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Anastomosis, FunctionalNCT05831956

The Efficacy and Safety of Using Collagen Patch on Anastomotic Site in Colorectal Surgery

An observational study of Anastomosis, Functional, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In order to investigate the effects of collagen wound dressing on colonic anastomosis during colectomy, we conducted a retrospective cohort study. The goal of study was to determine whether the use of collagen wound dressing results in improving clinical outcomes for patients undergoing laparoscopic colectomy. Read more about this study

Who is it for?
Ages 20 to 100 years
Conditions the study is for
Anastomosis, Functional
What is being tested?
Laparoscopic colectomy
Type of treatment
Surgery or procedure
How many people
241 participants
Where
1 siteTaiwan
Study dates
28 Sep 2022to 15 Mar 2023
Phase
Observational
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 20 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who underwent laparoscopic colectomy.

Who may be able to join

  • Patients who underwent laparoscopic colectomy.

Who cannot join

  • Patients who underwent open surgery, emergent surgery, or had prior chemotherapy or concurrent chemoradiotherapy were excluded from the study

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Taipei Medical University

    New Taipei City, 235

Other trials in Taiwan

About this study

Official title: Taipei Medical University Shuang-Ho Hospital

In order to investigate the effects of collagen wound dressing on colonic anastomosis during colectomy, we conducted a retrospective cohort study. The goal of study was to determine whether the use of collagen wound dressing results in improving clinical outcomes for patients undergoing laparoscopic colectomy.

Read the detailed description

Wound healing occurs in four distinct phases: hemostasis, inflammation, proliferation, and tissue remodeling. Numerous factors can influence these phases, which can be classified as either local or systemic. Local factors include infection, presence of foreign bodies, inadequate oxygenation, and other issues affecting the wound itself, while systemic factors encompass a wide range of considerations such as age, gender, presence of systemic disease, ischemia, stress, medication use, obesity, cigarette and alcohol use, nutritional status, and immunocompromised conditions.

Anastomotic healing in the colon is similar to the healing process in skin while there's still some differences. While the cellular and histological processes involved in colonic healing are well known, the pathophysiological process is not fully understood and requires further studies . Unlike skin healing, the process of patients undergoing colonic resection and anastomosis healing can only be inferred by observing certain parameters, such as amount of drainage, time to first flatus and defecation and the patient's symptoms. These parameters are used to guide the patient's recovery program. Complications such as anastomotic leakage, bleeding or stricture would lead to longer hospital stay, mortality and morbidity. The most devastating one is anastomotic leakage. Although we have found some strategies to lower the rate in colorectal surgery such as colon preparation or antibiotics administration, the leakage still bothers a lot.

Besides controlling the local and systemic factors, several biomaterial products have been designed to progress the healing. Collagen plays crucial roles in all of the four healing phases. As a result, collagen wound dressing, derived from bovine, equine, avian or porcine, has been applied in different sites of wound to promote healing. Several studies have concluded that collagen wound dressing resulted in better outcomes but limited to in vitro studies or animal based research. Pantelis D. concluded that fibrin in combination with the collagen patch can improve healing in high-risk mice that underwent colonic anastomosis surgery. Pommergaard HC. also concluded that the collagen wound dressing can lower the leakage rate in mouse colon anastomosis surgery.

Another limitation is that most studies have small sample sizes and lack of long term observation. Parker et al designed a non-randomized study and concluded that collagen wound dressing is safe and easy to apply in human colorectal surgery. Marano et al compared the complication rate of two cohorts and revealed that collagen wound dressing can lower the complication rate in the patients who underwent upper gastrointestinal surgery. As of now, it is premature to conclude that collagen wound dressing is effective in human colonic anastomosis due to the lack of human studies and larger sample size. In order to investigate the effects of collagen wound dressing on colonic anastomosis during colectomy, we conducted a retrospective cohort study. Our goal was to determine whether the use of collagen wound dressing results in improving clinical outcomes for patients undergoing laparoscopic colectomy.

Being tested
Laparoscopic colectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic colectomyProcedure or surgery

    Patients who under went laparoscopic colectomy

Study groups in NCT05831956
Study groupRoleWhat they receive
Collagen group /Control groupPatients who received collagen patches on the anastomotic site during colectomy were allocated to the collagen group. Patients without collagen patches on the anastomotic site during colectomy were allocated to the control group.
Receives: Procedure: Laparoscopic colectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bowel function recovery

    The primary outcome measurements were the number of days until first flatus and defecation after surgery, which were recorded as the number of days from surgery to the first occurrence of each event.

    Measured: 0-30 days after colectomy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2023
  2. Study start28 Sep 2022
  3. Primary completion24 Feb 2023
  4. Study completion15 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
241 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05831956
Sponsor's protocol ID
N202209004
Status last verified
Apr 2023
First submitted
16 Apr 2023
Last updated
26 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Huang PY, Tsai MC, Kiu KT, Yen MH, Chang TC. Collagen patch cover facilitates recovery of bowel function after laparoscopic colectomy. BMC Surg. 2024 Feb 20;24(1):66. doi: 10.1186/s12893-024-02339-w.

    PubMed 38378522

Questions about this trial

What is this clinical trial studying?

An observational study of Anastomosis, Functional, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.

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 1 inclusion and 1 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 26 Apr 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 Taiwan. 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?

Bowel function recovery (time frame: 0-30 days after colectomy). 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 NCT05831956, 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 26 Apr 2023.

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