorectal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Single Incision Laparoscopic Surgery (SILS) for Colorectal Disease', 'orgStudyIdInfo': {'id': 'RJ-SILS-CRC2017'}, 'secondaryIdInfos': [{'id': 'SHSDC', 'type': 'OTHER', 'domain': 'SHSDC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'single incision laparoscopic surgery', 'description': 'patients with colorectal cancer and undergo single incision laparoscopic surgery', 'interventionNames': ['Procedure: single incision laparoscopic surgery']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Conventional laparoscopic surgery', 'description': 'patients with colorectal cancer and undergo conventional laparoscopic surgery', 'interventionNames': ['Procedure: conventional laparoscopic surgery']}], 'interventions': [{'name': 'single incision laparoscopic surgery', 'type': 'PROCEDURE', 'description': 'Patients undergo single incision laparoscopic surgery', 'armGroupLabels': ['single incision laparoscopic surgery']}, {'name': 'conventional laparoscopic surgery', 'type': 'PROCEDURE', 'description': 'Patients undergo conventional laparoscopic surgery', 'armGroupLabels': ['Conventional laparoscopic surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201821', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'ruijin hospital North', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Liu Kun, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'ruijin hospitla North'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief physicion', 'investigatorFullName': 'Zhao Ren', 'investigatorAffiliation': 'Ruijin Hospital'}}}}