Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT06305975

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

Led by Cedars-Sinai Medical Center · Updated on 2024-05-09

100

Participants Needed

1

Research Sites

49 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent form provided
  • Willingness to comply with all study procedures and available for the study duration
  • At least 18 years of age
  • Undergoing planned laparoscopic surgery with a minimally invasive gynecologic surgeon at Cedars-Sinai Medical Center
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Urgent or non-scheduled surgery
  • Not eligible for umbilical entry

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cedars Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

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Research Team

R

Raanan Meyer, MD

CONTACT

K

Kacey Hamilton

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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