Banded Versus Nonbanded Sleeve Gastrectomy

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.

Table 1. Development of Type 2 Diabetes, Antihypertensive Medication Use, and Reflux Esophagitis At 3 Years in Relation to Baseline, Incidence of Vitamin Deficiencies Following Banded and Nonbanded Sleeve Gastrectomy
Category	Banded Sleeve Gastrectomy (n = 47)	Sleeve Gastrectomy (n = 47)	Chi Square, P
Type 2 diabetes
Comorbidity present at baseline	11	6	0.18
Remission, no. (% of base.)	10 (90.9)	4 (66.7)	0.21
Improvement, no. (% of base.)	1 (9.1)	2 (33.3)
Unchanged, no. (% of base.)	0	0
Worsened, no. (% of base.)	0	0
HbA1c at baseline, mean (95% CI)	6.8 (5.9–7.7)	7.3 (6.1–8.5)	1.0*
HbA1c 3 y, mean (95% CI)	5.9 (5.0–6.8)	5.9 (4.7–7.0)	1.0*
Antihypertensive medication use
Medication use at baseline	25	16	0.06
Stopped, no. (% of base.)	16 (64.0)	7 (43.8)	0.32
Lowered, no. (% of base.)	7 (28.0)	6 (37.5)
Unchanged, no. (% of base.)	1 (4.0)	2 (12.5)
Increased, no (% of base.)	0	1 (6.25)
Lost to follow-up, no.	1	0
Reflux esophagitis
Comorbidity present at baseline	11 (23.4)	6 (12.8)	0.18
Remission, no. (% of base.)	4 (36.4)	4 (66.7)	0.15
Improvement, no. (% of base.)	2 (18.2)	0
Unchanged, no. (% of base.)	3 (27.3)	0
Worsened, no. (% of base.)	0	1 (16.7)
Lost to follow-up, no.	2	1
De novo esophagitis, no. (%^†)	5 (20.8^†)	10 (30.3^†)	0.42
Vitamin deficiency (ref. interval)
Vitamin D3 (50–174.7 nmol/L)
baseline, no. (% of n)	8 (20.0; n = 40)	7 (18.4; n = 38)	0.86
3 years, no. (% of n)	11 (32.4; n = 34)	14 (37.8; n = 37)	0.63
Vitamin B1 (89–225.3 nmol/L)
baseline, no. (% of n)	0 (n = 40)	0 (n = 38)
3 years, no. (% of n)	0 (n = 31)	0 (n = 34)
Vitamin B12 (145.3–568.8 pmol/L)
Baseline, no. (% of n)	1 (2.5; n = 40)	0 (n = 38)	0.34
3 y, no. (% of n)	1 (2.9; n = 34)	1 (2.7; n = 37)	0.95
Folic acid (10.4–42.4 nmol/L)
Baseline, no. (% of n)	1 (2.5; n = 40)	4 (10.5; n = 38)	0.15
3 y, No. (% of n)	5 (15.6; n = 32)	11 (30.6; n = 36)	0.15

Table 1. Development of Type 2 Diabetes, Antihypertensive Medication Use, and Reflux Esophagitis At 3 Years in Relation to Baseline, Incidence of Vitamin Deficiencies Following Banded and Nonbanded Sleeve Gastrectomy

Characteristic	Banded Sleeve Gastrectomy (n = 47)	Sleeve Gastrectomy (n = 47)
Age, y, mean (95% CI)	43.3 (40.6–46)	40.9 (38.2–43.5)
Female, No. (%)	35 (74.5)	31 (66)
Weight, mean (95% CI), kg	147 (139.2–154.8)	147.5 (139.1–155.9)
BMI, mean (CI), kg/m²	51 (49.1–53)	50.7 (48.8–52.6)
Type 2 diabetes, no. (%)	11 (23.4%)	6 (12.8%)
Hypertension, no. (%)	26 (53.3)	20 (42.6%)
Gastroesophageal reflux complaint ≥1/wk, No. (%)	7 (14.9)	7 (14.9)
Hiatal hernia	9 (19.1)	6 (12.8)
Refluxesophagitis, no (%)	11 (23.4)	6 (12.8)

Complication and Category	Banded Sleeve Gastrectomy (n = 45)	Sleeve Gastrectomy (n = 46)	Chi Square, P
Minor early (≤30 days), no. (%)
Bleeding	0	1/47 (2.1)
Total	0	1 (2.1)	0.31
Minor late (>30 days), no. (%)
Regurgitation ≥1/wk	6 (13.3)	2 (4.3)
Gastroesophageal reflux RSI >13	3 (6.5)	4 (8.7)
Sleeve stenosis	0	1 (2.2)
Symptomatic cholelithiasis	2 (4.4)	2 (4.3)
Total	10 (22.2)	9 (19.6)	0.76
Major late (>30 days), No. (%)
Ring slippage	1 (2.2)	0
Gastroesophageal reflux with conversion to RYGB	2 (4.4)	1 (2.2)
Incisional hernia	0	1 (2.2)
Total	3 (6.6)	2 (4.3)	0.63

Banded Versus Nonbanded Sleeve Gastrectomy

A Randomized Controlled Trial With 3 Years of Follow-up

Abstract and Introduction

Abstract

Introduction

Tables

Tables

Tables

References

Authors and Disclosures

Authors and Disclosures

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