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The study is designed to compare two different insufflation devices during surgery, CONMED AirSeal to Lexicon, during Laparoscopic Sleeve Gastrectomy.
A Single-Center, Prospective, Randomized, Controlled Study Comparing Intraoperative and Perioperative Outcomes using the CONMED AirSealĀ® and Lexicon Insufflators during Laparoscopic Sleeve Gastrectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AirSealĀ® Insufflation System (AIS) | Active Comparator | Use of CONMED AirSealĀ® during Laparoscopic Sleeve Gastrectomy. |
|
| Lexicon Insufflator | Active Comparator | Use of Lexicon Insufflators during Laparoscopic Sleeve Gastrectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AirSealĀ® Insufflation System (AIS) | Device | insufflation device used during laparoscopic sleeve gastrectomy, |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-Operative Pain assessment on a 0-10 numerical rating scale(NRS). | Post-Operative Pain (shoulder, neck, chest and abdominal) assessment | 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time | Procedure time, recovery room time, length of 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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| cynthia Harris, BS | Contact | 18326776747 | cindy@clinregconsult.com |
| Name | Affiliation | Role |
|---|---|---|
| Nikhilesh Sekhar, MD FACS FASMBS | Bariatric and Specialty Surgery Center of Stamford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bariatric and Specialty Surgery Center of Stamford | Stamford | Connecticut | 06902 | United States |
We are 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 Lexicon Insufflators during Laparoscopic Sleeve Gastrectomy.
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| Lexicon AP 50/30 Insufflator | Device | insufflation device used during laparoscopic sleeve gastrectomy, |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |