The Safety and Feasibility of MONOFIX on Fascial Closure of Mid-line Wound After Minimally Invasive Colorectal Cancer Surgery
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
1 other identifier
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2023
CompletedFirst Submitted
Initial submission to the registry
May 14, 2023
CompletedFirst Posted
Study publicly available on registry
May 24, 2023
CompletedMay 24, 2023
May 1, 2023
4 months
May 14, 2023
May 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incisional hernia
Incisional hernia diagnosed by CT scan.
18 months from surgery
Secondary Outcomes (3)
Wound infection
1 month from surgery
Wound bleeding
1 month from surgery
Wound dehiscence
1 month from surgery
Study Arms (2)
Monofix
EXPERIMENTALIn 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.
Control group
NO INTERVENTIONIn 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
Eligibility Criteria
You may qualify if:
- Colorectal adenocarcinoma
- Elective (or planned) curative surgery
- Laparoscopic surgery
- Midline incision less than 10 cm
You may not qualify if:
- Previous laparotomy with midline incision more than 10cm.
- Systemic chemotherapy for any cause within the last 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, Gangnam, South Korea
Related Publications (1)
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.
PMID: 38877993DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 14, 2023
First Posted
May 24, 2023
Study Start
June 1, 2021
Primary Completion
September 30, 2021
Study Completion
April 5, 2023
Last Updated
May 24, 2023
Record last verified: 2023-05