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Completed

NCT Number: NCT06104579

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Person-level linkage of both databases looking for concordance in the diagnosis of organ-space surgical site infection

Other

Concordance between the two registers was analysed using Cohen´s Kappa.

Primary outcomes

  1. Rate of Organ-space surgical site infection

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospital de Granollers

Other

Collaborators

  • Institut Català d'Oncologia
  • Institut d'Investigació Biomèdica de Bellvitge

Registry information

Official study 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).

Important dates

Study start
2011
Primary completion
2016
Study completion
2023
First posted
Oct 27, 2023
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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