Lynn C
That about sums it up!!
May 15, 2008
2007 Report on Medscape
Table 1. Risk, Prevention, and Treatment of Postoperative Gastrointestinal and Nutritional Complications in Bariatric Patients
Complication Risk by Procedure Prevention Treatment LAGB RYGB BPD and DS Nutritional Vitamin deficiency Iron 0 ++ ++ Multivitamin with iron and vitamin C Ferrous sulfate 300 mg/d with vitamin C Vitamin B12 0 ++ + 1,000 μg/mo IM or 300-500 μg/d orally or nasal spray 500 μg/wk 1,000 μg/mo IM or 300-500 μg/d orally or 500 μg/wk nasal spray Folic acid 0 ++ ++ Folate 1 mg/d usually in multivitamin Folate 1 mg/d Fat-soluble vitamins A, D, E, K 0 + ++ Multivitamin, including at least 400 IU vitamin D Replace vitamin as indicated Thiamine 0 + ++ Multivitamin with thiamine 50 mg IV Mineral deficiency Calcium 0 + ++ 1,500 mg/d elemental calcium 1,500 mg/d elemental calcium Insufficient weight loss + 0 0 Obesity support group; dietary education Consider alternative bariatric operation Excessive weight loss 0 + ++ Dietary education; appropriate surgery Conduct dietary education; consider surgical revision Hepatobiliary Gallstones and sludge + ++ ++ Ursodeoxycholic acid 300 mg twice daily for 6 mo; consider elective cholecystectomy Conduct cholecystectomy Luminal Stomal ulceration 0 + + Avoid NSAIDs; consider prophylactic PPI (pouch must not be too large) Stop NSAIDs; prescribe PPI; conduct surgical revision Stomal stenosis 0 + + Surgical technique; prevent ulcers; avoid silastic band Conduct endoscopic dilation; remove silastic band; conduct surgical revision Band erosion + 0 0 Surgical technique Conduct surgical revision Staple line dehiscence 0 + 0 Surgical technique Conduct surgical revision Fistula 0 + + Surgical technique; prevent ulcers Treat endoscopically; consider surgical revision Internal hernia 0 + + Surgical technique Treat as surgical emergency Bile reflux 0 + 0 Roux limb must be long enough; rule out obstruction. Conduct surgical revision GI tract bleeding 0 + + Avoid NSAIDs Treat endoscopically; prescribe PPI Dumping syndrome 0 + + Small meals; dietary education Conduct dietary education; consider surgical reversal (rarely) GERD + 0 0 Choose correct procedure Prescribe PPI; conduct surgical revision Functional Vomiting ++ + + Small meals; prevent ulceration and stenosis Dilate stenosis endoscopically; conduct surgical revision; conduct dietary education Diarrhea 0 + ++ Appropriate diet Treat infection; rule out bacterial overgrowth; administer loperamide; consider surgical revision Bloating and flatulence 0 + ++ Consider small-bowel bacterial overgrowth Exclude and treat bacterial overgrowth; conduct dietary education BPD = biliopancreatic diversion; DS = duodenal switch; GERD = gastroesophageal reflux disease; GI = gastrointestinal; IM = intramuscular; IU = international units; IV = intravenous; LAGB = laparoscopic adjustable gastric band; NSAIDs = nonsteroidal anti-inflammatory drugs; PPI = proton pump inhibitor; RYGB = Roux-en-Y gastric bypass.
0, rare; +, occasional; ++, frequent.
Lap Band 12 year study
Feb 24, 2008
Obesity Surgery, 17, pp-pp
Background: This study examines 1,791 consecutive
laparoscopic adjustable gastric banding (LAGB) procedures
with up to 12 years follow-up. Long-term results
of LAGB with a high follow-up rate are not common.
Methods: Between September 1993 and December
2005, 1,791 consecutive patients (75.1% women, mean
age 38.7 years, mean weight 127.7 ± 24 kg, mean BMI
46.2 ± 7.7) underwent LAGB by the same surgical
team. Perigastric dissection was used in 77.8% of the
patients, while subsequently pars flaccida was used in
21.5% and a mixed approach in 0.8%. Data were analyzed
according to co-morbidities, conversion, shortand
long-term complications and weight loss.
Fluoroscopy-guided band adjustments were performed
and patients received intensive follow-up. The
effects of LAGB on life expectancy were measured in
a case/control study involving 821 surgically-treated
patients versus 821 treated by medical therapy.
