Clinical trial NCT06104579: Concordance Between Monitoring Systems for Organ/Space Surgical Site Infections in Rectal Surgery
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).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Organ-Space Surgical Site Infection
Keywords: Surgical Site Infection
Rectal cancer
Rectal Surgery
Databases concordance
Lead sponsor: Hospital de Granollers
Sponsor class: OTHER
Collaborators: name: Institut d'Investigació Biomèdica de Bellvitge
name: Institut Català d'Oncologia
First posted: 2023-10-27
Enrollment: 11367
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated on rectal surgery for rectal cancer in Catalonia, Spain.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Organ-space surgical site infection
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: L'Hospitalet De Llobregat
country: Spain
facility: Institut Català d'Oncologia
state: Barcelona
Study officials:
References: