Surgical Site InfectionNCT06035627
The Effect of Inadvertent Perioperative Hypothermia on Surgical Site Infection in Laparoscopic Choleistectomy.
An observational study of Surgical Site Infection and Perioperative Complication, run by Cumhuriyet University at 2 sites in Turkey (Türkiye).
Trial summary
There are conflicting results in the literature explaining the relationship between surgical site infection (SSI) and inadvertent perioperative hypothermia (IPH). Although it is thought that the risk of IPH is lower in laparoscopic surgery types due to the short duration of the surgical procedure, these conflicting… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection, Perioperative Complication
- What is being tested?
- Prevention hypothermia
- How many people
- 100 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 May 2023to 15 Aug 2024
- How long will I take part?
- 1 Year
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: laparoscopic cholecystectomy patients who met the inclusion and exclusion criteria
Who may be able to join
- Being aged 18-65 years old,
- Having an ASA score of I-II,
- Remaining in the hospital for at least 24 hours in the postoperative period,
- Undergoing laparoscopic cholecystectomy
Who cannot join
- Being under 18 or over 65,
- Having an ASA score above III,
- Requiring emergency surgery
- Having a neurological, psychiatric, or neuromuscular disease,
- Being addicted to alcohol and/or other toxic substances,
- Being pregnant or having a suspected pregnancy,
Show all 9Show fewer
- Undergoing open surgery, or being converted to an open procedure during surgery,
- Having symptoms of fever
- Having an active infection excluding cholecystitis.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Cumhuriyet University
Sivas, Suşehri, 58140
Pınar YILMAZ EKER, Ph.D., +905309468919, yilmazpinar20@gmail.com
- Recruiting
Sivas Cumhuriyet University
Sivas, 58140
Pınar YILMAZ EKER, Ph.D., +905309468919, yilmazpinar20@gmail.com
About this study
Official title: Uncontrolled Inadvertent Perioperative Hypothermia as a Risk Factor for Surgical Site Infection in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial
There are conflicting results in the literature explaining the relationship between surgical site infection (SSI) and inadvertent perioperative hypothermia (IPH). Although it is thought that the risk of IPH is lower in laparoscopic surgery types due to the short duration of the surgical procedure, these conflicting results raise doubts as to whether there is a relationship between IPH and SSI in laparoscopic surgery patients. A randomized controlled study will be planned in the future to examine the effect of IPH on SSI in patients who will undergo laparoscopic cholecystectomies. The study will be conducted in the general surgery clinic and operating room of a university hospital. It will be completed with a total of 100 patients, 50 of whom will be in the case group, and 50 will be in the control group.
Read the detailed description
Objective: This study was conducted to examine the effect of inadvertent perioperative hypothermia (IPH) on Surgical Site Infection (SSI) in patients undergoing laparoscopic cholecystectomy.
Summary of Background Data: There are conflicting results in the literature explaining the relationship between SSI and IPH. Although the risk of IPH is thought to be lower in laparoscopic surgery types due to the short duration of the surgical procedure, these conflicting results raise doubts about the existence of a relationship between IPH and SSI in laparoscopic surgery patients.
Methods: This study will be a quasi-experimental and randomized controlled study in the future. The study will be conducted with patients who will have undergone laparoscopic cholecystectomy in the general surgery clinic and operating room of a university hospital. The study will be completed with a total of 100 patients, 50 in the case group, and 50 in the control group. During the study, preoperative, intraoperative, and postoperative body temperatures, as well as biomarkers of the patients, will be monitored using a form developed by the researchers. Additionally, patients will be followed up postoperatively to evaluate the potential impact of IPH on SSI.
- Being tested
- Prevention hypothermia
- Keywords
- inadvertent perioperative hypothermia, surgical site infection, laparoscopic cholecystectomies, perioperative nursing
- 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.
Prevention hypothermiaOther
Hypothermia was prevented by warming the case group. control group remained stable. As a result, the presence of surgical site infection was followed.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | The population of the study consisted of patients who were being treated in the general surgery clinic of the hospital, who met the sampling criteria, who were to undergo laparoscopic cholecystectomy, and who agreed to participate in the study. The sample size of the study was determined by the G*Power 3.1.9.7 program. In the power analysis, when α =0.05, β=0.10, and 1-β =0.90, the sample size was determined as 50 people per group and a total of 100 people. Receives: Other: Prevention hypothermia | |
| Control group | The population of the study consisted of patients who were being treated in the general surgery clinic of the hospital, who met the sampling criteria, who were to undergo laparoscopic cholecystectomy, and who agreed to participate in the study. The sample size of the study was determined by the G*Power 3.1.9.7 program. In the power analysis, when α =0.05, β=0.10, and 1-β =0.90, the sample size was determined as 50 people per group and a total of 100 people. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of inadvertent perioperative hypothermia
This study aims to evaluate whether inadvertent perioperative hypothermia has an effect on surgical site infection. For this, applications to prevent hypothermia will be applied to the patients in the experimental group
Measured: September 15, 2022- September 15, 2023
Secondary outcomes (1)
Following surgical site infection
After the applications for preventing hypothermia in the experimental group and the patients in the experimental and control groups will be examined for surgical site infection.
