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Pneumoperitoneum Management With Low vs. Higher Pressure

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03128281
Collaborator
ConMed Corporation (Industry)
0
Enrollment
3
Arms
48
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Questionnaires
  • Device: Conventional Insufflation System (CIS)
  • Device: ConMed AirSeal Insufflation System (AIS) at Low Pressure
  • Device: ConMed AirSeal Insufflation System (AIS) at Higher Pressure
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jul 1, 2018
Anticipated Primary Completion Date :
Jul 1, 2021
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Conventional Insufflation System (CIS)

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.

Behavioral: Questionnaires
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.
Other Names:
  • Surveys

    • Device: Conventional Insufflation System (CIS)
    CIS with pressure target of 15±1 mmHg used for pneumoperitoneum during laparoscopic/robotic surgery.
    Other Names:
  • CIS

    		•
    Experimental: ConMed AirSeal Insufflation System (AIS) at Low Pressure

    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.

    Behavioral: Questionnaires
    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.
    Other Names:
  • Surveys

    • Device: ConMed AirSeal Insufflation System (AIS) at Low Pressure
    AIS with an insufflation pressure target of 9±1 mmHg used for pneumoperitoneum during laparoscopic/robotic surgery.
    Other Names:
  • AIS

    		•
    Active Comparator: ConMed AirSeal Insufflation System (AIS) at Higher Pressure

    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.

    Behavioral: Questionnaires
    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.
    Other Names:
  • Surveys

    • Device: ConMed AirSeal Insufflation System (AIS) at Higher Pressure
    AIS with an insufflation pressure target of 15±1 mmHg used for pneumoperitoneum during laparoscopic/robotic surgery.
    Other Names:
  • AIS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Shoulder Pain After Laparoscopic/Robotic Surgery [Post-operative day 1]

      Incidence of shoulder pain defined by a positive (>0) score for an 11-point pain intensity numeric rating scale (PI-NRS).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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...)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • ConMed Corporation

    Investigators

    • Principal Investigator: Pedro T. Ramirez, MD, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT03128281
    Other Study ID Numbers:
    • 2015-0973
    • NCI-2018-01330
    First Posted:
    Apr 25, 2017
    Last Update Posted:
    May 30, 2019
    Last Verified:
    May 1, 2019
    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
    Keywords provided by M.D. Anderson Cancer Center
    Malignant Neoplasms of Female Genital Organs
    Laparoscopic gynecologic surgery
    Robotic gynecologic surgery
    AirSeal® Insufflation System
    AIS
    Conventional Insufflation System
    CIS
    Questionnaires
    Surveys
    Additional relevant MeSH terms:
    Neoplasms
    Genital Neoplasms, Female
    Pneumoperitoneum

    Study Results

    No Results Posted as of May 30, 2019