Colorectal SurgeryPREVISQCORNCT03883399
Survey on Practice and Comparison With Best Evidence in Surgical Site Infection Prevention in Colorectal Surgery
An observational study of Colorectal Surgery and Surgical Site Infection, run by Hospital de Granollers at 1 site in Spain.
Trial summary
Web-based survey to colorectal surgeons assessing knowledge, beliefs and practices regarding the use of preventative measures for SSI. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Surgery, Surgical Site Infection
- What is being tested?
- Survey
- How many people
- 355 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2018to 30 Jul 2019
- 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: Members of the Colorectal Chapter of the Spanish Association of Surgeons (AEC) and the Spanish Association of Coloproctology (AECP)
Who may be able to join
- Colorectal surgeons members of the Colorectal Chapter of the Spanish Association of Surgeons (AEC) and the Spanish Association of Coloproctology (AECP)
Who cannot join
- none
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: Awareness of Practice and Comparison With Best Evidence in Surgical Site Infection Prevention in Colorectal Surgery
Web-based survey to colorectal surgeons assessing knowledge, beliefs and practices regarding the use of preventative measures for SSI.
Read the detailed description
A web-based survey (SurveyMonkey©; https://es.surveymonkey.com/r/FBVR59C) to the members of the Colorectal Chapter of the Spanish Association of Surgeons (AEC) and the Spanish Association of Coloproctology (AECP). A link to the web page containing the survey is disseminated via email, newsletter and Twitter.
A board from the Surgical Infection Section did a review of evidence and previous guidelines to be used in the evaluation of the results. The most recent clinical practice guidelines have been analysed. Furthermore, an extensive review of specific measures for colorectal surgery has been published and used for evaluation. According to the review, the preventive measures analysed in the survey have been distributed into two groups: high or low level of evidence.
The survey aim to assess knowledge, beliefs, and practices of attending colorectal surgeons on preventative measures including mechanical bowel preparation (MBP), oral antibiotic prophylaxis and the use of drains. Furthermore, the questions address the level of accordance between their beliefs and the protocols or the usual practice of their units. The agreement rate between the beliefs and usual practice of all respondents will be calculated on a scale from 0 to 100. For discussion, the responses on the implementation of major surgical site infection (SSI) prevention measures will be compared with the recommendations of the expert group. Other questions are related to the types of complications that surgeons believe are prevented by the use of oral antibiotic prophylaxis or MBP, reasons for not using either of them, type of oral and systemic antibiotics and cathartics used, and strategies already in place or that should be implemented to reduce SSI rates at respondents' hospitals.
The results will be expressed in percentages on the total answers obtained. Responses will be entered into a computerized database that will be analysed using the SPSS program (v.10.0, Chicago, IL, USA). The results will be analysed using the chi-square test with statistical significance defined as p <0.05.
- Conditions
- Colorectal Surgery, Surgical Site Infection
- Being tested
- Survey
- Keywords
- Surgical Site Infection, Prevention, Survey, Colorectal surgery, Guidelines
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Survey among colorectal surgeons
| Study group | Role | What they receive |
|---|---|---|
| Colorectal surgeons | Survey among Spanish colorectal surgeons Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Awareness of practice - Percentage of responders who use each preventive measures for surgical site infection
Percentage of responders who use each preventive measures for surgical site infection (including mechanical bowel preparation and oral antibiotic prophylaxis), compared to their beliefs and knowledge of scientific evidence.
Measured: 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start1 Nov 2018
- Primary completion30 Jun 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal SurgeryStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Granollers
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josep Maria Badia, Hospital de Granollers
- Investigators
- Josep M Badia, Principal investigator, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883399
- Sponsor's protocol ID
- PREVISQCOR-19
- Acronym
- PREVISQCOR
- Status last verified
- Oct 2019
- First submitted
- 11 Mar 2019
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awareness of Practice and Comparison With Best Evidence in Surgical Site Infection Prevention in Colorectal Surgery
- ClinicalTrials.gov ID
- NCT03883399
- Acronym / sponsor ID
- PREVISQCOR / PREVISQCOR-19
- Conditions
- Colorectal Surgery, Surgical Site Infection
- Keywords
- Surgical Site Infection, Prevention, Survey, Colorectal surgery, Guidelines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Hospital de GranollersUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 20 Mar 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.
Web-based survey to colorectal surgeons assessing knowledge, beliefs and practices regarding the use of preventative measures for SSI.
Detailed description
A web-based survey (SurveyMonkey©; https://es.surveymonkey.com/r/FBVR59C) to the members of the Colorectal Chapter of the Spanish Association of Surgeons (AEC) and the Spanish Association of Coloproctology (AECP). A link to the web page containing the survey is disseminated via email, newsletter and Twitter.
A board from the Surgical Infection Section did a review of evidence and previous guidelines to be used in the evaluation of the results. The most recent clinical practice guidelines have been analysed. Furthermore, an extensive review of specific measures for colorectal surgery has been published and used for evaluation. According to the review, the preventive measures analysed in the survey have been distributed into two groups: high or low level of evidence.
The survey aim to assess knowledge, beliefs, and practices of attending colorectal surgeons on preventative measures including mechanical bowel preparation (MBP), oral antibiotic prophylaxis and the use of drains. Furthermore, the questions address the level of accordance between their beliefs and the protocols or the usual practice of their units. The agreement rate between the beliefs and usual practice of all respondents will be calculated on a scale from 0 to 100. For discussion, the responses on the implementation of major surgical site infection (SSI) prevention measures will be compared with the recommendations of the expert group. Other questions are related to the types of complications that surgeons believe are prevented by the use of oral antibiotic prophylaxis or MBP, reasons for not using either of them, type of oral and systemic antibiotics and cathartics used, and strategies already in place or that should be implemented to reduce SSI rates at respondents' hospitals.
The results will be expressed in percentages on the total answers obtained. Responses will be entered into a computerized database that will be analysed using the SPSS program (v.10.0, Chicago, IL, USA). The results will be analysed using the chi-square test with statistical significance defined as p <0.05.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal surgeons | – | Other: SurveySurvey among Spanish colorectal surgeons |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Members of the Colorectal Chapter of the Spanish Association of Surgeons (AEC) and the Spanish Association of Coloproctology (AECP)
Key inclusion criteria (1 listed)
- Colorectal surgeons members of the Colorectal Chapter of the Spanish Association of Surgeons (AEC) and the Spanish Association of Coloproctology (AECP)
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| SurveySurvey among colorectal surgeons | Other | Colorectal surgeons |
Primary outcome
Awareness of practice - Percentage of responders who use each preventive measures for surgical site infection
Time frame: 2019
Percentage of responders who use each preventive measures for surgical site infection (including mechanical bowel preparation and oral antibiotic prophylaxis), compared to their beliefs and knowledge of scientific evidence.
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 9 Oct 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Colorectal Surgery
Not yet recruiting
Tailored Nutrition vs. Exercise Prehabilitation Before Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Neoplasms
Not yet recruiting
Nurse-Led Prehabilitation Before Major Abdominal Cancer Surgery
Colorectal Cancer
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
RecruitingPhase 2
Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, ERASur Trial
Metastatic Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8
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.
Josep M Badia principal investigator
Universitat Internacional de Catalunya
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 Surgery and Surgical Site 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 9 Oct 2019. 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?
Awareness of practice - Percentage of responders who use each preventive measures for surgical site infection (time frame: 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2019.