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

M.D. Anderson Cancer Center0 sitesStarted: July 1, 2018Last updated: May 30, 2019

Conditions

Interventions

Trial Snapshot

Phase: Phase 2
Status: Withdrawn
Sponsor: M.D. Anderson Cancer Center
Primary Endpoint: Incidence of Shoulder Pain After Laparoscopic/Robotic Surgery

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: Single (Participant)

Eligibility Criteria

Ages: 18 Years to 80 Years (Adult, Older Adult)
Sex: Female
Accepts Healthy Volunteers: No

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...)