Concordance Between Monitoring Systems for Organ/Space Surgical Site Infections in Rectal Surgery

Completed

• Conditions: Rectal Cancer; Organ-Space Surgical Site Infection
• Interventions: Other: Person-level linkage of both databases looking for concordance in the diagnosis of organ-space surgical site infection

• Registration Number: NCT06104579
• Lead Sponsor: Hospital de Granollers

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.

Study Timeline

• Study Start: 2011-01-01
• Primary Completion: 2016-12-31
• Study Completion: 2023-07-30
• Status Verified: 2023-10
• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-23
• Study First Posted: 2023-10-27
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11367

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients operated on rectal surgery, included in the Catalan Infection Surveillance Program	Person-level linkage of both databases looking for concordance in the diagnosis of organ-space surgical site infection	Patients included in the voluntary Catalan Infection Surveillance Program, and followed for 30 days postoperatively, and who suffered an organ-space surgical infection.
Patients operated on rectal cancer, included in the Catalan Cancer Registry	Person-level linkage of both databases looking for concordance in the diagnosis of organ-space surgical site infection	Patients operated on rectal cancer, included in two compulsory audits of the Catalan Cancer registry, and who suffered an organ-space surgical infection.

Primary Outcome Measures

Name	Time	Method
Rate of Organ-space surgical site infection	30 days	As 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

Trial Locations

Locations (1)

Institut Català d'Oncologia; 🇪🇸 L'Hospitalet De Llobregat, Barcelona, Spain