Rectal CancerNCT06104579
Concordance Between Monitoring Systems for Organ/Space Surgical Site Infections in Rectal Surgery
An observational study of Rectal Cancer and Organ-Space Surgical Site Infection, run by Hospital de Granollers at 1 site in Spain.
Trial summary
The Catalan Cancer Plan (CCP) undertakes periodic audits of cancer treatment outcomes, including organ/space surgical site infections (O/S-SSI) rates, while the Catalan Healthcare-associated Infections Surveillance Programme (VINCat) carries out standardized prospective surveillance of surgical site infections (SSIs)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Organ-Space Surgical Site Infection
- What is being tested?
- Person-level linkage of both databases looking for concordance in the diagnosis of organ-space surgical site infection
- How many people
- 11,367 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2011to 30 Jul 2023
- How long will I take part?
- 30 Days
- 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 operated on rectal surgery for rectal cancer in Catalonia, Spain.
Who may be able to join
- Patients > 18 years old
- Eligible patients with tumour ≤ 13 cm from anal verge, as measured by Magnetic Resonance Imaging
- Primary adenocarcinoma
- Oncological resection with curative intent
- Cancer stages: I-II-III
Who cannot join
- Transanal local resection
- Emergency colorectal surgeries
- Presence of metastases found in the diagnostic process or during the surgical procedure
- Recurrence of the disease treated before the study period
- Non-resectable tumour or palliative surgery
- Patients operated in private centres
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institut Català d'Oncologia
L'Hospitalet de Llobregat, Barcelona, 08908
About this study
Official title: Quality Check: Concordance Between Two Monitoring Systems for Postoperative Organ/Space Surgical Site Infections in Rectal Cancer Surgery. Linkage of Data From the Catalan Cancer Plan (CCP) and the Catalan Healthcare-associated Infections Surveillance Programme (VINCat).
The Catalan Cancer Plan (CCP) undertakes periodic audits of cancer treatment outcomes, including organ/space surgical site infections (O/S-SSI) rates, while the Catalan Healthcare-associated Infections Surveillance Programme (VINCat) carries out standardized prospective surveillance of surgical site infections (SSIs) in colorectal surgery. This cohort study aimed to assess the concordance between these two monitoring systems for O/S-SSI following primary rectal cancer surgery.
Read the detailed description
The healthcare system in Catalonia (Spain) monitors and reports SSI in cancer patients through two principal mechanisms. First of all, the Catalan Cancer Plan (CCP) is a Health Department structure that aims to improve the quality of care for cancer patients by means of periodic auditing of outcomes with real-world data and feedback to professionals. One indicator included in these compulsory audits is the occurrence of O/S-SSI.
On the other hand, the Catalan Healthcare-associated Infections Surveillance Programme (VINCat) is a nationwide network for hospital-acquired infections (HAI) which conducts surveillance in colorectal surgery.
The two systems thus operate with an important difference: the CCP audits are mandatory and cover all cancer surgeries performed in centres funded through the public healthcare system, while VINCat is a voluntary registry programme among participating centres. The selected cases and methods used to detect O/S-SSI may therefore vary substantially between auditing systems.
This retrospective population-based cohort study aims to assess the concordance between clinical audits of the CCP and the VINCat registry as a preliminary step to studies correlating local recurrence after rectal cancer surgery and O/S-SSI.
- Conditions
- Rectal Cancer, Organ-Space Surgical Site Infection
- Being tested
- Person-level linkage of both databases looking for concordance in the diagnosis of organ-space surgical site infection
- Keywords
- Surgical Site Infection, Rectal cancer, Rectal Surgery, Databases concordance
- Medical subject headings
- Rectal Neoplasms, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Person-level linkage of both databases looking for concordance in the diagnosis of organ-space surgical site infectionOther
Concordance between the two registers was analysed using Cohen´s Kappa.
| Study group | Role | What they receive |
|---|---|---|
| Patients operated on rectal cancer, included in the Catalan Cancer Registry | Patients operated on rectal cancer, included in two compulsory audits of the Catalan Cancer registry, and who suffered an organ-space surgical infection. Receives: Other: Person-level linkage of both databases looking for concordance in the diagnosis of organ-space surgical site infection | |
| Patients operated on rectal surgery, included in the Catalan Infection Surveillance Program | Patients included in the voluntary Catalan Infection Surveillance Program, and followed for 30 days postoperatively, and who suffered an organ-space surgical infection. Receives: Other: Person-level linkage of both databases looking for concordance in the diagnosis of organ-space surgical site infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Organ-space surgical site infection
As described by the Centers for Disease Control: an infection occurring within 30 days of the surgical procedure and involves any part of the body deeper than the fascial/muscle layers that is opened or manipulated during surgery. In addition, the patient must present at least one of the following associated events: a purulent drainage from a drain placed into the organ/space
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 posted27 Oct 2023
- Study start1 Jan 2011
- Primary completion31 Dec 2016
- Study completion30 Jul 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 Rectal CancerStudies 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
- Prospective
- Enrolment
- 11,367 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Hospital de Granollers
- Sponsor type
- University, hospital or other
- Collaborators
- Institut d'Investigació Biomèdica de Bellvitge, Institut Català d'Oncologia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104579
- Sponsor's protocol ID
- VINCat_PDO
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2023
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: : Restrictions apply to the availability of these data, which belong to two national databases and are not publicly available. Data was obtained from the Catalan Cancer Plan and VINCat, and are only available with the permission of their Technical Committees.
