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NCT05872334 Clinical Trial

The Safety and Feasibility of MONOFIX on Fascial Closure of Mid-line Wound After Minimally Invasive Colorectal Cancer Surgery

Rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05872334
Other study ID # MONOFIX_01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date April 5, 2023

Study information
Verified date May 2023
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date April 5, 2023
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Monofix
a new absorbable barbed suture device

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul Gangnam

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incisional hernia Incisional hernia diagnosed by CT scan. 18 months from surgery
Secondary Wound infection In cases where microorganisms were identified in the wound culture results. 1 month from surgery
Secondary Wound bleeding In cases where bleeding was visually observed from the wound or a hematoma was observed on the CT scan. 1 month from surgery
Secondary Wound dehiscence In cases where the fascial closure was incomplete, causing part of the abdominal organs to protrude outside the abdomen, requiring surgical treatment. 1 month from surgery
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