Veress Entry With/Without Concomitant CO2
Condition: Laparoscopy; Laparoscopic Surgery; Insufflation; Gynecologic Surgical Procedures
Study type: Interventional

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.
    

Intervention name(s): Veress needle entry with concomitant CO2; Veress needle entry with subsequent CO2
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Laparoscopic Entry; Veress Needle; Intraperitoneal insufflation; Time; Complications