Observation of the Implementation of a Bundle of Care in Colorectal Surgery to Reduce Surgical Site Infections Successfully

December 16, 2020 updated by: Luzerner Kantonsspital
This study aims to evaluate whether the colorectal bundle designed and implemented at Cantonal Hospital Lucerne, will lead to a significant reduction of SSIs. The impact of potential risk factors for SSIs will additionally be evaluated.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Surgical site infections (SSIs) remain a relevant problem in colorectal surgery. The aim of this study is to implement a bundle of care in order to reduce SSIs in colorectal surgery.

All patients undergoing colorectal surgery between October 2018 and September 2021 will be included in a prospective observational study. Since our colorectal bundle has been established gradually, patients will be grouped in a pre-implementation (2018-2019), implementation (2019-2020) and post implementation phase (2020-2021), in order to assess the effectiveness of the actions undertaken. Primary endpoint of this study will be surgical site infection (SSI) rate, while secondary endpoints encompass potential risk factors for SSIs. We assume that obesity, age, diabetes, alcoholism and smoking may lead to a higher risk for SSIs.

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lucerne, Switzerland, 6000
        • Recruiting
        • Cantonal Hospital of Lucerne
        • Contact:
          • Jörn-Markus Gass

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing colorectal surgery in the Cantonal Hospital of Lucerne October 2020-September 2021

Description

Inclusion Criteria:

over 18 elective or emergency colorectal surgery written informed consent

Exclusion Criteria:

pregnant no informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pre-implementation phase (October 2018 - September 2019)

During this time period, 137 patients underwent colorectal surgery. Only basic measures for preventing SSI were performed:

  1. Hair was removed in the operating field with a clipper instead of shaving hair.
  2. Blood glucose was monitored only during the operation.
  3. Antibiotic prophylaxis was applied 60 minutes before the operation.
  4. The application of an antibiotic prophylaxis was repeated if the operation lasted longer than 4 hours.
  5. Measures of warming were only applied during the operation and in the recovery room.
  6. Instruments and gloves were changed after finishing the anastomosis.
Implementation phase (October 2019 - September 2020)

During this phase, additional measures have been introduced:

  1. Implementation of wound protectors during colorectal surgery.
  2. Colorectal operations were only performed with the support of an experienced consultant surgeon.
Post-implementation phase (October 2020 - September 2021)

During this phase, additional measures are implemented.

  1. Close monitoring of blood glucose. During the stay in the recovery room and for 48 hours post-operative, blood glucose is monitored closely. Moreover, if blood glucose is higher than 9 mmol/l, the patient will be treated with insulin. This measure is applied to diabetic as well as to non-diabetic-patients.
  2. The measures of warming will be intensified. First of all, during the operation and during the stay in the recovery room patients will be placed on warming mattresses. Moreover, a warming towel will be placed on the operating field directly after the operation.
  3. The patients will be asked to take a shower the night before surgery. In case of an emergency operation, patients will be asked to wash the axilla, trunk, genitalia, groins and umbilicus
Behavioral: Bundle of Care
Hair removal with Clipper Glucose Control Preoperative antibiotics Repeat antibiotics after 4 Hours Optimize Body temperature Instrument change for colorectal anastomosis Use of wound protectors Experienced surgeon Preoperative showering

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Site infection
Time Frame: 30 days
rate of SSIs and classification of SSIs (superficial SSI, deep SSI or organ space SSI)
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk factors for SSI
Time Frame: at surgery
Determination of the risk factors for SSI (Obesity, age, diabetes, alcoholism, immune-deficit illnesses (such as HIV and Hepatitis), smoking, immunosuppressive drugs, chemotherapy, radiotherapy, COPD, pAVK, renal insufficiency and poor Nutrition)
at surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luzerner Kantonsspital

Investigators

  • Principal Investigator: Jörn-Markus Gass, Cantonal Hospital of Lucerne, Spitalstrasse, 6000 Lucerne 16

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

September 30, 2021

Study Registration Dates

First Submitted

December 16, 2020

First Submitted That Met QC Criteria

December 16, 2020

First Posted (Actual)

December 21, 2020

Study Record Updates

Last Update Posted (Actual)

December 21, 2020

Last Update Submitted That Met QC Criteria

December 16, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 220-00051

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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