Centro per lo Studio, la Ricerca
E la Terapia dell’Obesità
C.S.R.T.O.
Direttore: dott. Pietro Pizzi
Policlinico di Monza. Via Amati 111. 20052 Monza
E-mail: [email protected]
[email protected]
XXICONGRESSO NAZIONALE
S.I.C.O.B.
Società Italiana di Chirurgia dell’Obesità e
Malattie Metaboliche
CAGLIARI - 25-27 APRILE 2013
Policlinico di Monza. Via Amati 111. 20052 Monza
E-mail: [email protected]
[email protected]
BMI-EWL trends, short and long-term slippages in
patients operated with the new-HAGA LAGB(Heliogast
System) for morbid obesity, according to four different
techniques. Definitive results (follow-up 48 months)in a
pilot prospective randomized study.
P.Pizzi*, A:Alberti*, G.De Lorenzis**, M.Pizzi*
* Centro per lo Studio, la Ricerca e la Terapia dell’Obesità (C.S.R.T.O.). Policlinico di Monza
** Centro dell’Obesità. Casa di Cura Città di Parma
Centro per lo Studio, la Ricerca e la Terapia dell’Obesità. C.S.R.T.O. Direttore dott. P.Pizzi
XVII Congresso S.I.C.O.B. – Roma 2009
BMI-EWL trends, short and long-term complications in
154 patients operated with the new-HAGA
LAGB(Heliogast System) for morbid obesity, according to
four different techniques. A pilot prospective
randomized study.
P.Pizzi*, A:Alberti*, D.Lochis*, G.De Lorenzis**, G.Mari***, M.Pizzi***
* Centro per lo Studio, la Ricerca e la Terapia dell’Obesità (C.S.R.T.O.). Policlinico di Monza
** Centro dell’Obesità. Casa di Cura Città di Parma
*** Università degli Studi di Milano
Centro per lo Studio, la Ricerca e la Terapia dell’Obesità. C.S.R.T.O. Direttore dott. P.Pizzi
Methods 1
154 patients enrolled were randomly assigned to four groups
according to the different surgical techniques:
1.“pars flaccida tech” with anterior fixation
pts. 38
2.“pars flaccida tech” without anterior fixation
pts. 39
3.“two-steps perigastric tech” with anterior fixation
pts. 39
4. “two-steps perigastric tech” without anterior fixation pts. 38
5
Centro per lo Studio, la Ricerca e la Terapia dell’Obesità. C.S.R.T.O. Direttore dott. P.Pizzi
Methods 2
Long-term study
(24 months)
Long-term study
(48 months)
132 consecutive patients operated
with the new-HAGA LAGB
(Heliogast Sustem)
120 consecutive patients operated
with the new-HAGA LAGB
(Heliogast Sustem)
Between September 2008 to
Mars 2009
Between September 2008 to
Mars 2009
Centro per lo Studio, la Ricerca e la Terapia dell’Obesità.
C.S.R.T.O. Direttore dott. P. Pizzi
Results 1
Preliminary study
Long-term study
(24 months)
154 pts. 27:127 = M:F
132 pts. 17:115 = M:F
Mean age
Mean age
38.7 M (18-53)
38.6 M (18-53)
40.3 F (16-66)
40.2 F (16-66)
International HAGA results : 6658 pts.
39.3 M (16-68)
41.2 F (16-71)
Centro per lo Studio, la Ricerca e la Terapia dell’Obesità.
C.S.R.T.O. Direttore dott. P. Pizzi
Results 2
Long-term study
(36 months December 2011)
Long-term study
(48 months December 2012)
128 pts. 15:113 = M:F
120 pts. 12:108 = M:F
Mean age
Mean age
38.4 M (18-53)
38.2 M (18-53)
40.1 F (16-66)
40.2 F (16-66)
Centro per lo Studio, la Ricerca e la Terapia dell’Obesità.
C.S.R.T.O. Direttore dott. P. Pizzi
Results 3
Preliminary study
Long-term study
(24 months December 2010)
154 pts. 27:127 = M:F
132 pts. 17:115 = M:F
Mean BMI
Mean BMI
44.6 M
30.7 M
42.1 F
29.2 F
International HAGA results : 6011 pts.
43.2 M
42.9 F
Centro per lo Studio, la Ricerca e la Terapia dell’Obesità.
C.S.R.T.O. Direttore dott. P. Pizzi
Results 4
Long-term study
(36 months December 2011)
128 pts. 15:113 = M:F
Long-term study
(48 months December 2012)
120 pts. 15:113 = M:F
Mean BMI
Mean BMI
30.6 M
30.4 M
28.8 F
28.9 F
International HAGA results : 6658 pts.
32.4 M
29.6 F
Internetional HAGA results: 8254 pts.
