Colorectal NeoplasmsNCT04129177
Reduction of Surgical Site Infections in Elective Colorectal Surgery After the Implementation of a Bundle of Care.
An observational study of Colorectal Neoplasms and Surgical Wound Infection, run by Hospital de Granollers at 1 site in Spain.
Trial summary
Background. The Nosocomial Infection Surveillance Program in Catalonia (VINCat) monitors SSI in elective colorectal surgery since 2007 in 56 hospitals (7.5 million population). These hospitals perform active and prospective standardized surveillance of elective colorectal resections. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Neoplasms, Surgical Wound Infection
- What is being tested?
- Implementation of a bundle of surgical infection preventive measures
- Type of treatment
- Pill or oral medicine
- How many people
- 12,000 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2018to 30 Jun 2020
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing elective colorectal surgery in Catalonia in the period 2012-2018
Who may be able to join
- Elective colorectal resection
Who cannot join
- Emergency surgery - Infection present at operation
Trial locations and contacts
1 site in 1 country.
Spain1 site
Fundació Privada Hospital Asil de Granollers
Granollers, Barcelona, 08402
About this study
Official title: Reduction of Surgical Site Infections in Elective Colorectal Surgery After the Implementation of a Bundle of Preventative Measures. Multicenter Study of the Nococomial Infection Surveillance Program in Catalonia.
Background. The Nosocomial Infection Surveillance Program in Catalonia (VINCat) monitors SSI in elective colorectal surgery since 2007 in 56 hospitals (7.5 million population). These hospitals perform active and prospective standardized surveillance of elective colorectal resections. Post-discharge surveillance is mandatory up to 30 days after surgery. Between 2007 and 2015, the SSI rate did not change significantly, with a cumulated incidence of 5,491 SSI in a total of 29,006 interventions (19%). In 2015, a working group of VINCat specialists and surgeons from the Catalan Society of Surgery was set up to formulate a specific bundle of SSI preventative measures for colorectal surgery.
Aim. To analyse the effect of a specific bundle for SSI prevention in elective colorectal surgery.
Methods. In 2016, a bundle of six preventative measures was recommended to the VINCat hospitals. Bundle measures were: systemic and oral antibiotic prophylaxis, mechanical bowel preparation (MBP), laparoscopic surgery, maintenance of normothermia, and the use of a double-ring wound retractor. The results of SSI before and after the implementation of the bundle are compared. The results are analysed using the chi-square test (statistical significance p <0.05).
Read the detailed description
Surgical location infection (ILQ) is the most frequent complication of surgery and an important source of clinical and economic problems for health systems. The reduction of its incidence is important because of its impact on patient comfort and the health resources used. The ILQ includes the categories of: superficial incisional (IIS, affects skin and subcutaneous tissue); deep incisional (IIP, affects deep soft tissues), and organ-space or organ-cavitary (IOE, affects any anatomical structure other than the incision manipulated during the intervention). Surgical procedures are distributed in the categories of clean, clean-contaminated, contaminated and dirty or infected surgery depending on your risk of ILQ.
Elective colorectal surgery belongs to the clean-contaminated surgery category, it is one of the most frequent surgical procedures in Western society and the one with the highest rate of postoperative infection. The ILQ after colorectal procedures represents a measurable indicator of the quality of a health system. Endogenous factors of the patient and exogenous factors related to the surgical procedure are involved in the development of the ILQ.
Despite the introduction of laparoscopy and the standardization of perioperative measures of prophylaxis, the clean-contaminated nature of these procedures, the increase in comorbidities and age of patients and the increase in the complexity of surgical procedures do not improve the Postoperative ILQ rates. It is necessary to investigate the usefulness of complementary prophylactic measures that allow lowering the level of wound contamination and reducing the rate of ILQ.
The grouping of ILQ prevention measures into bundles or packages of measures with a high level of evidence is a strategy that has proven effective in various types of surgical procedures. The overall effectiveness of a package of measures depends on the degree of individual effectiveness of each of the measures included in the bundle.
The Nosocomial Infection Surveillance Program in Catalonia (VINCat) has been monitoring ILQ rates in elective colorectal surgery since 2007 in 55 hospitals. These hospitals perform active and prospective standardized surveillance of elective colorectal resections. Post-discharge surveillance is mandatory up to 30 days after surgery. Between 2007 and 2015, the rate of ILQ did not change significantly, with a cumulative incidence of 5,491 ILQ in a total of 29,006 interventions (19%). Given the persistence of these infection rates, in 2015, an interdisciplinary working group was formed that included infection control nurses, infectious disease specialists, anesthetists and surgeons of the Catalan Society of Surgery. Its objective was to design a specific package of ILQ preventive measures for elective colorectal surgery that could affect the incisional infection and organ / space.
In 2016, a package of 6 measures of prevention of ILQ in colorectal surgery was implanted in hospitals belonging to VINCat.
