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Pneumoperitoneum Management With Low vs. Higher Pressure
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
2 other identifiers
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2018
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2017
CompletedFirst Posted
Study publicly available on registry
April 25, 2017
CompletedStudy Start
First participant enrolled
July 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedMay 30, 2019
May 1, 2019
3 years
April 20, 2017
May 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Post-operative day 1
Study Arms (3)
Conventional Insufflation System (CIS)
EXPERIMENTALQuestionnaires 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.
ConMed AirSeal Insufflation System (AIS) at Low Pressure
EXPERIMENTALQuestionnaires 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.
ConMed AirSeal Insufflation System (AIS) at Higher Pressure
ACTIVE COMPARATORQuestionnaires 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.
Interventions
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.
CIS with pressure target of 15±1 mmHg used for pneumoperitoneum during laparoscopic/robotic surgery.
AIS with an insufflation pressure target of 9±1 mmHg used for pneumoperitoneum during laparoscopic/robotic surgery.
AIS with an insufflation pressure target of 15±1 mmHg used for pneumoperitoneum during laparoscopic/robotic surgery.
Eligibility Criteria
You may qualify if:
- All gynecologic laparoscopic/robotic surgeries EXCEPT diagnostic laparoscopies
- 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
You may not qualify if:
- 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...)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- CONMED Corporationcollaborator
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pedro T. Ramirez, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2017
First Posted
April 25, 2017
Study Start
July 1, 2018
Primary Completion
July 1, 2021
Study Completion
July 1, 2022
Last Updated
May 30, 2019
Record last verified: 2019-05