NCT06035627

The Effect of Inadvertent Perioperative Hypothermia on Surgical Site Infection in Laparoscopic Choleistectomy.

Uncontrolled Inadvertent Perioperative Hypothermia as a Risk Factor for Surgical Site Infection in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Cumhuriyet University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Surgical Site Infection
• Perioperative Complication

Interventions

Type	Name	Description
OTHER	Prevention hypothermia	Hypothermia was prevented by warming the case group. control group remained stable. As a result, the presence of surgical site infection was followed.

Timeline

• Start date: 2023-05-15
• Primary completion: 2024-05-15
• Completion: 2024-08-15
• First posted: 2023-09-13
• Last updated: 2023-09-13

Locations

2 sites across 1 country: Turkey (Türkiye)