Ongoing Clinical Trials for Hysterectomy
This article describes 2 ongoing clinical trials related to hysterectomy procedures. These studies focus on improving surgical outcomes through better blood flow monitoring during surgery and preventing post-operative infections using different antibiotic approaches.
Clinical trial locations
- Finland
- France
Study on Blood Flow in the Vaginal Area After Total Laparoscopic Hysterectomy Using Indocyanine Green for Patients Undergoing Hysterectomy
This trial is taking place in France and focuses on studying blood flow patterns during and after laparoscopic surgery. The study uses a special fluorescent dye called indocyanine green to help surgeons visualize how well blood is circulating in the surgical area during the procedure.
Main focus: The primary goal is to evaluate blood flow in the vaginal area after the uterus is removed. By using indocyanine green, which glows under a special camera, surgeons can see in real-time whether the tissue is receiving adequate blood supply. This information could help improve surgical techniques and reduce complications such as bleeding or infection.
Who can participate: This study is for adult women who need to have their uterus removed through laparoscopic surgery. Laparoscopy is a type of surgery that uses small incisions and a camera to guide the procedure, rather than one large cut.
Who cannot participate: Women who have already had their uterus and cervix completely removed in a previous surgery are not eligible. Additionally, patients considered part of vulnerable populations who may have difficulty providing informed consent cannot join the study.
Investigational substance: Indocyanine green is a diagnostic dye that is injected into the bloodstream during surgery. It binds to proteins in the blood and glows when exposed to near-infrared light, allowing the surgical team to clearly see blood vessels and assess whether tissues are receiving proper blood flow.
A study comparing azithromycin with cefuroxime versus cefuroxime alone for preventing infections in patients undergoing hysterectomy
This clinical trial is being conducted in Finland and examines different strategies for preventing infections after surgery. The research compares using two antibiotics together versus using one antibiotic alone to see which approach better prevents post-operative complications.
Main focus: The study aims to determine whether combining azithromycin with cefuroxime is more effective than using cefuroxime alone in preventing various types of infections that can occur after surgery. These include wound infections, pelvic infections, urinary tract infections, and fever. Patients will be monitored for 30 days after their procedure to identify any signs of infection.
Who can participate: This study is for adult women aged 18 to 65 who are scheduled to have their uterus removed for non-cancerous conditions at a public hospital in Finland. Participants must be able to understand information in Finnish or Swedish and must not have allergies to the antibiotics used in the study. Women who are not pregnant or breastfeeding and who have not taken antibiotics in the week before surgery are eligible.
Who cannot participate: The study excludes women younger than 18 or older than 65, those with known allergies to azithromycin or cefuroxime, women who are currently pregnant or breastfeeding, and those with active infections requiring antibiotic treatment. Patients with immune system disorders, serious liver or kidney problems, or those who have participated in another clinical trial within the last 30 days are also not eligible.
Investigational drugs: The study uses two antibiotics. Azithromycin is a macrolide antibiotic that stops bacteria from growing by preventing them from making proteins they need to survive. Cefuroxime is a cephalosporin antibiotic that works by preventing bacteria from building their protective cell walls. Both medications are given orally before surgery to help prevent infections from developing afterward.
Summary
These two clinical trials represent different approaches to improving outcomes for women undergoing surgical removal of the uterus. The French study focuses on using advanced imaging technology during surgery to ensure proper blood flow, which could help reduce complications. The Finnish study takes a preventive approach by investigating which antibiotic strategy is most effective at stopping infections before they start.
Both trials are limited to adult women, though they have different age restrictions and eligibility requirements based on their specific research questions. The French trial is open to all adult women needing laparoscopic surgery, while the Finnish study has an upper age limit of 65 and additional restrictions related to antibiotic allergies and recent antibiotic use.
These studies highlight ongoing efforts to refine surgical techniques and post-operative care protocols. While one focuses on intraoperative monitoring and the other on infection prevention, both aim to reduce complications and improve recovery for women undergoing this common gynecological procedure.