Results: Most common baseline co-morbidities (%)
were hypertension (35.6), osteoarthritis (57.8), diabetes
(22), dyslipidemia (27.1), sleep apnea syndrome
(31.4), depression (21.2), sweet eating (22.5) and binge
eating (18.5). Conversion to open was 1.7%: due to
technical difficulties (1.2) and due to intraoperative
complications (0.5).Together with the re-positioning of
the band, additional surgery was performed in 11.9%
of the patients: hiatal hernia repair (2.4), cholecystectomy
(7.8) and other procedures (1.7). There was no
mortality. Reoperation was required in 106 patients
(5.9%): band removal 55 (3.7%), band repositioning 50
(2.7 %), and other 1 (0.05 %). Port-related complications
occurred in 200 patietns (11.2%). 41 patients
(2.3%) underwent further surgery due to unsatisfactory
results: removal of the band in 12 (0.7%), biliopancreatic
diversion in 5 (0.27%) and a biliopancreatic
diversion with gastric preservation (“bandinaro”) in 24
(1.3%). Weight in kg was 103.7 ± 21.6, 102.5 ± 22.5,
105.0 ± 23.6, 106.8 ± 24.3, 103.3 ± 26.2 and 101.4 ± 27.1
at 1, 3, 5, 7, 9, 11 years after LAGB. BMI at the same
intervals was 37.7 ± 7.1, 37.2 ± 7.2, 38.1 ± 7.6, 38.5 ±
7.9, 37.5 ± 8.5 and 37.7 ± 9.1. The case/control study
found a statistically significant difference in survival in
favor of the surgically-treated group.
Conclusions: LAGB can achieve effective, safe and
stable long-term weight loss. In experienced hands,
the complication rate is low. Follow-up is paramount.
Key words: Morbid obesity, laparoscopy, adjustable gastric
banding, intragastric balloon, bariatric surgery, longterm outcome
Introduction
Laparoscopic adjustable gastric banding (LAGB)
with the Lap-Band® is the most commonly performed
surgical procedure for morbid obesity in Europe, Australia and South America.1 Since FDA
approval in 2001, the Lap-Band® has ranked second
among all bariatric procedures performed in the U.S,1 and, to date, approximately 300,000 of these
procedures have been performed worldwide. Shortand medium-term series have found the band to be both safe and effective. However, a paucity of large long-term follow-up studies has created uncertainty
Laparoscopic Adjustable Gastric Banding in 1,791
Consecutive Obese Patients: 12-Year Results
Franco Favretti; Gianni Segato; David Ashton1; Luca Busetto2; Maurizio
De Luca; Marco Mazza2; Andrea Ceoloni; Oscar Banzato; Elisa Calo2;
Giuliano Enzi2
Department of Surgery, Regional Hospital - Vicenza, Italy (Director Franco Favretti); 2Obesity Unit,
Department of Medical and Surgical Sciences, University of Padua, Italy (Director Giuliano Enzi);
1The Healthier Weight Centre, Princess Grace Hospital, London, UK (Director David Ashton)
Presented at the 11th World Congress of the International
Federation for the Surgery of Obesity, Sydney, Australia,
September 1, 2006.
Correspondence to: Franco Favretti, MD, Contrà Chioare n. 13,
36100 Vicenza Italy. Fax: (+39) 0444 752482; e-mail: [email protected]
Favretti 1/17/07 4:13 PM Page 1
Property of Springer Media (Obesity Surgery). Not for posting, reproduction or distribution.
in some about the Lap-Band®’s efficacy over time.
This paper reports the long-term outcomes of a very large group of Lap-Band® patients.
Materials and Methods
From September 1993 through December 2005,
1,791 consecutive patients underwent LAGB surgery
for morbid obesity at our institutions (Obesity
Centers of Vicenza Regional Hospital and Padova
University) (Table 1). All operations were performed
by the same team of surgeons utilizing the
Lap-Band® (Inamed/Allergan), Santa Barbara, CA,
USA) and all patients met the eligibility criteria for bariatric surgery according to the NIH Consensus Conference Statement of 1991.2
Outcomes measured over 12 years included mortality,
complications, weight loss and resolution/improvement
of co-morbidities. Life expectancy was evaluated
in an adjunct study of LAGB vs medical therapy.
Preoperatively-recorded characteristics of 1,345
female (75.1%) and 446 male (24.9%) patients
were: mean age 38.7 ± 10.9 years, mean height 1.66
± 0.09 meters, mean weight 127.7 ± 24.3 kg, and
mean BMI 46.2 ± 7.7.
Baseline co-morbidities were present in 71% of
our patients: 57.8% suffered from osteoarthritis,
35.6% hypertension, 31.4% obstructive sleep apnea
syndrome (OSAS), 27.1% dyslipidemia, 22.0%
type II diabetes, 21.2% depression, 9.3% hyperuricemia,
8.7% gallstones, 4.9% amenorrhea, and
1.4% heart failure.
Out of 1,791 patients, 125 (7%) underwent preoperative
application of a Bioenterics Intragastric
Balloon (BIB) with the aim of reducing the surgical
risk. Their mean age was 44.8 ± 11.8 years, mean
height 1.68 ± 0.10 meters, mean weight 161.4 ±
30.1 kg and mean BMI 56.8 ± 9.1.
