Implementation of Mandatory Hiatoplasty in Sleeve Gastrectomy: Strategy for Gastro-Esophageal Reflux Disease (GERD) Risk Reduction
Conditions: Postgastrectomy Syndromes, Gastroesophageal Reflux
Sponsor: Instituto Mexicano del Seguro Social

Official Title: Implementation of Mandatory Hiatoplasty in
Sleeve Gastrectomy: Strategy for Gastro-Esophageal Reflux
Disease (GERD) Risk Reduction.Implementation of
NCT number: not available
Date: 03/11/2024

2
Abstract.
Background. Limited research supports hiatal hernia repair and reduced acid production as protective
factors. Despite the scarcity of direct evidence,the multifactorial nature of postoperative GERD
underscores the potential significance of hiatoplasty in preventing complications. The inclusion of
mandatory hiatoplasty in gastric sleeve protocols is considered a promising advancement for
improving patient outcomes and reducing long-term complications.
Objective. This study aims to assess the effectiveness of mandatory hiatoplasty during gastric sleeve
surgery in decreasing postoperative GERD incidence in patients at a specialized bariatric surgery
hospital in Tijuana, Baja California.
Methodology. This is a retrospective case series study based on clinical records of patients who
underwent some type of bariatric surgery in hospital centers specialized in bariatric and high volume
surgery in the city of Tijuana, Baja California, Mexico, from March to June 2022. The following
information of interest will be obtained: age, sex, comorbidities, BMI, surgery performed, surgical time,
trans and postoperative complications. Once the data capture process has been completed, a
descriptive analysis will be performed with the SPSS statistical program in version 26 for MacOS.
Means and standard deviation will be obtained for quantitative variables as well as frequencies and
percentages for qualitative variables.
Key words. Incidence, Complications, Bariatric surgery, Obesity.

3
THEORETICAL FRAMEWORK
Obesity is a worldwide epidemic that has been developing over the last decades and
represents one of the main public health problems today due to the numerous
related comorbidities.
According to the World Health Organization (WHO), 13% of all adults in the world
(approximately 650 million) suffer from some degree of overweight or obesity (1).
The future scenario is not very encouraging since the WHO also reports that more
than 350 million non-adult people suffer from this same condition, in addition, obesity
worldwide has had an unexpected increase during the last 30 years; being that the
prevalence of obesity and overweight increased up to 40% in some developed
countries (1).
Excess body weight increases the risk of a group of cardiometabolic disorders, such
as type 2 diabetes mellitus, hypertension, and dyslipidemia, and is associated with
an increased risk of coronary artery disease, stroke, and mortality (2).
It is estimated that, if this trend continues, 2.7 billion adults will be overweight, more
than 1 billion will be affected by obesity, and 177 million adults will suffer severe
obesity-triggered consequences by 2025 (3).
OBESITY IN MEXICO
According to the National Health and Nutrition Survey 2018-2019 (ENSANUT
2018-2019), the prevalence of overweight for that time span was 39.1% of the
Mexican population over 18 years of age (36.6% in women and 42.5% in men),
obesity 36.1% (40.2% in women and 30.5% in men) and abdominal adiposity 81.6%
(88.4% in women and 72.1% in men), with the northern region of the country being
the most affected. Similarly, the prevalence of abdominal adiposity was higher in the
northern regions (83%) than in the center of the country (79%) (4).
From 2000 to 2018, the trend of obesity prevalence increased by 42.2% to reach an
obesity prevalence of 36.1% by 2018. It was also observed that the higher the
degree of obesity, the greater the increase in relative prevalence, so that grade I
obesity increased by 28.8% while grade III or morbid obesity increased by 96.5%,
indistinctly in men and women. Compared to 2000, all categories of obesity and
abdominal adiposity increased by 2018 (4).

