Veress Entry With/Without Concomitant CO2
Completed · Not applicable
Conditions studied: Laparoscopy, Laparoscopic Surgery, Insufflation, Gynecologic Surgical Procedures
In brief
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.
Key facts
- Study ID
- NCT02896036
- Run by
- University of South Florida
- People needed
- 100
- Starts
- 2016-08-01
- Expected to finish
- 2018-03-10
- Last updated by the study team
- 2018-03-30
Who can join
Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.
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
- 3 or more previous cesarean sections through a Pfannenstiel incision
Where it is running
- Tampa General Hospital — Tampa, Florida, United States
Full record on ClinicalTrials.gov
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