The perigastric dissection, as has been previously
described,3 was performed in 1,393 patients
(77.8%), the pars flaccida technique was subsequently used in 384 (21.5%) and the combined approach5 in 14 (0.8%). Table 1 shows the number
of operations performed per year. Patients were followed at 1, 3, 6, and 12 months postoperatively and yearly thereafter. All data concerning mortality, complications, reoperations, weight loss and co-morbidities were recorded during the follow-up visits. Band adjustments were performed with barium swallow under fluoroscopy. The co-morbilities were specifically investigated in 830 consecutive patients, consisting of 647 women (77.9%) and 183 men (22.1%), from September 1993 until November 2005.6 For this group of patients, a
complete cardiovascular risk factor profile was collected both before and 12 to 18 months after surgery (mean follow-up time: 15.3 ± 2.1 months). The effects of gastric banding surgery on life expectancy were measured in a case/control study of 821 patients from our Lap-Band® series com-
Favretti et al
2 Obesity Surgery, 17, 2007
Table 1. Number of operations per year and follow-up rate (mean follow-up: 91%)
Year No. of operations Total Follow-up No. of Patients Follow-up
Years Follow-up Rate
1993 4 4 12 4 100%
1994 18 22 11 22 100%
1995 59 81 10 74 91.3%
1996 129 210 9 188 89.5%
1997 130 340 8 311 91.4%
1998 143 483 7 415 85.9%
1999 168 651 6 588 90.3%
2000 192 843 5 765 90.7%
2001 133 976 4 895 91.7%
2002 143 1119 3 1001 89.4%
2003 201 1320 2 1198 90.7%
2004 198 1515 1 1381 90.9.1%
2005 273 1791 – – –
Favretti 1/17/07 4:13 PM Page 2
pared with 821 patients treated by medical therapy
in other Italian medical centers included in the
Multi-site Cohort of the Italian Study Group on
Morbid Obesity7 (Figure 1).
Results
The follow-up rate at 12 years was 91%. The conversion
rate was 1.7%, of which 1.2% was due to technical
problems such as difficult perigastric dissection
and giant left liver lobe hypertrophy, and 0.5% was
caused by intraoperative complications such gastric
perforation and bleeding. There was no surgical mortality
in our entire series of 1,791 patients.
The 125/1791 patients who had a BIB applied
preoperatively lost 24.7 ± 11.7 kg, 8.7 points of
BMI, and a %EWL of 27.9 ± 11.8 at time of Lap-
Band® placement. This group of patients showed the
same conversion and intraoperative complication rate as the rest of the series. Major complications requiring reoperation occurred in 106 patients (5.9%). These included stomach slippage and pouch dilatation in 70 patients (3.9%) (band removed in 20 patients – 1.1%, repositioned in 50 patients – 2.8%), erosion in 16 patients (0.9%) (band removed), psychological intolerance in 14 patients (0.7%) (band removed), miscellaneous (HIV, infection, mircroperforation) in 5 patients (0.27%) (band removed) and gastric necrosis in 1 (0.05%) patient (gastrectomy performed) (Table 2). If we exclude the 31 major complications of the learning curve period (first 100 patients), the complication rate is reduced to 4.4%. Of the 41 patients (2.3 %) with unsatisfactory results, the band was removed in 12 (0.7%). A classical biliopancreatic diversion (BPD) was performed in 5 (0.27%), and a BPD with gastric preservation (“bandinaro”) was done in 24 (1.3%) (Table 2). Minor complications requiring reoperation occurred at the port-site in 200 patients (11.2%). The port was substituted in 182 (10.2%), repositioned in 9 (0.5%) and removed in 9 (0.5%). These port issues, almost entirely related to the port-tubing transition, were more common early in our experience. With refinements to the placement technique and design improvements, these complications have been largely eliminated. Weight loss (kg, BMI, %EWL) for the entire series is shown in Table 3 and in Figures 2, 3 and 4. At 10 years, the average weight was 101.4 ± 27.1 kg (loss of 26.3 kg), the BMI 37.7 ± 9.1 (loss of 8.5 points) and the %EWL was 38.5 ± 27.9. Results of morbidly obese (BMI ²49) and superobese
(BMI ³50) were separated into two groups for
