Author's Accepted Manuscript
Five-year weight loss in primary gastric bypass and revisional gastric bypass for failed adjustable gastric banding: Results of a Case-Matched Study Jérémie Thereaux M.D., Nicola Corigliano M.D., Ph. D., Christine Poitou M.D, Ph.D., Jean-Michel Oppert M.D., Ph.D., Sebastien Czernichow M.D., Ph.D., Jean-Luc Bouillot M.D. www.elsevier.com/locate/buildenv
PII: DOI: Reference:
S1550-7289(14)00236-6 http://dx.doi.org/10.1016/j.soard.2014.05.033 SOARD2031
To appear in:
Surgery for Obesity and Related Diseases
Cite this article as: Jérémie Thereaux M.D., Nicola Corigliano M.D., Ph.D., Christine Poitou M.D, Ph.D., Jean-Michel Oppert M.D., Ph.D., Sebastien Czernichow M.D., Ph. D., Jean-Luc Bouillot M.D., Five-year weight loss in primary gastric bypass and revisional gastric bypass for failed adjustable gastric banding: Results of a Case-Matched Study, Surgery for Obesity and Related Diseases, http://dx.doi.org/10.1016/j. soard.2014.05.033 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting galley proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Five-year weight loss in primary gastric bypass and revisional gastric bypass for failed adjustable gastric banding Results of a Case-Matched Study
Short Title: Mid term outcomes of revisional gastric by-pass.
Jérémie Thereaux, M.D., Nicola Corigliano, M.D., Ph.D., Christine Poitou, M.D, Ph.D., JeanMichel Oppert, M.D., Ph.D., Sebastien Czernichow, M.D., Ph.D., Jean-Luc Bouillot, M.D.
From the Department of General, Digestive and Metabolic Surgery (J.T., N.C., J.-L.B.), the Department of Nutrition (S.C.). Ambroise Paré University Hospital, Versailles Saint-Quentin University, Assistance Publique- Hôpitaux de Paris, 9, Avenue Charles de Gaulle, 92100 Boulogne, France.
From the Centre for Research in Epidemiology and Population Health (INSERM U1018) (S.C.), Paul Brousse Hospital, Villejuif, France.
From the Department of Nutrition (C.P., J.-M.O.), Pitié-Salpêtrière Hospital, Assistance Publique- Hôpitaux de Paris, Pierre-et-Marie-Curie-Paris 6 University, Human Nutrition
1
Research Center Île-de-France (CRNH IdF), Institute of cardiometabolic disease and nutrition (ICAN), 83, boulevard de l’Hôpital, 75013 Paris, France
Address reprint requests to Prof. Jean-Luc Bouillot at the Department of General, Digestive and Metabolic Surgery , Ambroise Paré University Hospital, Versailles Saint-Quentin University, Assistance Publique-Hôpitaux de Paris, 9, Avenue Charles de Gaulle, 92100 Boulogne-Billancourt, France, or at [email protected]
Acknowledgment section We would like to thank Alain Beauchet and Claire Carette for their participation in the elaboration of this study. Conflict of Interest Discosures: Jérémie Thereaux, Nicola Corigliano, Christine Poitou, JeanMichel Oppert, Sébastien Czernichow and Jean-Luc Bouillot have no conflicts of interest or financial ties to disclose. Funding/Support: None Previous Presentation: None
2
Background: Despite their now frequent use, the long-term results for adjustable gastric bands are variable and often less. Laparoscopic gastric bypass (LRYGB) provides good early results, and seems to be the revisional procedure of choice. Nevertheless, the long-term outcomes following revisonal LRYGB (rLRYGB) for failed adjustable gastric banding have not been compared with those for primary LRYGB (pLRYGB). Objective: To compare weight loss and changes in obesity related co-morbidities five years after pLRYGB and rLRYGB for failed adjustable gastric banding. Settings: The prospective database of a single surgery university center (Paris, France) was queried for clinical and other relevant data. Methods: From January 2004 to September 2008, 58 and 272 patients have undergone rLRYGB and pLRYGB. Rate of lost to follow-up was 13.3%. We matched 45 patients undergoing rLRYGB (case group) with 45 undergoing pLRYGB (control group) for age, sex and initial Body Mass Index (BMI). Results: Case and control groups did not differ for initial BMI (46.9±7.2 vs. 46.9±7.5 kg/m²; P=0.99), age (43.4±9.4 vs. 43.6±9.8y; P=0.91), or sex ratio (91.1% female, P=0.99). The rates of coexisting conditions in the two groups were similar. At 5 years, weight loss (kg) (39.9±16.4 vs. 31.4±15.8; P=0.02), percentage of weight loss (%) (30.8±9.8 vs. 24.8±11.5; P=0.03) and percentage of excess weight loss (%) (68.4±20.6 vs. 55.7 ±26.3; P=0.007) were higher for pLRYGB than rLRYGB. Rates of remission and improvement of coexisting conditions were similar. Conclusion: After 5 years of follow-up, pLRYGB provides greater weight loss than rLRYGB with similar rates of improvement and remission of coexisting conditions. Patients and surgeons should be aware of such results before primary and revisional bariatric surgery. KeyWords: bariatric surgery, gastric bypass, failed adjustable gastric banding, mid-term outcomes
3
Introduction
The prevalence of adult obesity, defined as a body mass index (BMI; weight in kilograms divided by the square of height in meters) exceeding 30 kg/m², is of increasing concern worldwide and especially in North America. The most recent report of the U.S. National Center for Health Statistics indicates that 34.4% of the U.S. and 24.1% of the Canadian populations are obese.1 There is convincing evidence suggesting that bariatric surgery performs better than conventional therapy both for decreasing the rate of coexisting conditions associated with morbid obesity and for attaining long-term loss of excess weight.2 Three procedures are currently in used for the treatment of morbid obesity: laparoscopic adjustable gastric banding (LAGB), laparoscopic gastric bypass (LRYGB) and, more recently introduced, laparoscopic sleeve gastrectomy (LSG). In Europe, LAGB was initially widely used because the initial associated morbidity and mortality are close to zero and it is straightforward to remove.
