Veress Entry With/Without Concomitant CO2

NCT02896036 | Completed DMC

• 1 other identifier: Pro00025352
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Laparoscopic Entry; Veress Needle; Intraperitoneal insufflation; Time; Complications

Outcome Measures

Primary Outcomes (1)

• Time required for adequate intraperitoneal insufflation.

  Time from insertion of Veress to insufflation of peritoneum to 15 mmHg.

  intraoperative

Secondary Outcomes (8)

• Evaluate rates of failed entry between the two techniques

  intraoperative

• Evaluate rates of extraperitoneal insufflation between the two techniques

  intraoperative

• Evaluate rates of vascular injury between the two techniques

  intraoperative

• Evaluate rates of visceral injury between the two techniques

  intraoperative

• Evaluate rates of gas embolism between the two techniques

  intraoperative

Study Arms (2)

Veress needle entry with concomitant CO2

EXPERIMENTAL

For the group of participants who will be randomized to concomitant CO2 insufflation; 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. If the opening pressure is less than or equal to 10 mmHg, the process of insufflation will be allowed to continue. In case of a higher opening pressure, the veress will be withdrawn and reinserted up to 3 times. A failed entry will be called if the peritoneal cavity cannot be insufflated after 3 attempts.

Procedure: Veress needle entry with concomitant CO2

Veress needle entry with subsequent CO2

ACTIVE COMPARATOR

For the other group of participants who will be randomized to subsequent CO2 insufflation; the Veress needle will be connected to the CO2 tubing, and a skin incision will be made with the scalpel, followed by insertion of the Veress needle. The gas insufflation will be started and the opening pressure will be noted. If the opening pressure is less than or equal to 10 mmHg, the process of insufflation will be allowed to continue. In case of a higher opening pressure, the Veress needle will be withdrawn and reinserted up to 3 times. Each time the needle is to reinserted, the CO2 insufflator will be switched off until the location of the Veress needle is felt to be adequate.

Procedure: Veress needle entry with subsequent CO2

Interventions

Veress needle entry with concomitant CO2 PROCEDURE

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.

Veress needle entry with concomitant CO2

Veress needle entry with subsequent CO2 PROCEDURE

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.

Veress needle entry with subsequent CO2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All female patients within the ages of 18-70 presenting to TGH for benign gynecologic laparoscopic surgery performed by the study investigators. The following surgeries will be considered as part of the study:
• Diagnostic laparoscopy
• Laparoscopic adnexal surgery
• Laparoscopic hysterectomy
• Laparoscopic myomectomy
• Robotic assisted hysterectomy
• Robotic assisted myomectomy

You may not qualify if:

• Patients unable to provide informed consent
• Previous midline laparotomy
• or more previous cesarean sections through a Pfannenstiel incision

Sponsors & Collaborators

• University of South Florida: lead
• Tampa General Hospital: collaborator

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Study Officials

• Emad Mikhail, MD

  University of South Florida Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

• Anthony Imudia, MD

  University of South Florida Department of Obstetrics and Gynecology

  STUDY DIRECTOR

• Elisabeth Sappenfield, MD

  University of South Florida Department of Obstetrics and Gynecology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: September 12, 2016
• Study Start: August 1, 2016
• Primary Completion: March 10, 2018
• Study Completion: March 10, 2018
• Last Updated: March 30, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)