Comparing two methods for abdominal entry in laparoscopic gynecologic surgery
Blunt Fascial vs. Veress Needle Peritoneal Entry in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial
This study is testing whether using a blunt entry technique instead of a Veress needle for starting laparoscopic gynecologic surgery can make the surgery quicker and safer for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06305975 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of two different peritoneal entry techniques, blunt fascial and Veress needle, on intraoperative and postoperative outcomes in patients undergoing laparoscopic gynecologic surgery. Participants will be randomly assigned to one of the two techniques, and various metrics such as insufflation times, entry failures, complications, and postoperative pain scores will be collected. The hypothesis is that the blunt entry technique will result in shorter insufflation times while maintaining similar surgical outcomes compared to the Veress needle technique.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for conventional laparoscopic surgery at Cedars-Sinai Medical Center.
Not a fit: Patients who are pregnant, require urgent surgery, or are not eligible for umbilical entry may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical efficiency and reduced postoperative pain for patients undergoing laparoscopic gynecologic procedures.
How similar studies have performed: Previous studies have explored various entry techniques in laparoscopic surgery, but this specific comparison of blunt fascial versus Veress needle entry is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. 18 years of age or older 4. Undergoing conventional laparoscopic surgery at Cedars-Sinai Medical Center with a surgeon in the Minimally Invasive Gynecologic Surgery division. Exclusion Criteria: 1. Pregnancy 2. Urgent/non-scheduled surgery 3. Non-eligible for umbilical entry
Where this trial is running
Los Angeles, California
- Cedars Sinai Medical Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Raanan Meyer, MD — Cedars-Sinai Medical Center
- Study coordinator: Raanan Meyer, MD
- Email: Raanan.Meyer@cshs.org
- Phone: 3104234073
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.