evaluation/comparison and weight loss in terms of kg and BMI is reported in Table 4 and shown in Figures 5 and 6. At 10 years the weight of the morbidly obese group was 94.6 ± 18.0 kg of the superobese group and was 123.2 ± 38.5 kg, indicating weight losses of 23.8 kg and 29.6 kg, respectively. At 10 years, the BMI in the morbidly obese group was 35.2 ± 5.4 and in the super-obese group was 44.9 ± 13.9, down 7.4 and 11.3 points, respectively. The %EWL in the morbidly and super-obese groups is reported in Table 5 and shown in Figure 7. At 10 years, %EWL was 40.3 ± 27.6 and 36.0 ± 30.2, respectively. The effect of LAGB was specifically analyzed in our first 830 consecutive patients. At baseline, the prevalence of diabetes was 11.2% (17.7% of men and 9.2% of women, P<0.05); 36.2% of the diabetic
patients had been treated with oral hypoglycemic drugs and the remainder with diet; none were on
Weight Loss by Laparoscopic Adjustable Gastric Banding
Obesity Surgery, 17, 2007 3
Figure 1. Case/Control Study involving 821 patients of
our Lap-Band® series and 821 patients treated by medical
therapy in other Italian Medical Centres. Matching and Selection of Patients in the Case Group and Control Group 4,640 Patients (BMI>40) in 6 Italian Medical Centers (1976-1996) Matching for Sex (M/F) Age (<40, 40-49, 50-59, 60-69, >70) and BMI (40-44, 45-49, 50+) 821 patients treated by Lap-Band®
821 patients treated by medical therapy
1,015 Patients treated by
Lap-Band® Obesity
Center of Padua (1994 al 2001) 1,388 patients treated after 1994 821 patients with BMI >40
Favretti 1/17/07 4:13 PM Page 3
insulin. Also preoperatively, ypercholesterolemia
was diagnosed in 53.9% of patients (48.4% in men
and 55.4% in women), low HDL-cholesterol in
13.1% (18.8% in men and 11.5% in women) and
hypertriglyceridemia in 19.4% (30.6% in men and
16.0% in women, P<0.01). The prevalence of hypertension
was 32.2% (45.9% in men and 27.9% in women, P<0.001), with 60.6% of hypertensive
patients being treated pharmacologically.6
Postoperatively, these co-morbidities resolved or
have been markedly improved.
The results of the case/control study on the life
expectancy after LAGB are shown in Figure 8.
Kaplan-Meier survival curves were calculated at 6
months and at 1, 2, 3 and 5 years, and differences in
survival between groups was evaluated by log-rank
test. The survival rate was significantly higher in the
LAGB group (P<0.0007). Relative risk of death
after adjustment for sex, age and BMI in the surgical group was 0.38 (95% CI: 0.17 – 0.85).7
The results of the case/control study showed
increased life expectancy after of the Lap-Band®, as
compared with medical treatment alone (Figure 8).
Discussion
True judgment of any bariatric procedure requires
sound data, not only with regard to the surgical technique
and its related mortality, morbidity and weight
loss, but also regarding the procedure’s impact on
baseline co-morbidities and life expectancy. Such
data can be provided only by studies that have a very
high follow-up rate extended over the long term.
Thus, it was our aim to provide a thorough analysis
of the Lap-Band® procedure by comprehensive longterm
data. A homogeneous series of 1,791 consecutive patients was treated by the same team and followed for up to 12 years. In addition, the impact of the band on life expectancy was analyzed by a con-
Favretti et al
4 Obesity Surgery, 17, 2007
Table 2. Major complications requiring reoperation (106/1791 patients; Sept. 1993-Dec. 2005)
Complications Number Rate of Reoperation Number Rate of
Complications Complications
Stomach Slippage 70 3.9% Removal 20 1.1%
+ Pouch Dilatation Repositioning 50 2.8%
Erosion 16 0.9% Removal 16 0.9%
Psychological 14 0.7% Removal 14 0.7%
Intolerance
Miscellaneous 5 0.27% Removal 5 0.27%
(HIV, Infections,
Microperforations)
Gastric Necrosis 1 0.05% Gastrectomy 1 0.05%
Total 106 5.9% Total 106 5.9%
Unsatisfactory 41 2.3% BPD 5 0.27%
Results Removal 12 0.7%
(Lack of Compliance) “BandInaro” 24 1.3%
Table 3. Weight loss (kg, BMI, %EWL) of the entire
series
Time Weight BMI %EWL*
0 127.7±24.3 46.2±7.7 ---
1 y 103.7±21.6 37.7±7.1 40.3±19.7
2 y 101.5±23.3 36.8±7.6 43.7±21.7
3 y 102.5±22.5 37.2±7.2 41.2±23.2
4 y 104.1±23.5 37.8±7.5 38.6±24.4
5 y 105.0±23.6 38.1±7.6 37.3±25.3
6 y 105.3±24.6 38.1±8.1 37.4±28.2
7 y 106.8±24.3 38.5±7.9 35.9±26.7
8 y 105.0±24.0 37.8±7.9 37.7±26.7
9 y 103.3±26.2 37.5±8.5 38.5±27.9
10 y 101.4±27.1 37.7±9.1 35.4±29.6
11 y 101.2±31.9 38.1±11.5 38.4±32.8
12 y 84.0±27.5 31.6±8.5 49.2±49.5
Values are mean ± SD. *Based on Metropolitan tables.
