Trials / Completed
CompletedNCT06104579
Concordance Between Monitoring Systems for Organ/Space Surgical Site Infections in Rectal Surgery
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).
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 11,367 (actual)
- Sponsor
- Hospital de Granollers · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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) 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 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. |
Timeline
- Start date
- 2011-01-01
- Primary completion
- 2016-12-31
- Completion
- 2023-07-30
- First posted
- 2023-10-27
- Last updated
- 2024-05-31
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT06104579. Inclusion in this directory is not an endorsement.