Clinical Trials in Laparoscopic Surgery
This article provides information about ongoing clinical trials related to laparoscopic surgery. Currently, there is 1 clinical trial investigating fluid therapy approaches during laparoscopic procedures. The trial is examining how different fluid solutions affect patient outcomes during minimally invasive surgery.
Clinical trial locations
Study on the Effects of Human Albumin Solution and Electrolyte Drug Combination for Fluid Therapy in Patients Undergoing Laparoscopic Surgery
This clinical trial is taking place in Sweden and focuses on understanding how different types of fluids affect patients during laparoscopic surgery. Laparoscopic surgery is a minimally invasive procedure performed through small incisions using a camera, which requires the abdomen to be inflated with carbon dioxide to create space for the surgeon to work.
What is the trial studying?
The trial compares two different fluid treatments used during surgery: Ringer’s solution and human albumin solution. Ringer’s solution is a mixture of salts and water that helps maintain the body’s fluid balance and keeps blood pressure stable. Human albumin solution is a protein derived from human blood that helps increase blood volume and improve circulation. Both treatments are given directly into a vein through an intravenous infusion.
The main goal is to determine which fluid therapy is more effective in maintaining proper blood volume and circulation during the procedure, especially when the abdomen is inflated with carbon dioxide, which can reduce blood flow back to the heart.
Who can participate?
Participants must meet several criteria to join this study:
- Age between 18 and 80 years old
- Scheduled for major laparoscopic abdominal surgery lasting 90 minutes or more
- Belong to the American Society of Anesthesiology classification I to III, which assesses patient fitness before surgery
- Must provide written consent to participate
- Female participants of childbearing age must use adequate contraception such as birth control pills, an intrauterine device, or a contraceptive implant, or have a negative pregnancy test. Women who have not had menstruation for 12 months are considered postmenopausal and do not need contraception
Who cannot participate?
The trial excludes certain patients to ensure safety:
- Patients outside the specified age range
- Patients who are not suitable candidates for laparoscopic surgery
- Patients with medical conditions that make fluid therapy unsafe
- Patients who belong to vulnerable populations requiring special protection or care
What happens during the trial?
Before surgery, participants receive fluid therapy to optimize blood volume. During the operation, researchers observe how the fluid affects blood volume and circulation, particularly by monitoring changes in hemoglobin levels. After surgery, various measurements are taken, including changes in plasma albumin, kidney function, and overall fluid balance. These assessments continue for 24 hours after the procedure.
The study is expected to conclude by December 31, 2025, and aims to provide insights into the best fluid management practices during laparoscopic surgery to ensure patient safety and improve surgical outcomes.
Summary
Currently, there is one ongoing clinical trial related to laparoscopic surgery, taking place in Sweden. This trial focuses specifically on fluid therapy management during laparoscopic procedures, comparing the effectiveness of human albumin solution versus Ringer’s solution. The research addresses an important aspect of surgical care, as proper fluid management is crucial during minimally invasive procedures where the abdomen is inflated with carbon dioxide. The trial’s findings could help establish better guidelines for fluid therapy in surgical settings, potentially benefiting patients undergoing similar procedures in the future.