Favretti 1/17/07 4:13 PM Page 4
sistent case/control epidemiological study.
The 91% follow-up rate has allowed us to provide
reliable data regarding what actually happens to this
group of patients. It is well known in bariatric circles
that not all the patients accept the stipulated follow-
up plan. We were able to track most of our
patients using an aggressive approach that sometimes
involved the Registry Offices, the Health
Authorities and even the Police.
A mortality rate of 0 in 1,791 consecutive LAGB
patients attests to the benign nature of the surgery.
In addition, this standardized laparoscopic procedure
offered patients a low rate of major complications
requiring reoperation (only 5.9 %, including
the learning curve period).
Although most of the Lap-Bands® in the series
were placed using the perigastric dissection technique (77.8 %),3 we used the pars flaccida technique
(21.5 %)4 in the last 3 years and have utilized the
combined approach5 in only 0.8% of our cases. The
pars flaccida technique is the easiest to use and has been found to have drastically reduced the occurrence of certain complications.9-12 Lap-Band® surgeons
should be experienced in all three approaches to apply whichever is necessary according to the local anatomy and fat distribution. Of the major complications requiring reoperation (5.9%), stomach slippage with pouch dilatation accounts for 3.9%. In many cases, these complications share overlapping aspects and the same treatment: removal of the band in 20 (1.1%) and repositioning in 50 (2.8%) in our series. These data compare favorably with those reported in other series,12-
15 likely due to the fact that we were able to identify
and standardize the key points of the perigastric technique at a very early stage in our experience. Our low erosion rate of 0.9% is similar to that reported in other series.15,17-20 One of the most appealing aspects
of the LAGB is its total reversibility, which is important in cases of psychological intolerance of the prosthesis. In fact, 14 patients (0.8%) of our series required removal of the prosthesis. In case of unsatisfactory results, due mainly to the patient’s lack of compliance, we offer the patient a biliopancreatic diversion with gastric preservation (“bandinaro”).
8 This procedure was performed by laparoscopy
in 24 patients (1.3%), while the classic biliopancreatic diversion was done in 5 (0.27%). Removal of the band was requested by 12 patients (0.7%).
Weight Loss by Laparoscopic Adjustable Gastric Banding
Obesity Surgery, 17, 2007 5
0 20 40 60 80 100 120 140 160 180 200 0 1 y 2 y 3 y 4 y 5 y 6 y 7 y 8 y 9 y 10 y 11 y 12 y Figure 2. Weight loss (kg) of the entire series.
0
10
20
30
40
50
60
70
0 1 y 2 y 3 y 4 y 5 y 6 y 7 y 8 y 9 y 10 y 11 y 12 y
Figure 3. Weight loss (BMI) of the entire series.
0
10
20
30
40
50
60
70
0 1 y 2 y 3 y 4 y 5 y 6 y 7 y 8 y 9 y 10 y 11 y 12 y
Figure 4. Weight loss (%EWL) of the entire series.
1791
1381 1198 1001 895 765 588 415 311 188 74 22
4
1791
1381 1198 1001 895 765 588 415 311 188 74 22
4
BMI (kg/m2) Weight (kg)
1791
1381
1198 1001 895
765 588
415 311
188
74
22
4
%EWL
Favretti 1/17/07 4:13 PM Page 5
We considered minor complications requiring reoperation
to be those occurring at the port-site (11.2%).
In most cases (10.2%), a leak was detected and the
port was replaced. In a minority of patients, the port
had to be repositioned for pain (0.5%) or removed
because of infection (0.5%). Over the length of our
series, we used all four generations of access port provided
by the manufacturer (Inamed/Allergan), and
experience indicates that with the present “low profile”
port, the leakage rate has been greatly reduced.
The preoperative weight loss (24.7 ± 11.7 kg) produced
by the BioEnterics Intragastric Balloon (BIB)
in 125/1971 super-obese patients (BMI 56.8 ± 9.1)
was associated with the same conversion rate as the
remaining series and the same rate of intra-operative
complications as well. Preoperative weight loss to
reduce the surgical risk in super-obese candidates
for bariatric surgery is an established indication for
use of the BIB.21 This sequential therapy should be
considered in patients with extreme obesity. With regard to the weight loss curves (kg, BMI, %EWL) (Table 3, Figures 2, 3 and 4) for the entire series of 1791 patients, in the long term (i.e., at 10 years) the average weight had decreased 26.3 kg, BMI was down 8.5 points and %EWL was 38.5. The curves were stable over time, with no statisti-
Favretti et al
6 Obesity Surgery, 17, 2007
Table 4.Weight loss (kg, BMI) in morbidly obese and super-obese patients
Time Number of Patients Weight (kg) BMI (kg/m2)
MORBID SUPER MORBID SUPER MORBID SUPER
0 y 1307 484 118.4±16.9 152.8±23.7*** 42.6±4.3 56.2±5.8***
1 y 998 383 96.6±16.3 122.1±22.9*** 34.8±4.7 45.0±7.0***
2 y 862 336 95.3±20.2 117.4±23.4*** 34.3±6.2 43.3±7.3***
3 y 710 291 96.4±18.1 118.0±24.8*** 34.7±5.2 43.5±7.7***
4 y 642 253 97.7±18.7 120.3±26.6*** 35.2±5.4 44.3±8.1***
5 y 546 219 98.6±18.9 121.3±26.6*** 35.6±5.5 44.6±8.4***
6 y 417 171 98.6±19.4 122.3±28.0*** 35.4±5.8 44.9±9.1***
7 y 290 125 100.5±19.8 121.8±27.4*** 35.8±5.7 44.8±8.7***
8 y 227 84 99.0±19.1 122.0±28.1*** 35.4±5.6 44.5±9.4***
9 y 140 48 96.7±18.2 123.6±35.2*** 35.0±5.4 44.9±13.9***
10 y 56 18 94.6±18.0 123.2±38.5** 35.2±5.4 45.7±13.5***
11 y 17 5 92.1±20.3 137.7±48.9* 34.4±6.6 53.0±16.2**
12 y 4 0 84.0±27.5 – 31.6±8.5 –
Student’s t-test: *P<0.05; **P<0.01; ***P<0.001. Values are mean ± SD.
0
20
40
60
80
100
120
140
160
180
0y 1y 2y 3y 4y 5y 6y 7y 8y 9y 10y 11y 12y
Super Morbid
Figure 5. Weight loss (kg) in super and morbid obese
patients.
0
10
20
30
40
50
60
70
0y 1y 2y 3y 4y 5y 6y 7y 8y 9y 10y 11y 12y
Super Morbid
Figure 6. Weight loss (BMI) in super and morbid obese
patients.
484
383
336 291 253 219 171 125 84 48 18
5
1307
998 862 710 642 546 417 290 227 140 56 17
4
Weight (kg)
484
383
336 291 253 219 171 125 84 48 18
5
1307
998 862 710 642 546 417 290 227 140 56 17
4
BMI (kg/m2)
Favretti 1/17/07 4:13 PM Page 6
cally detectable rebound. Stable curves in the long
term were visible in the weight loss curves (kg,
BMI) of the morbidly obese and super-obese groups
(Table 4, Figures 5 and 6) where we observed a
weight loss of 23.8 and 29.6 kg, respectively at 10
years. The BMI was down 7.4 and 11.3 points in the
same time-span, respectively.
%EWL in the morbidly obese and in the superobese
(Table 5 and Figure 7) was 40.3 and 36.0,
respectively at 10 years. After the 4th year, there
was no statistical difference between the value of
the two curves and they tended to merge together.
The weight loss observed in morbidly obese
patients in the first 12 to 18 months after LAGB was
associated with clinically-significant improvements
in multiple cardiovascular risk factors. However,
only a low level of correlation was observed between
the degree of body weight reduction and the magnitude
of cardiovascular risk improvement. In particular,
a 10% to 11% weight loss appeared to be associated
with the maximal benefit in diabetic control,
with no further gain being derived from more pronounced
levels of body weight reduction.6,23
Weight Loss by Laparoscopic Adjustable Gastric Banding
Obesity Surgery, 17, 2007 7
Table 5.Weight loss (%EWL) in morbidly obese and super-obese patients Time Number of Patients Weight Loss %EWL*
MORBID SUPER MORBID SUPER MORBID SUPER
0 y 1307 484 --- --- --- ---
1 y 998 383 21.7±11.2 30.9±15.6*** 42.3±20.4 35.1±16.6***
2 y 862 336 23.2±15.5 34.4±16.9*** 45.2±25.5 39.8±18.5**
3 y 710 291 21.8±13.4 33.7±18.0*** 42.1±20.4 39.1±19.5*
4 y 642 253 20.5±13.5 31.0±19.2*** 39.6±25.5 36.2±21.0*
5 y 546 219 19.8±13.8 30.1±19.6*** 38.1±26.5 35.1±21.7
6 y 417 171 20.1±15.1 29.1±21.5*** 38.7±29.7 33.9±23.9*
7 y 290 125 18.7±13.5 29.0±20.4*** 36.6±27.8 34.0±23.9
8 y 227 84 19.9±13.9 28.7±20.5** 38.8±27.2 34.5±24.9
9 y 140 48 20.2±13.9 26.1±22.4 40.3±27.6 32.9±28.7
10 y 56 18 17.6±14.2 29.2±22.7 35.2±29.7 36.0±30.2
11 y 17 5 20.5±18.6 25.7±5.1 40.9±36.1 28.3±13.3
12 y 4 0 16.5±14.6 – 49.2±49.5 –
Student’s t-test: *P<0.05; **P<0.01; ***P<0.001. Values are mean ± SD. *based on the Metropolitan Tables.22
0
10
20
30
40
50
60
0y 1y 2y 3y 4y 5y 6y 7y 8y 9y 10y 11y 12y
Super Morbid
Figure 7. Weight loss (%EWL) in super and morbid
obese patients.