Measured: 16 September 16, 2023 - October 25, 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start15 May 2023
- Primary completion15 May 2024 (estimated)
- Study completion15 Aug 2024 (estimated)
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 Surgical Site InfectionStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar YILMAZ EKER, Cumhuriyet University
- Investigators
- Pınar YILMAZ EKER, Ph.D, Principal investigator, corresponding researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035627
- Sponsor's protocol ID
- PYILMAZEKER
- Status last verified
- Sep 2023
- First submitted
- 28 Aug 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Connelly L, Cramer E, DeMott Q, Piperno J, Coyne B, Winfield C, Swanberg M. The Optimal Time and Method for Surgical Prewarming: A Comprehensive Review of the Literature. J Perianesth Nurs. 2017 Jun;32(3):199-209. doi: 10.1016/j.jopan.2015.11.010. Epub 2016 Sep 1.
PubMed 28527547Horn EP, Bein B, Broch O, Iden T, Bohm R, Latz SK, Hocker J. Warming before and after epidural block before general anaesthesia for major abdominal surgery prevents perioperative hypothermia: A randomised controlled trial. Eur J Anaesthesiol. 2016 May;33(5):334-40. doi: 10.1097/EJA.0000000000000369.
PubMed 26555870Scott AV, Stonemetz JL, Wasey JO, Johnson DJ, Rivers RJ, Koch CG, Frank SM. Compliance with Surgical Care Improvement Project for Body Temperature Management (SCIP Inf-10) Is Associated with Improved Clinical Outcomes. Anesthesiology. 2015 Jul;123(1):116-25. doi: 10.1097/ALN.0000000000000681.
PubMed 25909970Sessler DI. Perioperative thermoregulation and heat balance. Lancet. 2016 Jun 25;387(10038):2655-2664. doi: 10.1016/S0140-6736(15)00981-2. Epub 2016 Jan 8.
PubMed 26775126Ryczek E, White J, Poole RL, Reeves NL, Torkington J, Carolan-Rees G. Normothermic Insufflation to Prevent Perioperative Hypothermia and Improve Quality of Recovery in Elective Colectomy Patients: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Dec 20;8(12):e14533. doi: 10.2196/14533.
PubMed 31859685Chen HY, Su LJ, Wu HZ, Zou H, Yang R, Zhu YX. Risk factors for inadvertent intraoperative hypothermia in patients undergoing laparoscopic surgery: A prospective cohort study. PLoS One. 2021 Sep 23;16(9):e0257816. doi: 10.1371/journal.pone.0257816. eCollection 2021.
PubMed 34555101
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uncontrolled Inadvertent Perioperative Hypothermia as a Risk Factor for Surgical Site Infection in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06035627
- Acronym / sponsor ID
- PYILMAZEKER
- Keywords
- inadvertent perioperative hypothermia, surgical site infection, laparoscopic cholecystectomies, perioperative nursing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 May 2024 (estimated)
- Study completion
- 15 Aug 2024 (estimated)
- First posted
- 13 Sep 2023 (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.
There are conflicting results in the literature explaining the relationship between surgical site infection (SSI) and inadvertent perioperative hypothermia (IPH). Although it is thought that the risk of IPH is lower in laparoscopic surgery types due to the short duration of the surgical procedure, these conflicting results raise doubts as to whether there is a relationship between IPH and SSI in laparoscopic surgery patients. A randomized controlled study will be planned in the future to examine the effect of IPH on SSI in patients who will undergo laparoscopic cholecystectomies. The study will be conducted in the general surgery clinic and operating room of a university hospital. It will be completed with a total of 100 patients, 50 of whom will be in the case group, and 50 will be in the control group.
Detailed description
Objective: This study was conducted to examine the effect of inadvertent perioperative hypothermia (IPH) on Surgical Site Infection (SSI) in patients undergoing laparoscopic cholecystectomy.
Summary of Background Data: There are conflicting results in the literature explaining the relationship between SSI and IPH. Although the risk of IPH is thought to be lower in laparoscopic surgery types due to the short duration of the surgical procedure, these conflicting results raise doubts about the existence of a relationship between IPH and SSI in laparoscopic surgery patients.
