Skip to content

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06104579
Enrollment
11367
Registered
2023-10-27
Start date
2011-01-01
Completion date
2023-07-30
Last updated
2024-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Organ-Space Surgical Site Infection, Rectal Cancer

Keywords

Surgical Site Infection, Rectal cancer, Rectal Surgery, Databases concordance

Brief 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.

Interventions

OTHERPerson-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.

Sponsors

Institut d'Investigació Biomèdica de Bellvitge
CollaboratorOTHER
Institut Català d'Oncologia
CollaboratorOTHER
Hospital de Granollers
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Rate of Organ-space surgical site infection30 daysAs 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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026