Incidence of Surgical Site InfectionStOPNCT02428179
Impact of Structured Communication in the OR on Surgical Site Infections: Prospective Observational Clinical Trial
An observational study of Incidence of Surgical Site Infection and Short Intraoperative Briefings, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Surgical site infection (SSI) is the most frequent complication in patients that undergo abdominal surgery. A previous prospective observational study in 167 patients undergoing elective open abdominal procedures showed that case-relevant communication protects from organ/space SSI whereas case-irrelevant… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Incidence of Surgical Site Infection, Short Intraoperative Briefings, Mortality
- What is being tested?
- StOP? - Intervention group
- Type of treatment
- Surgery or procedure
- How many people
- 3,003 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2015to Jan 2017
- 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 abdominal surgery
Who may be able to join
- Patients undergoing elective or emergency surgery
Who cannot join
- Preexisting surgical site infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: StOP?-Trial: Impact of Structured Communication in the OR on Surgical Site Infections: Prospective Observational Clinical Trial
Surgical site infection (SSI) is the most frequent complication in patients that undergo abdominal surgery. A previous prospective observational study in 167 patients undergoing elective open abdominal procedures showed that case-relevant communication protects from organ/space SSI whereas case-irrelevant communication during the last 20 minutes of the procedure is a risk factor for incisional SSI. Therefore, the introduction of a clinical applicable intervention "structured briefing using the StOP protocol" has been developed and was tested in pilot experiments. This intervention aims at improving case-relevant communication during the procedure and to reduce excess case-irrelevant communication at the end of an operation.
The hypothesis is: structured briefings during an operation reduce the incidence of SSI after surgery.
Read the detailed description
Background
A number of publications has shown a relatively high rate of complications that are related to the treatment and not to the disease. Such iatrogenic incidents are an important influence on patient morbidity and increase healthcare costs. Therefore, patient safety and minimizing the risk of iatrogenic harm has become a major concern in healthcare. Surgical site infection (SSI) is one of the most frequent complication in patients that undergo surgery, leading to considerable costs.
In a previous study, the investigators established an empirical relationship between communication during surgery and SSI was shown in a prospective observational study in 167 patients undergoing major elective open abdominal procedures. An analysis of 11383 communication events observed by a team of trained work psychologists showed a relationship between intraoperative communication and SSI. Adjusted logistic regression analysis revealed that more case-relevant communication during the entire procedure was associated with a significant reduction in organ/space SSI (odds ratio 0.861, 95% confidence interval 0.750-0.987; P=0.034). Interestingly, case-irrelevant communication during the last 20 minutes of the procedure was associated with a significant increase of incisional SSI (odds ratio 1.1153, 95% confidence interval 1.040-1.196; P=0.002). Distractors such as noise and traffic were also assessed but had no effect on SSI. The current study is based on these observations, which reveal that case-relevant communication protects from organ/space SSI and case-irrelevant communication during the last 20 minutes of the procedure is a risk factor for SSI.
These findings can be interpreted in light of previous studies assessing communication in surgery and similar collaborative tasks which showed that explicit task-relevant communication fosters the development of a shared mental model of the task within the team. This facilitates coordination, because all team members are informed about the state of task progress, and can better anticipate their contribution. This is particularly important in critical phases of the procedure, as well as in OR teams composed of members with different levels of knowledge and expertise. Explicit task-related communication may be particularly useful to inform non-sterile team members (anesthetists, scrub nurses) that do not have full sight of the operative field at all times.
Although case-irrelevant communication in surgical teams has been found to foster a positive team-climate, it can be seen as a distractor if it diverts the attention away from the main task. This is more likely during the closing phase (last 20 minutes), because for most of the team members, the central task is already finished, and clearing and cleaning are routine tasks. If during routine tasks the team engages in too much non-patient relevant communication, attention to the closure may be diverted.
Given the previously found results, the introduction of a clinically applicable intervention (described below) has been tested in pilot studies. This intervention aims to assure a short discussion of case-relevant aspects at specific moments of the procedure, draw the attention of the on case-relevant communication during the main phase and to prevent a high increase in case-irrelevant communication at the end of an operation.
