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Pneumoperitoneum Management With Low vs. Higher Pressure

Primary Purpose

Malignant Neoplasms of Female Genital Organs

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Questionnaires
Conventional Insufflation System (CIS)
ConMed AirSeal Insufflation System (AIS) at Low Pressure
ConMed AirSeal Insufflation System (AIS) at Higher Pressure
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Neoplasms of Female Genital Organs focused on measuring Malignant Neoplasms of Female Genital Organs, Laparoscopic gynecologic surgery, Robotic gynecologic surgery, AirSeal® Insufflation System, AIS, Conventional Insufflation System, CIS, Questionnaires, Surveys

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. All gynecologic laparoscopic/robotic surgeries EXCEPT diagnostic laparoscopies
  2. 18-80 years of age
  3. Capable and willing to provide Informed consent
  4. Acceptable candidate for laparoscopic/robotic GYN surgery as per discretion of the surgeon
  5. If patient agrees to participate in the optional patient reported outcomes portion of the study, patient must be English speaking and willing to complete the MD Anderson Symptom Inventory (MDASI) questionnaires

Exclusion Criteria:

  1. Active cutaneous infection or inflammation
  2. Pre-existing active or untreated immunodeficiency disorder and/or chronic use of systemic steroids
  3. Uncontrolled diabetes mellitus
  4. Severe co-existing morbidities having a life expectancy of less than 30 days
  5. Significant anemia with hemoglobin level less than 7 g/dL or a hematocrit less than 21%
  6. Females who are pregnant or lactating
  7. Patients presenting with ascites
  8. Patients with Chronic Pain Syndrome or requiring/using chronic pain medications
  9. Patients undergoing diagnostic laparoscopy
  10. Patients planning to undergo hand-assisted laparoscopy
  11. Severe comorbidities (atrial fibrillation, pulmonary hypertension, etc...)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Conventional Insufflation System (CIS)

    ConMed AirSeal Insufflation System (AIS) at Low Pressure

    ConMed AirSeal Insufflation System (AIS) at Higher Pressure

    Arm Description

    Questionnaires completed 30 days before surgery, two (2) hours after surgery, when leaving the post-anesthesia care unit (PACU), and at hospital discharge. Conventional Insufflation System (CIS) used for pneumoperitoneum during laparoscopic/robotic surgery.

    Questionnaires completed 30 days before surgery, two (2) hours after surgery, when leaving the post-anesthesia care unit (PACU), and at hospital discharge. ConMed AirSeal Insufflation System (AIS) at Low Pressure used for pneumoperitoneum during laparoscopic/robotic surgery.

    Questionnaires completed 30 days before surgery, two (2) hours after surgery, when leaving the post-anesthesia care unit (PACU), and at hospital discharge. ConMed AirSeal Insufflation System (AIS) at Higher Pressure used for pneumoperitoneum during laparoscopic/robotic surgery.

    Outcomes

    Primary Outcome Measures

    Incidence of Shoulder Pain After Laparoscopic/Robotic Surgery
    Incidence of shoulder pain defined by a positive (>0) score for an 11-point pain intensity numeric rating scale (PI-NRS).

    Secondary Outcome Measures

    Full Information

    First Posted
    April 20, 2017
    Last Updated
    May 29, 2019
    Sponsor
    M.D. Anderson Cancer Center
    Collaborators
    CONMED Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03128281
    Brief Title
    Pneumoperitoneum Management With Low vs. Higher Pressure
    Official Title
    A Single Center, Prospective, Randomized, Controlled Study to Evaluate Shoulder Pain, Cardiovascular Changes, Pulmonary Pressures and Perioperative Outcomes Related to the Use of the AirSeal® Insufflation System (AIS) at Low and Higher Pressure Pneumoperitoneum vs. Conventional Insufflation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Sponsor issue
    Study Start Date
    July 2018 (Anticipated)
    Primary Completion Date
    July 2021 (Anticipated)
    Study Completion Date
    July 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    M.D. Anderson Cancer Center
    Collaborators
    CONMED Corporation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The goal of this clinical research study is to compare the level of pain 2 hours after surgery in patients after the use of the AirSeal® Insufflation System (AIS) at a high or low pressure setting or the standard insufflator (the conventional insufflation system, or CIS). "Insufflation" is the creation of a pressure barrier of air/gas within the abdomen that allows the surgeon more space to work in.
    Detailed Description
    Baseline Visit: If participant agrees to take part in this study, within 30 days before surgery, participant will be asked to complete a questionnaire about participant's pain level and any drugs participant may be taking for it. It should take about 5 minutes to complete. Study Groups: Participant will be randomly assigned to 1 of 3 groups (as in a roll of dice). This is done because no one knows if one study group is better, the same, or worse than the other group. Participant has an equal chance of being placed in each group. Participant will not know which group participant is assigned to. If participant is in Group 1, participant will have the CIS used during surgery. If participant is in Group 2, participant will have the AIS used at a lower pressure during surgery. If participant is in Group 3, participant will have the AIS used at a higher pressure during surgery. Surgery: Participant will then have surgery. Participant will sign a separate consent for the surgery that explains the procedure, the risks of the surgery, and the risks of CIS. Blood (about 3 teaspoons each time) will be collected 1 time before surgery, 2 times during surgery, and 1 time after surgery is completed. Routine tests and tests to learn how participant's body reacts to inflammation will be performed on this blood. Questionnaires: After surgery, participant will complete the questionnaire about participant's pain level and any drugs participant is taking. Participant will complete this questionnaire: Two (2) hours after surgery, When participant leaves the post-anesthesia care unit (PACU), and When participant is discharged from the hospital If participant is discharged the same day as participant's surgery, participant will be called by the study staff to answer the questionnaire the following day. Length of Study Participation: Participation in the study will be over after participant completes the questionnaire after participant is discharged, unless participant agrees to complete additional optional questionnaires. This is an investigational study. Both AirSeal® insufflation system (AIS) and conventional insufflation systems (CIS) are FDA approved and commercially available. It is investigational to compare the effects of high and low pressures using the AIS. Up to 240 participants will be enrolled in this study. All will take part at MD Anderson.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malignant Neoplasms of Female Genital Organs
    Keywords
    Malignant Neoplasms of Female Genital Organs, Laparoscopic gynecologic surgery, Robotic gynecologic surgery, AirSeal® Insufflation System, AIS, Conventional Insufflation System, CIS, Questionnaires, Surveys

