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

Samsung Medical Center120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

120

Conditions

Colon Cancer Rectal Cancer Colon Adenocarcinoma Rectal Adenocarcinoma

Interventions

MonofixDEVICE

a new absorbable barbed suture device

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Samsung Medical Center

Seoul, Gangnam, South Korea

Outcomes

Primary Outcomes

Incisional hernia

Incisional hernia diagnosed by CT scan.

Time frame: 18 months from surgery

Secondary Outcomes

Wound infection

In cases where microorganisms were identified in the wound culture results.

Time frame: 1 month from surgery

Wound bleeding

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

Wound dehiscence

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

Data from ClinicalTrials.gov

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