Veress Entry With/Without Concomitant CO2

Summary

Purpose: The primary objective is to compare the time required for adequate intraperitoneal insufflation (from skin incision to reaching intraperitoneal pressure of 15 mmHg). Also the number of attempts needed before successful entry is achieved. The secondary objectives will evaluate rates of secondary outcomes measures such as; failed entry, extra peritoneal insufflation, vascular injury, visceral injury, gas embolism, solid organ injury, and omental injury between the two techniques.

Study design: prospective randomized control trial

Hypothesis: The investigators hypothesize that participant's undergoing laparoscopic surgery for benign Gynecologic indications at TGH who undergo laparoscopic entry technique of Veress needle entry with concomitant CO2 insufflation will require less time to achieve a 15 mmHg of intraperitoneal pressure as opposed to Veress needle entry with subsequent CO2 insufflation, and will require less number of attempts to achieve successful entry.

Conditions

• Laparoscopy
• Laparoscopic Surgery
• Insufflation
• Gynecologic Surgical Procedures

Interventions

PROCEDURE

Veress needle entry with concomitant CO2

The Veress will be connected to the CO2 tubing, and a skin incision will be made with the scalpel, followed by starting the CO2 gas insufflation and insertion of the Veress needle.

PROCEDURE

Veress needle entry with subsequent CO2

A skin incision will be made with the scalpel. The Veress needle will be inserted until intraperitoneal location obtained. This will be followed by starting CO2 gas insufflation until the standard 15 mmHg.

Sponsors & Collaborators

• Tampa General Hospital

  collaborator OTHER

• University of South Florida

  lead OTHER

Principal Investigators

• Emad Mikhail, MD · University of South Florida Department of Obstetrics and Gynecology

• Anthony Imudia, MD · University of South Florida Department of Obstetrics and Gynecology

• Elisabeth Sappenfield, MD · University of South Florida Department of Obstetrics and Gynecology

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-08-31

Primary Completion

2018-03-10

Completion

2018-03-10

Countries

• United States

Study Locations