Ambit. A multicenter study is proposed in 55 hospitals in Catalonia. This is a cohort study of the prospective VINCat database, which collects data on surgical patients with the purpose of improving quality. Sixty-five VINCat hospitals participate in the surveillance of ILQ in colorectal surgery, an effort focused on improving the ILQ in colon and rectal operations since 2007. There are more than 43,000 case records since that date. VINCat hospitals are predominantly public hospitals.
Workgroup. The working group is multicentre and interdisciplinary, including doctors and nurses of different specialties related to the prevention and control of surgical infection (surgical nursing, anesthesia, infectious diseases, infection spread and surgery) of different hospitals in the territory. The working group has a long experience in the surveillance and prevention of nosocomial and surgical infection and with the necessary means to carry out the project.
Recipients The study recipients are all patients undergoing elective colorectal surgery, one of the most frequent major abdominal surgical procedures in our hospitals and one of the ones that causes the most complications and health costs.
Hypothesis. Implantation of a package of ILQ prevention measures in colorectal surgery, which includes the combination of oral antibiotic and mechanical colon preparation (PMC) may decrease the rate of ILQ in elective colon surgery.
Goals. Principal. Evaluate the effect of the implementation of a package of specific measures (bundle) in reducing the ILQ rate
- Conditions
- Colorectal Neoplasms, Surgical Wound Infection
- Being tested
- Implementation of a bundle of surgical infection preventive measures
- Keywords
- Surgical site infection, Colorectal surgery, Surveillance, Bundle approach
- Medical subject headings
- Colorectal Neoplasms, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of a bundle of surgical infection preventive measuresOther
A bundle of six preventative measures is recommended to the VINCat hospitals. Bundle measures were: systemic and oral antibiotic prophylaxis, mechanical bowel preparation (MBP), laparoscopic surgery, maintenance of normothermia, and the use of a double-ring wound retractor.
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection rate
Rate of Surgical site infection according to the definitions of the CDC-NHSN (Centers for Disease Control and Prevention-National Healthcare Safety Network)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start1 Oct 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12,000 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Hospital de Granollers
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josep M Badia, Hospital de Granollers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129177
- Sponsor's protocol ID
- HGranollers
- Status last verified
- Oct 2024
- First submitted
- 15 Oct 2019
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Badia JM, Arroyo-Garcia N, Vazquez A, Almendral A, Gomila-Grange A, Fraccalvieri D, Pares D, Abad-Torrent A, Pascual M, Solis-Pena A, Puig-Asensio M, Pera M, Gudiol F, Limon E, Pujol M; Members of the VINCat Colorectal Surveillance Team; VINCat Program*. Leveraging a nationwide infection surveillance program to implement a colorectal surgical site infection reduction bundle: a pragmatic, prospective, and multicenter cohort study. Int J Surg. 2023 Apr 1;109(4):737-751. doi: 10.1097/JS9.0000000000000277.
PubMed 36917127
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Surgical Site Infections in Elective Colorectal Surgery After the Implementation of a Bundle of Preventative Measures. Multicenter Study of the Nococomial Infection Surveillance Program in Catalonia.
- ClinicalTrials.gov ID
- NCT04129177
- Acronym / sponsor ID
- HGranollers
- Conditions
- Colorectal Neoplasms, Surgical Wound Infection
- Keywords
- Surgical site infection, Colorectal surgery, Surveillance, Bundle approach
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,000 participants (actual)
- Lead sponsor
- Hospital de GranollersUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 16 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background. The Nosocomial Infection Surveillance Program in Catalonia (VINCat) monitors SSI in elective colorectal surgery since 2007 in 56 hospitals (7.5 million population). These hospitals perform active and prospective standardized surveillance of elective colorectal resections. Post-discharge surveillance is mandatory up to 30 days after surgery. Between 2007 and 2015, the SSI rate did not change significantly, with a cumulated incidence of 5,491 SSI in a total of 29,006 interventions (19%). In 2015, a working group of VINCat specialists and surgeons from the Catalan Society of Surgery was set up to formulate a specific bundle of SSI preventative measures for colorectal surgery.
Aim. To analyse the effect of a specific bundle for SSI prevention in elective colorectal surgery.
Methods. In 2016, a bundle of six preventative measures was recommended to the VINCat hospitals. Bundle measures were: systemic and oral antibiotic prophylaxis, mechanical bowel preparation (MBP), laparoscopic surgery, maintenance of normothermia, and the use of a double-ring wound retractor. The results of SSI before and after the implementation of the bundle are compared. The results are analysed using the chi-square test (statistical significance p <0.05).
Detailed description
Surgical location infection (ILQ) is the most frequent complication of surgery and an important source of clinical and economic problems for health systems. The reduction of its incidence is important because of its impact on patient comfort and the health resources used. The ILQ includes the categories of: superficial incisional (IIS, affects skin and subcutaneous tissue); deep incisional (IIP, affects deep soft tissues), and organ-space or organ-cavitary (IOE, affects any anatomical structure other than the incision manipulated during the intervention). Surgical procedures are distributed in the categories of clean, clean-contaminated, contaminated and dirty or infected surgery depending on your risk of ILQ.
