Blunt Fascial vs. Veress Needle Peritoneal Entry in Laparoscopic Gynecologic Surgery
Blunt Fascial vs. Veress Needle Peritoneal Entry in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial
Cedars-Sinai Medical Center
100 participants
Mar 22, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- 18 years of age or older
- Undergoing conventional laparoscopic surgery at Cedars-Sinai Medical Center with a surgeon in the Minimally Invasive Gynecologic Surgery division.
Exclusion Criteria3
- Pregnancy
- Urgent/non-scheduled surgery
- Non-eligible for umbilical entry
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Interventions
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 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)
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NCT06305975