Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor issue
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasms of Female Genital Organs | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ConMed AirSeal Insufflation System (AIS) at Higher Pressure | Device | — | UNRESOLVED |
| ConMed AirSeal Insufflation System (AIS) at Low Pressure | Device | — | UNRESOLVED |
| Conventional Insufflation System (CIS) | Device | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Conventional Insufflation System (CIS)
- description
- 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.
- interventionNames
- Behavioral: Questionnaires
- Device: Conventional Insufflation System (CIS)
- type
- EXPERIMENTAL
- label
- ConMed AirSeal Insufflation System (AIS) at Low Pressure
- description
- 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.
- interventionNames
- Behavioral: Questionnaires
- Device: ConMed AirSeal Insufflation System (AIS) at Low Pressure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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...)
References
Publications (0)
Data not yet available