Recruiting

Blunt Fascial vs. Veress Needle

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT06305975

Conditions

Laparoscopic Surgery

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Blunt fascial abdominal entry

Veress needle abdominal entry

Study Details

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.

Conditions

Laparoscopic Surgery

Study ID

NCT06305975

Start date

Mar 22, 2024

Status verified date

May, 2024

Completion date

Mar 1, 2025

Anticipated

Primary completion date

Mar 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Blunt fascial entry

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

active comparator: Veress needle entry technique

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

Interventions

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.

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.

Primary outcome measure

  • Insufflation time [ Time Frame: Intraoperative ]
  • Success upon peritoneal entry [ Time Frame: Intraoperative ]

Central Contacts and Locations

Central contacts

Raanan Meyer, MD

3104234073Raanan.Meyer@cshs.org

Kacey Hamilton

3104234073

Locations

Cedars Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Raanan Meyer, MD

310-423-9268Raanan.Meyer@cshs.org

Kacey Hamilton, MD

3104239268Kacey.Hamilton@cshs.org

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

May 9, 2024

Last verified

May, 2024

Keywords

  • Abdominal entry
  • Laparoscopy
  • Insufflation time
  • Postoperative pain
  • Safety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2024-05-09.