Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT01475903 |
| Other study ID # |
CHU-0093 |
| Secondary ID |
2010-A00406-33 |
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
April 18, 2011 |
| Last updated |
November 17, 2011 |
| Start date |
November 2011 |
| Est. completion date |
May 2015 |
Study information
| Verified date |
November 2011 |
| Source |
University Hospital, Clermont-Ferrand |
| Contact |
Patrick LACARIN |
| Phone |
04 73 75 11 95 |
| Email |
placarin[@]chu-clermontferrand.fr |
| Is FDA regulated |
No |
| Health authority |
France: Ministry of Health |
| Study type |
Observational
|
Clinical Trial Summary
Bariatric surgery is now recognized as a procedure of choice for the treatment of morbid
obesity, resulting in long-term effectiveness on weight loss and comorbidities. The two
types of procedures, most often performed in Europe, are adjustable gastric banding (AGB), a
purely restrictive reversible procedure, and gastric bypass (GBP), an irreversible
procedure, which associates restriction and mild malabsorption. Longitudinal sleeve
gastrectomy (LSG) is another bariatric procedure which tends to develop quickly. More
recent, this technique is recognized in France by the High Authority of Health since 2008,
consisting of fundus and greater curvature resection, removing 75 % the gastric volume,
leaving a narrow gastric tube or "sleeve".
Although malabsorption does not occur in most bariatric procedures, micronutrient
deficiencies are possible. GBP is known to induce nutritional and vitamin deficiencies
concerning iron, calcium, vitamins B12, B9, D and proteins. Restrictive procedures have
minor effects on normal physiological digestive processes but could lead to vitamin
deficiency secondary to decreased nutrient intake and a tendency towards avoidance of
certain types of food due to intolerance. Studies of nutritional complications of bariatric
surgery concern essentially AGB, GBP and vertical banded gastroplasty (VBG) which is no
longer performed in France. The nutritional impact of LSG remains to be evaluated. To date,
data concerning evaluation of nutritional status from patients who underwent LSG are almost
non-existent. Considering this type of surgical procedure, the investigators expect to
observe essentially a deficiency in vitamin B12 and iron. Indeed, defined as a purely
restrictive intervention, LSG consists of gastric fundus resection which is the site of
intrinsic factor production, itself necessary for vitamin B12 absorption. Moreover, decrease
of hydrochloric acid production and potential vomiting caused by gastric resection can alter
iron absorption.
In view of the increasing popularity of this surgical technique, assessment of the
nutritional consequences of longitudinal sleeve gastrectomy seems to be necessary.
Description:
Bariatric surgery is now recognized as a procedure of choice for the treatment of morbid
obesity, resulting in long-term effectiveness on weight loss and comorbidities. The two
types of procedures, most often performed in Europe, are adjustable gastric banding (AGB), a
purely restrictive reversible procedure, and gastric bypass (GBP), an irreversible
procedure, which associates restriction and mild malabsorption. Longitudinal sleeve
gastrectomy (LSG) is another bariatric procedure which tends to develop quickly. More
recent, this technique is recognized in France by the High Authority of Health since 2008,
consisting of fundus and greater curvature resection, removing 75 % the gastric volume,
leaving a narrow gastric tube or "sleeve".
Although malabsorption does not occur in most bariatric procedures, micronutrient
deficiencies are possible. GBP is known to induce nutritional and vitamin deficiencies
concerning iron, calcium, vitamins B12, B9, D and proteins. Restrictive procedures have
minor effects on normal physiological digestive processes but could lead to vitamin
deficiency secondary to decreased nutrient intake and a tendency towards avoidance of
certain types of food due to intolerance. Studies of nutritional complications of bariatric
surgery concern essentially AGB, GBP and vertical banded gastroplasty (VBG) which is no
longer performed in France. The nutritional impact of LSG remains to be evaluated. To date,
data concerning evaluation of nutritional status from patients who underwent LSG are almost
non-existent. Considering this type of surgical procedure, the investigators expect to
observe essentially a deficiency in vitamin B12 and iron. Indeed, defined as a purely
restrictive intervention, LSG consists of gastric fundus resection which is the site of
intrinsic factor production, itself necessary for vitamin B12 absorption. Moreover, decrease
of hydrochloric acid production and potential vomiting caused by gastric resection can alter
iron absorption.
In view of the increasing popularity of this surgical technique, assessment of the
nutritional consequences of longitudinal sleeve gastrectomy seems to be necessary.
