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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03883399
Other study ID # PREVISQCOR-19
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2018
Est. completion date July 30, 2019

Study information

Verified date October 2019
Source Hospital de Granollers
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Web-based survey to colorectal surgeons assessing knowledge, beliefs and practices regarding the use of preventative measures for SSI.


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.


Recruitment information / eligibility

Status Completed
Enrollment 355
Est. completion date July 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Colorectal surgeons members of the Colorectal Chapter of the Spanish Association of Surgeons (AEC) and the Spanish Association of Coloproctology (AECP)

Exclusion Criteria:

- none

Study Design


Intervention

Other:
Survey
Survey among colorectal surgeons

Locations

Country Name City State
Spain Fundació Privada Hospital Asil de Granollers Granollers Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Hospital de Granollers

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2019
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