Blunt Fascial vs. Veress Needle Peritoneal Entry in Laparoscopic Gynecologic Surgery

Not Applicable

Recruiting

• Conditions: Laparoscopic Surgery
• Interventions: Procedure: Blunt fascial abdominal entry; Procedure: Veress needle abdominal entry

• Registration Number: NCT06305975
• Lead Sponsor: Cedars-Sinai Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2024-02-22
• Study First Submitted QC: 2024-03-05
• Study First Posted: 2024-03-12
• Study Start: 2024-03-22
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blunt fascial entry	Blunt fascial abdominal entry	The blunt fascial entry technique will be used for patients in this arm
Veress needle entry technique	Veress needle abdominal entry	The Veress needle entry technique will be used for patients in this arm

Primary Outcome Measures

Name	Time	Method
Insufflation time	Intraoperative	The time it takes to insufflate the abdominal cavity to 15 mm Hg.
Success upon peritoneal entry	Intraoperative	Successful abdominal entry in the first trial

Secondary Outcome Measures

Name	Time	Method
Intraoperative complications	Intraoperative	- Intraoperative complications upon peritoneal entry
Postoperative complications	Postoperative period within 30 days of surgery	Any postoperative complications
Patients pain scores	Day of surgery, postoperatively and before discharge	* First reported pain score in PACU using the numerical rating scale (0-10).; * Last reported pain score in PACU prior to discharge using the numerical rating scale (0-10).
Analgesics use	Day of surgery, postoperatively and before discharge	- Total analgesic requirements in PACU
Length of hospital stay	Day of surgery, postoperatively and before discharge. In rare cases, hospital stay will be longer than one day.	- Length of stay- from arrival to PACU to discharge home)

Trial Locations

Locations (1)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States