4
The ENSANUT 2021 details a prevalence of overweight and obesity in the
population aged 20 years or older of 72.4% (75% in women and 69.6% in men).
Likewise, it argues that in 2015 10.8% of all deaths worldwide were attributed to
excess weight and in 2016 this figure increased to 12.3%. When comparing only
obesity, it is observed that in men there was an increase of 18.6% between 2012
(26.8%) and 2021 (31.8%); while in women the increase was 9.6% in the period
2012 (37.5%) to 2020 (41.1%) (5).
OBESITY IN BAJA CALIFORNIA
The ENSANUT 2018-2019 concluded that the north of the country is the region most
affected by obesity as such in addition to being one of the regions with the highest
prevalence of abdominal adiposity and overweight compared to the southern and
central regions of the country (4).
In the same way, the ENSANUT 2012 dictated a prevalence of overweight and
obesity for that year of 35% and 39% respectively in the adult population of the state
of Baja California, giving a total of almost 75% of the population with one of these
conditions (6).
A study by Hernandez et al. in the city of Tijuana in 2014 found a similar prevalence
of these entities (74%) in a sample of comparable size with the ENSANUT 2012
(1072 people) being slightly more prevalent in women (43%) than in men (40%) (7).
OBESITY IN THE UNITED STATES
In the United States, obesity is also a serious public health problem, 42.4% of the
population over the age of majority suffer from obesity, among men the prevalence of
obesity was 40.3% while in women it was 39.7%. On the other hand, the prevalence
of obesity in its severe form was 9.2% of U.S. adults, being more prevalent in women
(11.5%) than in men (6.9%). From 1999 to 2018, the prevalence of obesity has been
increasing from 30.5% to 42.4%, likewise severe obesity increased from 4.7% to
9.2% in that same time span (8).
TREATMENT OF OBESITY
Through various mechanisms, obesity continues to worsen the cardiometabolic
health of people around the world, increasing the risk of a cardiovascular event.

5
Therefore, it is necessary to establish an effective treatment for obesity, in addition to
seeking to improve the associated comorbidities such as diabetes and arterial
hypertension (9).
For years, obesity and weight loss have been studied and it has always been
concluded that all the metabolic alterations related to obesity can be reduced or even
avoided by making different interventions in the lifestyle of individuals (10). The
American Heart Association (AHA) and other institutions such as the American
College of Cardiology have included in their treatment guidelines for obesity this type
of recommendations for healthy lifestyle changes such as exercise and a decrease
in the consumption of sugars and fats, with the objective of having a loss of ≥10% of
total body weight; however, achieving this objective, even with pharmaceutical
treatment is difficult and few people manage to achieve it (11,12).
Education regarding healthy lifestyle habits and even intensive interventions in
patients with comorbidities have been a challenge for the personnel in charge of
such tasks, a study called Look AHEAD that was developed over 8 years comparing
intensive lifestyle interventions in patients with type 2 Diabetes Mellitus (DM2)
against education and support groups on diabetes in obese and overweight people,
aimed to reduce cardiovascular risk at 10 years of follow-up without achieving such a
result (13). However, an analysis of this same study concluded that people who lose
≥10% weight reduce their risk of a cardiovascular event by up to 20% (14).
Furthermore, according to evidence from the American Association of Clinical
Endocrinology, a body weight loss of ≥10 % is recommended for the specific
prevention of diabetes in obesity (15).
CHANGES IN CALORIC INTAKE
In patients suffering from obesity, different cardiovascular markers usually show
improvement in response to weight change conditioned by caloric restriction (11).
Blood pressure is the marker with the most sensitive response in relation to weight
change, different studies have concluded that approximately for each 1% of weight
loss or gain, systolic blood pressure can decrease or increase respectively from 0.3
- 0.4 mmHg in those individuals who follow a low calorie diet or with a focus on body
fat loss (16, 17). Other markers such as blood glucose, glycosylated hemoglobin,
and lipid profile are also highly benefited by dietary changes (18). Not only have
diets that restrict caloric intake as such had a good impact on the cardiometabolic

