Adenocarcinoma ColonANASTOPATCHNCT04109105
Study for the Efficacy and Security Analysis in the Protection of Ileocolic Anastomosis Conducted in Laparoscopic Right Hemicolectomy Because of Colon Cancer, Using a NHS-PEG Coated Collagen Patch.
An observational study of Adenocarcinoma Colon, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial summary
The aim of this study is to analyse the effectiveness and security in the prevention of anastomotic leakage by protecting the ileocolic anastomosis with a reabsorbable NHS-PEG collagen patch. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma Colon
- What is being tested?
- NHS-PEG coated collagen patch
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2019to 15 May 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing a programmed right laparoscopic hemicolectomy for right colon adenocarcinoma with curative intention at the Virgen Macarena University Hospital during the necessary period of time to achieve the proposed number of patients.
Who may be able to join
- ≥ 18 years old.
- Ability to understand and make their own decision to participate in the study.
- Pre-surgery right colon adenocarcinoma pathological diagnosis.
- Patient with a mechanic, intra or extracorporeal ileocolic anastomosis.
Who cannot join
- Urgent intervention.
- Simultaneous colon cancer.
- M1 pre-surgery staging.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
Juan Carlos Gómez Rosado, 955 00 80 00, juanc.gomez.rosado.sspa@juntadeandalucia.es
About this study
Official title: Prospective Pilot Study for the Efficacy and Security Analysis in the Protection of Ileocolic Anastomosis Conducted in Laparoscopic Right Hemicolectomy Because of Colon Cancer, Using a Using a NHS-PEG (N-hydroxysuccinimide Functionalized Polyethylene Glycol) Coated Collagen Patch.
The aim of this study is to analyse the effectiveness and security in the prevention of anastomotic leakage by protecting the ileocolic anastomosis with a reabsorbable NHS-PEG collagen patch.
- Conditions
- Adenocarcinoma Colon
- Being tested
- NHS-PEG coated collagen patch
- Keywords
- Colon neoplasia, Ascendant colon, Surgical anastomosis, Anastomotic leak, Collagen, Polyethylene glycol, Hemopatch
- Medical subject headings
- Colonic Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NHS-PEG coated collagen patchOther
Also called Hemopatch
Analysis of the number and seriousness of leaks in the ileocolic anastomosis after using a NHS-PEG coated collagen patch reinforcement.
| Study group | Role | What they receive |
|---|---|---|
| NHS-PEG coated collagen patch cohort | Patients diagnosed of colon adenocarcinoma that have ileocolic anastomosis after undergoing a laparoscopic right hemicolectomy surgery. Receives: Other: NHS-PEG coated collagen patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness and security analysis in the prevention of anastomosis leakage through the protection of ileocolic anastomosis with NHS-PEG coated collagen patch.
Ileocolic anastomosis leakage existence of evidence and seriousness.
Measured: Up to 30 days after the surgery
Secondary outcomes (4)
Analysis of the percentage of leaks in the ileocolic anastomosis reinforced with NHS-PEG coated collagen patch.
Percentage of leaks that occur in the ileocolic anastomosis after being reinforced with NHS-PEG coated collagen patch.
Measured: Up to 30 days after the surgery
Number of complications related to anastomotic leakage in patients with ileocolic anastomosis reinforced with NHS-PEG coated collagen patch.
Number and type of complications due to the anastomotic leakage in patients with ileocolic anastomosis reinforced with NHS-PEG coated collagen patch.
Measured: Up to 30 days after the surgery
Number of surgical repetitions.
Number of following surgeries that the patient has to undergo due to the failure of the collagen patch ileocolic anastomosis protection.
Measured: Up to 30 days after the surgery
Number of hospital readmissions.
Number of times that the patient has to be rehospitalized due to the failure of the collagen patch ileocolic anastomosis protection.
Measured: Up to 30 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start15 Jan 2019
- Primary completion15 Dec 2019 (estimated)
- Study completion15 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma ColonStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan Carlos Gómez Rosado, Principal investigator, Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109105
- Sponsor's protocol ID
- FIS-HEMOPATCH-2018-02
- Acronym
- ANASTOPATCH
- Status last verified
- Sep 2019
- First submitted
- 27 Sep 2019
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pilot Study for the Efficacy and Security Analysis in the Protection of Ileocolic Anastomosis Conducted in Laparoscopic Right Hemicolectomy Because of Colon Cancer, Using a Using a NHS-PEG (N-hydroxysuccinimide Functionalized Polyethylene Glycol) Coated Collagen Patch.
- ClinicalTrials.gov ID
- NCT04109105
- Acronym / sponsor ID
- ANASTOPATCH / FIS-HEMOPATCH-2018-02
- Conditions
- Adenocarcinoma Colon
- Keywords
- Colon neoplasia, Ascendant colon, Surgical anastomosis, Anastomotic leak, Collagen, Polyethylene glycol, Hemopatch
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 15 Dec 2019 (estimated)
- Study completion
- 15 May 2020 (estimated)
- First posted
- 30 Sep 2019 (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.
The aim of this study is to analyse the effectiveness and security in the prevention of anastomotic leakage by protecting the ileocolic anastomosis with a reabsorbable NHS-PEG collagen patch.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NHS-PEG coated collagen patch cohort | – | Other: NHS-PEG coated collagen patchPatients diagnosed of colon adenocarcinoma that have ileocolic anastomosis after undergoing a laparoscopic right hemicolectomy surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing a programmed right laparoscopic hemicolectomy for right colon adenocarcinoma with curative intention at the Virgen Macarena University Hospital during the necessary period of time to achieve the proposed number of patients.
Key inclusion criteria (4 listed)
- ≥ 18 years old.
- Ability to understand and make their own decision to participate in the study.
- Pre-surgery right colon adenocarcinoma pathological diagnosis.
- Patient with a mechanic, intra or extracorporeal ileocolic anastomosis.
Key exclusion criteria (3 listed)
- Urgent intervention.
- Simultaneous colon cancer.
- M1 pre-surgery staging.
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 |
|---|---|---|
| NHS-PEG coated collagen patchAlso: HemopatchAnalysis of the number and seriousness of leaks in the ileocolic anastomosis after using a NHS-PEG coated collagen patch reinforcement. | Other | NHS-PEG coated collagen patch cohort |
Primary outcome
Effectiveness and security analysis in the prevention of anastomosis leakage through the protection of ileocolic anastomosis with NHS-PEG coated collagen patch.
Time frame: Up to 30 days after the surgery
Ileocolic anastomosis leakage existence of evidence and seriousness.
4 secondary outcomes
Analysis of the percentage of leaks in the ileocolic anastomosis reinforced with NHS-PEG coated collagen patch.
Time frame: Up to 30 days after the surgery
Number of complications related to anastomotic leakage in patients with ileocolic anastomosis reinforced with NHS-PEG coated collagen patch.
Time frame: Up to 30 days after the surgery
Number of surgical repetitions.
Time frame: Up to 30 days after the surgery
Number of hospital readmissions.
Time frame: Up to 30 days after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
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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.
Juan Carlos Gómez Rosado principal investigator
Hospital Universitario Virgen Macarena
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 Adenocarcinoma Colon, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
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 3 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: status not confirmed, as of the sponsor's last update on 2 Oct 2019. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Carlos Gómez Rosado (955 00 80 00, juanc.gomez.rosado.sspa@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness and security analysis in the prevention of anastomosis leakage through the protection of ileocolic anastomosis with NHS-PEG coated collagen patch. (time frame: Up to 30 days after the surgery). 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 2 Oct 2019.