3,4
However, many studies have now reported variable and often less long-term results associated with high frequency of mechanical complications often leading to explantation.5 First approved by the US Food and Drug Administration in 2001, the frequency of LAGB procedures increased threefold between 2004 and 2007 in the US
6
and is now declining;7
consequently, it is likely that the number of conversions of LAGB into other bariatric procedures will increase sharply in next few years. Many studies have assessed the feasibility and early outcomes of LRYGB following failed LAGB.
8,9
However, these studies suffer from various limitations, including small
sample sizes, the absence of long term results and the absence of comparison with a primary
4
procedure. To the best of our knowledge, no study has compared long-term outcomes between pLRYGB and rLRYGB after failed adjustable gastric banding. We report a case-matched study assessing five year weight and comorbidity outcomes in obese patients undergoing pLRYGB or rLRYGB for failed adjustable gastric banding.
Methods
PATIENTS Since January 2004, all of our patients undergoing primary or revisional LRYGB have been prospectively included in an electronic database registered with the French national data protection agency (―Commission Nationale Informatique et Libertés‖, CNIL, #1689730). Patients were orally informed for studies participation at their hospital admission. The study has been approved by our local ethics committee. All procedures performed due to failure of sleeve gastrectomy, of loop gastric bypass (mini gastric bypass) or of vertical banded gastroplasty were excluded. We retrospectively reviewed the remaining cases and identified 279 patients (49 rLRYGB and 230 pLRYGB) with 5 years of follow-up available who were eligible for matching. Forty-five of the 49 patients who underwent rLRYGB (cases) were electronically matched on a one-to-one basis, with patients undergoing pLRYGB (controls; N=45) for sex, age (±2 years) and preoperative BMI (± 2kg/m²). Matching process was impossible for 4 rLRYGB because there was no control patient (pLRYGB) available to fit the matching criteria (Figure 1).
Each patient was evaluated pre-operatively for at least 6 months and followed-up post-operatively in the University Nutrition Department at Pitié-Salpêtrière Hospital, Paris, France. The indication for bariatric surgery was endorsed by a multidisciplinary team. 5
Bariatric surgery was offered to patients in accordance with French guidelines for bariatric surgery, which are similar to those of the US National Institutes of Health.10
Hypertension was defined as a blood pressure above 140 mmHg (systolic) and/or 90 mmHg (diastolic) or use of antihypertensive medication. Diabetes was defined as fasting blood glucose above 7 mmol/l on at least two different occasions or use of antidiabetic medication. Dyslipidemia was defined as a total cholesterol concentration above 5.7 mmol/l and/or a serum High Density Lipoprotein (HDL) level below 1.0 mmol/L and/or a triglyceride level above 1.7 mmol/l, or use of lipid-lowering medication. All subjects had a nocturnal polygraphy and were considered to have obstructive sleep apnea syndrome if the apnea– hypopnea index was >5 events/h, or if they were already being treated with nocturnal continuous positive-airway pressure. Joint pain and gastroesophageal reflux disease was clinically assessed.
SURGERY We have been using a standardized surgical technique for LRYGB since 2004. Gastric banding could be converted to LRYGB by a one-step or two-step procedure. In cases of LAGB conversion to LRYGB in a single-step procedure, systematic esophagogastric fibroscopy and upper gastrointestinal series were performed: the aim was to eliminate band erosion and esophagogastric dilation, which are incompatible to our opinion with band conversion in a single-step procedure. All bands were emptied two months before the revisional procedure. Most cases of two-step procedure involved patients referred to our department after band removal (mostly due to esophagogastric dilation and band slippage).
6
The stomach was initially divided beneath the first vessel of the lesser curve, using a linear stapler to create a proximal gastric pouch. The alimentary limb was created by dividing the jejunum 30-40 cm after Treitz’s angle and then bringing up in a transmesocolic retrogastric manner. Terminolateral gastrojejunal anastomosis was performed with a 25 mm circular stapler. The length of the alimentary limb (Roux limb) was determined according to the preoperative BMI, from 120 cm (BMI < 50 kg/m²) to 150 cm (BMI ≥ 50 kg/m²). In cases of prior LAGB, extensive adhesiolysis of the left upper quadrant was initially performed and the band was removed. The stomach was initially divided below the fibrosis and the rest of the procedure was as described above.