6
risk of patients, other dietary patterns such as those that restrict sugar and sodium
intake or adherence to the "Mediterranean" diet have been shown to improve
markers such as blood pressure and multiple markers of inflammation associated
with obesity (19).
EXERCISE
Exercise represents an energy expenditure in large volumes, which has a direct
impact on weight and therefore on the cardiovascular risk of individuals (20).
The American College of Sports Medicine suggests that a total of 225-420 minutes
of aerobic exercise per week is necessary for a 5 - 7.5 kg weight loss (21). Even so,
the AHA states that physical activity alone is not an ideal approach to achieve the
initial weight loss goal and must be accompanied by dietary changes (22). Shaw et
al. found in their study that combining exercise and diet results in an additional
weight loss of approximately 1 kg compared to diet alone, and they report an
additional 1.5 kg of weight loss when comparing high-intensity exercise versus
low-intensity exercise (23).
PHARMACOTHERAPY
Guidelines approved in various countries recommend the use of drugs for weight
loss in those patients with a BMI greater than 27 with comorbidities associated with
obesity or in those whose BMI is greater than 30, in conjunction with diet, exercise
and lifestyle changes (9,10).
There are 5 groups of popular drugs approved by the US Food and Drug
Administration
(FDA)
for
use
in
patients
with
obesity;
they
have
different
mechanisms of action with effects on satiety, energy expenditure, caloric absorption,
among
others.
These
drugs
are:
pancreatic
lipase
inhibitors,
phentermine,
bupropion, serotonergic agonists and glucagon-like peptide-1 (GLP-1) agonists (24,
25).
Despite the recommendations of the guidelines and the growing number and variety
of approaches to treat obesity and mitigate its associated risk, the epidemic
continues to grow largely and unabated (9). Because of this, new therapies have
emerged over the years, among them emerging one of the most accepted
treatments with the best results evidenced during the last years, bariatric surgery
(26).

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BARIATRIC SURGERY AND OBESITY
Bariatric surgery was one of the first interventions shown to significantly reduce
obesity-associated cardiovascular morbidity and thus mortality (27), and it is the only
evidence-based treatment that offers substantial, sustainable and long-lasting weight
reduction even in morbidly obese individuals or in those for whom pharmacological
and nutritional medical therapy has failed (28).
Although lipid control is now almost entirely a drug therapy, bariatric surgery has
been shown to be the most effective way to achieve significant and durable weight
loss in obesity (29). Data from long-term and follow-up studies now support that
improvements in metabolic risk in association with weight loss after bariatric surgery
translate into reductions in adverse cardiovascular outcomes and mortality (10, 30).
Currently the recommendation for performing bariatric surgery is in those patients
over the age of 18, with a BMI equal to or greater than 35 with comorbidities
associated with obesity or in those with a BMI of 40 or more regardless of the
existence or not of comorbidities (11). Bariatric surgery in persons under 18 years of
age continues to be a controversial issue, although in extraordinary scenarios it may
be indicated in cases of morbid obesity in childhood or adolescence with associated
comorbidities and/or failure of previous medical and nutritional treatment (31).
Originally, it was postulated that the various benefits obtained by bariatric surgery
were closely related to procedures with restrictive and/or malabsorptive effects (32);
however, it is now known that incretin and bile acid signaling (as well as probably
alterations in the microbiota) also have an important contribution both to weight loss
and to the positive impact on cardiovascular risk (33).
There are multiple bariatric techniques and procedures, currently worldwide and
according to reports from the International Federation for the Surgery of Obesity and
Metabolic Disorders (IFSO), the most performed is the laparoscopic vertical (or
sleeve) gastrectomy (LSG), also known as gastric sleeve, followed by Roux-en-Y
gastric bypass (RYGB), considered the gold standard due to its high level of efficacy,
single-anastomosis
gastric
bypass
(BAGUA/OAGB),
single-anastomosis
duodeno-ileal bypass with sleeve gastrectomy (SADI-S), among others (34).
SLEEVE GASTRECTOMY