MAIN OBJECTIVE
The main objective of this study is to assess during a 2-year prospective follow-up, the
prevalence of nutrient deficiencies in patients undergoing a longitudinal sleeve gastrectomy
for morbid obesity
Obesity, defined by a body mass index (BMI) higher than 30 kg/m2, is a chronic metabolic
disease the prevalence of which reaches epidemic proportions. Obesity increases the risk of
hypertension, diabetes, and atherosclerosis, all risk factors for the leading cause of death
worldwide—cardiovascular disease. Moreover, obesity can lead to obstructive sleep apnea,
osteoarthritis, non-alcoholic fatty liver disease, cancer, etc…(Fried 2007). It represents
one of society's major public health problems in (WHO 2000).
The treatment of obesity is primarily a medical matter. A multidisciplinary approach is
recommended with nutritional, dietary and psychological follow-up. It requires a
modification of life-style and long-term support. However, the long-term results of
conventional medical therapy are disappointing, especially for morbid obesity. Bariatric
surgery is now recognized as a procedure of choice for the treatment of morbid obesity. It's
role in the therapeutic strategy is justified by long-term effectiveness on weight loss and
comorbidities associated with high body mass index.
There are two types of bariatric procedures:
- Restrictive procedures, consisting of a reduction of the stomach volume : vertical
banded gastroplasty (VBG), adjustable gastric banding (AGB), sleeve gastrectomy (SG)
- And combined procedures (restrictive and malabsorptive) : gastric by-pass and
biliopancreatic diversion (BPD) with or without duodenal switch (DS).
The two types of procedures most often performed in Europe are AGB et GBP (Coupe 2009). VBG
is tending to disappear in France, and biliopancreatic diversion (BPD), with or without
duodenal switch (DS) is a complex procedure that is reserved for only very specific
situations (Ziegler 2009).
Sleeve gastrectomy is a relatively new bariatric procedure. It was initially introduced as
either the restrictive component of BPD-DS or the first step of a staged approach for weight
loss. In the latter, super-obese patients with increased operative risks undergo SG to
initiate enough weight loss to allow for a second stage gastric bypass or BPD-DS. It has
been recently used as a definitive bariatric surgery procedure following reports of
significant reduction in BMI and comorbidities. It is recognized in France by the High
Authority of Health since 2008. SG is a laparoscopic bariatric procedure, in which the
fundus and the greater curvature of the stomach are removed, leaving a narrow gastric tube
or "sleeve" (Hakea 2009). Because of this partial gastrectomy, SG also affects ghrelin
secretion which is an orexigenic hormone. These changes in the concentration of gut peptides
induce a loss of appetite. The acceleration of the gastric emptying could also participate
in weight loss (Ankar 2008). The advantages of sleeve gastrectomy reside in a lower rate of
complications compared with BPG due in particular to the absence of implanted devices, the
conservation of digestive continuity and the absence of malabsorption (Gums 2007). In terms
of weight loss, the gastric by-pass appeared the most effective, followed by the sleeve
gastrectomy, then the adjustable gastric ring. According to a recent meta-analysis, the loss
of weight expressed in percentage of reduced excess weight was 61,6 % for the BPG and 47,5 %
for the GB within 2 years of the procedure (Buchwald 2004). Concerning the sleeve
gastrectomy, a review of the literature comprising 15 studies and including 646 patients,
shows evidence of a reduction of excess weight of 49 % and 56 % after 6 months and 1 year
respectively with a resolution of co-morbidity such as arterial high blood pressure and type
2 diabetes, from 60 to 100 % (Gums : 2007). The data on long-term follow-up is less well
documented.
The risk of nutritional deficiencies depends on the percentage of weight loss and the type
of surgical procedure performed The nutritional deficits observed after gastric surgery can
be explained by various mechanisms according to the technique used. T BPG, which is both
restrictive and malabsorptive surgery, is frequently at the origin of nutritional and
vitamin deficiencies essentially concerning proteins, iron, calcium, vitamins B12, B9 and D.
In contrast, in the absence of malabsorption, the nutritional deficits induced by AGB are
less pronounced and particularly linked to contribution deficiencies due to vomiting, food
aversions and modification of food supply .Studies evaluating the nutritional status of
patients before and after surgery are scarce and prevalency of the reported deficits varies
greatly according to the population studied, the type of surgery used, the systematic
prescription or not of vitamin complements, and the duration of follow-up.
