Malignant Neoplasms of Female Genital Organs Clinical Trial
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
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.
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.
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