8
Sleeve gastrectomy has become, during the last decade, the most commonly
performed bariatric procedure in the world (35). This procedure has evolved in a
hybrid fashion to give rise to the emergence of new techniques and consists of
removing portions of the fundus and antrum of the stomach by means of a vertical
plication, leaving as a remnant a "sleeve" stomach, significantly restricting its
capacity and through which food passes into the small intestine (36).
Vertical gastrectomy or popularly known as gastric sleeve can lead to a weight loss
of up to 30% of body weight in the first postoperative year, with a smaller weight loss
for up to 5 years (37).
In addition to the restrictive effect that results from removing a portion of the
stomach, there are other mediators that are related to satiety and hypocaloric effects
such as GLP-1 and Peptide YY (PYY) (38) as well as ghrelin, an orexigenic hormone
that significantly reduces its levels due to the reduction of ghrelin secreting cells
P-D1 that are found mostly in the gastric fundus (39). Also, gastric sleeve has effects
on the microbiota that are believed to be related to weight loss through a reduction in
caloric energy absorption (40).
The gastric sleeve has been shown to have the greatest improvement in metabolic
risk compared to any other bariatric procedure (41-43). The metabolic risk markers
that have benefited the most are: reduction of blood pressure, glycosylated
hemoglobin and inflammatory markers, among others that have not yet been fully
studied (44).
COMPLICATIONS ASSOCIATED WITH SLEEVE GASTRECTOMY
Bariatric surgery has become for many the best method to treat obesity, especially in
severe cases and due to the multiple benefits obtained after this type of procedure;
however, as with any major surgery, there is a risk of complications, and although in
the bariatric field they are relatively uncommon, when they occur they may require a
multidisciplinary management that is not simple (45).
Sleeve gastrectomy, as a leading technique in metabolic and bariatric surgery, has
gained popularity for its effectiveness in achieving considerable weight loss in a short
period of time. However, this procedure is not without complications. The most
common complications include bleeding, nutritional deficiencies and leakage (46).
One
of
the
most
prominent chronic complications of gastric sleeve is the
development of postoperative de novo gastroesophageal reflux disease (GERD),

9
which can range from esophagitis to more serious conditions such as Barrett's
esophagus and esophageal cancer (47). The prevalence of GERD in the Western
population is estimated at 7.7%, and its pathogenesis is multifactorial, involving
factors such as hypotonia of the lower esophageal sphincter (LES), inadequate
transient relaxations of the LES, and the contribution of hiatal hernia (48).
In this context, mandatory hiatoplasty emerges as a potentially valuable strategy to
mitigate the risk of postoperative GERD in patients undergoing gastric sleeve.
Although specific research on mandatory hiatoplasty in this procedure is limited, the
literature suggests that repair of hiatal hernias and decreased acid production by
fundus resection are protective factors against postoperative GERD (47). Therefore,
it is plausible to consider that the inclusion of hiatoplasty as a mandatory step in the
gastric sleeve could contribute significantly to the reduction of the incidence of
postoperative GERD.
This
perspective
finds
support
in the understanding of the complexity and
multifactoriality of postoperative GERD. Hiatoplasty, by repairing hiatal hernias and
potentially improving lower esophageal sphincter function, could play a key role in
preventing this type of complication. Given the importance of minimizing the risks
associated with bariatric surgery, the implementation of mandatory gastric sleeve
hiatoplasty represents a promising strategy that deserves careful consideration in the
design of surgical protocols.
Although direct evidence on the efficacy of mandatory hiatoplasty in this setting is
still limited, the potential benefits in terms of reduced risk of postoperative GERD
warrant further investigation and consideration of this technique in surgical practice.
Its inclusion in gastric sleeve protocols could therefore represent a significant
advance in improving patient outcomes and decreasing long-term complications
related to this procedure.

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JUSTIFICATION
Magnitude and impact. The development of a protocol that includes mandatory
hiatoplasty in the gastric sleeve is essential given the postoperative complications
associated with this procedure. The gastric sleeve, recognized for its effectiveness in
achieving significant weight loss, also presents inherent risks such as bleeding,
nutritional deficiencies and leakage, with GERD being one of the most worrisome
chronic complications. This condition impairs the patient's quality of life and can also
trigger more serious problems such as Barrett's esophagus and, in extreme cases,
esophageal cancer. Therefore, reducing these complications by adopting mandatory
hiatoplasty can have a significant impact on the long-term safety and well-being of
patients undergoing bariatric surgery.
Significance. The transcendence of implementing a protocol with mandatory
hiatoplasty in the gastric sleeve lies in its potential to positively alter surgical practice
in bariatric surgery. The inclusion of this procedure could represent a significant
advance in the prevention of postoperative GERD, a complication that significantly
affects the patient's quality of life and increases the burden on the health care
system
due to the need for prolonged treatment and follow-up. Furthermore, by considering
the multifactoriality of the pathogenesis of GERD, mandatory hiatoplasty aligns with
a comprehensive view of surgical management, addressing key factors such as
hiatal hernia and lower esophageal sphincter function. This perspective could,
therefore, set a new standard in bariatric surgery, focusing on prevention and
long-term care.
Feasibility. From a feasibility standpoint, the development and implementation of this
protocol are feasible. The hiatoplasty technique, although requiring specialized
surgical skills, is a well-established procedure and can be effectively integrated into
gastric
sleeve
practice.
In
addition,
growing
concern
about
postoperative
complications in bariatric surgery has generated substantial interest in improving
existing techniques and adopting new approaches that can reduce these risks. With
adequate resources for training and skill development, as well as institutional
support, implementation of this protocol is not only feasible, but also a progressive
step toward safer and more effective surgical care in the treatment of obesity and its
comorbidities.

