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

Rectal Cancer Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06104579
• Other study ID #: VINCat_PDO
• Status: Completed
• Start date: January 1, 2011
• Est. completion date: July 30, 2023

Study information

• Verified date: October 2023
• Source: Hospital de Granollers
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11367
• Est. completion date: July 30, 2023
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Rectal Cancer
• Rectal Neoplasms
• Surgical Wound Infection

Intervention

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.

Locations

Country	Name	City	State
Spain	Institut Català d'Oncologia	L'Hospitalet De Llobregat	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Hospital de Granollers	Institut Català d'Oncologia, Institut d'Investigació Biomèdica de Bellvitge

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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