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

Not Applicable

Completed

• Conditions: Colon Cancer; Rectal Cancer; Colon Adenocarcinoma; Rectal Adenocarcinoma
• Interventions: Device: Monofix

• Registration Number: NCT05872334
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Primary Completion: 2021-09-30
• Study Completion: 2023-04-05
• Status Verified: 2023-05
• Study First Submitted: 2023-05-14
• Study First Submitted QC: 2023-05-14
• Last Update Submitted: 2023-05-14
• Study First Posted: 2023-05-24
• Last Update Posted: 2023-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Monofix	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.

Primary Outcome Measures

Name	Time	Method
Incisional hernia	18 months from surgery	Incisional hernia diagnosed by CT scan.

Secondary Outcome Measures

Name	Time	Method
Wound bleeding	1 month from surgery	In cases where bleeding was visually observed from the wound or a hematoma was observed on the CT scan.
Wound dehiscence	1 month from surgery	In cases where the fascial closure was incomplete, causing part of the abdominal organs to protrude outside the abdomen, requiring surgical treatment.
Wound infection	1 month from surgery	In cases where microorganisms were identified in the wound culture results.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Gangnam, Korea, Republic of