Evidence map›Paper›PMID 33001381›Full record

Trial reportObesity surgery2021

Randomized Prospective Clinical Study of Spatz3® Adjustable Intragastric Balloon Treatment with a Control Group: a Large-Scale Brazilian Experiment.

Ricardo José Fittipaldi-Fernandez, Idiberto José Zotarelli-Filho, Cristina Fajardo Diestel, Márcia Regina Simas Torres Klein, Marcelo Falcão de Santana, João Henrique Felicio de Lima, Fernando Santos Silva Bastos, Newton Teixeira Dos Santos

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Obesity surgery, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
2.7field-weighted citation impact, top 9% of its field
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

11 citing papers in PubMed, 19 citations in OpenAlex.

  1. Review
  2. Article
  3. Endoscopic tips for intragastric balloon use for obesity: what you need to know.VideoGIE : an official video journal of the American Society for Gastrointestinal Endoscopy · 2024
    Review
  4. Update on Endoscopic Treatments for Obesity.Current obesity reports · 2024
    Review
  5. Metabolic and Bariatric Endoscopy: A Mini-Review.Life (Basel, Switzerland) · 2023
    Review
  6. Article
  7. Progress in the study of intragastric occupancy device for weight reduction.Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2023
    Article
  8. Review
  9. Article
  10. Six intragastric balloons: Which to choose?World journal of gastrointestinal endoscopy · 2021
    Review
  11. Review
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

8 authors at 4 institutions in 1 country.

Ricardo José Fittipaldi-FernandezEndogastroRio Clinic, Rio de Janeiro, RJ, Brazil.
Idiberto José Zotarelli-FilhoFACERES - Faculty of Medicine , Sao Jose do Rio Preto, SP, Brazil. dr.idibertozotarelli@faceres.com.br.ORCID http://orcid.org/0000-0003-4328-1829
Cristina Fajardo DiestelDepartment of Applied Nutrition, Nutrition Institute, Rio de Janeiro State University, Rio de Janeiro, RJ, Brazil.
Márcia Regina Simas Torres KleinDepartment of Applied Nutrition, Nutrition Institute, Rio de Janeiro State University, Rio de Janeiro, RJ, Brazil.
Marcelo Falcão de SantanaIFEC-Instituto Falcão de Endoscopia e Cirurgia (Falcão Institute of Endoscopy and Surgery), Salvador, BA, Brazil.
João Henrique Felicio de LimaEndobatel-Digestive endoscopy, Universidade Federal do Paraná-UFPR (Federal University of Paraná), Curitiba, PR, Brazil.
Fernando Santos Silva BastosIFEC-Instituto Falcão de Endoscopia e Cirurgia (Falcão Institute of Endoscopy and Surgery), Salvador, BA, Brazil.
Newton Teixeira Dos SantosNT Santos Serviços médicos (NT Santos-Medical services), Rio de Janeiro, RJ, Brazil.
Escola Bahiana de Medicina e Saúde Pública · BRUniversidade do Estado do Rio de Janeiro · BRFaculdade Ceres · BRUniversidade Federal do Paraná · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo analyze the results regarding weight loss and complications related to the Spatz3® adjustable intragastric balloon (IGB) in Brazil.

methodsThis randomized prospective study covered patients who had undergone treatment using a Spatz3® adjustable IGB between October 2016 and June 2018 at a private clinic in Rio de Janeiro, Brazil. The patients had a minimum body mass index (BMI) of 27 kg/m

resultsOne hundred eighty patients underwent a Spatz3® balloon implant in the period. The patients were randomly divided into one group in which the Spatz balloon was kept at the same volume (600 mL) throughout treatment (Control Group), and another adjustment group with 250 mL greater volume. The complication rate was 16.14%. No death or major complication occurred during the study. Mean BMI decreased from 39.51 to 32.84 kg/m

conclusionThis study shows that Spatz3® IGB treatment is an effective procedure for weight reduction, with no mortality but higher morbidity compared with traditional IGBs. This procedure also enabled the balloon to stay in place for longer. The efficacy of upward adjustment still requires further confirmation.

Indexed as

Gastric BalloonObesity, MorbidBody Mass IndexBrazilHumansProspective StudiesTreatment OutcomeComplicationsIntragastric balloonObesityOverweightWeight loss

Identifiers

PMID33001381
OpenAlexW3090060483

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.