Evidence map›Paper›PMID 39985715›Full record

ArticleObesity surgery2025

Flap Valve-Preserving Vertical Sleeve Gastrectomy (INNOVATE-VSG): Clinical Trial Study Protocol.

Ninh T Nguyen, Kishore M Gadde, Ravinder K Mittal

Abstract readClinical Trial Protocol
In one paragraph

Article in Obesity surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Ninh T NguyenUniversity of California, Irvine Medical Center, Orange, USA. ninhn@uci.edu.
Kishore M GaddeUniversity of California, Irvine Medical Center, Orange, USA.
Ravinder K MittalUniversity of California, San Diego, San Diego, USA.

Funding

Mechanistic and clinical outcomes of a surgical innovation aimed at minimizing GERD associated with vertical sleeve gastrectomy (INNOVATE-VSG)R01DK138047 · NIDDK · UNIVERSITY OF CALIFORNIA-IRVINE · PI RAVINDER K. MITTAL, NINH T NGUYEN · 2024 to 2026
$944k
NIDDK NIH HHS R01 DK138047
6 · The paper itself

Abstract

backgroundConventional vertical sleeve gastrectomy (cVSG), the most commonly performed bariatric surgery, is associated with low complications, durable weight loss, and significant improvement of many obesity-related comorbidities. However, numerous studies have reported that patients who underwent the cVSG have worsening or new onset (de novo) gastroesophageal reflux disease (GERD) which could be related to a negative effect of the operative procedure on the geometry of the gastroesophageal junction impacting on the function of the native gastroesophageal valve. It is imperative to innovate the cVSG procedure because chronic GERD is a debilitating condition associated with increased risk for Barrett's esophagus and esophageal cancer. INNOVATE-VSG aims to test whether a modified flap valve-preserving VSG (fvpVSG), compared to cVSG, will be associated with improvement of preexisting GERD.

methodsThe fvpVSG incorporates the following surgical modifications that strengthen the antireflux barrier: achieving 3 cm intrabdominal esophageal length; repair of the diaphragmatic crura; and preservation of 3 cm length of gastric fundus/cardia during the sleeve gastrectomy procedure which will be used to symmetrically wrap around the distal esophagus (120-160° wrap) to restore the naturally occurring gastroesophageal valve. A total of 44 obese patients (BMI 35-50 kg/m DISCUSSION: Data generated from the INNOVATE-VSG trial will be used to design a larger multi-center randomized clinical trial to confirm the value of preserving a functioning gastroesophageal valve following sleeve gastrectomy.

Indexed as

GastrectomyGastroesophageal RefluxObesity, MorbidSurgical FlapsAdultFemaleHumansMaleMiddle AgedOrgan Sparing TreatmentsRandomized Controlled Trials as TopicTreatment OutcomeWeight LossAntireflux barrierBariatric surgeryGastroesophageal reflux disease (GERD)Gastroesophageal valveSleeve gastrectomy

Identifiers

PMID39985715
PMCPMC11906530

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.