Clinical Trials Directory

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

TypeNameDescription
OTHERPerson-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.

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.