FOLLOW-UP AND OUTCOMES
All patients were required to attend follow-up consultations (one-day hospitalization for complete evaluation) at our University Nutrition Departments at one, 3 and 6 months and then every year after surgery. End points in the present study were 5-year follow-up data. Mean follow-up was 6.1±1.1 years. Remission of hypertension, dyslipidemia and obstructive sleep apnea syndrome were defined as normalization of the corresponding baseline characteristics without any drugs or use of a continuous positive-pressure airway machine. Remission of diabetes was defined as a Glycated Hemoglobin A1c (HBA1c) 60 days) mortality, our rate is similar to the rate of 0.75% from the LABS consortium study. 29
Currently, there is no clear consensus about what is the best bariatric procedure to be performed as a first line surgery. The literature suggests that LRYGB seems to be better to LAGB on the basis of long-term outcomes 2,30 and in recent randomized studies indicate that early outcomes seem to be similar after LSG and LRYGB.31 Hence, physicians may propose LRYGB, LAGB or laparoscopic sleeve gastrectomy for most common cases. There is a trend to tailor the procedure to the patient and choices are made on an individual case basis. Some physicians prefer to begin obesity management with a less risky procedure, such as LAGB; this allows subsequent conversion, in cases of weight loss failure, to a more aggressive procedure such as LRYGB or LSG. Some prefer to perform the most aggressive procedure first, such as LRYGB which has good long-term results, although a higher post-operative morbidity and mortality. Our study was not designed to answer the major question of which procedure to propose to which patient, initially. Our results emphasize that both patients and physicians should be aware that rLRYGB after failed adjustable gastric banding may result in lower long-term weight loss although the resolution of coexisting conditions appears similar to that with primary interventions. However, our results strongly confirm that LRYGB, as a
13
revisional procedure for failed gastric banding, allows good weight loss at 5 years and is a valuable alternative to rescue majority of patients with failed adjustable banding.
Conclusion
Although rLRYGB allows substantial 5-years weight loss leading to rescue a majority of patients, this study clearly indicates that pLRYGB results in better weight loss at five years compared to rLRYGB for failed adjustable gastric banding. In the era where bariatric procedures are tailored to patients needs, patients and physicians should be aware that revisional LRYGB after failed adjustable gastric banding could result in lower long-term weight loss, although rates of remission and improvement of coexisting conditions seem comparable.
14
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Sjostrom L, Lindroos AK, Peltonen M, et al. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med 2004; 351: 2683-93.
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Perathoner A, Zitt M, Lanthaler M, Pratschke J, Biebl M, Mittermair R. Long-term follow-up evaluation of revisional gastric bypass after failed adjustable gastric banding. Surg Endosc 2013; 27: 4305-12.
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Weber M, Muller MK, Bucher T, et al. Laparoscopic gastric bypass is superior to laparoscopic gastric banding for treatment of morbid obesity. Ann Surg 2004; 240: 975-82.
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Ortega E, Morinigo R, Flores L, et al. Predictive factors of excess body weight loss 1 year after laparoscopic bariatric surgery. Surg Endosc 2012; 26: 1744-50.
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Topart P, Becouarn G, Ritz P. One-year weight loss after primary or revisional Rouxen-Y gastric bypass for failed adjustable gastric banding. Surg Obes Relat Dis 2009; 5: 459-62.
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Jennings NA, Boyle M, Mahawar K, Balupuri S, Small PK. Revisional laparoscopic Roux-en-Y gastric bypass following failed laparoscopic adjustable gastric banding. Obes Surg 2013; 23: 947-52.
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Courcoulas AP, Christian NJ, Belle SH, et al. Weight change and health outcomes at 3 years after bariatric surgery among individuals with severe obesity. JAMA. 2013; 11: 2416-25.
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Weber M, Muller MK, Michel JM, et al. Laparoscopic Roux-en-Y gastric bypass, but not rebanding, should be proposed as rescue procedure for patients with failed laparoscopic gastric banding. Ann Surg 2003; 238: 827-33.
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Peterli R, Borbely Y, Kern B, et al. Early Results of the Swiss Multicentre Bypass Or Sleeve Study (SM-BOSS): A Prospective Randomized Trial Comparing Laparoscopic Sleeve Gastrectomy and Roux-en-Y Gastric Bypass. Ann Surg 2013; 258: 690-4.
