Review Article

Gastric Electrical Stimulation with the Enterra System: A Systematic Review

Table 2

Study characteristics.

StudyFollow-upMeasureOutcome at 12 months (unless otherwise stated)

Forster et al., 2001 [9]12 MSymptomsSignificant improvement in N and V
GENo significant improvement

Abell et al., 2002 [10]3 MSymptomsMVF: 21 to 0; MNF: 21 to 2
GENo significant improvement
12 MSymptomsWVF down to average 90%; WNF: 28 to 1
GENo significant improvement reported
MedicationSignificant decrease in use of AE/PK; patients requiring none rose 5 to 14

Abell et al., 2003 [22] 2 MSymptomsWVF in combined group (all patients) significantly reduced
12 MSymptomsWNF down to 64% baseline in combined group
GE78% to 56% 2-hour retention of ILM (); 46% to 16% 4-hour retention of ILM ()
Quality of lifePCS: 25.8 to 32.4; MCS: 36.1 to 45.1 (combined group)
Nutrition9 out of 14 discontinued nutrition

Abell et al., 2003 [26] 60 MSymptomsMean TSS scores: 35.6 to 16.6; at 60 M TSS score mean at 20.3 (), WVS: 3.9 to 1.4 ()
Quality of lifeOverall score increased by mean 2.1 points by 60 M

Forster et al., 2003 [27] 12 MSymptomsTSS severity mean: 20 to 9.1; frequency mean: 21 to 10
Quality of lifeMCS: 37 to 48; PCS: 24 to 33
GENo change
BMIBMI and body weight increased significantly

Lin et al., 2004 [23] 12 MSymptomsTSS severity mean: 17.6 to 7.9; frequency mean: 18.5 to 8.9 ()
GENo significant change (significance seen at 6 M)
Quality of lifeMCS: 36.9 to 46; PCS: 23.8 to 33.5 ()
Days in hospitalMean hospital stay reduced by 52 days compared to the prior year

McCallum et al., 2005 [17] 12 MSymptomsTSS severity: 17.1 to 8.6; frequency: 19.2 to 9.89 ()
GENo significant change
Quality of lifePCS: 28.6 to 37.7; MCS: 39.7 to 49.6 ()
Days in hospitalReduced by a mean of 25 days compared to the prior year

van der Voort et al., 2005 [18] 12 MSymptomsWVF: 26 to 4; WNF: 34 to 12 ()
GE2-hour retention of ILM: 83 to 25%; 4-hour retention of ILM: 38 to 17% ()

Lin et al., 2005 [24] 12 MSymptomsOn PK: TSS: 18.1 to 7.4; off PK: TSS: 17 to 2.6
On AE: TSS: 19.1 to 9.9; off AE: TSS: 17.7 to 5
Quality of lifeOn medication at follow-up: PCS: 21.3 to 33.8; MCS: 36.4 to 50.2
Days in hospital50 to 14.9 patients had no admissions
MedicationPatients requiring PK reduced from 27 to 19; patients requiring AE reduced from 26 to 17

Mason et al., 2005 [33]20 MSymptomsNo significance reported
GERate of emptying: 0.17% to 0.38% per minute ()

Lin et al., 2006 [25] 36 MSymptomsTSS: 21 to 6 ()
Days in hospital31 to 5 ()
MedicationMedication use significantly reduced
NutritionPatients requiring nutrition reduced from 15 to 8 ()

Anand et al., 2007 [28] 48 MSymptomsTSS: 15.6 to 10.9; WVF down to 62%; WNF down to 59%, by 4 years
GE2-hour retention of ILM: 55 to 42%; 4-hour retention of ILM: 26 to 17% by 4 Y
SurvivalNo significant differences in survival
Quality of lifeIDIOMS score from 16.3 to 10.6 ()

Lin et al., 2008 [12] 12 MSymptomsTSS decreased from 19.9 to 9.1 ()
GE2-hour ILM retention: 73% to 63%; 4-hour retention from 46% to 34% (); N and V correlate with GE

McKenna et al., 2008 [15] 9.5 MSymptomsTSS: 17.1 to 7.7; DG: 16.9 to 5.6 ()
GENo significant change reported
Quality of lifeNo significant change

Brody et al., 2008 [13]12 MSymptomsTSS severity: 19.05 to 14.05; frequency: 20.39 to 15.71
GE2-hour retention of ILM: 66% to 50% ()

McCallum et al., 2010 [16] 3 MSymptomsNo significant findings
12 MSymptomsWVF: 19.5 to 4.25; TSS frequency: 18.74 to 11.95; severity: 17.08 to 10.69
GE2-hour retention: 76.5 to 51%; 4-hour retention of ILM: 46.5 to 20.5%
Quality of lifeMCS: 29.53 to 36.43; PCS: 33.53 to 40.35
Days in hospital40 to 10

McCallum et al., 2011 [29]56 MSymptomsTSS: 19.4 to 9.2; DG: 19.8 to 8.7; IG: 18.6 to 9.7; PSG: 19.1 to 10.9 at 56 M
GE2-hour retention: 70 to 66%; 4-hour retention of ILM: 37 to 30% at 56 M

O’Loughlin et al., 2013 [30]14 MSymptomsTotal GCSI from 13.4 to 6.6
GECorrelation between GCSI and preoperative gastric emptying
MedicationSignificance not reported

McCallum et al., 2013 [19] 12 MSymptomsWVF and TSS reduction between ON and OFF not significant
TSS frequency score from 21.74 ± 1.75 to 13 ± 7.92;
TSS severity score from 18.75 ± 6.34 to 10.26 ± 7.09;
TSS reduction for epigastric pain and burning not significant
GE2 hr ILM retention reduction from 63.5% to 49% (); 4 hr ILM reduction from 26% to 16.5% ()
Median from 2 to 0 ()
Days in hospital26.96 to 24.74 ()
BMIPCS from 32.66 ± 8.8 to 37.86 ± 13.28 (); MCS: 34.11 ± 11.67 to 41.27 ± 12.29 (); PF, VT
Quality of lifeSF, MH, and RP

Ross et al., 2014 [32]6 MQuality of lifeImprovement in overall GSRS score,
Median MHC score from 29.15 to 46.6,
Median PHC score from 28.5 to 31.1,

Brody et al., 2015 [14]12 MSymptomsTSS functional from 3.2 ± 0.6 to 2.4 ± 0.8;
TSS pain from 2.8 ± 0.8 to 2.1 ± 0.8;

DG: diabeticgastroparesis; IG: idiopathicgastroparesis; PSG: postsurgicalgastroparesis; CTG: connective tissue disorder.