Blunt Fascial vs. Veress Needle Entry for Laparoscopic Surgery
(BluntFascial Trial)
Trial Summary
Do I need to stop taking my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the idea that Blunt Fascial vs. Veress Needle Entry for Laparoscopic Surgery is an effective treatment?
The available research shows that both the Blunt Fascial (open) and Veress Needle (closed) techniques for laparoscopic surgery have their own benefits and risks. The study comparing these techniques found that the choice between them should be based on factors like the surgeon's experience and patient-specific details. The Veress Needle technique is associated with a low rate of injuries, but these can be serious if they occur. On the other hand, the open technique is suggested to reduce the risk of major injuries, especially in patients with abdominal scars. Another study introduced a new blunt-tipped tool that might be safer and faster than the Veress Needle, suggesting that alternatives to both traditional methods are being explored for better safety and efficiency.12345
What safety data exists for Blunt Fascial vs. Veress Needle Entry in laparoscopic surgery?
The Veress needle technique, commonly used for initiating pneumoperitoneum in laparoscopic surgery, has a low but notable risk of entry-related injuries, such as intestinal and major vascular injuries, occurring in 0.04-0.1% of cases. These injuries can result in mortality rates between 2.5 and 30% if undiagnosed. The open entry technique, although less popular, is considered safer with fewer complications. Studies comparing the two techniques suggest that the choice should be based on factors like patient characteristics and surgeon experience, as the Veress needle is associated with higher rates of complications, including vascular injuries and bowel perforations. Efforts to improve safety include developing devices like the abdominal wall entry suction device and improved Veress needle prototypes.24678
Is Blunt fascial abdominal entry, Veress needle abdominal entry a promising treatment?
The Veress needle technique is commonly used in laparoscopic surgery to create space in the abdomen for better visibility. It is a popular choice among surgeons due to its effectiveness in initiating the procedure. However, the choice between the Veress needle and other techniques often depends on the surgeon's experience and preference, as well as patient-specific factors.23489
What is the purpose of this trial?
This study aims to investigate the effect of two peritoneal entry techniques on intraoperative and post-operative outcomes among patients undergoing laparoscopic surgery with a minimally invasive gynecologic surgeon. Patients will be randomized to either blunt fascial or veress needle peritoneal entry. Insufflation times, failed entries, complications and post-operative pain scores will be collected.The investigators hypothesize that the blunt entry technique will be associated with shorter insufflation times and similar intraoperative and postoperative outcomes compared with the veress needle entry technique.Primary Objective: To evaluate the insufflation times and success upon peritoneal entry according to peritoneal entry technique.Secondary Objectives: To evaluate the surgical outcomes and patients pain scores according to peritoneal entry technique.
Research Team
Raanan Meyer, MD
Principal Investigator
Cedars-Sinai Medical Center
Eligibility Criteria
This trial is for adults over 18 who are having laparoscopic surgery at Cedars-Sinai Medical Center with a Minimally Invasive Gynecologic Surgery division surgeon. Participants must consent to the study's procedures and be available throughout its duration.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo laparoscopic gynecologic surgery using either the blunt fascial or Veress needle peritoneal entry technique
Follow-up
Participants are monitored for postoperative complications and pain scores
Treatment Details
Interventions
- Blunt fascial abdominal entry
- Veress needle abdominal entry
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cedars-Sinai Medical Center
Lead Sponsor