Concordance Between Monitoring Systems for Organ/Space Surgical Site Infections in Rectal Surgery
NCT ID: NCT06104579
Last Updated: 2024-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
11367 participants
OBSERVATIONAL
2011-01-01
2023-07-30
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Person-level linkage of both databases looking for concordance in the diagnosis of organ-space surgical site infection
Concordance between the two registers was analysed using Cohen´s Kappa.
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.
Person-level linkage of both databases looking for concordance in the diagnosis of organ-space surgical site infection
Concordance between the two registers was analysed using Cohen´s Kappa.
Interventions
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Person-level linkage of both databases looking for concordance in the diagnosis of organ-space surgical site infection
Concordance between the two registers was analysed using Cohen´s Kappa.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Institut d'Investigació Biomèdica de Bellvitge
OTHER
Institut Català d'Oncologia
OTHER
Hospital de Granollers
OTHER
Responsible Party
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Locations
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Institut Català d'Oncologia
L'Hospitalet de Llobregat, Barcelona, Spain
Countries
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References
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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.
Other Identifiers
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VINCat_PDO
Identifier Type: -
Identifier Source: org_study_id
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