Clinical trial NCT06305975: Blunt Fascial vs. Veress Needle Peritoneal Entry in Laparoscopic Gynecologic Surgery
Official title: Blunt Fascial vs. Veress Needle Peritoneal Entry in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laparoscopic Surgery
Keywords: Abdominal entry
Laparoscopy
Insufflation time
Postoperative pain
Safety
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Insufflation time
timeFrame: Intraoperative
measure: Success upon peritoneal entry
timeFrame: Intraoperative
Secondary outcomes:
measure: Intraoperative complications
timeFrame: Intraoperative
measure: Postoperative complications
timeFrame: Postoperative period within 30 days of surgery
measure: Patients pain scores
timeFrame: Day of surgery, postoperatively and before discharge
measure: Analgesics use
timeFrame: Day of surgery, postoperatively and before discharge
measure: Length of hospital stay
timeFrame: Day of surgery, postoperatively and before discharge. In rare cases, hospital stay will be longer than one day.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Raanan Meyer, MD
role: PRINCIPAL_INVESTIGATOR
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