Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-02-28 @ 3:53 AM
Study NCT ID:
NCT02253303
Status:
UNKNOWN
Last Update Posted:
2014-10-01
First Post:
2014-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Extraction-site, - Midline Incision vs Off-midline Incision-
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-09-26', 'studyFirstSubmitDate': '2014-09-24', 'studyFirstSubmitQcDate': '2014-09-26', 'lastUpdatePostDateStruct': {'date': '2014-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incisional hernia', 'timeFrame': '1 year', 'description': 'Numbers of participants with incisional hernia'}], 'primaryOutcomes': [{'measure': 'cosmetic effect', 'timeFrame': '1 year', 'description': 'Scar assessment score on the patient and observer scar assessment scale(POSAS)'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '7 days, 14 days and 30 days', 'description': 'Questionnaire on the SF-36 v2 acute'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Colon Cancer']}, 'referencesModule': {'references': [{'pmid': '23375702', 'type': 'BACKGROUND', 'citation': 'Samia H, Lawrence J, Nobel T, Stein S, Champagne BJ, Delaney CP. Extraction site location and incisional hernias after laparoscopic colorectal surgery: should we be avoiding the midline? Am J Surg. 2013 Mar;205(3):264-7; discussion 268. doi: 10.1016/j.amjsurg.2013.01.006. Epub 2013 Jan 31.'}, {'pmid': '18347858', 'type': 'BACKGROUND', 'citation': 'Singh R, Omiccioli A, Hegge S, McKinley C. Does the extraction-site location in laparoscopic colorectal surgery have an impact on incisional hernia rates? Surg Endosc. 2008 Dec;22(12):2596-600. doi: 10.1007/s00464-008-9845-8. Epub 2008 Mar 18.'}, {'pmid': '22580878', 'type': 'BACKGROUND', 'citation': 'Lee L, Mappin-Kasirer B, Sender Liberman A, Stein B, Charlebois P, Vassiliou M, Fried GM, Feldman LS. High incidence of symptomatic incisional hernia after midline extraction in laparoscopic colon resection. Surg Endosc. 2012 Nov;26(11):3180-5. doi: 10.1007/s00464-012-2311-7. Epub 2012 May 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the midline extraction incision in patients with colon cancer. A prospective randomized controlled trial is conducted to compare midline extraction incision with off-midline extraction incision.', 'detailedDescription': 'Laparoscopic colon surgery is less invasive and more cosmetic than open surgery. But the extraction-site incision is 4 to 5 cm, and it is the largest and most painful incision in laparoscopic colon surgery. The purpose of this study is to evaluate the midline extraction incision in patients with colon cancer. A prospective randomized controlled trial is conducted to compare midline extraction incision with off-midline extraction incision. The investigators hypothesize that the use of the midline extraction incision in laparoscopic colon surgery will result in more cosmetic effect and better quality of life compared to the off-midline extraction incision.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Tumor size is less than 5cm\n* No history of laparotomy\n* No bowel obstruction by tumor\n\nExclusion Criteria:\n\n* Patients who can't respond to medical question\n* Patients who receive steroids or insulin therapy\n* Uncontrolled DM\n* Severe respiratory failure(HOT)"}, 'identificationModule': {'nctId': 'NCT02253303', 'briefTitle': 'Evaluation of the Extraction-site, - Midline Incision vs Off-midline Incision-', 'organization': {'class': 'OTHER', 'fullName': 'Wakayama Medical University'}, 'officialTitle': 'Evaluation of the Extraction-site Location in Laparoscopic Colorectal Surgery - Midline Incision vs Off-midline Incision-', 'orgStudyIdInfo': {'id': 'WMU1398'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Midline incision', 'description': 'The extraction-site incision in laparoscopic colectomy is middline', 'interventionNames': ['Other: midline incision or off-midline incision']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'off-midline incision', 'description': 'The extraction-site incision in laparoscopic colectomy is off-middline', 'interventionNames': ['Other: midline incision or off-midline incision']}], 'interventions': [{'name': 'midline incision or off-midline incision', 'type': 'OTHER', 'description': 'Eligible patients are randomized to midline incision or off-midline incision group in laparoscopic colectomy', 'armGroupLabels': ['Midline incision', 'off-midline incision']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Katsunari Takifuji', 'role': 'CONTACT', 'email': 'takifuji@wakayama-med.ac.jp', 'phone': '073-447-2300', 'phoneExt': '5112'}, {'name': 'Tsukasa Hotta', 'role': 'CONTACT', 'email': 'hotta@wakayama-med.ac.jp', 'phone': '073-447-2300', 'phoneExt': '5112'}], 'overallOfficials': [{'name': 'HIroki Yamaue, Chief prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Second Department of Surgery, Wakayama Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hiroki Yamaue', 'class': 'OTHER'}, 'collaborators': [{'name': 'Katsunari Takifuji', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief and professor of second department of surgery', 'investigatorFullName': 'Hiroki Yamaue', 'investigatorAffiliation': 'Wakayama Medical University'}}}}