19
Figure 1. Flow diagram for matching Legends: LRYGB=Laparoscopic Gastric Bypass. rLRYGB= Revisional Laparoscopic Gastric Bypass after failed adjustable gastric banding. pLRYGB= Primary Laparoscopic Gastric Bypass. January 2004 - September 2008 330 LRYGB (58 rLRYGB and 272 pLRYGB)
Not eligible for matching Lost to follow-up (N=44) (8 rLRYGB and 36 pLRYGB)
Death within five post-operative years (N=7) (1 rLRYGB and 6 pLRYGB)
Eligible for matching 49 rLRYGB (case group) 230 pLRYGB (control group)
Matching impossible N= 4 cases
Results of matching process 45 cases 45 control
20
0 -5
Weight Change (%)
-10 -15 57/58
-20
Primary LRYGB 54/58
53/58
50/58
52/58
49/58
-25 262/272
-30
252/272
LRYGB after failed adjustable gastric banding
230/272
256/272
235/272
245/272
-35 -40 -45 0
0,5 y
1y
2y
3y
4y
5y
Years of Follow-up
Figure 2. Weight Change after the Gastric Bypass Procedure over Five Years of Follow-up for the 330 Patients. Bars denote Standard-deviation LRYGB denote Laparoscopic Gastric Bypass
21
Table 1. Demographics and baseline health status characteristics of the patients at time of the gastric bypass procedure* Primary laparoscopic gastric bypass (N=45)
Laparoscopic gastric bypass after failed gastric banding (N=45)
P value‡
Characteristics
Female (%)
41 (91.1%)
41 (91.1%)
0.99
Age (years)
43.6±9.8 (25-63)
43.4±9.4 (24-63)
0.91
BMI at the time of gastric banding (kg/m²) †
NA
47.8±7.1 (37.1-66.6)
0.53∫
Weight (kg)
127.4±20.0 (96-197)
128.0±22.6 (96-187)
0.87
BMI (kg/m²) †
46.9±7.5 (35.3-65.8)
46.9±7.2 (35.3-65.3)
0.99
Maximal BMI (kg/m²) †
51.1±8.2 (38.1-77.5)
50.2±7.3 (38.1-65.7)
0.52
Hypertension
27 (60.0%)
23 (51.1%)
0.4
All
18 (40.0%)
10 (22.2%)
0.07
Use of insulin
7 (38.9%)
3 (30.0%)
0.70
19 (42.2%)
24 (53.3%)
0.29
Dyslipidemia
13 (28.9%)
11 (24.4%)
0.63
Joint pain
35 (77.8%)
37 (82.2%)
0.60
Gastroesophageal reflux disease
9 (20.0%)
12 (26.7%)
0.45
Diabetes
Obstructive sleep apnea syndrome
*Plus-minus values are means ±SD (range) or number (%), as appropriate. †Body-mass index. ‡ P values are for the comparison between the two groups. Values were calculated with paired two-sided Student’s t test or Chi-squared tests or Fisher’s exact tests as appropriate. ∫ Comparison with BMI at the time of LGBP for the primary gastric bypass group NA = not applicable
22
Table 2. Body weight status characteristics and remission or improvement of coexisting conditions of the patients 5 years after the gastric bypass procedure* Primary laparoscopic gastric bypass (N=45)
Laparoscopic gastric bypass after failed gastric banding (N=45)
P value‡
Weight (kg)
87.4±15.0 (61-133)
96.7±24.7 (49-175)
0.06
BMI (kg/m²) †
32.2±5.7 (21.1-48.9)
35.2±7.4 (22.7-55.2)
0.01
Weight loss (kg)
39.9±16.4 (12-92)
31.4±15.8 (-4-91)
0.02
% Weight loss (%)
30.8±9.8 (11.6-60.1)
24.8±11.5 (-2.7-52.9)
0.03
% Excess Weight Loss (%)
68.4±20.6 (27.5-113.9)
55.7±26.3 (-6.4 -112.5)
0.007
% Patients with Excess Weight Loss ≥ 50%
36 (80%)
23 (51%)
0.004
Hypertension ∫
24 (88.9%)
19 (82.6%)
0.69
Diabetes ∫
17 (94.4%)
10 (100%)
1.0
Obstructive sleep apnea ∫
19 (100%)
21 (87.5%)
0.24
Dyslipidemia ∫
13 (100%)
10 (90.1%)
0.46
Joint pain ∫
32 (91.4%)
32 (86.5%)
0.71
Gastroesophageal reflux disease ∫
6 (66.7%)
9 (75.0%)
1.0
Characteristics
*Plus-minus values are means ±SD (range) or number (%), as appropriate. †Body-mass index is the weight in kilograms. ‡ P values are for the comparison between the two groups. Values were calculated with Wilcoxon signed-rank tests, Chi squared tests or Fisher's exact tests as appropriate. ∫ Remission or improvement of the corresponding coexisting condition
23
Table 3. Body weight status characteristics of the patients 5 years after the gastric bypass procedure according to weight at time of the first bariatric procedure*
Primary laparoscopic gastric bypass (N=45)
Laparoscopic gastric bypass after failed gastric banding (N=45)‡
P value†
Weight loss (kg)
39.9±16.4 (12-92)
34.2±21.9 (-14-131)
0.11
% Weight loss (%)
30.8±9.8 (11.6-60.1)
25.9±13.5 (-10-61.8)
0.09
% Excess Weight Loss (%)
68.4±20.6 (27.5-113.9)
56.1±29.7 (-26.6-117.3)
0.02
% Patients with Excess Weight Loss ≥ 50%
36 (80%)
27 (60%)
0.04
Characteristics
*Plus-minus values are means ±SD (range) or number (%), as appropriate. † P values are for the comparison between the two groups. Values were calculated with Wilcoxon signed-rank tests or Chi square tests, as appropriate. ‡ Changes in weight according to weight at time of band implantation
24
Five-year weight loss in primary gastric bypass and revisional gastric bypass for failed adjustable gastric banding: Results of a Case-Matched Study Jérémie Thereaux M.D., Nicola Corigliano M.D., Ph. D., Christine Poitou M.D, Ph.D., Jean-Michel Oppert M.D., Ph.D., Sebastien Czernichow M.D., Ph.D., Jean-Luc Bouillot M.D. www.elsevier.com/locate/buildenv
PII: DOI: Reference:
S1550-7289(14)00236-6 http://dx.doi.org/10.1016/j.soard.2014.05.033 SOARD2031
To appear in:
Surgery for Obesity and Related Diseases
Cite this article as: Jérémie Thereaux M.D., Nicola Corigliano M.D., Ph.D., Christine Poitou M.D, Ph.D., Jean-Michel Oppert M.D., Ph.D., Sebastien Czernichow M.D., Ph. D., Jean-Luc Bouillot M.D., Five-year weight loss in primary gastric bypass and revisional gastric bypass for failed adjustable gastric banding: Results of a Case-Matched Study, Surgery for Obesity and Related Diseases, http://dx.doi.org/10.1016/j. soard.2014.05.033 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting galley proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Five-year weight loss in primary gastric bypass and revisional gastric bypass for failed adjustable gastric banding Results of a Case-Matched Study
Short Title: Mid term outcomes of revisional gastric by-pass.