32.5 M
29.5 F
Centro per lo Studio, la Ricerca e la Terapia dell’Obesità.
C.S.R.T.O. Direttore dott. P. Pizzi
Results 5
Preliminary study
(6 months)
Long-term study
(18 months)
154 pts. 27:127 = M:F
147 pts. 24:123 = M:F
Mean EWL evaluation at 3 months
on 107 pts.
17.3 M : 18.1 F
Mean EWL evaluation at 12 months
on 147 pts
41.6 M : 46.9 F
International HAGA results : 6235 pts.
17.1 M
17.8 F
International HAGA results : 6328 pts.
42.1 M
45.6 F
Mean EWL evaluation at 6 months
on 39 pts.
27.7 M : 31.3 F
Mean EWL evaluation at 18 months
on 147 pts.
49.3 M : 54.5 F
International HAGA results : 6011 pts:
27.0 M
29.0 F
International HAGA results: 6500 pts.
48.5 M
53.8 F
Centro per lo Studio, la Ricerca e la Terapia dell’Obesità.
C.S.R.T.O. Direttore dott. P. Pizzi
Results 6
Long-term study
(24 months December 2010)
Long-term study
(48 months December 2012)
132 pts. 17:115 = M:F
128 pts. 15:113 = M:F
Mean EWL evaluation at 12 months
on 147 pts
41.6 M : 46.9 F
Mean EWL evaluation at 36 months
on 128 pts
49.7 M : 54.9 F
International HAGA results : 6328 pts.
42.1 M
45.6 F
International HAGA results : 6658 pts.
49.1 M
53.9 F
Mean EWL evaluation at 24 months
on 132 pts.
49.8 M : 54.7 F
Mean EWL evaluation at 48 months
on 120 pts.
49.7 M : 54.9 F
International HAGA results: 6658 pts.
42.1 M
45.6 F
International HAGA results: 8254 pts.
49.0 M
53.8 F
Results 7
Long-term study (24 months)
132 pts. 17:115 = M:F
Long-term study
(24 months December 2010)
Slippage
1° pt. (F): “pars flaccida” technique
without anterior fixation
3 pts. Female
1° pt.: 8 months after surgery
2° pt.: 9 months after surgery
3° pt.:20 months after surgery
2° pt. (F): “two-steps perigastric”
technique
without
anterior
fixation
1 pt. Male
4° pt.:15 months after surgery
Centro per lo Studio, la Ricerca e la Terapia dell’Obesità.
C.S.R.T.O. Direttore dott. P. Pizzi
3° pt. (F): “pars flaccida” technique
without anterior fixation
4° pt. (M): “two-steps perigastric”
technique
without
anterior
fixation
Results 8
1° pt. (F): slippage 8 months after
surgery
2° pt. (F): slippage 9 months after
surgery
September 2008: band placement
BMI 41.7
December 2008: band placement
BMI 43.6
May 2009: slippage with gastric
obstruction (BMI 30.1) and
band re-placement
September 2009: slippage with
subtotal gastric obstruction (BMI
33.8) and band re-placement
October 2009: new slippage without
gastric obstruction (BMI 34.5)
and indication for RYGBP
December 2010 (BMI 26.9)
Centro per lo Studio, la Ricerca e la Terapia dell’Obesità.
C.S.R.T.O. Direttore dott. P. Pizzi
Results 9
3° pt. (F): slippage 20 months after
surgery
4° pt. (M): slippage 15 months after
surgery
January 2009:
BMI 44.3
Mars 2009:
BMI 42.9
band placement
band
placement
September 2010: slippage with
subtotal gastric obstruction (BMI
27.2) and band re-placement
June 2010: slippage with subtotal
gastric obstruction (BMI 26.8)
and band re-placement
December 2010 (BMI 26.7)
December 2010 (BMI 26.5)
Centro per lo Studio, la Ricerca e la Terapia dell’Obesità.
C.S.R.T.O. Direttore dott. P. Pizzi
Conclusions 1
Preliminary study
(6 months)
Long-term study
(24 months December 2010)
In our study the new-HAGA LAGB
(Heliogast System) for morbid
obesity is a safe and well
reproducible procedure for all
the four different techniques we
used.
132 pts. 17:115 = M:F
In all groups we found an efficacy in
the BMI and EWL trends at 3 and
6 months.
Our results were similar or even
better than the International
HAGA LAGB results.
Centro per lo Studio, la Ricerca e la Terapia dell’Obesità.
