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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05872334

Enrollment

120

Registered

2023-05-24

Start date

2021-06-01

Completion date

2023-04-05

Last updated

2023-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Adenocarcinoma, Colon Cancer, Rectal Adenocarcinoma, Rectal Cancer

Keywords

minimally invasive surgery, Barbed suture

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.

Interventions

DEVICEMonofix

a new absorbable barbed suture device

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Incisional hernia	18 months from surgery	Incisional hernia diagnosed by CT scan.

Secondary

Measure	Time frame	Description
Wound infection	1 month from surgery	In cases where microorganisms were identified in the wound culture results.
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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026