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Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated With VSG (INNOVATE-VSG)

ConditionsObesityBariatric SurgerySleeve GastrectomyGastroesophageal Reflux Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of California, Irvine

About this trial

This is a two-site randomized clinical trial aiming to test whether a modified investigational bariatric surgical procedure can improve gastroesophageal reflux disease (GERD) after sleeve gastrectomy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female subjects aged 18-65 years

Body mass index (BMI) 35-55 kg/m2

Must meet the BMI criteria before and after 6 months of nonsurgical weight management

Presence of GERD defined for this trial as acid exposure time (AET) of 4.9% or above as assessed with the Bravo pH test.

Disqualifiers

Hiatal hernia >2cm (defined as maximum axial height from end of the esophagus to diaphragm by any study including upper endoscopy esophagram and or at the time of surgery)

Evidence of clinically significant major esophageal motility disorder as determined by the site primary investigator

Severe gastroparesis

Previous bariatric or anti-reflux procedure

Trial design

Design model

Parallel

Treatments tested in this trial

  • Modified Vertical Sleeve Gastrectomy (mVSG)

    Procedure/Surgery

    The modified procedure preserves the gastric sling fibers and re-establishes the gastroesophageal flap valve (GEFV).

  • Conventional Vertical Sleeve Gastrectomy (cVSG)

    Procedure/Surgery

    Vertical Sleeve Gastrectomy as standard procedure

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Modified Vertical Sleeve Gastrectomy (mVSG)Experimental treatment 1 intervention
Group B: Conventional Vertical Sleeve Gastrectomy (cVSG)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

% Acid Exposure Time (%AET)

Change in %AET in percentage points at Month 6-9 relative to pre-surgery %AET assessed with the Bravo pH test

Time frame
Pre-surgery, Month 6-9 post surgery

Secondary outcomes

1

LES pressure

Change in LES pressure in millimeters of mercury (mmHg) assessed with High Resolution Esophageal Manometry (HREM)

Time frame
Pre-surgery, Month 6-9 post surgery
2

Intragastric pressure

Change in intragastric pressure in millimeters of mercury (mmHg) assessed with HREM

Time frame
Pre-surgery, Month 6-9 post surgery
3

LES compliance

Change in LES compliance in ratio of mm3/mmHg assessed with EndoFLIP

Time frame
Pre-surgery, Month 6-9 post surgery
4

GEFV length

Change in GEFV length in millimeters (mm) assessed with endoscopic exam

Time frame
Pre-surgery, Month 6-9 post surgery

Other outcomes

1

GERD-HRQL score

Change in GERD-HRQL score assessed with GERD-HRQL questionnaire

Time frame
Pre-surgery, Months 4, 6-9, 12 post surgery
2

Health-related quality of life

Change in SF-36 score assessed with SF-36 questionnaire

Time frame
Pre-surgery, Months 4, 6-9, 12 post surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Irvine

Lead sponsor

University of California, San Diego

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
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