Clinical trial NCT02896036: Veress Entry With/Without Concomitant CO2
Official title: Laparoscopic Entry Technique With a Veress Needle Insertion With and Without Concomitant CO2 Insufflation - Does it Matter?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopy
Laparoscopic Surgery
Insufflation
Gynecologic Surgical Procedures
Keywords: Laparoscopic Entry
Veress Needle
Intraperitoneal insufflation
Time
Complications
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Tampa General Hospital
First posted: 2016-09-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: Subject Recruitment and Consent:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time required for adequate intraperitoneal insufflation.
timeFrame: intraoperative
Secondary outcomes:
measure: Evaluate rates of failed entry between the two techniques
timeFrame: intraoperative
measure: Evaluate rates of extraperitoneal insufflation between the two techniques
timeFrame: intraoperative
measure: Evaluate rates of vascular injury between the two techniques
timeFrame: intraoperative
measure: Evaluate rates of visceral injury between the two techniques
timeFrame: intraoperative
measure: Evaluate rates of gas embolism between the two techniques
timeFrame: intraoperative
measure: Evaluate rates of solid organ injury between the two techniques
timeFrame: intraoperative
measure: Evaluate rates of omental injury between the two techniques
timeFrame: intraoperative
measure: Evaluate number of entry attempts.
timeFrame: intraoperative
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
Study officials:
affiliation: University of South Florida Department of Obstetrics and Gynecology
name: Emad Mikhail, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Florida Department of Obstetrics and Gynecology
name: Anthony Imudia, MD
role: STUDY_DIRECTOR
affiliation: University of South Florida Department of Obstetrics and Gynecology
name: Elisabeth Sappenfield, MD
role: STUDY_CHAIR
References: