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

NCT ID: NCT05872334

Last Updated: 2023-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2023-04-05

Brief Summary

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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

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Conditions

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Colon Cancer Rectal Cancer Colon Adenocarcinoma Rectal Adenocarcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Monofix

Intervention Type DEVICE

a new absorbable barbed suture device

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Monofix

a new absorbable barbed suture device

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Woo Yong Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Medical Center

Seoul, Gangnam, South Korea

Site Status

Countries

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South Korea

References

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Pyo DH, Yun SH, Lee WY. A prospective single-arm clinical trial to assess the safety and efficacy of monofilament polydioxanone barbed suture, MONOFIX(R), on abdominal fascial closure. World J Surg. 2024 Jul;48(7):1674-1680. doi: 10.1002/wjs.12247. Epub 2024 Jun 15.

Reference Type DERIVED
PMID: 38877993 (View on PubMed)

Other Identifiers

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MONOFIX_01

Identifier Type: -

Identifier Source: org_study_id

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