The most frequent deficit is the deficiency in vitamin B12, found in 1/3 of the one year
follow up BPG patients (Malone 2008). Folate deficiency (vitamin B9) is also frequent,
arising in 20 % of cases (Pournaras 2009). Both are at the origin of macrocytic anaemia,
leucopenia, thrombopenia and glossitis. Sometimes irreversible neurological affections can
also arise in the case of B12 deficiency. The effects of bariatric surgery on vitamin D and
calcium are rarely specified in the long term, but it is important to note that it is not
rare to observe vitamin D deficiencies pre-existent to surgery affecting between 21 and 57 %
of obese subjects according to certain studies, (Toh 2009, Hamoui 2004), responsible for an
increase in osseous fragility and secondary hyper-parathyroidism. The patients most at risk
of osteomalacia would be the ones whose BMI is over 50, menopause women, patients having
undergone a massive loss of weight after surgery and patients deficient in vitamin D prior
to surgery (Malone 2008). Bariatric sideropenic anaemia is also frequent after surgery
whether restrictive or malabsorptive, affecting 5 to 10 % of the subjects in most of the
studies and as many as 74 % according to one study (Sadoul 2007). It is linked to
contribution deficiency due to decreased consumption of meat, in the case of malabsorption
(BPG) but also due to lack of production of gastric hydrochloric acid which allows the
conversion of the ferrous iron foodstuffs to ferric iron, which is the absorbable form.
Other vitamin deficiencies were reported, in particular the deficit in vitamin B1 (or
thiamine) , essentially due to vomiting because of the gastric limitation, and which can be
revealed by an intravenous drip of thiamine-free glucose. Vitamin B1 deficiency, although
rather rare, is potentially serious because of neurological damage such as the sometimes
irreversible Gayet-Wernicke's syndrome, (Poitou 2008; Morel 2008). Deficits in liposoluble
vitamins A, E and K are exceptional except in the case of serious malabsorption induced by
bilic-pancreatic diversion and duodenal switch. Zinc, magnesium and selenium deficiencies
are also described but remain rare and originate mostly through exoskeleton or cutaneous
disorders but cases of cardiomyopathy by selenium deficiency was also reported .
To date, recommendations on the optimal vitamin supplementation to be prescribed according
to the method of surgery used are not clearly defined. According to recent recommendations
of the HAS for the surgical care of adult obesity, " the medical and surgical follow-up must
emphasize the prevention of, and the detection of, vitamin or nutritional deficiency
including the identification of clinical (in particular neurological) and biological
symptoms of undernutrition or vitamin deficiency. A systematic multivitamin supplementation
must be established after malabsorptive surgery (multivitamins, vitamin D, calcium, iron and
vitamin B12). " However, certain authors report deficiencies in spite of systematic
prescription of multivitamin supplements after by-pass surgery .Data on the prescribed
doses, controls, or even the preliminary nutritional state before surgery remains badly
specified. On one hand, the rarity of prospective studies evaluating these parameters
explains the difficulty in estimating these nutritional complications. On the other hand,
the various studies listed refer essentially to gastric by-pass, the adjustable gastric
ring, and the calibrated vertical gastroplasty which is tending to disappear. The impact of
the sleeve gastrectomy on the nutritional state of the patients remains to be specified. To
date, data concerning the vitamin and nutritional evaluation of patients operated by sleeve
gastrectomy is almost non-existent. A recent review of the literature did not reveal any
nutritional recommendations specifically for sleeve gastrectomy mostly due to the very small
number of studies available. An American team studied the evolution of the nutritional
assessment in the case of sleeve gastrectomy but the parameters studied were limited to
albumin, haemoglobin and calcium. A decrease of the haemoglobinaemia was objectivized to 5
of 36 patients followed during 1 year .An Australian team also retrospectively estimated
prevalency of nutritional deficiencies after bariatric surgery, but the data concerning
sleeve gastrectomy is not significant considering the large number of patients lost sight of
in 1 year (> 80 %) (Toh 2009).
The growing interest in LSG as a surgical procedure for managing morbid obesity requires
further investigation of it's metabolic consequences.
In view of the increasing popularity of this surgical technique the evaluation of the
nutritional repercussions of sleeve gastrectomy appears indispensable. If the investigators
consider the surgical aspect of this procedure, the investigators would expect to observe a
deficiency in vitamin B12 and iron. Indeed, defined as a purely restrictive procedure, the
sleeve gastrectomy consists of the resection of the gastric fundus, the seat of production
of the intrinsic factor, itself necessary for the absorption of vitamin B12. Moreover, the
decrease in production of hydrochloric acid and the potential vomiting caused by the vast
gastric resection can potentially have an effect on the absorption of iron. The study
proposed here aims to make a prospective follow-up of the nutritional and vitamin assessment
of obese patients operated by sleeve gastrectomy at the University Hospital of
Clermont-Ferrand. Every patient will receive a clinical and biological assessment including
the dosages of vitamins and trace elements prior to surgery then after 3, 6, 12, 18 and 24
months. The effect of sleeve gastrectomy on the nutritional status of the operated patients
will thus be evaluated with a view to answering the question: Is sleeve gastrectomy a purely
restrictive surgical technique ?
