Table 4. Randomized Controlled Trials of Surgical Interventions

Study, Year Goal Sample Size (N), Race, Sex, and Age Co-Intervention Baseline BMIa
(mean kg/m2)
Duration Groups Weight Change Between-Group Difference P-value Patients Lost to Followup and Adverse Effects Trial Quality
de Wit et al., 2002100 L N: 50
Race: NR
Female: 68%
NR   1 yr ASBG:       Loss to followup: 2%

Surgical complications
Laparoscopic: 0%
Open: 16.7% (incisional hernias, migrating band)

Access port complications
Laparoscopic: 20%
Open: 21%

Mean hospital stay (days)
Laparoscopic: 7.8%
Open: 11.8%

Patients with readmission
Laparoscopic: 20%
Open: 29%

Fair
51.3 (laparoscopic) laparoscopic -35.0 kg -1.4 kg NS
49.7 (open) open -34.4 kg
Weiner et al., 2001102 L N: 101
Race: NR
Female: 85%
"Interdisciplinary obesity surgery program"     Placement of laparoscopic ASGB:          
49.5 (esophagogastric) 18 mos Esophagogastric Data in graph form: > 40 kg loss in both groups NR NS Loss to followup: 4%

Band slippage
Esophagogastric: 0%
Retrogastric: 2%

Pouch dilation
Esophagogastric: 0%
Retrograde: 6%

Esophageal dilation
Esophagogastric: 4%
Retrograde: 4%

Hunger at 18 mos
Esophagogastric: 2%
Retrograde: 4%

Dysphagia at 18 mos
Esophagogastric: 2%
Retrograde: 2%

Recurrent vomiting at 18 mo
Esophagogastric: 2%
Retrograde: 2%

Esophagitis at 18 mos
Esophagogastric: 2%
Retrograde: 2%

Fair
48.5 (retrogastric) Retrogastric  
Weiss et al., 2002101 L N: 52
Race: NR
Female: 90%
NR     Placement of laparoscopic ASGB: Median BMI        
42.5 (gastric) 23-24 mos Gastric -17.4 kg/m2 1.5 kg/m2 NS Loss to followup: NR
Mortality: NR
Conversion to open surgery
Gastric: 3.6%
Esophagogastric: 3.8%
Need for reoperation
Gastric: 10.7%
Esophagogastric: 19.2%
Heartburn at 2 yrs
Gastric: 11.1%
Esophagogastric: 14.3%
Dysphagia at 2 yrs
Gastric: 0%
Esophagogastric: 57.1%
Fair
41.8 (esophagogastric) Esophagogastric -18.9 kg/m2
    25% loss  
Gastric 100% 0%
Esophagogastric 100%
  Gain  
Gastric 0% 0%
Esophagogastric 0%

Notes: ASGB, adjustable silicone gastric banding; L, weight loss; NR, not reported.

aPresented as baseline mean or range unless otherwise noted.

Return to Document