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

Samsung Medical Center

Status: Completed

Conditions: Rectal Adenocarcinoma; Colon Cancer; Colon Adenocarcinoma; Rectal Cancer

Treatments: Device: Monofix

Study type: Interventional

Funder types: Other

Identifiers

NCT05872334

MONOFIX_01

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Monofix

Experimental group

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.

Treatment:

Device: Monofix

Control group

No Intervention group

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.