The Safety and Feasibility of MONOFIX on Fascial Closure of Mid-line Wound After Minimally Invasive Colorectal Cancer Surgery
NCT ID: NCT05872334
Last Updated: 2023-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2021-06-01
2023-04-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
SINGLE
Study Groups
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Monofix
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.
Monofix
a new absorbable barbed suture device
Control group
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.
No interventions assigned to this group
Interventions
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Monofix
a new absorbable barbed suture device
Eligibility Criteria
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Inclusion Criteria
* Elective (or planned) curative surgery
* Laparoscopic surgery
* Midline incision less than 10 cm
Exclusion Criteria
* Systemic chemotherapy for any cause within the last 6 months.
18 Years
80 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Woo Yong Lee
Professor
Locations
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Samsung Medical Center
Seoul, Gangnam, South Korea
Countries
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References
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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.
Other Identifiers
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MONOFIX_01
Identifier Type: -
Identifier Source: org_study_id
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