Back to resultsThe Safety and Feasibility of MONOFIX on Fascial Closure of Mid-line Wound After Minimally Invasive Colorectal Cancer Surgery
Primary Purpose
Colon Cancer, Rectal Cancer, Colon Adenocarcinoma
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Monofix
Sponsored by
About this trial
This is an interventional prevention trial for Colon Cancer focused on measuring minimally invasive surgery, Barbed suture
Eligibility Criteria
Inclusion Criteria: Colorectal adenocarcinoma Elective (or planned) curative surgery Laparoscopic surgery Midline incision less than 10 cm Exclusion Criteria: Previous laparotomy with midline incision more than 10cm. Systemic chemotherapy for any cause within the last 6 months.
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Monofix
Control group
Arm 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.
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.
Outcomes
Primary Outcome Measures
Incisional hernia
Incisional hernia diagnosed by CT scan.
Secondary Outcome Measures
Wound infection
In cases where microorganisms were identified in the wound culture results.
Wound bleeding
In cases where bleeding was visually observed from the wound or a hematoma was observed on the CT scan.
Wound dehiscence
In cases where the fascial closure was incomplete, causing part of the abdominal organs to protrude outside the abdomen, requiring surgical treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05872334
Brief Title
The Safety and Feasibility of MONOFIX on Fascial Closure of Mid-line Wound After Minimally Invasive Colorectal Cancer Surgery
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
April 5, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Rectal Cancer, Colon Adenocarcinoma, Rectal Adenocarcinoma
Keywords
minimally invasive surgery, Barbed suture
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Monofix
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
Monofix
Intervention Description
a new absorbable barbed suture device
Primary Outcome Measure Information:
Title
Incisional hernia
Description
Incisional hernia diagnosed by CT scan.
Time Frame
18 months from surgery
Secondary Outcome Measure Information:
Title
Wound infection
Description
In cases where microorganisms were identified in the wound culture results.
Time Frame
1 month from surgery
Title
Wound bleeding
Description
In cases where bleeding was visually observed from the wound or a hematoma was observed on the CT scan.
Time Frame
1 month from surgery
Title
Wound dehiscence
Description
In cases where the fascial closure was incomplete, causing part of the abdominal organs to protrude outside the abdomen, requiring surgical treatment.
Time Frame
1 month from surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Colorectal adenocarcinoma
Elective (or planned) curative surgery
Laparoscopic surgery
Midline incision less than 10 cm
Exclusion Criteria:
Previous laparotomy with midline incision more than 10cm.
Systemic chemotherapy for any cause within the last 6 months.
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Gangnam
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Safety and Feasibility of MONOFIX on Fascial Closure of Mid-line Wound After Minimally Invasive Colorectal Cancer Surgery
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