Anastomotic LeakANACARENCT02634112
Spanish National Registry of ANAstomotic Leakage in CAncer of the REctum (ANACARE)
An observational study of Anastomotic Leak, run by Hospital Universitario La Fe.
Trial summary
Primary Endpoint: The main objective of this National Registry is to identify the incidence and to analyse the risk factors for anastomotic leakage in rectal cancer surgery From the operational point of view, the aim of this Registry is to systematize the collection of information on the different surgical services. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomotic Leak
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Nov 2016
- How long will I take part?
- 1 Month
- 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: It is a record of the surgical procedure performed in patients undergoing rectal cancer surgery electively, resected with curative intent and anastomosis, with or without protective ileostomy. Participating Hospitals should include all patients undergoing rectal cancer surgery CONSECUTIVE during the study period. An estimated number of centers and patients a priori is not fixed; will depend on the publicity of the record between the members of the Spanish Association of Surgeons and the commitment and involvement of the researchers involved.
Who may be able to join
- Patient with not less than 18 years.
- Patients who are to undergo surgery for rectal cancer (within 15cm from the anal margin by rigid colonoscopy), elective, resected with local curative intent (R0 and R1) and anastomosis with or without proximal stoma .
- Patient permit registration information of the surgical procedure, which has been submitted by signing the written informed consent.
Who cannot join
- Patients underwent the following procedures:
- No resected.
- Local resection= R2.
- Resection without anastomosis
- Patients participating in a clinical trial that would alter this trial.
- Patients who are lacking basic relevant information to complete the requested data in the registry.
About this study
Official title: Spanish National Registry of Anastomotic Leakage in Rectal Cancer Surgery. Observational, Prospective and Multicenter Study
Primary Endpoint:
The main objective of this National Registry is to identify the incidence and to analyse the risk factors for anastomotic leakage in rectal cancer surgery From the operational point of view, the aim of this Registry is to systematize the collection of information on the different surgical services. This Registry claims to have National audit functions, allowing thus the knowledge of the procedures performed at each center that could enable the establishment of the best standard of care.
Read more
Secondary Endpoints:
To determine the real incidence of anastomotic leakage according to the different locations and techniques: uniform definition of anastomotic leakage.
To analyze the preoperative risk factors of anastomotic leakage: PATIENT FACTOR.
To analyse the variability in the practice of rectal anastomosis: SURGEON FACTOR.
To analyse the influence of different stapling devices in rectal anastomosis: INSTRUMENTAL FACTOR To know the current treatment of anastomotic leakage and the associated morbidity and mortality.
To create and validate an anastomotic leakage predictive Score.
Read the detailed description
Study Procedures:
This is a Registry of the surgical procedure performed in patients undergoing elective surgery for rectal cancer, resected with curative intent, with anastomosis, with or without protective ileostomy.
Patients will be included pre-operatively, through a website access to the study database. This inclusion could be done until the day before surgery. Participating sites must include all patients undergoing rectal cancer consecutively during the study duration (approximately 1 year).
Data will be collected until day 30 after patient´s discharge. No further follow-up is planned, except for those established by clinical practice.
The study aims to be an extensive and comprehensive registry of all patients meeting inclusion criteria for a period of one year.
An estimated number of centers and patients is not fixed a priori; will depend on the dissemination of the Registry between the members of the Spanish Association of Surgeons and the commitment and involvement of the involved investigators.
An estimated number of centers and patients is not fixed a priori; will depend on the dissemination of the Registry between the members of the Spanish Association of Surgeons and the commitment and involvement of the involved investigators.
All Spanish surgeons, members or not of the Spanish Association of Surgeons, will be invited to participate.
Minimum requirements for all participants will be established, being the most important the commitment with the Registry (quality of information and regular updates).
Other criterion that will be considered in the selection of the participating sites is to have a sufficient volume of patients that enables the collection of information, and to present a high history of rectal cancer surgeries per year. The existence of a Coloproctology Unit and publications in the area will be also evaluated.
Data will be recorded in an electronic Case Report Form.
It will contains the following variables, between others:
Identification data of the responsible physician Administrative data of the procedure Patient demographic data Preoperative data Intraoperative data Postoperative data Final follow-up (30 days after surgery) The information collected will be always a reflect of clinical practice at each site, as one of the results that will be analyzed are the differences in the practice from site to site.
- Conditions
- Anastomotic Leak
- Keywords
- anastomotic leakage, rectal cancer surgery, anastomotic leakage predictive score
- Medical subject headings
- Anastomotic Leak
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of anastomotic leakage in rectal cancer surgery in a Spanish National Audit
The aim of this Registry is to systematize the collection of information on the different surgical services. This Registry claims to have National audit functions, allowing thus the knowledge of the procedures performed at each center, that could enable the establishment of the best standard of care.