Objective
To perform a prospective clinical trial to test the impact of structured intraoperative briefings on SSI. The incidence of SSIs will be compared before and after the introduction of this intervention.
Methods
- Intraoperative briefings: First briefing: after exposure of the organ of interest, Second briefing: Intraoperative briefing before closure of the operative field.
- Trainings and Retrainings
- Optional Interventions: Transparent drape between anesthesia and sterile team; Controlling noise and potential distractors during wound closure; Nutritional support during the operation
- Conditions
- Incidence of Surgical Site Infection, Short Intraoperative Briefings, Mortality, Shared Mental Model
- Being tested
- StOP? - Control group, StOP? - Intervention group
- Keywords
- Surgical site infection, Intraoperative briefings, Mortality, Wound closure, Surgical procedure
- 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.
StOP? - Control groupProcedure or surgery
Control group - Surgical procedure without Study Intervention
StOP? - Intervention groupProcedure or surgery
Intervention group - Surgical procedure with intraoperative briefings, optional interventions: Transparent drape between anesthesia and sterile team, Controlling noise and potential distractors during wound closure, Nutritional support during the operation
| Study group | Role | What they receive |
|---|---|---|
| Control group without Study intervention | Control group without Study intervention Receives: Procedure: StOP? - Control group | |
| Group with Study intervention | Group with Study intervention Receives: Procedure: StOP? - Intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of surgical Site infections
Measured: 30 days postoperative
Secondary outcomes (3)
Postoperative mortality
Measured: 30 days postoperative
Type of Operation / Laparoscopic procedure
Measured: 30 days postoperative
Grade of contamination
Measured: 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Incidence of Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 3,003 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne Hospitals, Triemli Hospital, Kantonsspital Chur, Switzerland
- Responsible party
- Sponsor
- Investigators
- Guido Beldi, Prof. Dr. med., Principal investigator, Visceral and transplant surgery, University hospital, Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428179
- Sponsor's protocol ID
- 161/14
- Acronym
- StOP
- Status last verified
- Mar 2017
- First submitted
- 23 Apr 2015
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sax H, Uckay I, Balmelli C, Bernasconi E, Boubaker K, Muhlemann K, Ruef C, Troillet N, Widmer A, Zanetti G, Pittet D. Overall burden of healthcare-associated infections among surgical patients. Results of a national study. Ann Surg. 2011 Feb;253(2):365-70. doi: 10.1097/SLA.0b013e318202fda9.
PubMed 21217517Weber WP, Zwahlen M, Reck S, Feder-Mengus C, Misteli H, Rosenthal R, Brandenberger D, Oertli D, Widmer AF, Marti WR. Economic burden of surgical site infections at a European university hospital. Infect Control Hosp Epidemiol. 2008 Jul;29(7):623-9. doi: 10.1086/589331.
PubMed 18564917Mazzocco K, Petitti DB, Fong KT, Bonacum D, Brookey J, Graham S, Lasky RE, Sexton JB, Thomas EJ. Surgical team behaviors and patient outcomes. Am J Surg. 2009 May;197(5):678-85. doi: 10.1016/j.amjsurg.2008.03.002. Epub 2008 Sep 11.
PubMed 18789425Nurok M, Sundt TM 3rd, Frankel A. Teamwork and communication in the operating room: relationship to discrete outcomes and research challenges. Anesthesiol Clin. 2011 Mar;29(1):1-11. doi: 10.1016/j.anclin.2010.11.012.
PubMed 21295749Catchpole K, Mishra A, Handa A, McCulloch P. Teamwork and error in the operating room: analysis of skills and roles. Ann Surg. 2008 Apr;247(4):699-706. doi: 10.1097/SLA.0b013e3181642ec8.
PubMed 18362635Bley M, Gutknecht S, Burla L, Zindel C, Weber M, Wrann S. Does health insurance status influence surgical complications? An analysis of abdominal, thoracic and vascular interventions in a Swiss tertiary referral centre. Swiss Med Wkly. 2025 Dec 10;155:4179. doi: 10.57187/s.4179.