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional Insufflation System (CIS)
    Arm Type
    Experimental
    Arm Description
    Questionnaires completed 30 days before surgery, two (2) hours after surgery, when leaving the post-anesthesia care unit (PACU), and at hospital discharge. Conventional Insufflation System (CIS) used for pneumoperitoneum during laparoscopic/robotic surgery.
    Arm Title
    ConMed AirSeal Insufflation System (AIS) at Low Pressure
    Arm Type
    Experimental
    Arm Description
    Questionnaires completed 30 days before surgery, two (2) hours after surgery, when leaving the post-anesthesia care unit (PACU), and at hospital discharge. ConMed AirSeal Insufflation System (AIS) at Low Pressure used for pneumoperitoneum during laparoscopic/robotic surgery.
    Arm Title
    ConMed AirSeal Insufflation System (AIS) at Higher Pressure
    Arm Type
    Active Comparator
    Arm Description
    Questionnaires completed 30 days before surgery, two (2) hours after surgery, when leaving the post-anesthesia care unit (PACU), and at hospital discharge. ConMed AirSeal Insufflation System (AIS) at Higher Pressure used for pneumoperitoneum during laparoscopic/robotic surgery.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Questionnaires
    Other Intervention Name(s)
    Surveys
    Intervention Description
    Questionnaires completed 30 days before surgery, two (2) hours after surgery, when leaving the post-anesthesia care unit (PACU), and at hospital discharge. Questionnaires ask about pain level and any drugs taken for it. It should take about 5 minutes to complete.
    Intervention Type
    Device
    Intervention Name(s)
    Conventional Insufflation System (CIS)
    Other Intervention Name(s)
    CIS
    Intervention Description
    CIS with pressure target of 15±1 mmHg used for pneumoperitoneum during laparoscopic/robotic surgery.
    Intervention Type
    Device
    Intervention Name(s)
    ConMed AirSeal Insufflation System (AIS) at Low Pressure
    Other Intervention Name(s)
    AIS
    Intervention Description
    AIS with an insufflation pressure target of 9±1 mmHg used for pneumoperitoneum during laparoscopic/robotic surgery.
    Intervention Type
    Device
    Intervention Name(s)
    ConMed AirSeal Insufflation System (AIS) at Higher Pressure
    Other Intervention Name(s)
    AIS
    Intervention Description
    AIS with an insufflation pressure target of 15±1 mmHg used for pneumoperitoneum during laparoscopic/robotic surgery.
    Primary Outcome Measure Information:
    Title
    Incidence of Shoulder Pain After Laparoscopic/Robotic Surgery
    Description
    Incidence of shoulder pain defined by a positive (>0) score for an 11-point pain intensity numeric rating scale (PI-NRS).
    Time Frame
    Post-operative day 1

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All gynecologic laparoscopic/robotic surgeries EXCEPT diagnostic laparoscopies 18-80 years of age Capable and willing to provide Informed consent Acceptable candidate for laparoscopic/robotic GYN surgery as per discretion of the surgeon If patient agrees to participate in the optional patient reported outcomes portion of the study, patient must be English speaking and willing to complete the MD Anderson Symptom Inventory (MDASI) questionnaires Exclusion Criteria: Active cutaneous infection or inflammation Pre-existing active or untreated immunodeficiency disorder and/or chronic use of systemic steroids Uncontrolled diabetes mellitus Severe co-existing morbidities having a life expectancy of less than 30 days Significant anemia with hemoglobin level less than 7 g/dL or a hematocrit less than 21% Females who are pregnant or lactating Patients presenting with ascites Patients with Chronic Pain Syndrome or requiring/using chronic pain medications Patients undergoing diagnostic laparoscopy Patients planning to undergo hand-assisted laparoscopy Severe comorbidities (atrial fibrillation, pulmonary hypertension, etc...)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pedro T. Ramirez, MD
    Organizational Affiliation
    M.D. Anderson Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.mdanderson.org
    Description
    University of Texas MD Anderson Cancer Center Website

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