Laparoscopy Clinical Trial
Official title:
Laparoscopic Entry Technique With a Veress Needle Insertion With and Without Concomitant CO2 Insufflation - Does it Matter?
Verified date | March 2018 |
Source | University of South Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | March 10, 2018 |
Est. primary completion date | March 10, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Patients unable to provide informed consent - Previous midline laparotomy - 3 or more previous cesarean sections through a Pfannenstiel incision |
Country | Name | City | State |
---|---|---|---|
United States | Tampa General Hospital | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
University of South Florida | Tampa General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time required for adequate intraperitoneal insufflation. | Time from insertion of Veress to insufflation of peritoneum to 15 mmHg. | intraoperative | |
Secondary | Evaluate rates of failed entry between the two techniques | Evaluate occurrence of failed entry (more than 3 attempts with the Veress without intraperitoneal insufflation) | intraoperative | |
Secondary | Evaluate rates of extraperitoneal insufflation between the two techniques | intraoperative | ||
Secondary | Evaluate rates of vascular injury between the two techniques | intraoperative | ||
Secondary | Evaluate rates of visceral injury between the two techniques | intraoperative | ||
Secondary | Evaluate rates of gas embolism between the two techniques | omental injury between the two techniques | intraoperative | |
Secondary | Evaluate rates of solid organ injury between the two techniques | intraoperative | ||
Secondary | Evaluate rates of omental injury between the two techniques | intraoperative | ||
Secondary | Evaluate number of entry attempts. | Record the number of attempts taken with Veress needle to obtain successful intraperitoneal entry. | intraoperative |
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