PubMed 41474101
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- StOP?-Trial: Impact of Structured Communication in the OR on Surgical Site Infections: Prospective Observational Clinical Trial
- ClinicalTrials.gov ID
- NCT02428179
- Acronym / sponsor ID
- StOP / 161/14
- Conditions
- Incidence of Surgical Site Infection, Short Intraoperative Briefings, Mortality, Shared Mental Model
- Keywords
- Surgical site infection, Intraoperative briefings, Mortality, Wound closure, Surgical procedure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,003 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Lausanne Hospitals, Triemli Hospital, Kantonsspital Chur, Switzerland
- Study start
- Apr 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 28 Apr 2015 (estimated)
- 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.
Surgical site infection (SSI) is the most frequent complication in patients that undergo abdominal surgery. A previous prospective observational study in 167 patients undergoing elective open abdominal procedures showed that case-relevant communication protects from organ/space SSI whereas case-irrelevant communication during the last 20 minutes of the procedure is a risk factor for incisional SSI. Therefore, the introduction of a clinical applicable intervention "structured briefing using the StOP protocol" has been developed and was tested in pilot experiments. This intervention aims at improving case-relevant communication during the procedure and to reduce excess case-irrelevant communication at the end of an operation.
The hypothesis is: structured briefings during an operation reduce the incidence of SSI after surgery.
Detailed description
Background
A number of publications has shown a relatively high rate of complications that are related to the treatment and not to the disease. Such iatrogenic incidents are an important influence on patient morbidity and increase healthcare costs. Therefore, patient safety and minimizing the risk of iatrogenic harm has become a major concern in healthcare. Surgical site infection (SSI) is one of the most frequent complication in patients that undergo surgery, leading to considerable costs.
In a previous study, the investigators established an empirical relationship between communication during surgery and SSI was shown in a prospective observational study in 167 patients undergoing major elective open abdominal procedures. An analysis of 11383 communication events observed by a team of trained work psychologists showed a relationship between intraoperative communication and SSI. Adjusted logistic regression analysis revealed that more case-relevant communication during the entire procedure was associated with a significant reduction in organ/space SSI (odds ratio 0.861, 95% confidence interval 0.750-0.987; P=0.034). Interestingly, case-irrelevant communication during the last 20 minutes of the procedure was associated with a significant increase of incisional SSI (odds ratio 1.1153, 95% confidence interval 1.040-1.196; P=0.002). Distractors such as noise and traffic were also assessed but had no effect on SSI. The current study is based on these observations, which reveal that case-relevant communication protects from organ/space SSI and case-irrelevant communication during the last 20 minutes of the procedure is a risk factor for SSI.
These findings can be interpreted in light of previous studies assessing communication in surgery and similar collaborative tasks which showed that explicit task-relevant communication fosters the development of a shared mental model of the task within the team. This facilitates coordination, because all team members are informed about the state of task progress, and can better anticipate their contribution. This is particularly important in critical phases of the procedure, as well as in OR teams composed of members with different levels of knowledge and expertise. Explicit task-related communication may be particularly useful to inform non-sterile team members (anesthetists, scrub nurses) that do not have full sight of the operative field at all times.
Although case-irrelevant communication in surgical teams has been found to foster a positive team-climate, it can be seen as a distractor if it diverts the attention away from the main task. This is more likely during the closing phase (last 20 minutes), because for most of the team members, the central task is already finished, and clearing and cleaning are routine tasks. If during routine tasks the team engages in too much non-patient relevant communication, attention to the closure may be diverted.
Given the previously found results, the introduction of a clinically applicable intervention (described below) has been tested in pilot studies. This intervention aims to assure a short discussion of case-relevant aspects at specific moments of the procedure, draw the attention of the on case-relevant communication during the main phase and to prevent a high increase in case-irrelevant communication at the end of an operation.
Objective
To perform a prospective clinical trial to test the impact of structured intraoperative briefings on SSI. The incidence of SSIs will be compared before and after the introduction of this intervention.