90
92.5
95
97.5
100
0.5 1 2 3 4 5
years
Survival
Figure 8. Life Expectancy in a Case/Control Study involving
821 patients of our Lap-Band® Series and 821
patients treated by medical therapy in other Italian Medical Centers.
484
383
336 291
253 219 171 125 84
48
18
5
LAGB non-LAGB
1307
998
862
710
642 546 417
290 227
140
56
17
4
%EWL
% Survival
Favretti 1/17/07 4:13 PM Page 7
Life Expectancy Study
Working together with Epidemiolgists and
Internists of the Multisites Cohort of the Italian
Study Group on Morbid Obesity, our group was
able to conduct a case/control study on the effect of
LAGB on life expectancy.
Of our patients, 821/1791were matched with 821
similar patients who received only medical treatment
(Figure 1). The 5-year survival in the LAGB-treated
group and in the medically-treated group is shown in
Figure 8, where a statistically significant difference in
survival is seen in favor of the surgically-treated
group, with a 60% reduction in total mortality.7
It has been uncommon to find reports of long-term
results with gastric banding. The fact that the band
was only introduced in 1993 would explain the lack
of long-term data. It is even less common to find studies
that provide the impact of a single bariatric operation
on the life expectancy of the patients. Thus, the
data presented here will enable comparison of the different
operations as bariatric surgery advances.
Conclusions
This study affirms that the LAGB is safe and effective
for the treatment of both morbidly obese and superobese
patients in the short, medium and long term. In
experienced hands, the complication rate is low and
stable weight loss to at least 12 years has occurred.
References
1. Buchwald H, Williams SE. Bariatric surery worldwide
2003. Obes Surg 2004; 14: 1157-64.
2. Gastrointestinal surgery for severe obesity. National
Institutes of Health Consensus Development Conference
Draft Statement. Obes Surg 1991; 1: 257-65.
3. Favretti F, Cadiére G, Segato G et al. Laparoscopic banding:
selection and technique in 830 patients. Obes Surg 2002:
12: 385-90.
4. Fielding G, Allen J. A step-by-step guide to placement of
the Lap-Band adjustable gastric banding system. Am J Surg
2002; 184 (Suppl): 26S-30S.
5. Weiner S, Engert R, Weiner S. Outcome after laparoscopic
adjustable gastric banding – 8 years experience. Obes Surg
2003; 13: 427-34.
6. Busetto L, Sergi G, Enzi G et al. Short term effects of
weight loss on the cardiovascular risk factors in morbidly
obese patients. Obes Res 2004; 12: 1-8.
7. Busetto L, Mazza M, Mirabelli D et al. Total mortality in
morbid obese patients treated with laparoscopic adjustable
gastric banding: a case-control study. Obes Metab 2006; 2
(Suppl): 365 (abst).
8. Cadiere GB, Favretti F, Himpens J et al. Anneau gastrique
et derivation bilio-pancreatique par laparoscopie. Le Journal
de Cielio-chirurgie 2001; 38: 32-5.
9. Fielding GA, Duncombe J. Clinical and radiological followup
of laparoscopic adjustable gastric bands, 1998 and 2000: A
comparison of two techniques. Obes Surg 2005; 15: 634-40.
10. O’Brien PE, Dixon JB, Laurie C et al. A prospective randomized
trial of placement of the laparoscopic adjustable
gastric band: comparison of the perigastric and pars flaccida
pathways. Obes Surg 2005’ 15: 820-6.
11. Dargent J. Pouch dilatation and slippage after adjustable
gastric banding: Is it still an issue? Obes Surg 2003; 13:
111-5.
12. Chevallier J-M, Zinzindohoue F, Douard R et al.
Complications after laparoscopic adjustable gastric banding
for morbid obesity: experience with 1,000 patients over 7
years. Obes Surg 2004; 14: 407-14.
13. Parikh MS, Fielding GA, Ren CJ. U.S. experience with 749
laparoscopic adjustable gastric bands: intermediate outcomes.
Surg Endosc 2005; 19: 1631-5.
14. Ponce J, Paynter S, Fromm R. Laparoscopic adjustable gastric
banding: 1,014 consecutive cases. J Am Coll Surg 2005;
201: 529-35.
15. O’Brien P, Dixon J. Weight loss and early and late complications
– the international experience. Am J Surg 2002;
184: 42S-45S.
