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Comparison of Pneumoinsufflation Modes and Pressure Settings in Gynecology

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ClinicalTrials.gov Identifier: NCT02853591
Recruitment Status : Active, not recruiting
First Posted : August 3, 2016
Last Update Posted : July 26, 2019
Sponsor:
Collaborator:
ConMed Corporation
Information provided by (Responsible Party):
Pamela Frazzini Padilla, The Cleveland Clinic

Brief Summary:
This study seeks to evaluate post-operative patient pain and quality of life, and intra-operative hemodynamic status and changes in inflammatory markers, with use of a pressure-barrier insufflator and conventional insufflator at high and low pneumoperitoneum pressure settings.

Condition or disease Intervention/treatment Phase
Pain Pneumoperitoneum Inflammation Quality of Life Procedure: Pneumoinsufflator mode and setting Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized-Controlled Trial of Conventional Pneumoinsufflation and Pressure-Barrier Insufflation at High and Low Pressures in Gynecologic Surgery
Study Start Date : October 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : November 2019

Arm Intervention/treatment
Active Comparator: Standard High Pressure (15mmHg)
Pneumoinsufflator mode and setting: standard at 15mmHg
Procedure: Pneumoinsufflator mode and setting
Patients undergoing total laparoscopic hysterectomy will be randomized to pneumoperitoneum creation by one of two modes (standard or pressure-barrier) at one of two set pressures (15mmHg or 9mmHg) for a four-armed factorial designed study.
Other Name: Intra-abdominal pressure

Experimental: AirSeal High Pressure (15mmHg)
Pneumoinsufflator mode and setting: pressure-barrier at 15mmHg
Procedure: Pneumoinsufflator mode and setting
Patients undergoing total laparoscopic hysterectomy will be randomized to pneumoperitoneum creation by one of two modes (standard or pressure-barrier) at one of two set pressures (15mmHg or 9mmHg) for a four-armed factorial designed study.
Other Name: Intra-abdominal pressure

Experimental: Standard Low Pressure (9mmHg)
Pneumoinsufflator mode and setting: standard at 9mmHg
Procedure: Pneumoinsufflator mode and setting
Patients undergoing total laparoscopic hysterectomy will be randomized to pneumoperitoneum creation by one of two modes (standard or pressure-barrier) at one of two set pressures (15mmHg or 9mmHg) for a four-armed factorial designed study.
Other Name: Intra-abdominal pressure

Experimental: AirSeal Low Pressure (9mmHg)
Pneumoinsufflator mode and setting: pressure-barrier at 9 mmHg
Procedure: Pneumoinsufflator mode and setting
Patients undergoing total laparoscopic hysterectomy will be randomized to pneumoperitoneum creation by one of two modes (standard or pressure-barrier) at one of two set pressures (15mmHg or 9mmHg) for a four-armed factorial designed study.
Other Name: Intra-abdominal pressure




Primary Outcome Measures :
  1. Pain score [ Time Frame: 2 hours post-surgery ]
    Numerical rating scale


Secondary Outcome Measures :
  1. Pain score on a NRS [ Time Frame: 1 day post-surgery ]
    Numerical rating scale

  2. Narcotic usage [ Time Frame: 2 hours and 1 day post-surgery ]
    Morphine equivalents

  3. Heart rate [ Time Frame: Intra-operative (1. prior to anesthesia induction; 2. after induction prior to incision; 3. with pneumoperitoneum prior to Trendelenburg; 4. 10 minutes after trendelenburg; 5. 30 minutes after trendelenburg; 6. 5 minutes after pneumoperitoneum release ]
    beats per minute

  4. Mean arterial pressure [ Time Frame: Intra-operative (1. prior to anesthesia induction; 2. after induction prior to incision; 3. with pneumoperitoneum prior to Trendelenburg; 4. 10 minutes after trendelenburg; 5. 30 minutes after trendelenburg; 6. 5 minutes after pneumoperitoneum release ]
    mmHg

  5. Total peripheral resistance [ Time Frame: Intra-operative (1. prior to anesthesia induction; 2. after induction prior to incision; 3. with pneumoperitoneum prior to Trendelenburg; 4. 10 minutes after trendelenburg; 5. 30 minutes after trendelenburg; 6. 5 minutes after pneumoperitoneum release ]
    (mmHg*min)/mL

  6. Oxygen saturation [ Time Frame: Intra-operative (1. prior to anesthesia induction; 2. after induction prior to incision; 3. with pneumoperitoneum prior to Trendelenburg; 4. 10 minutes after trendelenburg; 5. 30 minutes after trendelenburg; 6. 5 minutes after pneumoperitoneum release ]
    oxygen saturation percent

  7. Respiratory rate [ Time Frame: Intra-operative (1. prior to anesthesia induction; 2. after induction prior to incision; 3. with pneumoperitoneum prior to Trendelenburg; 4. 10 minutes after trendelenburg; 5. 30 minutes after trendelenburg; 6. 5 minutes after pneumoperitoneum release ]
    breaths per minute

  8. Tidal volume [ Time Frame: Intra-operative (1. prior to anesthesia induction; 2. after induction prior to incision; 3. with pneumoperitoneum prior to Trendelenburg; 4. 10 minutes after trendelenburg; 5. 30 minutes after trendelenburg; 6. 5 minutes after pneumoperitoneum release ]
    liters

