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

Cedars-Sinai Medical Center

Status: Enrolling

Conditions: Laparoscopic Surgery

Treatments: Procedure: Veress needle abdominal entry; Procedure: Blunt fascial abdominal entry

Study type: Interventional

Funder types: Other

Identifiers

NCT06305975

STUDY00003169

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Blunt fascial entry

Experimental group

Description:

The blunt fascial entry technique will be used for patients in this arm

Treatment:

Procedure: Blunt fascial abdominal entry

Veress needle entry technique

Active Comparator group

Description:

The Veress needle entry technique will be used for patients in this arm

Treatment:

Procedure: Veress needle abdominal entry