C.S.R.T.O. Direttore dott. P. Pizzi
3 pts. Female and 1 pt. Male with
complications (slippage)
1° pt.(F): 8 months after surgery
2° pt.(F): 9 months after surgery
3° pt.(F):20 months after surgery
4°pt.(M):15 months after surgery
Conclusions 2
Long-term study
(24 months December 2010)
Long-term study
(24 months)
From Mars 2009 to December 2010
we operated of new-HAGA LAGB
(Heliogast System) 528 patients:
From Mars 2009 to December 2010
we operated of new-HAGA LAGB
(Heliogast System) 528 patients:
all patients with anterior
fixation.
513
pts.
with
“pars
flaccida”technique and anterior
fixation
15 pts. with “two-steps perigastric”
technique and anterior fixation
Centro per lo Studio, la Ricerca e la Terapia dell’Obesità.
C.S.R.T.O. Direttore dott. P. Pizzi
NO SLIPPAGES
extra study group
Conclusions 3
Long-term study
(24 months December 2010)
From
September
2008
to
December 2010 we operated with
the new-HAGA LAGB (Heliogast
System) 682 patients for morbid
obesity
4 pts. (study group of 154 pts.)
with slippages (all pts. without
anterior fixation).
Long-term study
(36 months December 2011)
128 pts 15:113 = M:F
From September 2008 to December
2011 we operated with the newHAGA LAGB (Heliogast System)
912 patients for morbid obesity.
8 pts. (study group of 154 pts.) with
slippages (1 pt. with anterior
fixation and 7 pts. without
anterior fixation).
3
pts. (extra study group of 154
pts.) with slippages ( all with
anterior fixation and old HAGA).
Conclusions 4
Long-term study slippages
(24 months December 2010)
Long-term study slippages
(36 months December 2011)
132 pts. 17:115 = M:F
128 pts. 15:113 = M:F
3 pts. Female and 1 pt. Male with
complications (slippage)
December 2010
4 pts. (3 F, 1 M) without anterior
fixation
1° pt.(F): 8 months after surgery
2° pt.(F): 9 months after surgery
3° pt.(F):20 months after surgery
4°pt.(M):15 months after surgery
December 2011
1 pts. (M) with anterior fixation
3 pts ( 2M, 1F) without anterior
fixation
Centro per lo Studio, la Ricerca e la Terapia dell’Obesità.
C.S.R.T.O. Direttore dott. P. Pizzi
Conclusions 5
Long-term study slippages
(36 months December 2011)
128 pts. 15:113 = M:F
4 pts. Female and 4 pt. Male with
complications (slippage)
1° pt.(F): 8 months after surgery
2° pt.(F): 9 months after surgery
3° pt.(M):15 months after surgery
4°pt.(F):20 months after surgery
5° pt.(M):22 months after surgery
6° pt.(M):23 months after surgery
7° pt. (F): 29 months after surgery
8° pt.(M):31 months after surgery
Centro per lo Studio, la Ricerca e la Terapia dell’Obesità.
C.S.R.T.O. Direttore dott. P. Pizzi
Long-term study slippages
(48 months December 2012)
120 pts. 12:108 = M:F
From September 2008 to December
2012 we operated with the newHAGA LAGB (Heliogast System)
1193 patients for morbid obesity.
2 pt. Female with complications
(slippage, all without anterior
fixation and “pars flaccida”
technique)
Conclusions 6
Long-term study slippages
(48 months December 2012)
Long-term study slippages
(48 months December 2012)
120 pts. 12:108 = M:F
From September 2008 to December
2012 we operated with the newHAGA LAGB (Heliogast System)
1193 patients for morbid obesity.
120 pts. 12:108 = M:F
2 pt. Female with complications
(slippage, all without anterior
fixation and “pars flaccida”
technique)
Centro per lo Studio, la Ricerca e la Terapia dell’Obesità.
C.S.R.T.O. Direttore dott. P. Pizzi
10 slippages
9 pts. without anterior fixation
1 pt. with anterior fixation
Conclusions 7
From October 2010 we utilize an stitch under new-HAGA
between the gastric greater curvature, gastric body and
lesser gastric curvature.
We feel that this technique decrease the number of
slippages.
We performed a randomized study in 100 patients
operated with the new-HAGA (Heliogast System) LAGB for
morbid obesity with “pars flaccida” technique, all without
anterior fixation: 50 pts. with stitch and 50 pts. without
stitch under band.
A longer follow-up will give us the chance to evaluate the
incidence of slippages.
Conclusions 8
Possible causes of slippage
•Patient’s compliance missing
•Gastric banding structure
•Gastric banding with anterior fixation
•Gastric banding without anterior fixation
•Gastric pouch to big
•Etcetera !!!!!!!!
Centro per lo Studio, la Ricerca
E la Terapia dell’Obesità
C.S.R.T.O.
Direttore: dott. Pietro Pizzi
Policlinico di Monza. Via Amati 111. 20052 Monza
E-mail: [email protected]
[email protected]