Colon CancerNCT05872334
The Safety and Feasibility of MONOFIX on Fascial Closure of Mid-line Wound After Minimally Invasive Colorectal Cancer Surgery
A study testing Monofix in people with Colon Cancer and Rectal Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Cancer, Rectal Cancer, Colon Adenocarcinoma
- What is being tested?
- Monofix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2021to 5 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colorectal adenocarcinoma
- Elective (or planned) curative surgery
- Laparoscopic surgery
- Midline incision less than 10 cm
Who cannot join
- Previous laparotomy with midline incision more than 10cm.
- Systemic chemotherapy for any cause within the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Being tested
- Monofix
- Keywords
- minimally invasive surgery, Barbed suture
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonofixDevice
a new absorbable barbed suture device
| Study group | Role | What they receive |
|---|---|---|
| Monofix | Experimental | 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. Receives: Device: Monofix |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incisional hernia
Incisional hernia diagnosed by CT scan.
Measured: 18 months from surgery
Secondary outcomes (3)
Wound infection
In cases where microorganisms were identified in the wound culture results.
Measured: 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.
Measured: 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.
Measured: 1 month from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Jun 2021
- Primary completion30 Sep 2021
- Study completion5 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woo Yong Lee, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872334
- Sponsor's protocol ID
- MONOFIX_01
- Status last verified
- May 2023
- First submitted
- 14 May 2023
- Last updated
- 24 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38877993
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05872334
- Acronym / sponsor ID
- MONOFIX_01
- Keywords
- minimally invasive surgery, Barbed suture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monofix | Experimental | Device: MonofixIn 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Colorectal adenocarcinoma
- Elective (or planned) curative surgery
- Laparoscopic surgery
- Midline incision less than 10 cm
Key exclusion criteria (2 listed)
- Previous laparotomy with midline incision more than 10cm.
- Systemic chemotherapy for any cause within the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monofixa new absorbable barbed suture device | Device | Monofix |
Primary outcome
Incisional hernia
Time frame: 18 months from surgery
Incisional hernia diagnosed by CT scan.
3 secondary outcomes
Wound infection
Time frame: 1 month from surgery
Wound bleeding
Time frame: 1 month from surgery
Wound dehiscence
Time frame: 1 month from surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Derived from this study: PubMed 38877993Pyo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monofix in people with Colon Cancer and Rectal Cancer, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incisional hernia (time frame: 18 months from surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05872334, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.