Elective colorectal surgery belongs to the clean-contaminated surgery category, it is one of the most frequent surgical procedures in Western society and the one with the highest rate of postoperative infection. The ILQ after colorectal procedures represents a measurable indicator of the quality of a health system. Endogenous factors of the patient and exogenous factors related to the surgical procedure are involved in the development of the ILQ.
Despite the introduction of laparoscopy and the standardization of perioperative measures of prophylaxis, the clean-contaminated nature of these procedures, the increase in comorbidities and age of patients and the increase in the complexity of surgical procedures do not improve the Postoperative ILQ rates. It is necessary to investigate the usefulness of complementary prophylactic measures that allow lowering the level of wound contamination and reducing the rate of ILQ.
The grouping of ILQ prevention measures into bundles or packages of measures with a high level of evidence is a strategy that has proven effective in various types of surgical procedures. The overall effectiveness of a package of measures depends on the degree of individual effectiveness of each of the measures included in the bundle.
The Nosocomial Infection Surveillance Program in Catalonia (VINCat) has been monitoring ILQ rates in elective colorectal surgery since 2007 in 55 hospitals. These hospitals perform active and prospective standardized surveillance of elective colorectal resections. Post-discharge surveillance is mandatory up to 30 days after surgery. Between 2007 and 2015, the rate of ILQ did not change significantly, with a cumulative incidence of 5,491 ILQ in a total of 29,006 interventions (19%). Given the persistence of these infection rates, in 2015, an interdisciplinary working group was formed that included infection control nurses, infectious disease specialists, anesthetists and surgeons of the Catalan Society of Surgery. Its objective was to design a specific package of ILQ preventive measures for elective colorectal surgery that could affect the incisional infection and organ / space.
In 2016, a package of 6 measures of prevention of ILQ in colorectal surgery was implanted in hospitals belonging to VINCat.
Ambit. A multicenter study is proposed in 55 hospitals in Catalonia. This is a cohort study of the prospective VINCat database, which collects data on surgical patients with the purpose of improving quality. Sixty-five VINCat hospitals participate in the surveillance of ILQ in colorectal surgery, an effort focused on improving the ILQ in colon and rectal operations since 2007. There are more than 43,000 case records since that date. VINCat hospitals are predominantly public hospitals.
Workgroup. The working group is multicentre and interdisciplinary, including doctors and nurses of different specialties related to the prevention and control of surgical infection (surgical nursing, anesthesia, infectious diseases, infection spread and surgery) of different hospitals in the territory. The working group has a long experience in the surveillance and prevention of nosocomial and surgical infection and with the necessary means to carry out the project.
Recipients The study recipients are all patients undergoing elective colorectal surgery, one of the most frequent major abdominal surgical procedures in our hospitals and one of the ones that causes the most complications and health costs.
Hypothesis. Implantation of a package of ILQ prevention measures in colorectal surgery, which includes the combination of oral antibiotic and mechanical colon preparation (PMC) may decrease the rate of ILQ in elective colon surgery.
Goals. Principal. Evaluate the effect of the implementation of a package of specific measures (bundle) in reducing the ILQ rate
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing elective colorectal surgery in Catalonia in the period 2012-2018
Key inclusion criteria (1 listed)
- Elective colorectal resection
Key exclusion criteria (1 listed)
- Emergency surgery - Infection present at operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation of a bundle of surgical infection preventive measuresA bundle of six preventative measures is recommended to the VINCat hospitals. Bundle measures were: systemic and oral antibiotic prophylaxis, mechanical bowel preparation (MBP), laparoscopic surgery, maintenance of normothermia, and the use of a double-ring wound retractor. | Other | – |
Primary outcome
Surgical site infection rate
Time frame: 30 days
Rate of Surgical site infection according to the definitions of the CDC-NHSN (Centers for Disease Control and Prevention-National Healthcare Safety Network)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Derived from this study: PubMed 36917127Badia JM, Arroyo-Garcia N, Vazquez A, Almendral A, Gomila-Grange A, Fraccalvieri D, Pares D, Abad-Torrent A, Pascual M, Solis-Pena A, Puig-Asensio M, Pera M, Gudiol F, Limon E, Pujol M; Members of the VINCat Colorectal Surveillance Team; VINCat Program*. Leveraging a nationwide infection surveillance program to implement a colorectal surgical site infection reduction bundle: a pragmatic, prospective, and multicenter cohort study. Int J Surg. 2023 Apr 1;109(4):737-751. doi: 10.1097/JS9.0000000000000277.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms and Surgical Wound Infection, run by Hospital de Granollers at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical site infection rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04129177, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.