16. Favretti F, Cadiere G, Segato G et al. Laparoscopic
adjustable silicone gastric banding (Lap-Band®): How to
avoid complications. Obes Surg 1997; 7: 352-8. 17. Niville E, Dams A, Van Der Speeten K et al. Results of lap rebanding procedures after Lap-Band removal for band erosion – a mid-term evaluation. Obes Surg 2005; 15: 630-3. 18. Dargent J. Surgical treatment of morbid obesity by adjustable gastric band: the case for a conservative strategy in the case of failure – a 9-year series. Obes Surg 2004; 14: 986-90. 19. Belachew M, Belva PH, Desaive C. Long-term results of laparoscopic adjustable gastric banding for the treatment of morbid obesity. Obes Surg 2002; 12: 564-8. 20. Angrisani L, Alkilani M, Basso N. Laparoscopic Italian experience with the Lap-Band®. Obes Surg 2001; 11: 307-10.
21. Busetto L, Segato G, De Luca M et al. Preoperative weight loss by intragastric balloon in super-obese patients treated with laparoscopic gastric banding: a case-control study. Obes Surg 2004; 14: 1-6. 22. Deitel M, Greenstein RJ. Recommendations for reporting weight loss. Obes Surg 2003; 13: 159-60. 23. Goldstein DJ. Beneficial health effects of modest weight loss. Int J Obes 1992; 16: 397-415.
(Received September 5, 2006; accepted December 16, 2006)
Favretti et al
8 Obesity Surgery, 17, 2007
10/21/06
Oct 21, 2006
So this is new
Oct 14, 2006
I would love to jump out of bed every day and look forward to hopping on the dreadmill but I just can't find that drive - I know without exercise my results are limited but still I can bring myself to be enthusiastic about it..Arrgggghh.
2/12/06
Feb 12, 2006
1/4/06
Jan 04, 2006
To fill or not to fill - that is the question....well not really the question is where the heck did my fill go? I am a victim of the disappearing fill. I received a 1.5 cc fill in November and was going in for my second fill today. When the doc got the needle in he was unable to pull any fluid from my band. Where does 1.2ccs go?? Inquiring minds want to know.
I have a feeling that my first fill was not a great success (rather then there being a problem with the band itseld) maybe this is wishful thinking but I am going to ride with it a while. I do feel different after this fill (I now have 1 cc for sure) than I did on the first one. Life is a learning experience but next time I go in I better have at least 1 cc in my band!!
On a happy note - I am officially down 59 lbs 34 of those since surgery. My B12 is fine now and my cholesterol has gone fro 207 to 196 (baby steps). Speaking of baby steps - time to throw my but on the treadmill, like it or not!! TTFN
12/12/05
Dec 12, 2005
Well it has been exactly 3 months since my surgery. I was feeling kinda down - didn't feel like I have lost much lately (gotta get another fill in 3 weeks) so I did my monthly measurements and pictures - now I can see it.
11/21/05
Nov 21, 2005
I haven't done a lot of self analyzing to this point but I read a good post this afternoon. "How do you change your eating habits". My response turned into a personal insight so I thought I would post it here rather than take over someone elses post. My thoughts:
Cool, I have been wondering the same thing lately. I have a 1.5 cc fill in my 4 cc band and I don't think that I have any restriction - I go back to the doc on 1/4/05 and told DH that I was going to get more fill even if I had to fight for it (I have a feeling that because I am losing at the rate that I should my doc will not want to give me an additional fill) But then I started asking myself - "what is restriction?"
I don't want to be so tight that I can't eat the thinks I like - chicken, tuna, bread occasionally. But I have this mind set that says I need "restriction" - maybe we should change that word - to me restriction means a physical inability to do something. I follow the rules - eat how and what I should - I only eat when I am hungry (depending on what I ate last that can be 2-4 hours between meals), I don't drink with or right after meals and I eat until I am full (about 1 - 1 1/2 cups of food). I am losing 1-2 lbs a week on average. Funny - sounds like I may have restriction?
I have had bad days where a bag of pita chips and hummus go down no problem. So I figure - oh well its not like I have restriction. Instead I should be saying "that was a bad choice - don't do it again just because you can". If I get tightened up to the point where I can't eat a bunch of pita chips and hummus chances are I won't be able to eat chicken at all and that is not what the band is about.
Everyone is right - the band is a wonderful tool (I am down a total of 55 lbs since preop and feel great) but I need to wrap my head around the fact that the band will not do it for me - and that has been the hardest part. Just because I can eat like I did before - doesn't mean I should. And the band isn't going to help with that unless it is to tight - thus taking away my ability to choose what I eat.
11/7/05
Nov 07, 2005
OK I'm 1 week shy of 2 months but I felt like taking pictures today so I have some new ones. I am starting to be able to see the loss now - My clothes don't fit any more. This is a size 22 top and my baggy 24 bottoms (I didn't fit into the bottoms 6 months ago) I have been wearing 26/28 's for so long that I forgot that I owned some of the stuff I'm wearing now.