Jérémie Thereaux, M.D., Nicola Corigliano, M.D., Ph.D., Christine Poitou, M.D, Ph.D., JeanMichel Oppert, M.D., Ph.D., Sebastien Czernichow, M.D., Ph.D., Jean-Luc Bouillot, M.D.
From the Department of General, Digestive and Metabolic Surgery (J.T., N.C., J.-L.B.), the Department of Nutrition (S.C.). Ambroise Paré University Hospital, Versailles Saint-Quentin University, Assistance Publique- Hôpitaux de Paris, 9, Avenue Charles de Gaulle, 92100 Boulogne, France.
From the Centre for Research in Epidemiology and Population Health (INSERM U1018) (S.C.), Paul Brousse Hospital, Villejuif, France.
From the Department of Nutrition (C.P., J.-M.O.), Pitié-Salpêtrière Hospital, Assistance Publique- Hôpitaux de Paris, Pierre-et-Marie-Curie-Paris 6 University, Human Nutrition
1
Research Center Île-de-France (CRNH IdF), Institute of cardiometabolic disease and nutrition (ICAN), 83, boulevard de l’Hôpital, 75013 Paris, France
Address reprint requests to Prof. Jean-Luc Bouillot at the Department of General, Digestive and Metabolic Surgery , Ambroise Paré University Hospital, Versailles Saint-Quentin University, Assistance Publique-Hôpitaux de Paris, 9, Avenue Charles de Gaulle, 92100 Boulogne-Billancourt, France, or at [email protected]
Acknowledgment section We would like to thank Alain Beauchet and Claire Carette for their participation in the elaboration of this study. Conflict of Interest Discosures: Jérémie Thereaux, Nicola Corigliano, Christine Poitou, JeanMichel Oppert, Sébastien Czernichow and Jean-Luc Bouillot have no conflicts of interest or financial ties to disclose. Funding/Support: None Previous Presentation: None
2
Background: Despite their now frequent use, the long-term results for adjustable gastric bands are variable and often less. Laparoscopic gastric bypass (LRYGB) provides good early results, and seems to be the revisional procedure of choice. Nevertheless, the long-term outcomes following revisonal LRYGB (rLRYGB) for failed adjustable gastric banding have not been compared with those for primary LRYGB (pLRYGB). Objective: To compare weight loss and changes in obesity related co-morbidities five years after pLRYGB and rLRYGB for failed adjustable gastric banding. Settings: The prospective database of a single surgery university center (Paris, France) was queried for clinical and other relevant data. Methods: From January 2004 to September 2008, 58 and 272 patients have undergone rLRYGB and pLRYGB. Rate of lost to follow-up was 13.3%. We matched 45 patients undergoing rLRYGB (case group) with 45 undergoing pLRYGB (control group) for age, sex and initial Body Mass Index (BMI). Results: Case and control groups did not differ for initial BMI (46.9±7.2 vs. 46.9±7.5 kg/m²; P=0.99), age (43.4±9.4 vs. 43.6±9.8y; P=0.91), or sex ratio (91.1% female, P=0.99). The rates of coexisting conditions in the two groups were similar. At 5 years, weight loss (kg) (39.9±16.4 vs. 31.4±15.8; P=0.02), percentage of weight loss (%) (30.8±9.8 vs. 24.8±11.5; P=0.03) and percentage of excess weight loss (%) (68.4±20.6 vs. 55.7 ±26.3; P=0.007) were higher for pLRYGB than rLRYGB. Rates of remission and improvement of coexisting conditions were similar. Conclusion: After 5 years of follow-up, pLRYGB provides greater weight loss than rLRYGB with similar rates of improvement and remission of coexisting conditions. Patients and surgeons should be aware of such results before primary and revisional bariatric surgery. KeyWords: bariatric surgery, gastric bypass, failed adjustable gastric banding, mid-term outcomes
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Introduction
The prevalence of adult obesity, defined as a body mass index (BMI; weight in kilograms divided by the square of height in meters) exceeding 30 kg/m², is of increasing concern worldwide and especially in North America. The most recent report of the U.S. National Center for Health Statistics indicates that 34.4% of the U.S. and 24.1% of the Canadian populations are obese.1 There is convincing evidence suggesting that bariatric surgery performs better than conventional therapy both for decreasing the rate of coexisting conditions associated with morbid obesity and for attaining long-term loss of excess weight.2 Three procedures are currently in used for the treatment of morbid obesity: laparoscopic adjustable gastric banding (LAGB), laparoscopic gastric bypass (LRYGB) and, more recently introduced, laparoscopic sleeve gastrectomy (LSG). In Europe, LAGB was initially widely used because the initial associated morbidity and mortality are close to zero and it is straightforward to remove.
