NCT06305975

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This will be a single-center, single-blinded randomized controlled trial evaluating the impact of peritoneal entry technique on insufflation times, entry failure, post-operative pain and surgical outcomes among patients undergoing laparoscopic gynecologic surgery. The investigators hypothesize that the blunt fascial entry technique will be associated with shorter insufflation times with no effect on other surgical outcomes. The study will include 2 groups corresponding to the entry techniques: blunt facial entry and Veress needle entry. Participants will be 1:1 allocated to each technique by block randomization. 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.

Conditions

• Laparoscopic Surgery

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2024-03-22
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2024-03-12
• Last updated: 2024-05-09

Locations

1 site across 1 country: United States