Publications
Matallana C, Pera M, Espin-Basany E, Biondo S, Badia JM, Limon E, Pujol M, de Lacy B, Aliste L, Borras JM, Manchon-Walsh P. Quality check: concordance between two monitoring systems for postoperative organ/space-surgical site infections in rectal cancer surgery. Linkage of data from the Catalan Cancer Plan and the VINCat infection surveillance programme. World J Surg Oncol. 2024 May 25;22(1):138. doi: 10.1186/s12957-024-03410-9.
PubMed 38789966
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Check: Concordance Between Two Monitoring Systems for Postoperative Organ/Space Surgical Site Infections in Rectal Cancer Surgery. Linkage of Data From the Catalan Cancer Plan (CCP) and the Catalan Healthcare-associated Infections Surveillance Programme (VINCat).
- ClinicalTrials.gov ID
- NCT06104579
- Acronym / sponsor ID
- VINCat_PDO
- Conditions
- Rectal Cancer, Organ-Space Surgical Site Infection
- Keywords
- Surgical Site Infection, Rectal cancer, Rectal Surgery, Databases concordance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,367 participants (actual)
- Lead sponsor
- Hospital de GranollersUniversity, hospital or other
- Collaborators
- Institut d'Investigació Biomèdica de Bellvitge, Institut Català d'Oncologia
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 27 Oct 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.
The Catalan Cancer Plan (CCP) undertakes periodic audits of cancer treatment outcomes, including organ/space surgical site infections (O/S-SSI) rates, while the Catalan Healthcare-associated Infections Surveillance Programme (VINCat) carries out standardized prospective surveillance of surgical site infections (SSIs) in colorectal surgery. This cohort study aimed to assess the concordance between these two monitoring systems for O/S-SSI following primary rectal cancer surgery.
Detailed description
The healthcare system in Catalonia (Spain) monitors and reports SSI in cancer patients through two principal mechanisms. First of all, the Catalan Cancer Plan (CCP) is a Health Department structure that aims to improve the quality of care for cancer patients by means of periodic auditing of outcomes with real-world data and feedback to professionals. One indicator included in these compulsory audits is the occurrence of O/S-SSI.
On the other hand, the Catalan Healthcare-associated Infections Surveillance Programme (VINCat) is a nationwide network for hospital-acquired infections (HAI) which conducts surveillance in colorectal surgery.
The two systems thus operate with an important difference: the CCP audits are mandatory and cover all cancer surgeries performed in centres funded through the public healthcare system, while VINCat is a voluntary registry programme among participating centres. The selected cases and methods used to detect O/S-SSI may therefore vary substantially between auditing systems.
This retrospective population-based cohort study aims to assess the concordance between clinical audits of the CCP and the VINCat registry as a preliminary step to studies correlating local recurrence after rectal cancer surgery and O/S-SSI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients operated on rectal cancer, included in the Catalan Cancer Registry | – | Other: Person-level linkage of both databases looking for concordance in the diagnosis of organ-space surgical site infectionPatients operated on rectal cancer, included in two compulsory audits of the Catalan Cancer registry, and who suffered an organ-space surgical infection. |
| Patients operated on rectal surgery, included in the Catalan Infection Surveillance Program | – | Other: Person-level linkage of both databases looking for concordance in the diagnosis of organ-space surgical site infectionPatients included in the voluntary Catalan Infection Surveillance Program, and followed for 30 days postoperatively, and who suffered an organ-space surgical infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients operated on rectal surgery for rectal cancer in Catalonia, Spain.
Key inclusion criteria (5 listed)
- Patients > 18 years old
- Eligible patients with tumour ≤ 13 cm from anal verge, as measured by Magnetic Resonance Imaging
- Primary adenocarcinoma
- Oncological resection with curative intent
- Cancer stages: I-II-III
Key exclusion criteria (6 listed)
- Transanal local resection
- Emergency colorectal surgeries
- Presence of metastases found in the diagnostic process or during the surgical procedure
- Recurrence of the disease treated before the study period
- Non-resectable tumour or palliative 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 |
|---|---|---|
| Person-level linkage of both databases looking for concordance in the diagnosis of organ-space surgical site infectionConcordance between the two registers was analysed using Cohen´s Kappa. | Other | Patients operated on rectal cancer, included in the Catalan Cancer Registry, Patients operated on rectal surgery, included in the Catalan Infection Surveillance Program |
Primary outcome
Rate of Organ-space surgical site infection
Time frame: 30 days
As described by the Centers for Disease Control: an infection occurring within 30 days of the surgical procedure and involves any part of the body deeper than the fascial/muscle layers that is opened or manipulated during surgery. In addition, the patient must present at least one of the following associated events: a purulent drainage from a drain placed into the organ/space
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 31 May 2024.
- Derived from this study: PubMed 38789966Matallana C, Pera M, Espin-Basany E, Biondo S, Badia JM, Limon E, Pujol M, de Lacy B, Aliste L, Borras JM, Manchon-Walsh P. Quality check: concordance between two monitoring systems for postoperative organ/space-surgical site infections in rectal cancer surgery. Linkage of data from the Catalan Cancer Plan and the VINCat infection surveillance programme. World J Surg Oncol. 2024 May 25;22(1):138. doi: 10.1186/s12957-024-03410-9.
- Individual participant dataSharing planned: No. : Restrictions apply to the availability of these data, which belong to two national databases and are not publicly available. Data was obtained from the Catalan Cancer Plan and VINCat, and are only available with the permission of their Technical Committees.
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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?
An observational study of Rectal Cancer and Organ-Space Surgical Site Infection, run by Hospital de Granollers 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 5 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: finished, as of the sponsor's last update on 31 May 2024. 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?
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?
Rate of Organ-space surgical site infection (time frame: 30 days). 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 NCT06104579, 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 31 May 2024.