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

NCT06104579 | Completed

• 1 other identifier: VINCat_PDO
• Study Type: observational
• Target: 11,367
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer; Organ-Space Surgical Site Infection

Keywords

Surgical Site Infection; Rectal cancer; Rectal Surgery; Databases concordance

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

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.

Patients operated on rectal cancer, included in the Catalan Cancer Registry; Patients operated on rectal surgery, included in the Catalan Infection Surveillance Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Granollers: lead
• Institut d'Investigació Biomèdica de Bellvitge: collaborator
• Institut Català d'Oncologia: collaborator

Study Sites (1)

Institut Català d'Oncologia

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Related Publications (1)

• Matallana C, Pera M, Espin-Basany E, Biondo S, Badia JM, Limon E, Pujol M, de Lacy B, Aliste L, Borras JM, Manchon-Walsh P. 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 and the VINCat infection surveillance programme. World J Surg Oncol. 2024 May 25;22(1):138. doi: 10.1186/s12957-024-03410-9.

  PMID: 38789966 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 27, 2023
• Study Start: January 1, 2011
• Primary Completion: December 31, 2016
• Study Completion: July 30, 2023
• Last Updated: May 31, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)