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Completed

NCT Number: NCT03939819

Endoscopic vs. Suction Device Calibration in Sleeve Gastrectomy

This study aims to compare the difference in staple usage and post-operative GERD (heartburn) between patients that had an endoscope used versus patients that had a suction calibration system used on them during "laparoscopic sleeve gastrectomy" (LSG).

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Key information

Conditions

Gastrectomy Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University Hospital Midtown

Atlanta, Georgia, 30322, United States

About this study

There are multiple choices for a surgeon and their patient when it comes to weight loss surgery. One of those options is a procedure called a "laparoscopic sleeve gastrectomy" (LSG). In this procedure the majority of the patient's stomach is removed leaving behind a stapled "sleeve" about the same size as the patient's esophagus.

During this procedure there are three main devices that surgeon inserts through the mouth and in to the stomach to calibrate the size of the "sleeve". They can use a standard weighted bougie, an endoscope, or a suction calibration device. This study aims to compare the difference in staple usage and post-operative GERD (heartburn) between patients that had an endoscope used versus patients that had a suction calibration system used on them during LSG.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years old or older
  • agreed with a surgeon that laparoscopic sleeve gastrectomy (LSG) is the best choice

Exclusion criteria

  • Had prior gastric surgery or bariatric surgery (including prior adjustable gastric band and/or sleeve gastrectomy)
  • Concomitant hiatal surgery
  • Paraesophageal hernia at time of surgery
  • Any subject with prescribed immunosuppressive drugs.
  • In the opinion of investigator, subject is not eligible to participate in the study.
  • If patient is a female and becomes pregnant at any time during the study duration

Treatment and study plan

ViSiGi® 3D suction calibration device

Device

ViSiGi 3D®is a non-sterile, single patient use device. The device comprises a tube with a closed, rounded tip, and holes at the distal end. The proximal end of ViSiGi 3D® includes an integral suction regulator and vented On/Off valve.

Esophagogastroduodenoscopy (EGD) calibration

Device

Gastroscope is an illuminated optical, slender and tubular instrument (a type of borescope) used in esophagogastroduodenoscopy.

Primary outcomes

  1. Number of Staple Load Firings

    Time frame: During sleeve gastrectomy (up to 5 hours)

    Staple usage will be recorded during the weight loss surgery procedure.

Secondary outcomes

  1. Operative Duration (Time)

    Time frame: During sleeve gastrectomy (up to 5 hours)

    Surgery start and completion time will be recorded, and operative duration will be calculated

  2. Intra-operative Cost for Patients

    Time frame: During sleeve gastrectomy (up to 5 hours)

    Cost data (administrative data) will be retrieved from internal database

  3. GERD Symptom Severity Score

    Time frame: 1-2 months prior to surgery, 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months)

    GERD-HRQL questionnaire will be administered pre-operatively and post-operatively. The instrument contains a total of 10 scaled items which are scored, and a patient-reported global satisfaction assessment which is not added to the total GERD-HRQL score. Higher score correlates with worse outcome. Scale: No symptoms = 0; Symptoms noticeable, but not bothersome = 1; Symptoms noticeable and bothersome, but not every day = 2; Symptoms bothersome every day = 3; Symptoms affect daily activities = 4; Symptoms are incapacitating, unable to do daily activities = 5

  4. Body Weight

    Time frame: 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months)

    Total body weight was calculated in Kg.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

Comparison Between Endoscopic vs. Suction Calibration System on Number of Staple Load Firings, Operative Duration, Cost, and Gastro-esophageal Reflux Disease Following Laparoscopic Sleeve Gastrectomy: is There a Difference

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 7, 2019
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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