  9. End tidal carbon dioxide [ Time Frame: Intra-operative (1. prior to anesthesia induction; 2. after induction prior to incision; 3. with pneumoperitoneum prior to Trendelenburg; 4. 10 minutes after trendelenburg; 5. 30 minutes after trendelenburg; 6. 5 minutes after pneumoperitoneum release ]
    mmHg

  10. Peak inspiratory pressure [ Time Frame: Intra-operative (1. prior to anesthesia induction; 2. after induction prior to incision; 3. with pneumoperitoneum prior to Trendelenburg; 4. 10 minutes after trendelenburg; 5. 30 minutes after trendelenburg; 6. 5 minutes after pneumoperitoneum release ]
    mmHg

  11. Stroke volume [ Time Frame: Intra-operative (1. prior to anesthesia induction; 2. after induction prior to incision; 3. with pneumoperitoneum prior to Trendelenburg; 4. 10 minutes after trendelenburg; 5. 30 minutes after trendelenburg; 6. 5 minutes after pneumoperitoneum release ]
    mL

  12. Stroke volume index [ Time Frame: Intra-operative (1. prior to anesthesia induction; 2. after induction prior to incision; 3. with pneumoperitoneum prior to Trendelenburg; 4. 10 minutes after trendelenburg; 5. 30 minutes after trendelenburg; 6. 5 minutes after pneumoperitoneum release ]
    mL/beat/m^2

  13. Stroke volume variation [ Time Frame: Intra-operative (1. prior to anesthesia induction; 2. after induction prior to incision; 3. with pneumoperitoneum prior to Trendelenburg; 4. 10 minutes after trendelenburg; 5. 30 minutes after trendelenburg; 6. 5 minutes after pneumoperitoneum release ]
    stroke volume variation percent

  14. Cardiac output [ Time Frame: Intra-operative (1. prior to anesthesia induction; 2. after induction prior to incision; 3. with pneumoperitoneum prior to Trendelenburg; 4. 10 minutes after trendelenburg; 5. 30 minutes after trendelenburg; 6. 5 minutes after pneumoperitoneum release ]
    L/min

  15. Cardiac index [ Time Frame: Intra-operative (1. prior to anesthesia induction; 2. after induction prior to incision; 3. with pneumoperitoneum prior to Trendelenburg; 4. 10 minutes after trendelenburg; 5. 30 minutes after trendelenburg; 6. 5 minutes after pneumoperitoneum release ]
    L/min/m^2

  16. Interleukin-6 (plasma) [ Time Frame: Baseline (pre-anesthesia), intra-operative (30 minutes after Trendelenburg), 2 hours post-surgery ]
    pg/mL

  17. C-reactive protein (plasma) [ Time Frame: Baseline (pre-anesthesia), intra-operative (30 minutes after Trendelenburg), 2 hours post-surgery ]
    mg/dL

  18. Tumor necrosis factor-alpha (plasma) [ Time Frame: Baseline (pre-anesthesia), intra-operative (30 minutes after Trendelenburg), 2 hours post-surgery ]
    pg/mL

  19. Epinephrine [ Time Frame: Baseline (pre-anesthesia), intra-operative (30 minutes after Trendelenburg), 2 hours post-surgery ]
    pg/mL

  20. Norepinephrine [ Time Frame: Baseline (pre-anesthesia), intra-operative (30 minutes after Trendelenburg), 2 hours post-surgery ]
    pg/mL

  21. Quality of life score based on the abdominal surgery impact scale [ Time Frame: 2 weeks post-surgery ]
    Abdominal surgery impact scale

  22. Conversion of low pneumoperitoneum to high pneumoperitoneum [ Time Frame: Intra-operative (procedure start to finish) ]
    Number of subjects

  23. Loss of pneumoperitoneum [ Time Frame: Intra-operative (procedure start to finish) ]
    number of events

  24. Total complications [ Time Frame: Within first 30 days after surgery ]
    Vascular/bladder/ureter/intestinal injuries, blood transfusion, venous thromboembolism

  25. Operative time [ Time Frame: Intra-operative (procedure start to finish) ]
    minutes

  26. Estimated blood loss [ Time Frame: Intra-operative (procedure start to finish) ]
    mL



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects must meet the following inclusion criteria to be eligible for the study.

    1. Understand and voluntarily sign an informed consent form.
    2. Female gender ages 18-65
    3. Scheduled for total laparoscopic hysterectomy for benign indications with or without oophorectomy (standard of care involves bilateral salpingectomy).

Exclusion Criteria:

  • Meeting any of the following exclusion criteria will make the subject ineligible for the study.

    1. Anticipated removal of uterus through any route except vagina (transvaginal morcellation is acceptable)
    2. Planned concomitant procedures including but not limited to resection of deep endometriosis, plastic surgery procedures, or bowel resection.
    3. Daily narcotic pain medication use for greater than 30 days leading into surgery
    4. Use of da Vinci® robot surgical assistance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853591


Locations
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United States, Florida
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Sponsors and Collaborators
The Cleveland Clinic
ConMed Corporation
Investigators
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Principal Investigator: Stephen Zimberg, MD Cleveland Clinic Florida
Principal Investigator: Pamela Frazzini Padilla, MD Cleveland Clinic Florida
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Responsible Party: Pamela Frazzini Padilla, Clinical Fellow, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02853591    
Other Study ID Numbers: FLA 16-056
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Pamela Frazzini Padilla, The Cleveland Clinic:
laparoscopy
hysterectomy
Additional relevant MeSH terms:
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Pneumoperitoneum
Inflammation
Pathologic Processes
Peritoneal Diseases
Digestive System Diseases