Menu
Not yet recruiting NCT07313930

Gastrectomy at Low Pressure Trial - (GALPT)

No phase Interventional Pain, Postoperative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AirSeal® Insufflation System (AIS), Lexicon AP 50/30 Insufflator.
Who it may be relevant to
Registry conditions: Pain, Postoperative. Basic parameters: 22 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

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

Interventions

  • Device AirSeal® Insufflation System (AIS)
    insufflation device used during laparoscopic sleeve gastrectomy,
  • Device Lexicon AP 50/30 Insufflator
    insufflation device used during laparoscopic sleeve gastrectomy,

Primary outcome measures

  • Post-Operative Pain assessment on a 0-10 numerical rating scale(NRS). [Time frame: 48 hours after surgery]
Secondary outcome measures (1)
  • Time [Time frame: 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Bariatric and Specialty Surgery Center of Stamford — Stamford

Identifiers

NCT: NCT07313930 · DD1250901

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