Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-01-08 @ 1:48 PM
Study NCT ID:
NCT03111134
Status:
UNKNOWN
Last Update Posted:
2017-04-12
First Post:
2017-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A New Abdomen Closure Technology Based on Component Separation: a Prospective Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-07', 'studyFirstSubmitDate': '2017-04-07', 'studyFirstSubmitQcDate': '2017-04-07', 'lastUpdatePostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Class A healing rate of the surgical incision', 'timeFrame': '1 month', 'description': 'Class A healing rate of the surgical incision after operation'}], 'secondaryOutcomes': [{'measure': 'the incidence rate of incisional complications', 'timeFrame': '1 month', 'description': 'the incidence rate of any incisional complications after the surgery'}, {'measure': 'the time of suture to clear', 'timeFrame': '1 month', 'description': 'the time of suture to clear after the surgery'}, {'measure': 'hospitalization time after operation', 'timeFrame': '1 year', 'description': 'hospitalization time after operation'}, {'measure': 'the incidence rate of unplanned second operation', 'timeFrame': '1 month', 'description': 'the incidence rate of unplanned second operation after the surgery'}, {'measure': 'the incidence rate of unplanned readmission', 'timeFrame': '1 month', 'description': 'the incidence rate of unplanned readmission after the surgery'}, {'measure': 'the incidence rate of acute pain', 'timeFrame': '1 month', 'description': 'the incidence rate of acute pain after the surgery'}, {'measure': 'the mortality', 'timeFrame': '1 month', 'description': 'the mortality after the surgery with any reason'}, {'measure': 'the incidence rate of incisional hernia', 'timeFrame': '3 years', 'description': 'the incidence rate of incisional hernia after the surgery'}, {'measure': 'hospitalization costs', 'timeFrame': '3 years', 'description': 'hospitalization costs for the surgery and its complications'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['abdominal wound closure techniques', 'layered closure', 'component separation technique'], 'conditions': ['Fascial Closure']}, 'descriptionModule': {'briefSummary': "At present, open-type abdominal surgery is routine access into the abdomen. Median incision is the common choice with open-type abdominal surgery. Layered abdomen-closing is often used at the end-time of the surgery. There are some common postoperative complications, such as incision pain, surgical site infection, surgical incision dehiscence and incisional hernia. The key to reduce the incidence of postoperative complications depends on safe and reliable technology of abdomen-closing.\n\nIt's usually difficult to close the abdomen after the incisional hernia surgery, and the recurrence of incisional hernia is high. But the recurrence fell off observably when component separation technology was applied to abdomen-closing of incisional hernia.\n\nBased on this, we hypothesis that modified-CST applied to abdomen-closing in routine abdominal surgery may improve the quality of wound-healing.\n\nIn this prospective single-blind randomized controlled trial, traditional abdomen-closing technology and modified-CST will be used to gastric cancer surgery, and the quality of wound-healing will be evaluated to confirm which kind of abdomen-closing technology better."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients \\>18 years of age\n* undergoing gastric cancer surgery\n* undergoing abdominal surgery first time\n* median upper abdominal incision applied (length of incision \\> 5cm)\n* randomly select abdominal closure technique agreed by patients and family members\n\nExclusion Criteria:\n\n* women who pregnant\n* coagulation disorders\n* undergoing immunological therapy\n* undergoing chemothearphy within 2 weeks before the surgery\n* undergoing Abdominal radiotherapy within 8 weeks before the surgery\n* spirit disease patients\n* the expecting life span less than 48 hours\n* no guarantees to follow-up for 3 years\n* patients with poor compliance'}, 'identificationModule': {'nctId': 'NCT03111134', 'briefTitle': 'A New Abdomen Closure Technology Based on Component Separation: a Prospective Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital of Digestive Diseases'}, 'officialTitle': 'A New Abdomen Closure Technology Based on Component Separation: a Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CST001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Routine Abdominal Closure'}, {'type': 'EXPERIMENTAL', 'label': 'New Abdominal Closure', 'description': 'modified component separation technique is used to abdomen closing.', 'interventionNames': ['Procedure: modified component separation technique']}], 'interventions': [{'name': 'modified component separation technique', 'type': 'PROCEDURE', 'description': 'a new abdomen closure technique based on component separation technique', 'armGroupLabels': ['New Abdominal Closure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': 'Xi’an', 'state': 'Shanxi', 'country': 'China', 'contacts': [{'name': 'Xiaonan Liu, Ph.D', 'role': 'CONTACT', 'email': 'liuxnxjh@163.com', 'phone': '+86 29 84771533'}], 'facility': 'Xijing Hospital', 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}], 'centralContacts': [{'name': 'Xiaonan Liu, Ph.D', 'role': 'CONTACT', 'email': 'liuxnxjh@163.com', 'phone': '86-029-84771533'}], 'overallOfficials': [{'name': 'Xiaonan Liu, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Xijing Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital of Digestive Diseases', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Xiaonan Liu', 'investigatorAffiliation': 'Xijing Hospital of Digestive Diseases'}}}}