Methods: This study will be a quasi-experimental and randomized controlled study in the future. The study will be conducted with patients who will have undergone laparoscopic cholecystectomy in the general surgery clinic and operating room of a university hospital. The study will be completed with a total of 100 patients, 50 in the case group, and 50 in the control group. During the study, preoperative, intraoperative, and postoperative body temperatures, as well as biomarkers of the patients, will be monitored using a form developed by the researchers. Additionally, patients will be followed up postoperatively to evaluate the potential impact of IPH on SSI.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Other: Prevention hypothermiaThe population of the study consisted of patients who were being treated in the general surgery clinic of the hospital, who met the sampling criteria, who were to undergo laparoscopic cholecystectomy, and who agreed to participate in the study. The sample size of the study was determined by the G*Power 3.1.9.7 program. In the power analysis, when α =0.05, β=0.10, and 1-β =0.90, the sample size was determined as 50 people per group and a total of 100 people. |
| Control group | – | –The population of the study consisted of patients who were being treated in the general surgery clinic of the hospital, who met the sampling criteria, who were to undergo laparoscopic cholecystectomy, and who agreed to participate in the study. The sample size of the study was determined by the G*Power 3.1.9.7 program. In the power analysis, when α =0.05, β=0.10, and 1-β =0.90, the sample size was determined as 50 people per group and a total of 100 people. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- laparoscopic cholecystectomy patients who met the inclusion and exclusion criteria
Key inclusion criteria (4 listed)
- Being aged 18-65 years old,
- Having an ASA score of I-II,
- Remaining in the hospital for at least 24 hours in the postoperative period,
- Undergoing laparoscopic cholecystectomy
Key exclusion criteria (9 listed)
- Being under 18 or over 65,
- Having an ASA score above III,
- Requiring emergency surgery
- Having a neurological, psychiatric, or neuromuscular disease,
- Being addicted to alcohol and/or other toxic substances,
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 |
|---|---|---|
| Prevention hypothermiaHypothermia was prevented by warming the case group. control group remained stable. As a result, the presence of surgical site infection was followed. | Other | Experimental group |
Primary outcome
Prevention of inadvertent perioperative hypothermia
Time frame: September 15, 2022- September 15, 2023
This study aims to evaluate whether inadvertent perioperative hypothermia has an effect on surgical site infection. For this, applications to prevent hypothermia will be applied to the patients in the experimental group
1 secondary outcome
Following surgical site infection
Time frame: 16 September 16, 2023 - October 25, 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Background: PubMed 28527547Connelly L, Cramer E, DeMott Q, Piperno J, Coyne B, Winfield C, Swanberg M. The Optimal Time and Method for Surgical Prewarming: A Comprehensive Review of the Literature. J Perianesth Nurs. 2017 Jun;32(3):199-209. doi: 10.1016/j.jopan.2015.11.010. Epub 2016 Sep 1.
- Background: PubMed 26555870Horn EP, Bein B, Broch O, Iden T, Bohm R, Latz SK, Hocker J. Warming before and after epidural block before general anaesthesia for major abdominal surgery prevents perioperative hypothermia: A randomised controlled trial. Eur J Anaesthesiol. 2016 May;33(5):334-40. doi: 10.1097/EJA.0000000000000369.
- Background: PubMed 25909970Scott AV, Stonemetz JL, Wasey JO, Johnson DJ, Rivers RJ, Koch CG, Frank SM. Compliance with Surgical Care Improvement Project for Body Temperature Management (SCIP Inf-10) Is Associated with Improved Clinical Outcomes. Anesthesiology. 2015 Jul;123(1):116-25. doi: 10.1097/ALN.0000000000000681.
- Background: PubMed 26775126Sessler DI. Perioperative thermoregulation and heat balance. Lancet. 2016 Jun 25;387(10038):2655-2664. doi: 10.1016/S0140-6736(15)00981-2. Epub 2016 Jan 8.
- Background: PubMed 31859685Ryczek E, White J, Poole RL, Reeves NL, Torkington J, Carolan-Rees G. Normothermic Insufflation to Prevent Perioperative Hypothermia and Improve Quality of Recovery in Elective Colectomy Patients: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Dec 20;8(12):e14533. doi: 10.2196/14533.
- Background: PubMed 34555101Chen HY, Su LJ, Wu HZ, Zou H, Yang R, Zhu YX. Risk factors for inadvertent intraoperative hypothermia in patients undergoing laparoscopic surgery: A prospective cohort study. PLoS One. 2021 Sep 23;16(9):e0257816. doi: 10.1371/journal.pone.0257816. eCollection 2021.
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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.
Pınar YILMAZ EKER, Ph.D principal investigator
corresponding researcher
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Site Infection and Perioperative Complication, run by Cumhuriyet University at 2 sites in Turkey (Türkiye).
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 4 inclusion and 9 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 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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 Pınar YILMAZ EKER, Ph.D. (+905309468919, yilmazpinar20@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of inadvertent perioperative hypothermia (time frame: September 15, 2022- September 15, 2023). 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 NCT06035627, 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 13 Sep 2023.