Methods
- Intraoperative briefings: First briefing: after exposure of the organ of interest, Second briefing: Intraoperative briefing before closure of the operative field.
- Trainings and Retrainings
- Optional Interventions: Transparent drape between anesthesia and sterile team; Controlling noise and potential distractors during wound closure; Nutritional support during the operation
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group without Study intervention | – | Procedure: StOP? - Control groupControl group without Study intervention |
| Group with Study intervention | – | Procedure: StOP? - Intervention groupGroup with Study intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing abdominal surgery
Key inclusion criteria (1 listed)
- Patients undergoing elective or emergency surgery
Key exclusion criteria (1 listed)
- Preexisting surgical site infection
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 |
|---|---|---|
| StOP? - Control groupControl group - Surgical procedure without Study Intervention | Procedure or surgery | Control group without Study intervention |
| StOP? - Intervention groupIntervention group - Surgical procedure with intraoperative briefings, optional interventions: Transparent drape between anesthesia and sterile team, Controlling noise and potential distractors during wound closure, Nutritional support during the operation | Procedure or surgery | Group with Study intervention |
Primary outcome
Incidence of surgical Site infections
Time frame: 30 days postoperative
3 secondary outcomes
Postoperative mortality
Time frame: 30 days postoperative
Type of Operation / Laparoscopic procedure
Time frame: 30 days postoperative
Grade of contamination
Time frame: 30 days postoperative
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 15 Mar 2017.
- Results publication: PubMed 21217517Sax H, Uckay I, Balmelli C, Bernasconi E, Boubaker K, Muhlemann K, Ruef C, Troillet N, Widmer A, Zanetti G, Pittet D. Overall burden of healthcare-associated infections among surgical patients. Results of a national study. Ann Surg. 2011 Feb;253(2):365-70. doi: 10.1097/SLA.0b013e318202fda9.
- Results publication: PubMed 18564917Weber WP, Zwahlen M, Reck S, Feder-Mengus C, Misteli H, Rosenthal R, Brandenberger D, Oertli D, Widmer AF, Marti WR. Economic burden of surgical site infections at a European university hospital. Infect Control Hosp Epidemiol. 2008 Jul;29(7):623-9. doi: 10.1086/589331.
- Results publication: PubMed 18789425Mazzocco K, Petitti DB, Fong KT, Bonacum D, Brookey J, Graham S, Lasky RE, Sexton JB, Thomas EJ. Surgical team behaviors and patient outcomes. Am J Surg. 2009 May;197(5):678-85. doi: 10.1016/j.amjsurg.2008.03.002. Epub 2008 Sep 11.
- Results publication: PubMed 21295749Nurok M, Sundt TM 3rd, Frankel A. Teamwork and communication in the operating room: relationship to discrete outcomes and research challenges. Anesthesiol Clin. 2011 Mar;29(1):1-11. doi: 10.1016/j.anclin.2010.11.012.
- Results publication: PubMed 18362635Catchpole K, Mishra A, Handa A, McCulloch P. Teamwork and error in the operating room: analysis of skills and roles. Ann Surg. 2008 Apr;247(4):699-706. doi: 10.1097/SLA.0b013e3181642ec8.
- Derived from this study: PubMed 41474101Bley M, Gutknecht S, Burla L, Zindel C, Weber M, Wrann S. Does health insurance status influence surgical complications? An analysis of abdominal, thoracic and vascular interventions in a Swiss tertiary referral centre. Swiss Med Wkly. 2025 Dec 10;155:4179. doi: 10.57187/s.4179.
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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.
Guido Beldi, Prof. Dr. med. principal investigator
Visceral and transplant surgery, University hospital, Berne
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 Incidence of Surgical Site Infection and Short Intraoperative Briefings, run by Insel Gruppe AG, University Hospital Bern 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: finished, as of the sponsor's last update on 15 Mar 2017. 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?
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?
Incidence of surgical Site infections (time frame: 30 days postoperative). 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 NCT02428179, which also lists 6 linked publications.
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 15 Mar 2017.