Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-30 @ 4:04 AM
Study NCT ID:
NCT05872334
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2023-05-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Safety and Feasibility of MONOFIX on Fascial Closure of Mid-line Wound After Minimally Invasive Colorectal Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal 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'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-14', 'studyFirstSubmitDate': '2023-05-14', 'studyFirstSubmitQcDate': '2023-05-14', 'lastUpdatePostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incisional hernia', 'timeFrame': '18 months from surgery', 'description': 'Incisional hernia diagnosed by CT scan.'}], 'secondaryOutcomes': [{'measure': 'Wound infection', 'timeFrame': '1 month from surgery', 'description': 'In cases where microorganisms were identified in the wound culture results.'}, {'measure': 'Wound bleeding', 'timeFrame': '1 month from surgery', 'description': 'In cases where bleeding was visually observed from the wound or a hematoma was observed on the CT scan.'}, {'measure': 'Wound dehiscence', 'timeFrame': '1 month from surgery', 'description': 'In cases where the fascial closure was incomplete, causing part of the abdominal organs to protrude outside the abdomen, requiring surgical treatment.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['minimally invasive surgery', 'Barbed suture'], 'conditions': ['Colon Cancer', 'Rectal Cancer', 'Colon Adenocarcinoma', 'Rectal Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '38877993', 'type': 'DERIVED', 'citation': 'Pyo DH, Yun SH, Lee WY. A prospective single-arm clinical trial to assess the safety and efficacy of monofilament polydioxanone barbed suture, MONOFIX(R), on abdominal fascial closure. World J Surg. 2024 Jul;48(7):1674-1680. doi: 10.1002/wjs.12247. Epub 2024 Jun 15.'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial aims to evaluate the safety and feasibility of mid-line fascial suturing using MONOFIX sutures in patients undergoing minimally invasive surgery for colorectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Colorectal adenocarcinoma\n* Elective (or planned) curative surgery\n* Laparoscopic surgery\n* Midline incision less than 10 cm\n\nExclusion Criteria:\n\n* Previous laparotomy with midline incision more than 10cm.\n* Systemic chemotherapy for any cause within the last 6 months.'}, 'identificationModule': {'nctId': 'NCT05872334', 'briefTitle': 'The Safety and Feasibility of MONOFIX on Fascial Closure of Mid-line Wound After Minimally Invasive Colorectal Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Exploratory Clinical Trial for Evaluating the Safety and Efficacy of MONOFIX® on Fascial Closure of Mid-line Wound for Patients With Colon Cancer Underwent Minimally Invasive Surgery: Single-center, Non-blinded, and Single-arm Design', 'orgStudyIdInfo': {'id': 'MONOFIX_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Monofix', 'description': 'In patients who underwent laparoscopic colorectal cancer surgery, the fascial closure of the midline incision was performed using a running suture type with Monofix, one of the barbed sutures.', 'interventionNames': ['Device: Monofix']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'In patients who underwent laparoscopic colorectal cancer surgery, the fascial closure of the midline incision was performed using an interrupted suture type with PDS-II, one of the monofilament sutures.'}], 'interventions': [{'name': 'Monofix', 'type': 'DEVICE', 'description': 'a new absorbable barbed suture device', 'armGroupLabels': ['Monofix']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'state': 'Gangnam', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Woo Yong Lee', 'investigatorAffiliation': 'Samsung Medical Center'}}}}