Measured: 1 month
Secondary outcomes (2)
Incidence of rectal anastomotic leakage rate between different types of surgeon
Measured: 1 month
Influence of different stapling devices in rectal anastomotic leakage rate
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionMay 2016 (estimated)
- Study completionNov 2016 (estimated)
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Fe
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Principal investigator, Blas Flor Lorente, Hospital Universitario La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634112
- Sponsor's protocol ID
- ANACARE
- Acronym
- ANACARE
- Status last verified
- Dec 2015
- First submitted
- 22 Sep 2015
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spanish National Registry of Anastomotic Leakage in Rectal Cancer Surgery. Observational, Prospective and Multicenter Study
- ClinicalTrials.gov ID
- NCT02634112
- Acronym / sponsor ID
- ANACARE / ANACARE
- Conditions
- Anastomotic Leak
- Keywords
- anastomotic leakage, rectal cancer surgery, anastomotic leakage predictive score
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Hospital Universitario La FeUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- Jan 2016
- Primary completion
- May 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 17 Dec 2015 (estimated)
- 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.
Primary Endpoint:
The main objective of this National Registry is to identify the incidence and to analyse the risk factors for anastomotic leakage in rectal cancer surgery From the operational point of view, the aim of this Registry is to systematize the collection of information on the different surgical services. This Registry claims to have National audit functions, allowing thus the knowledge of the procedures performed at each center that could enable the establishment of the best standard of care.
Secondary Endpoints:
To determine the real incidence of anastomotic leakage according to the different locations and techniques: uniform definition of anastomotic leakage.
To analyze the preoperative risk factors of anastomotic leakage: PATIENT FACTOR.
To analyse the variability in the practice of rectal anastomosis: SURGEON FACTOR.
To analyse the influence of different stapling devices in rectal anastomosis: INSTRUMENTAL FACTOR To know the current treatment of anastomotic leakage and the associated morbidity and mortality.
To create and validate an anastomotic leakage predictive Score.
Detailed description
Study Procedures:
This is a Registry of the surgical procedure performed in patients undergoing elective surgery for rectal cancer, resected with curative intent, with anastomosis, with or without protective ileostomy.
Patients will be included pre-operatively, through a website access to the study database. This inclusion could be done until the day before surgery. Participating sites must include all patients undergoing rectal cancer consecutively during the study duration (approximately 1 year).
Data will be collected until day 30 after patient´s discharge. No further follow-up is planned, except for those established by clinical practice.
The study aims to be an extensive and comprehensive registry of all patients meeting inclusion criteria for a period of one year.
An estimated number of centers and patients is not fixed a priori; will depend on the dissemination of the Registry between the members of the Spanish Association of Surgeons and the commitment and involvement of the involved investigators.
An estimated number of centers and patients is not fixed a priori; will depend on the dissemination of the Registry between the members of the Spanish Association of Surgeons and the commitment and involvement of the involved investigators.
All Spanish surgeons, members or not of the Spanish Association of Surgeons, will be invited to participate.
Minimum requirements for all participants will be established, being the most important the commitment with the Registry (quality of information and regular updates).
Other criterion that will be considered in the selection of the participating sites is to have a sufficient volume of patients that enables the collection of information, and to present a high history of rectal cancer surgeries per year. The existence of a Coloproctology Unit and publications in the area will be also evaluated.
Data will be recorded in an electronic Case Report Form.
It will contains the following variables, between others:
Identification data of the responsible physician Administrative data of the procedure Patient demographic data Preoperative data Intraoperative data Postoperative data Final follow-up (30 days after surgery) The information collected will be always a reflect of clinical practice at each site, as one of the results that will be analyzed are the differences in the practice from site to site.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It is a record of the surgical procedure performed in patients undergoing rectal cancer surgery electively, resected with curative intent and anastomosis, with or without protective ileostomy. Participating Hospitals should include all patients undergoing rectal cancer surgery CONSECUTIVE during the study period. An estimated number of centers and patients a priori is not fixed; will depend on the publicity of the record between the members of the Spanish Association of Surgeons and the commitment and involvement of the researchers involved.
Key inclusion criteria (3 listed)
- Patient with not less than 18 years.
- Patients who are to undergo surgery for rectal cancer (within 15cm from the anal margin by rigid colonoscopy), elective, resected with local curative intent (R0 and R1) and anastomosis with or without proximal stoma .
- Patient permit registration information of the surgical procedure, which has been submitted by signing the written informed consent.
Key exclusion criteria (6 listed)
- Patients underwent the following procedures:
- Patients participating in a clinical trial that would alter this trial.
- Patients who are lacking basic relevant information to complete the requested data in the registry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of anastomotic leakage in rectal cancer surgery in a Spanish National Audit
Time frame: 1 month
The aim of this Registry is to systematize the collection of information on the different surgical services. This Registry claims to have National audit functions, allowing thus the knowledge of the procedures performed at each center, that could enable the establishment of the best standard of care.
2 secondary outcomes
Incidence of rectal anastomotic leakage rate between different types of surgeon
Time frame: 1 month
Influence of different stapling devices in rectal anastomotic leakage rate
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Anastomotic Leak, run by Hospital Universitario La Fe.
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 3 inclusion and 6 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 17 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Incidence of anastomotic leakage in rectal cancer surgery in a Spanish National Audit (time frame: 1 month). 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 17 Dec 2015.