3,4
However, many studies have now reported variable and often less long-term results associated with high frequency of mechanical complications often leading to explantation.5 First approved by the US Food and Drug Administration in 2001, the frequency of LAGB procedures increased threefold between 2004 and 2007 in the US
6
and is now declining;7
consequently, it is likely that the number of conversions of LAGB into other bariatric procedures will increase sharply in next few years. Many studies have assessed the feasibility and early outcomes of LRYGB following failed LAGB.
8,9
However, these studies suffer from various limitations, including small
sample sizes, the absence of long term results and the absence of comparison with a primary
4
procedure. To the best of our knowledge, no study has compared long-term outcomes between pLRYGB and rLRYGB after failed adjustable gastric banding. We report a case-matched study assessing five year weight and comorbidity outcomes in obese patients undergoing pLRYGB or rLRYGB for failed adjustable gastric banding.
Methods
PATIENTS Since January 2004, all of our patients undergoing primary or revisional LRYGB have been prospectively included in an electronic database registered with the French national data protection agency (―Commission Nationale Informatique et Libertés‖, CNIL, #1689730). Patients were orally informed for studies participation at their hospital admission. The study has been approved by our local ethics committee. All procedures performed due to failure of sleeve gastrectomy, of loop gastric bypass (mini gastric bypass) or of vertical banded gastroplasty were excluded. We retrospectively reviewed the remaining cases and identified 279 patients (49 rLRYGB and 230 pLRYGB) with 5 years of follow-up available who were eligible for matching. Forty-five of the 49 patients who underwent rLRYGB (cases) were electronically matched on a one-to-one basis, with patients undergoing pLRYGB (controls; N=45) for sex, age (±2 years) and preoperative BMI (± 2kg/m²). Matching process was impossible for 4 rLRYGB because there was no control patient (pLRYGB) available to fit the matching criteria (Figure 1).
Each patient was evaluated pre-operatively for at least 6 months and followed-up post-operatively in the University Nutrition Department at Pitié-Salpêtrière Hospital, Paris, France. The indication for bariatric surgery was endorsed by a multidisciplinary team. 5
Bariatric surgery was offered to patients in accordance with French guidelines for bariatric surgery, which are similar to those of the US National Institutes of Health.10
Hypertension was defined as a blood pressure above 140 mmHg (systolic) and/or 90 mmHg (diastolic) or use of antihypertensive medication. Diabetes was defined as fasting blood glucose above 7 mmol/l on at least two different occasions or use of antidiabetic medication. Dyslipidemia was defined as a total cholesterol concentration above 5.7 mmol/l and/or a serum High Density Lipoprotein (HDL) level below 1.0 mmol/L and/or a triglyceride level above 1.7 mmol/l, or use of lipid-lowering medication. All subjects had a nocturnal polygraphy and were considered to have obstructive sleep apnea syndrome if the apnea– hypopnea index was >5 events/h, or if they were already being treated with nocturnal continuous positive-airway pressure. Joint pain and gastroesophageal reflux disease was clinically assessed.
SURGERY We have been using a standardized surgical technique for LRYGB since 2004. Gastric banding could be converted to LRYGB by a one-step or two-step procedure. In cases of LAGB conversion to LRYGB in a single-step procedure, systematic esophagogastric fibroscopy and upper gastrointestinal series were performed: the aim was to eliminate band erosion and esophagogastric dilation, which are incompatible to our opinion with band conversion in a single-step procedure. All bands were emptied two months before the revisional procedure. Most cases of two-step procedure involved patients referred to our department after band removal (mostly due to esophagogastric dilation and band slippage).
6
The stomach was initially divided beneath the first vessel of the lesser curve, using a linear stapler to create a proximal gastric pouch. The alimentary limb was created by dividing the jejunum 30-40 cm after Treitz’s angle and then bringing up in a transmesocolic retrogastric manner. Terminolateral gastrojejunal anastomosis was performed with a 25 mm circular stapler. The length of the alimentary limb (Roux limb) was determined according to the preoperative BMI, from 120 cm (BMI < 50 kg/m²) to 150 cm (BMI ≥ 50 kg/m²). In cases of prior LAGB, extensive adhesiolysis of the left upper quadrant was initially performed and the band was removed. The stomach was initially divided below the fibrosis and the rest of the procedure was as described above.
