Actively Recruiting
Supplemental High Flow Oxygen to Improve Postoperative Recovery and Reduce Infections in Obese Gynecological Cancer Patients
Led by National and Kapodistrian University of Athens · Updated on 2025-01-17
400
Participants Needed
1
Research Sites
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand if giving extra oxygen after surgery can help prevent wound infections in obese women with gynecological cancers such as endometrial or ovarian cancer. These infections and complications related to wound healing affect up to 10-20% of these patients and can lead to longer hospital stays and increased healthcare costs. The study will also explore factors that increase the risk of these infections in this group. Participants will receive supplemental oxygen after surgery using different masks depending on their oxygen levels: a Venturi mask if oxygen saturation is below 95% and a nasal oxygen mask otherwise, for the first two days after their operation. This approach is intended to improve tissue oxygenation and support healing. During the study, participants will be closely monitored for signs of surgical site infections and systemic inflammatory response syndrome within 30 days of their surgery. Researchers will assess wound healing and complications, track oxygen levels, and evaluate overall recovery. The study focuses on obese female patients between 18 and 85 years old who have undergone laparotomy for gynecological cancer treatment.
CONDITIONS
Official Title
Supplemental High Flow Oxygen to Reduce Infections in Obese Gynecological Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Obese (BMI >30 kg/m2) women with gynecological cancer
- Optimized preoperative blood counts: hemoglobin >11 g/dl, white blood cells between 4000-11000 X 10^9/L, platelets between 150,000-400,000 X 10^9/L
- If receiving neoadjuvant therapy, at least 3 weeks have passed since the last treatment cycle before surgery
You will not qualify if you...
- Active immunosuppression
- Existing infection of the abdominal wall
- Current sepsis
AI-Screening
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Trial Site Locations
Total: 1 location
1
First department of Obstetrics and Gynecology
Athens, Greece, 11528
Actively Recruiting
Research Team
V
Vasilios Pergialiotis, Assistant Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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