Clinical Research Directory
Browse clinical research sites, groups, and studies.
Blunt Fascial vs. Veress Needle Peritoneal Entry in Laparoscopic Gynecologic Surgery
Sponsor: Cedars-Sinai Medical Center
Summary
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.
Official title: Blunt Fascial vs. Veress Needle Peritoneal Entry in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2024-03-22
Completion Date
2025-03-01
Last Updated
2024-05-09
Healthy Volunteers
Yes
Conditions
Interventions
Blunt fascial abdominal entry
Blunt fascial entry technique description: a 5 mm incision is made in the umbilicus. Next, a curved Kelly forceps is used to open the fascia, and, if possible, the peritoneum. The Kelly forceps are then used to expand the opening to a 10 mm diameter. A 5 mm trocar is placed into the fascial hole and used to quickly insufflate the abdomen to 15 mm Hg. Once the abdomen is fully insufflated, a 10 mm trocar is placed using optical guidance.
Veress needle abdominal entry
Veress needle abdominal entry technique description: a 5 mm incision is made in the umbilicus. Next, a Veress needle is used to enter the peritoneal cavity and inflate the abdomen to 15 mm Hg. Once the abdomen is fully insufflated, a 10 mm trocar is placed using optical guidance.
Locations (1)
Cedars Sinai Medical Center
Los Angeles, California, United States