Banded Versus Nonbanded Sleeve Gastrectomy

A Randomized Controlled Trial With 3 Years of Follow-up

Jodok M. Fink, MD; Andrea Hetzenecker, MD; Gabriel Seifert, MD; Mira Runkel, MD; Claudia Laessle, MD; Stefan Fichtner-Feigl, MD; Goran Marjanovic, MD

Disclosures

Annals of Surgery. 2020;272(5):690-695. 

In This Article

Abstract and Introduction

Abstract

Objective: The aim of this study was to compare silicone-banded sleeve gastrectomy (BSG) to nonbanded sleeve gastrectomy (SG) regarding weight loss, obesity-related comorbidities, and complications.

Summary Background Data: As a primary bariatric procedure, SG leads to excellent weight loss, yet weight regain is a relevant issue in mid- to long-term follow-up. Retrospective analyses suggest that banding a sleeve using a silicone ring may decrease weight regain and improve weight loss.

Methods: The banded versus nonbanded sleeve gastrectomy single-center, randomized controlled trial was conducted from January 2015 to August 2019. The primary endpoint was defined as excess weight loss 3 years after surgery. Secondary endpoints included the surgery's impact on obesity-related comorbidities, quality of life, and complications. The study was registered under DRKS00007729.

Results: Among 94 patients randomized, 97% completed 3-year follow-up. Mean initial body mass index was 50.9 kg/m2 [95% confidence interval (CI), 49.6–52.2]. Mean adjusted excess weight loss 3 years after SG amounted to 62.3% (95% CI, 56.2–68.5) and 73.9% ( 95% CI, 67.8–80.0) after BSG (difference 11.6%, P = 0.0073). Remission of type 2 diabetes occurred in 66.7% (4/6) after SG and in 91.0% (10/11) following BSG (P = 0.21). Three years after surgery, ring implantation correlated with decreased frequency of symptomatic reflux episodes (P = 0.01) but increased frequency of regurgitation (P = 0.03). The rate of major complications was not different between the study groups (BSG, n = 3; SG, n = 2; P = 0.63). Quality of life was better following BSG (P = 0.001).

Conclusions: BSG provided better weight loss than nonbanded SG 3 years after surgery. Regurgitation was the main clinically relevant negative effect after BSG.

Introduction

Sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) are the most frequently performed bariatric operations.[1] Although both procedures are highly efficient, inadequate weight loss and weight regain are found in a considerable number of patients.[2,3] In recent years, focus of bariatric surgery has shifted away from weight loss toward metabolic surgery.[4] However, weight loss is a key objective for patients seeking bariatric surgery and correlates with the desired metabolic outcome.[5,6] Hence, improving weight loss and limiting weight regain must remain an essential objective.

With this rationale, nonadjustable silicone rings were placed around the pouch of an RYGB.[7] Meta-analyses comparing banded to nonbanded RYGB show a characteristic weight-loss -pattern: similar weight loss in short term follow-up, improved weight loss for banded RYGB in long-term follow-up.[8,9]

With the same rationale, a silicone ring banded sleeve gastrectomy (BSG) was implemented in 2009.[10] Indeed, studies comparing BSG to SG reveal superior weight loss for BSG in mid-term follow-up.[11–13] However, these reports rely on retrospective patient cohorts only.

The purpose of this prospective randomized trial was to compare BSG to SG analyzing weight loss, complications, and resolution of obesity-related comorbidities.

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