Reduction of Surgical Site Infections in Colorectal SurgeryNCT04677686
Observation of the Implementation of a Bundle of Care in Colorectal Surgery to Reduce Surgical Site Infections Successfully
An observational study of Reduction of Surgical Site Infections in Colorectal Surgery, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reduction of Surgical Site Infections in Colorectal Surgery
- What is being tested?
- Bundle of Care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2020to 30 Sep 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing colorectal surgery in the Cantonal Hospital of Lucerne October 2020-September 2021
Who may be able to join
- over 18 elective or emergency colorectal surgery written informed consent
Who cannot join
- pregnant no informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Cantonal Hospital of Lucerne
Lucerne, 6000
Jörn-Markus Gass
About this study
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.
Read the 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.
- Being tested
- Bundle of Care
- Keywords
- colorectal surgery, bundle of care, surgical site infection
- 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.
Bundle of CareBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Bundle of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site infection
rate of SSIs and classification of SSIs (superficial SSI, deep SSI or organ space SSI)
Measured: 30 days
Secondary outcomes (1)
Risk factors for SSI
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)
Measured: at surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 Oct 2020
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
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 Reduction of Surgical Site Infections in 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jörn-Markus Gass, Principal investigator, Cantonal Hospital of Lucerne, Spitalstrasse, 6000 Lucerne 16
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677686
- Sponsor's protocol ID
- 220-00051
- Status last verified
- Dec 2020
- First submitted
- 16 Dec 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brunner S, Liesenberg J, Fourie L, Metzger J, Scheiwiller A, Zschokke I, Lehnick D, Gass JM. Implementation of a Bundle of Care in Colorectal Surgery to Reduce Surgical Site Infections Successfully at Cantonal Hospital Lucerne: Study Protocol for a Prospective Observational Study. Int J Surg Protoc. 2021 Sep 23;25(1):220-226. doi: 10.29337/ijsp.150. eCollection 2021.
PubMed 34616960
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of the Implementation of a Bundle of Care in Colorectal Surgery to Reduce Surgical Site Infections Successfully
- ClinicalTrials.gov ID
- NCT04677686
- Acronym / sponsor ID
- 220-00051
- Keywords
- colorectal surgery, bundle of care, surgical site infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 21 Dec 2020 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) | – | Behavioral: Bundle of CareDuring 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing colorectal surgery in the Cantonal Hospital of Lucerne October 2020-September 2021
Key inclusion criteria (1 listed)
- over 18 elective or emergency colorectal surgery written informed consent
Key exclusion criteria (1 listed)
- pregnant no informed consent
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 |
|---|---|---|
| Bundle of CareHair 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 | Behavioural | Post-implementation phase (October 2020 - September 2021) |
Primary outcome
Surgical Site infection
Time frame: 30 days
rate of SSIs and classification of SSIs (superficial SSI, deep SSI or organ space SSI)
1 secondary outcome
Risk factors for SSI
Time frame: at surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Derived from this study: PubMed 34616960Brunner S, Liesenberg J, Fourie L, Metzger J, Scheiwiller A, Zschokke I, Lehnick D, Gass JM. Implementation of a Bundle of Care in Colorectal Surgery to Reduce Surgical Site Infections Successfully at Cantonal Hospital Lucerne: Study Protocol for a Prospective Observational Study. Int J Surg Protoc. 2021 Sep 23;25(1):220-226. doi: 10.29337/ijsp.150. eCollection 2021.
- Individual participant dataSharing planned: No
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.
Jörn-Markus Gass principal investigator
Cantonal Hospital of Lucerne, Spitalstrasse, 6000 Lucerne 16
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 Reduction of Surgical Site Infections in Colorectal Surgery, run by Luzerner Kantonsspital at 1 site in Switzerland.
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: status not confirmed, as of the sponsor's last update on 21 Dec 2020. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jörn-Markus Gass (0041412854835, markus.gass@luks.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site infection (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 NCT04677686, 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 21 Dec 2020.