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Completed

NCT Number: NCT05872334

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

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.

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Key information

Conditions

Colon Cancer Colon Adenocarcinoma Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Adenocarcinoma Rectal Cancer Rectal Diseases Rectal Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, Gangnam, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Monofix

Device

a new absorbable barbed suture device

Primary outcomes

  1. Incisional hernia

    Time frame: 18 months from surgery

    Incisional hernia diagnosed by CT scan.

Secondary outcomes

  1. Wound infection

    Time frame: 1 month from surgery

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

  2. Wound bleeding

    Time frame: 1 month from surgery

    In cases where bleeding was visually observed from the wound or a hematoma was observed on the CT scan.

  3. Wound dehiscence

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2023
First posted
May 24, 2023
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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