Gastrectomy at Low Pressure Trial - (GALPT)

SurgiQuest

Status: Not yet enrolling

Conditions: Pain, Postoperative

Treatments: Device: Lexicon AP 50/30 Insufflator; Device: AirSeal® Insufflation System (AIS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07313930

DD1250901

Details and patient eligibility

About

The study is designed to compare two different insufflation devices during surgery, CONMED AirSeal to Lexicon, during Laparoscopic Sleeve Gastrectomy.

Full description

A Single-Center, Prospective, Randomized, Controlled Study Comparing Intraoperative and Perioperative Outcomes using the CONMED AirSeal® and Lexicon Insufflators during Laparoscopic Sleeve Gastrectomy.

Enrollment: 74 estimated patients

Sex: All

Ages: 22 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• . Subject indicated for non-emergent sleeve gastrectomy surgery
• . Subject (or appropriate legal representatives) can 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 graded as 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 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 immunocompromise
• Subject 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

AirSeal® Insufflation System (AIS)

Active Comparator group

Description:

Use of CONMED AirSeal® during Laparoscopic Sleeve Gastrectomy.

Treatment:

Device: AirSeal® Insufflation System (AIS)

Lexicon Insufflator

Active Comparator group

Description:

Use of Lexicon Insufflators during Laparoscopic Sleeve Gastrectomy.

Treatment:

Device: Lexicon AP 50/30 Insufflator