Pain, Postoperative
Conditions
Keywords
Post-Procedure Comparative Pain Study
Brief summary
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.
Detailed description
A Single-Center, Prospective, Randomized, Controlled Study Comparing Intraoperative and Perioperative Outcomes using the CONMED AirSeal® and DV5 Insufflators during Robotic Laparoscopic Sleeve Gastrectomy.
Interventions
DEVICEAirSeal Insufflation system
AirSeal Insufflation system used during robotic sleeve gastrectomy
DEVICEDV5 Insufflation system
DV5 Insufflation system used during robotic laparoscopic sleeve gastrectomy.
Sponsors
SurgiQuest, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A Single-Center, Prospective, Randomized, Controlled Study Comparing Intraoperative and Perioperative Outcomes using the CONMED AirSeal® and DV5 Insufflators during Robotic Laparoscopic Sleeve Gastrectomy
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
\- • Subject indicated for non-emergent sleeve gastrectomy surgery * Subjects (or appropriate legal representatives) able to provide written informed consent to participate in the study * Male or Female aged 22 years to 65 years * Have no significant psychopathology that could limit the subject's ability to understand the procedure, comply with medical, surgical, and/or behavioral recommendations and office visits * Agree to refrain from any type of elective procedures that would affect body weight such as abdominal lipoplasty or liposuction, mammoplasty, or removal of excess skin for the duration of the trial. * Are American Society of Anesthesiologists (ASA) Class I, II, or III);
Exclusion criteria
* Subject participation in a different investigational clinical study within 90 days before screening and for the duration of this trial (unless previously approved by the investigator and Sponsor) * Subject requiring any surgical procedure in addition to Sleeve Gastrectomy * Previous malabsorptive or restrictive procedures performed for the treatment of obesity * Inability to provide informed consent * Unable or unwilling to attend follow-up visits and examinations * Uncontrolled hypertension (Systolic: ≥180 mmHg or Diastolic: ≥120 mmHg) and/or diabetes mellitus (Fasting blood sugar level: \>200 mg/dL) * Subject who falls into American Society of Anesthesiologists (ASA) Class ≥ IV * History of chronic alcohol or drug abuse within 2 years of the screening visit * Chronic renal failure or on dialysis * Significant complicating medical history or immunocompromised * Subject is undergoing surgery for malignant disease * History or presence of pre-existing autoimmune connective tissue disease, e.g., systemic lupus erythematosus or scleroderma * Immunocompromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders * Any medical condition which precludes compliance with the study * Subject with any other clinically significant unstable medical disorder, life threatening disease, or conditions that, in the opinion of the investigator, may jeopardize the subject's well-being and/or the soundness of this clinical study or which would contra-indicate a surgical procedure * Previous or current history of being on regular analgesia / pain killers * Advanced refusal of blood transfusion, (if necessary) * If female subject pregnant, planning to become pregnant within 3 months (up to 92 days of procedure), or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Assessment on a 0 - 10 numerical rating scale (NRS) | 48 hours after surgery | Post-Operative shoulder, neck, chest pain, and abdominal pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Procedure time, recovery room time, stay time |
Countries
United States
Contacts
Primary ContactCynthia L Harris, BS
Outcome results
None listed