Surveillance and Implementation of a Bundle of Care to Reduce Surgical Site Infection in Colorectal Surgery (CCR-VINCat)

NCT04496635 | Unknown

• 1 other identifier: CCR-VINCat 1
• Study Type: interventional
• Target: 60,000
• Locations: 1 country
• Sites: 1

Brief Summary

The Nosocomial Infection Surveillance Program in Catalonia (VINCat) monitors surgical site infection (SSI) in elective colorectal surgery since 2007 in 55 public and private acute care hospitals. These hospitals perform active and prospective standardized surveillance of elective colorectal resections. Post-discharge surveillance is mandatory at least up to 30 days after surgery. Hospitals are classified according to their size into three groups: \>500 hospital beds; 200-500 beds; \<200 beds. Aim. To examine the effect on SSI rate of a specific preventative bundle in elective colorectal surgery. Methods. Pragmatic study using VINCat prospective colorectal database from 2007 to 2018. In 2016, a bundle of six preventative measures was recommended to the VINCat hospitals. To compare the results of SSI before (baseline phase, BP) and after the bundle implementation (implementation phase, IP) a logistic regression model has been established. The results will be shown as Odds Ratio (OR) and the corresponding confidence intervalsCI95. The significance level will be fixed at 5% (P \< 0.05).

Conditions

Colon Rectal Cancer; Surgical Site Infection

Keywords

Surveillance; Preventative measures; Bundle of care; Colorectal surgery; Surgical site infection; Prevention

Outcome Measures

Primary Outcomes (1)

• Surgical site infection rate

  Overall surgical infection rate

  30 days

Secondary Outcomes (3)

• Organ/space surgical infection rate

  30 days

• Hospital type-Surgical infection rate

  30 days

• Analysis (logistic regression model) of the efficacy of each preventive measure

  30 days

Study Arms (2)

Baseline phase

NO INTERVENTION

Patients included in the VINCat program, and operated on colorectal surgery between 2007 and 2015 in Catalonia

Implementation phase

EXPERIMENTAL

Patients included in the VINCat program, and operated on colorectal surgery between 2016 and 2018 in Catalonia

Other: Implementation of a bundle of care

Interventions

Implementation of a bundle of care OTHER

Implementation phase

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Colon or rectal elective surgery.

You may not qualify if:

• Peritonitis at the time of intervention ("dirty" surgery) Patients who underwent multiple procedures during the same surgery, for example resection of liver metastases Centers that performed less tan 10 surgical procedures annually Centers that have not been able to ensure prospective surveillance during hospitalization or effective monitoring of cases within 30 days of the intervention

Sponsors & Collaborators

• Hospital de Granollers: lead

Study Sites (1)

Hospital General de Granollers

Granollers, Barcelona, 08402, Spain

RECRUITING

MeSH Terms

Conditions

Colonic 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; Colonic Diseases; Intestinal Diseases; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Josep M Badia-Perez, MD, PhD

  Fundació Hospital General de Granollers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gemma Molist, MD, PHD

CONTACT

+348425000; gmolist@fphag.org

Josep M Badia, MD, PhD

CONTACT

+34670702099; jmbadiaperez@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study compare two phases: baseline (BP), from 2008 to 2015, and implementation (IP), from 2016 to 2018.

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: August 3, 2020
• Study Start: January 1, 2007
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)