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).

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 11367

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • L'Hospitalet De Llobregat, Barcelona, Spain, 08908
      • Institut Catala d'Oncologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients operated on rectal surgery for rectal cancer in Catalonia, Spain.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients operated on rectal cancer, included in the Catalan Cancer Registry; Patients operated on rectal cancer, included in two compulsory audits of the Catalan Cancer registry, and who suffered an organ-space surgical infection.	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.
Patients operated on rectal surgery, included in the Catalan Infection Surveillance Program; Patients included in the voluntary Catalan Infection Surveillance Program, and followed for 30 days postoperatively, and who suffered an organ-space surgical infection.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Organ-space surgical site infection	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	30 days

Collaborators and Investigators

• Sponsor: Hospital de Granollers
• Collaborators: Institut Català d'Oncologia; Institut d'Investigació Biomèdica de Bellvitge

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Rectal cancer; Surgical Site Infection; Rectal Surgery; Databases concordance
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Postoperative Complications; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Wound Infection; Infections; Communicable Diseases; Rectal Neoplasms; Surgical Wound Infection
• Other Study ID Numbers: VINCat_PDO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: : Restrictions apply to the availability of these data, which belong to two national databases and are not publicly available. Data was obtained from the Catalan Cancer Plan and VINCat, and are only available with the permission of their Technical Committees.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No