Study Results
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Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2016-08-31
2018-03-10
Brief Summary
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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.
Detailed Description
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All female patients age 18-70 scheduled for benign gynecologic laparoscopic surgery at TGH by a participating attending surgeon will be recruited. Each participant will be educated about the study; its objectives, potential benefits and risks, and the research team will obtain informed consent. Plan to enroll 90 participants.
Materials and Methods:
This will be a randomized control trial in which participants will be randomly assigned to have laparoscopic entry with Veress needle connected to CO2 tubing for concomitant insufflation versus Veress needle entry with subsequent connection to CO2 tubing for insufflation. The investigators will inform the patients about the two entry techniques during the pre-operative office visit. Participants will be consented to participate in the study prior to the surgery by the study research coordinators during their pre-operative visit. Patients who do not consent for the study will still undergo the scheduled procedure with standard entry technique as clinically indicated by their provider. Randomization will occur in the operating room just before the surgery starts. The healthcare provider performing the procedure will open the next sequentially numbered envelope, within which there will be a piece of paper indicating the entry technique to be performed. This will then be recorded in the study log. The study log will include enrolled participants, assigned study number which will range from 001 to the minimum number of participants required for the study as indicated by sample size calculation (see below). The participant will be positioned in the dorsal lithotomy position and prepped and draped in the standard fashion. Preoperative antibiotics will be provided as per standard indication for the procedure. 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. For the other group of patients 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. The time will be recorded from incision to the time it takes to achieve intraperitoneal pressure of 15 mmHg. In addition to the above primary and secondary outcomes of the study, participant demographic information, procedure specific variables and outcomes will be collected and recorded in the study log (See data collection sheet). Common laparoscopic complications will also be recorded, including the following:
* Vascular injury: any tear or injury to any intraabdominal blood vessels.
* Visceral injury: any serosal (superficial) or full thickness (deep) injury to the small or the large bowel.
* Gas embolism: entrapment of carbon dioxide in an injured vein, artery or solid organ, and results in blockage of the right ventricle (RV) or pulmonary artery
* Solid organ injury: any injury of a solid abdominal or pelvic organ including but not limited to, liver, spleen or the uterus.
* Failed entry: failure to establish pneumoperitoneum after 3 attempts of Veress insufflation.
* Extraperitoneal insufflation: insufflating the preperitoneal space with carbon dioxide.
* Omental injury: any injury to the greater omentum that results in bleeding of omental insufflation.
Sample size: 90 patients will be recruited based on the sample size calculations already performed.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Veress needle entry with concomitant CO2
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.
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.
Veress needle entry with subsequent CO2
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Diagnostic laparoscopy
* Laparoscopic adnexal surgery
* Laparoscopic hysterectomy
* Laparoscopic myomectomy
* Robotic assisted hysterectomy
* Robotic assisted myomectomy
Exclusion Criteria
* Previous midline laparotomy
* 3 or more previous cesarean sections through a Pfannenstiel incision
18 Years
70 Years
FEMALE
No
Sponsors
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Tampa General Hospital
OTHER
University of South Florida
OTHER
Responsible Party
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Principal Investigators
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Emad Mikhail, MD
Role: PRINCIPAL_INVESTIGATOR
University of South Florida Department of Obstetrics and Gynecology
Anthony Imudia, MD
Role: STUDY_DIRECTOR
University of South Florida Department of Obstetrics and Gynecology
Elisabeth Sappenfield, MD
Role: STUDY_CHAIR
University of South Florida Department of Obstetrics and Gynecology
Locations
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Tampa General Hospital
Tampa, Florida, United States
Countries
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Other Identifiers
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Pro00025352
Identifier Type: -
Identifier Source: org_study_id