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Trial record 76 of 149 for:    Recruiting, Not yet recruiting, Available Studies | Prostatectomy

Ultralow Versus Standard Pneumoperitoneum Pressure (Ultralow)

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ClinicalTrials.gov Identifier: NCT03630393
Recruitment Status : Not yet recruiting
First Posted : August 14, 2018
Last Update Posted : March 19, 2019
Sponsor:
Collaborator:
ConMed Corporation
Information provided by (Responsible Party):
Ronney Abaza, OhioHealth

Brief Summary:
The investigators plan to compare insufflation pressures during robotic assisted laparoscopic prostatectomy (RALP). Standard pressure is typically 15 mmHg, while in a previous study the investigators determined that 6 mmHg is possible routinely. Therefore, the investigators plan to compare the clinical outcomes of participants at a pneumoperitoneal pressure of 15 versus 6 mmHg.

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: Pneumoperitoneum Pressure 6 mmHg Other: Pneumoperitoneum Pressure 15 mmHg Not Applicable

Detailed Description:
The investigators to examine the impact of low pressure during robotic assisted laparoscopic prostatectomy (RALP) with the intention of identifying whether lower pressures might benefit participants. The investigators hypothesize that a low insufflation pressure may provide an improvement in postoperative pain and abdominal distension in addition to potential physiologic benefits, and that these factors might then allow a shorter hospital stay. The investigators previously initiated a protocol in September of 2016 (IRB# 1066864) to perform RALPs at an insufflation pressure of 6 mmHg with the intention of increasing the pressure as needed on an individual participant level. In order to determine whether this might allow earlier discharge when successful, the investigators began allowing for same-day discharge in participants meeting appropriate criteria. Having now demonstrated feasibility in over 300 consecutive participants using this ultralow pneumoperitoneum protocol, the investigators now plan to conduct a randomized trial to compare a pressure of 6 mmHg with participants having RALP at a standard pressure of 15 mmHg to determine whether there is a true benefit.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Study of Ultralow Versus Standard Pneumoperitoneum Pressure During Robotic Prostatectomy Using the AirSeal® Insufflation System
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pressure 6 mmHg
Pneumoperitoneum Pressure 6 mmHg
Other: Pneumoperitoneum Pressure 6 mmHg
A pneumoperitoneum insufflation pressure of 6 mmHg will be used during RALP.

Active Comparator: Pressure 15 mmHg
Pneumoperitoneum Pressure 15 mmHg
Other: Pneumoperitoneum Pressure 15 mmHg
A pneumoperitoneum insufflation pressure of 15 mmHg will be used during RALP.




Primary Outcome Measures :
  1. Postoperative pain medication use [ Time Frame: Through 1 week postoperatively ]
    Morphine equivalents


Secondary Outcome Measures :
  1. Postoperative pain scores [ Time Frame: Through discharge postoperatively ]
    Pain scores on a 0-10 scale

  2. Operative ventilation [ Time Frame: Intraoperatively ]
    Average tidal volume (ml)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Males with prostate cancer who are eligible and electing to undergo robotic assisted laparoscopic prostatectomy (RALP)
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 or older
  2. Diagnosed with prostate cancer
  3. Electing to undergo robotic assisted laparoscopic prostatectomy (RALP)

Exclusion Criteria:

  1. Age < 18
  2. Emergency surgery
  3. Patients with a significant preoperative dependence on narcotic medications
  4. Unable to give informed consent
  5. Dementia, history of dementia, or other significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting
  6. Persons participating in any other research study involving an investigational drug or device or investigational surgical procedure that could interfere with the physiologic parameters being collected (for example, a study evaluating different anesthesia regimens that could confound study results)
  7. Non-English-speaking or reading

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): NCT03630393


Contacts
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Contact: Deborah Chervin 614-544-8430 deborah.chervin@ohiohealth.com
Contact: Tamara McMath, MPH 614-788-3869 tamara.mcmath@ohiohealth.com

Locations
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United States, Ohio
Dublin Methodist Hospital
Columbus, Ohio, United States, 43016
Sponsors and Collaborators
OhioHealth
ConMed Corporation
Investigators
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Principal Investigator: Ronney Abaza, MD OhioHealth

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Responsible Party: Ronney Abaza, Robotic Urologic Surgeon, OhioHealth
ClinicalTrials.gov Identifier: NCT03630393     History of Changes
Other Study ID Numbers: 1306218
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Ronney Abaza, OhioHealth:
Prostatectomy
Robotic
Urology

Additional relevant MeSH terms:
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Pneumoperitoneum
Peritoneal Diseases
Digestive System Diseases