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A study to compare two different insufflation devices during robotic laparoscopic sleeve gastrectomy surgery, AirSeal to DV5 insufflation, in Gastric Sleeve Procedures. Shoulder, neck and chest pain will be assessed.
A Single-Center, Prospective, Randomized, Controlled Study Comparing Intraoperative and Perioperative Outcomes using the CONMED AirSealĀ® and DV5 Insufflators during Robotic Laparoscopic Sleeve Gastrectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AirSealĀ® Insufflation System (AIS) | Active Comparator | Use of AirSealĀ® Insufflation System (AIS) during robotic laparoscopic sleeve gastrectomy. |
|
| DV5 Insufflator | Active Comparator | Use of DV5 Insufflator during robotic laparoscopic sleeve gastrectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AirSeal Insufflation system | Device | AirSeal Insufflation system used during robotic sleeve gastrectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Assessment on a 0 - 10 numerical rating scale (NRS) | Post-Operative shoulder, neck, chest pain, and abdominal pain | 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time | Procedure time, recovery room time, stay time | 1) Evening Surgery Day- (at 8 PM) 2) Morning- (Day 1 at 8:00 AM) 3) Evening- (Day 1 at 8 PM) 4) Morning -(Day 2 at 8 AM.) 5) Evening- (Day 2 at 8 PM) |
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Inclusion Criteria:
- ⢠Subject indicated for non-emergent sleeve gastrectomy surgery
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cynthia L Harris, BS | Contact | 8326776747 | cindy@clinregconsult.com |
| Name | Affiliation | Role |
|---|---|---|
| Anthony Gonzalez, MD FACS | Baptist Health South Miami Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Health South Miami Hospital | Miami | Florida | 33176 | United States |
We are just looking at the aggregate statistics.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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A Single-Center, Prospective, Randomized, Controlled Study Comparing Intraoperative and Perioperative Outcomes using the CONMED AirSealĀ® and DV5 Insufflators during Robotic Laparoscopic Sleeve Gastrectomy
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| DV5 Insufflation system | Device | DV5 Insufflation system used during robotic laparoscopic sleeve gastrectomy. |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |