Anastomotic LeakPhase 2/3NCT05264467
Leukocyte and and Platelet-rich Fibrin Plasma for the Prevention of Anastomotic Leakage in Colorectal Anastomosis
A Phase 2/3 study testing Platelet rich fibrin on colorectal anastomosis in people with Anastomotic Leak and Platelet-Rich Fibrin, run by Universidad de Concepcion at 1 site in Chile.
Trial summary
Anastomotic leak rate in colorectal surgery is estimated between 4 and 20 percent. Leukocyte and and platelet-rich fibrin plasma (L-PRF) is second generation platelet concentrate whose application in colorectal anastomosis in animals has shown promising results that suppose a lower leakage rate. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Anastomotic Leak, Platelet-Rich Fibrin, Colorectal Surgery
- What is being tested?
- Platelet rich fibrin on colorectal anastomosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteChile
- Study dates
- 12 Mar 2018to 10 Aug 2021
- Phase
- Phase 2/3
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients were submitted to elective colorectal anastomosis with mechanic anastomosis on or under the peritoneal reflection.
- Postoperative evaluation using contrast enema to objectify subclinical dehiscence.
Who cannot join
- Age under 15 years
- American Association of Anesthesiologists (ASA) grade IV or higher.
- Clinical signs of peritonitis
- Other major surgeries within 30 days of the procedure.
- Deficient nutritional state (defined by plasmatic albumin levels lower tan 2.8 mg/dl) Active treatment with corticoids and the impossibility of having contrast enema post-surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Leukocyte and and Platelet-rich Fibrin Plasma (L-PRF) for the Prevention of Anastomotic Leakage in Colorectal Anastomosis
Anastomotic leak rate in colorectal surgery is estimated between 4 and 20 percent. Leukocyte and and platelet-rich fibrin plasma (L-PRF) is second generation platelet concentrate whose application in colorectal anastomosis in animals has shown promising results that suppose a lower leakage rate. The objective of this study was to assess the feasibility of using L-PRF in colorectal surgery and to determine the incidence of anastomotic leakage after colorectal anastomosis.
Read the detailed description
Anastomotic leakage is an important and probably the most feared complication in colorectal surgery, due its high rate of morbidity, prolonged hospitalization and mortality.
The incidence of colorectal anastomotic leakage varies between 4 and 20%, and it definition is dissimilar depending on the articles reviewed. However, results from the Dutch Colorectal Surgery Audit, published in 2010 showed a global leakage rate of 11%.
To decrease this surgical complication several strategies and devices have been developed with discouraging results. Based on the scar theory of platelet concentrates, the use of platelet-rich plasma (PRF) and leukocyte and platelet-rich fibrin plasma (L-PRF) has been proposed to stimulate and improve cicatrization in colorectal anastomosis, showing promising results in animal studies.
L-PRF is a second generation platelet concentrate of better quality and simpler confection, that is obtained by a similar technique developed in France by Choukroun et al, in the absence of anticoagulants or gelling agents. Platelet concentrates and specially L- PRF are use in various areas of odontology and medicine, including colorectal surgery.
The main objective of this study was to evaluate the feasibility of using L-PRF in colorectal surgery and to determine its effect on anastomotic leakage after colorectal anastomosis.
This study was approved by the Ethical and Scientific Committee of Health Service of Concepción city (Code: 17-07-40). All participants were explained their rights and were asked for their consent to enroll them in the study. On the other hand, anonymity and confidentiality of the participants was assured during the study, as the patients personal information was not included in the research database, which was administered only by the main investigator and the statistical analyst.
This study was held following the recommendations of Helsinski Declaration and World Medical Association.