FOLLOW-UP AND OUTCOMES
All patients were required to attend follow-up consultations (one-day hospitalization for complete evaluation) at our University Nutrition Departments at one, 3 and 6 months and then every year after surgery. End points in the present study were 5-year follow-up data. Mean follow-up was 6.1±1.1 years. Remission of hypertension, dyslipidemia and obstructive sleep apnea syndrome were defined as normalization of the corresponding baseline characteristics without any drugs or use of a continuous positive-pressure airway machine. Remission of diabetes was defined as a Glycated Hemoglobin A1c (HBA1c) 60 days) mortality, our rate is similar to the rate of 0.75% from the LABS consortium study. 29
Currently, there is no clear consensus about what is the best bariatric procedure to be performed as a first line surgery. The literature suggests that LRYGB seems to be better to LAGB on the basis of long-term outcomes 2,30 and in recent randomized studies indicate that early outcomes seem to be similar after LSG and LRYGB.31 Hence, physicians may propose LRYGB, LAGB or laparoscopic sleeve gastrectomy for most common cases. There is a trend to tailor the procedure to the patient and choices are made on an individual case basis. Some physicians prefer to begin obesity management with a less risky procedure, such as LAGB; this allows subsequent conversion, in cases of weight loss failure, to a more aggressive procedure such as LRYGB or LSG. Some prefer to perform the most aggressive procedure first, such as LRYGB which has good long-term results, although a higher post-operative morbidity and mortality. Our study was not designed to answer the major question of which procedure to propose to which patient, initially. Our results emphasize that both patients and physicians should be aware that rLRYGB after failed adjustable gastric banding may result in lower long-term weight loss although the resolution of coexisting conditions appears similar to that with primary interventions. However, our results strongly confirm that LRYGB, as a
13
revisional procedure for failed gastric banding, allows good weight loss at 5 years and is a valuable alternative to rescue majority of patients with failed adjustable banding.
Conclusion
Although rLRYGB allows substantial 5-years weight loss leading to rescue a majority of patients, this study clearly indicates that pLRYGB results in better weight loss at five years compared to rLRYGB for failed adjustable gastric banding. In the era where bariatric procedures are tailored to patients needs, patients and physicians should be aware that revisional LRYGB after failed adjustable gastric banding could result in lower long-term weight loss, although rates of remission and improvement of coexisting conditions seem comparable.
14
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Reinhold RB. Critical analysis of long term weight loss following gastric bypass. Surg Gynecol Obstet 1982; 155:385-94.
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Edholm D, Svensson F, Naslund I, Karlsson FA, Rask E, Sundbom M. Long-term results 11 years after primary gastric bypass in 384 patients. Surg Obes Relat Dis 2012; 9: 708-13.
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Attiah MA, Halpern CH, Balmuri U, et al. Durability of Roux-en-Y gastric bypass surgery: a meta-regression study. Ann Surg 2012; 256:251-54.
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Perathoner A, Zitt M, Lanthaler M, Pratschke J, Biebl M, Mittermair R. Long-term follow-up evaluation of revisional gastric bypass after failed adjustable gastric banding. Surg Endosc 2013; 27: 4305-12.
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Van Dessel E, Hubens G, Ruppert M, Balliu L, Weyler J, Vaneerdeweg W. Roux-enY gastric bypass as a re-do procedure for failed restricive gastric surgery. Surg Endosc 2008; 22: 1014-18.
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Weber M, Muller MK, Bucher T, et al. Laparoscopic gastric bypass is superior to laparoscopic gastric banding for treatment of morbid obesity. Ann Surg 2004; 240: 975-82.
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Rosenthal RJ, Diaz AA, Arvidsson D, et al. International Sleeve Gastrectomy Expert Panel Consensus Statement: best practice guidelines based on experience of >12,000 cases. Surg Obes Relat Dis 2012; 8: 8-19.
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Ortega E, Morinigo R, Flores L, et al. Predictive factors of excess body weight loss 1 year after laparoscopic bariatric surgery. Surg Endosc 2012; 26: 1744-50.
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Topart P, Becouarn G, Ritz P. One-year weight loss after primary or revisional Rouxen-Y gastric bypass for failed adjustable gastric banding. Surg Obes Relat Dis 2009; 5: 459-62.
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Jennings NA, Boyle M, Mahawar K, Balupuri S, Small PK. Revisional laparoscopic Roux-en-Y gastric bypass following failed laparoscopic adjustable gastric banding. Obes Surg 2013; 23: 947-52.
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Courcoulas AP, Christian NJ, Belle SH, et al. Weight change and health outcomes at 3 years after bariatric surgery among individuals with severe obesity. JAMA. 2013; 11: 2416-25.
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Weber M, Muller MK, Michel JM, et al. Laparoscopic Roux-en-Y gastric bypass, but not rebanding, should be proposed as rescue procedure for patients with failed laparoscopic gastric banding. Ann Surg 2003; 238: 827-33.
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Peterli R, Borbely Y, Kern B, et al. Early Results of the Swiss Multicentre Bypass Or Sleeve Study (SM-BOSS): A Prospective Randomized Trial Comparing Laparoscopic Sleeve Gastrectomy and Roux-en-Y Gastric Bypass. Ann Surg 2013; 258: 690-4.
