Pneumoperitoneum Management With Low vs. Higher Pressure

May 29, 2019 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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...)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Shoulder Pain After Laparoscopic/Robotic Surgery
Time Frame: 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).
Post-operative day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

CONMED Corporation

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2018

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

April 20, 2017

First Submitted That Met QC Criteria

April 24, 2017

First Posted (Actual)

April 25, 2017

Study Record Updates

Last Update Posted (Actual)

May 30, 2019

Last Update Submitted That Met QC Criteria

May 29, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-0973
  • NCI-2018-01330 (Registry Identifier: NCI CTRP)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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