- Conditions
- Anastomotic Leak, Platelet-Rich Fibrin, Colorectal Surgery
- Being tested
- Platelet rich fibrin on colorectal anastomosis
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich fibrin on colorectal anastomosisBiological
Also called Control
Platelet rich fibrin on colorectal anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| PRF | Experimental | Not described Receives: Biological: Platelet rich fibrin on colorectal anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the incidence of anastomotic leakage after colorectal anastomosis
Anastomotic leak description in both arms.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start12 Mar 2018
- Primary completion9 Jul 2021
- Study completion10 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic LeakStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized one blinded experimental design
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Concepcion
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Vivanco Aguilar, Universidad de Concepcion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264467
- Sponsor's protocol ID
- UdeConcepcion
- Status last verified
- Feb 2022
- First submitted
- 28 Jan 2022
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Leukocyte and and Platelet-rich Fibrin Plasma (L-PRF) for the Prevention of Anastomotic Leakage in Colorectal Anastomosis
- ClinicalTrials.gov ID
- NCT05264467
- Acronym / sponsor ID
- UdeConcepcion
- Conditions
- Anastomotic Leak, Platelet-Rich Fibrin, Colorectal Surgery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Universidad de ConcepcionUniversity, hospital or other
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 9 Jul 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 3 Mar 2022 (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.
Anastomotic leak rate in colorectal surgery is estimated between 4 and 20 percent. Leukocyte and and platelet-rich fibrin plasma (L-PRF) is second generation platelet concentrate whose application in colorectal anastomosis in animals has shown promising results that suppose a lower leakage rate. The objective of this study was to assess the feasibility of using L-PRF in colorectal surgery and to determine the incidence of anastomotic leakage after colorectal anastomosis.
Detailed description
Anastomotic leakage is an important and probably the most feared complication in colorectal surgery, due its high rate of morbidity, prolonged hospitalization and mortality.
The incidence of colorectal anastomotic leakage varies between 4 and 20%, and it definition is dissimilar depending on the articles reviewed. However, results from the Dutch Colorectal Surgery Audit, published in 2010 showed a global leakage rate of 11%.
To decrease this surgical complication several strategies and devices have been developed with discouraging results. Based on the scar theory of platelet concentrates, the use of platelet-rich plasma (PRF) and leukocyte and platelet-rich fibrin plasma (L-PRF) has been proposed to stimulate and improve cicatrization in colorectal anastomosis, showing promising results in animal studies.
L-PRF is a second generation platelet concentrate of better quality and simpler confection, that is obtained by a similar technique developed in France by Choukroun et al, in the absence of anticoagulants or gelling agents. Platelet concentrates and specially L- PRF are use in various areas of odontology and medicine, including colorectal surgery.
The main objective of this study was to evaluate the feasibility of using L-PRF in colorectal surgery and to determine its effect on anastomotic leakage after colorectal anastomosis.
This study was approved by the Ethical and Scientific Committee of Health Service of Concepción city (Code: 17-07-40). All participants were explained their rights and were asked for their consent to enroll them in the study. On the other hand, anonymity and confidentiality of the participants was assured during the study, as the patients personal information was not included in the research database, which was administered only by the main investigator and the statistical analyst.
This study was held following the recommendations of Helsinski Declaration and World Medical Association.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized one blinded experimental design
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| PRF | Experimental | Biological: Platelet rich fibrin on colorectal anastomosis |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients were submitted to elective colorectal anastomosis with mechanic anastomosis on or under the peritoneal reflection.
- Postoperative evaluation using contrast enema to objectify subclinical dehiscence.
Key exclusion criteria (5 listed)
- Age under 15 years
- American Association of Anesthesiologists (ASA) grade IV or higher.
- Clinical signs of peritonitis
- Other major surgeries within 30 days of the procedure.
- Deficient nutritional state (defined by plasmatic albumin levels lower tan 2.8 mg/dl) Active treatment with corticoids and the impossibility of having contrast enema post-surgery.
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 |
|---|---|---|
| Platelet rich fibrin on colorectal anastomosisAlso: ControlPlatelet rich fibrin on colorectal anastomosis | Biological | PRF |
Primary outcome
Determine the incidence of anastomotic leakage after colorectal anastomosis
Time frame: 30 days
Anastomotic leak description in both arms.
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 3 Mar 2022.
- Individual participant dataSharing planned: No
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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 Phase 2/3 study testing Platelet rich fibrin on colorectal anastomosis in people with Anastomotic Leak and Platelet-Rich Fibrin, run by Universidad de Concepcion at 1 site in Chile.
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 2 inclusion and 5 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 3 Mar 2022. 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 Chile. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Determine the incidence of anastomotic leakage after colorectal anastomosis (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2022.