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Figure 1. Flow diagram for matching Legends: LRYGB=Laparoscopic Gastric Bypass. rLRYGB= Revisional Laparoscopic Gastric Bypass after failed adjustable gastric banding. pLRYGB= Primary Laparoscopic Gastric Bypass. January 2004 - September 2008 330 LRYGB (58 rLRYGB and 272 pLRYGB)
Not eligible for matching Lost to follow-up (N=44) (8 rLRYGB and 36 pLRYGB)
Death within five post-operative years (N=7) (1 rLRYGB and 6 pLRYGB)
Eligible for matching 49 rLRYGB (case group) 230 pLRYGB (control group)
Matching impossible N= 4 cases
Results of matching process 45 cases 45 control
20
0 -5
Weight Change (%)
-10 -15 57/58
-20
Primary LRYGB 54/58
53/58
50/58
52/58
49/58
-25 262/272
-30
252/272
LRYGB after failed adjustable gastric banding
230/272
256/272
235/272
245/272
-35 -40 -45 0
0,5 y
1y
2y
3y
4y
5y
Years of Follow-up
Figure 2. Weight Change after the Gastric Bypass Procedure over Five Years of Follow-up for the 330 Patients. Bars denote Standard-deviation LRYGB denote Laparoscopic Gastric Bypass
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Table 1. Demographics and baseline health status characteristics of the patients at time of the gastric bypass procedure* Primary laparoscopic gastric bypass (N=45)
Laparoscopic gastric bypass after failed gastric banding (N=45)
P value‡
Characteristics
Female (%)
41 (91.1%)
41 (91.1%)
0.99
Age (years)
43.6±9.8 (25-63)
43.4±9.4 (24-63)
0.91
BMI at the time of gastric banding (kg/m²) †
NA
47.8±7.1 (37.1-66.6)
0.53∫
Weight (kg)
127.4±20.0 (96-197)
128.0±22.6 (96-187)
0.87
BMI (kg/m²) †
46.9±7.5 (35.3-65.8)
46.9±7.2 (35.3-65.3)
0.99
Maximal BMI (kg/m²) †
51.1±8.2 (38.1-77.5)
50.2±7.3 (38.1-65.7)
0.52
Hypertension
27 (60.0%)
23 (51.1%)
0.4
All
18 (40.0%)
10 (22.2%)
0.07
Use of insulin
7 (38.9%)
3 (30.0%)
0.70
19 (42.2%)
24 (53.3%)
0.29
Dyslipidemia
13 (28.9%)
11 (24.4%)
0.63
Joint pain
35 (77.8%)
37 (82.2%)
0.60
Gastroesophageal reflux disease
9 (20.0%)
12 (26.7%)
0.45
Diabetes
Obstructive sleep apnea syndrome
*Plus-minus values are means ±SD (range) or number (%), as appropriate. †Body-mass index. ‡ P values are for the comparison between the two groups. Values were calculated with paired two-sided Student’s t test or Chi-squared tests or Fisher’s exact tests as appropriate. ∫ Comparison with BMI at the time of LGBP for the primary gastric bypass group NA = not applicable
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Table 2. Body weight status characteristics and remission or improvement of coexisting conditions of the patients 5 years after the gastric bypass procedure* Primary laparoscopic gastric bypass (N=45)
Laparoscopic gastric bypass after failed gastric banding (N=45)
P value‡
Weight (kg)
87.4±15.0 (61-133)
96.7±24.7 (49-175)
0.06
BMI (kg/m²) †
32.2±5.7 (21.1-48.9)
35.2±7.4 (22.7-55.2)
0.01
Weight loss (kg)
39.9±16.4 (12-92)
31.4±15.8 (-4-91)
0.02
% Weight loss (%)
30.8±9.8 (11.6-60.1)
24.8±11.5 (-2.7-52.9)
0.03
% Excess Weight Loss (%)
68.4±20.6 (27.5-113.9)
55.7±26.3 (-6.4 -112.5)
0.007
% Patients with Excess Weight Loss ≥ 50%
36 (80%)
23 (51%)
0.004
Hypertension ∫
24 (88.9%)
19 (82.6%)
0.69
Diabetes ∫
17 (94.4%)
10 (100%)
1.0
Obstructive sleep apnea ∫
19 (100%)
21 (87.5%)
0.24
Dyslipidemia ∫
13 (100%)
10 (90.1%)
0.46
Joint pain ∫
32 (91.4%)
32 (86.5%)
0.71
Gastroesophageal reflux disease ∫
6 (66.7%)
9 (75.0%)
1.0
Characteristics
*Plus-minus values are means ±SD (range) or number (%), as appropriate. †Body-mass index is the weight in kilograms. ‡ P values are for the comparison between the two groups. Values were calculated with Wilcoxon signed-rank tests, Chi squared tests or Fisher's exact tests as appropriate. ∫ Remission or improvement of the corresponding coexisting condition
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Table 3. Body weight status characteristics of the patients 5 years after the gastric bypass procedure according to weight at time of the first bariatric procedure*
Primary laparoscopic gastric bypass (N=45)
Laparoscopic gastric bypass after failed gastric banding (N=45)‡
P value†
Weight loss (kg)
39.9±16.4 (12-92)
34.2±21.9 (-14-131)
0.11
% Weight loss (%)
30.8±9.8 (11.6-60.1)
25.9±13.5 (-10-61.8)
0.09
% Excess Weight Loss (%)
68.4±20.6 (27.5-113.9)
56.1±29.7 (-26.6-117.3)
0.02
% Patients with Excess Weight Loss ≥ 50%
36 (80%)
27 (60%)
0.04
Characteristics
*Plus-minus values are means ±SD (range) or number (%), as appropriate. † P values are for the comparison between the two groups. Values were calculated with Wilcoxon signed-rank tests or Chi square tests, as appropriate. ‡ Changes in weight according to weight at time of band implantation
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