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.
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.
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.
- Conditions
- Anastomosis, Functional
- 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 group | Role | What they receive |
|---|---|---|
| Collagen group /Control group | Patients 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.
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.
- First posted26 Apr 2023
- Study start28 Sep 2022
- Primary completion24 Feb 2023
- Study completion15 Mar 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 Anastomosis, FunctionalStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tungcheng Chang, Taipei Medical University Shuang Ho Hospital
- Investigators
- Tung-Cheng Chang, MD,PhD, Study chair, Taipei Medical University Shuang Ho Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taipei Medical University Shuang-Ho Hospital
- ClinicalTrials.gov ID
- NCT05831956
- Acronym / sponsor ID
- N202209004
- Conditions
- Anastomosis, Functional
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 24 Feb 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 26 Apr 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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Collagen group /Control group | – | Procedure: Laparoscopic colectomyPatients 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. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent laparoscopic colectomy.
Key inclusion criteria (1 listed)
- Patients who underwent laparoscopic colectomy.
Key exclusion criteria (1 listed)
- Patients who underwent open surgery, emergent surgery, or had prior chemotherapy or concurrent chemoradiotherapy were excluded from the study
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 |
|---|---|---|
| Laparoscopic colectomyPatients who under went laparoscopic colectomy | Procedure or surgery | Collagen group /Control group |
Primary outcome
Bowel function recovery
Time frame: 0-30 days after colectomy
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.
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 26 Apr 2023.
- Derived from this study: PubMed 38378522Huang 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.
- Individual participant dataSharing planned: Undecided
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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.
Tung-Cheng Chang, MD,PhD study chair
Taipei Medical University Shuang Ho Hospital
1 site in 1 country: see every site and its status.
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.