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PROBLEM STATEMENT AND RESEARCH QUESTION
The increasing prevalence of obesity worldwide has led to an increased reliance on
surgical interventions such as sleeve gastrectomy for its effective treatment. Despite
its success in significant weight loss and improvement of related comorbidities,
gastric sleeve is not without postoperative complications, one of the most worrisome
being the development of postoperative GERD. This problem stands out for its
frequency and severity, significantly affecting the quality of life of patients and
presenting challenges in post-surgical clinical management.
The incidence of postoperative GERD in patients undergoing gastric sleeve surgery
is a growing concern. The prevalence of GERD in the general population is
considerable, and its occurrence or exacerbation after bariatric surgery represents a
significant clinical problem. Moreover, the management of postoperative GERD
involves additional costs for both the patient and the health care system, in terms of
long-term medication, clinical follow-up and, in some cases, surgical reintervention.
The complexity of this problem lies in the multifactorial nature of its etiology. Factors
such as hypotonia of the lower esophageal sphincter and the presence of hiatal
hernia contribute to the development of GERD. Therefore, it is imperative to explore
surgical strategies that can mitigate this risk. One such strategy is mandatory
hiatoplasty during sleeve gastrectomy, which, although not extensively investigated
in this specific setting, has the potential to address one of the key etiologic factors of
postoperative GERD.
However, the adoption of mandatory gastric sleeve hiatoplasty presents not only
technical challenges, but also involves considerations of surgeon training, hospital
resources, and acceptance of new surgical protocols. The need for a more
preventive and comprehensive approach to bariatric surgery is clear, but requires a
solid evidence base and adaptation of current surgical practices. This context raises
a significant issue: should mandatory hiatoplasty be integrated into the gastric sleeve
to reduce the incidence of postoperative GERD and improve long-term outcomes for
patients undergoing bariatric surgery?

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HYPOTHESIS
Alternative hypothesis
Mandatory hiatoplasty performed during gastric sleeve surgery significantly reduces
the incidence of postoperative gastroesophageal reflux disease (GERD) compared
to gastric sleeve performed without mandatory hiatoplasty.
Null hypothesis
Mandatory hiatoplasty performed during gastric sleeve surgery does not have a
significant impact on reducing the incidence of postoperative gastroesophageal
reflux disease (GERD) compared to gastric sleeve performed without mandatory
hiatoplasty.

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OBJECTIVES
General
To evaluate the efficacy of mandatory hiatoplasty performed during gastric sleeve
surgery in reducing the incidence of postoperative gastroesophageal reflux disease
(GERD) in patients undergoing this procedure in a hospital specializing in bariatric
surgery in Tijuana, Baja California.
Specific
Demographic characteristics and comorbidities in patients undergoing gastric
sleeve with hiatoplasty: These patients usually have significant obesity, often
accompanied by comorbidities such as type 2 diabetes, hypertension, sleep apnea,
and gastroesophageal reflux disease (GERD). Demographic characteristics may
vary, but the prevalence of obesity and its associated comorbidities is high in many
regions, including Tijuana, Baja California.
Incidence of postoperative GERD in patients undergoing gastric sleeve with
mandatory hiatoplasty: Hiatoplasty is often performed to reduce the risk of
postoperative GERD by repairing a herniated hiatus during gastric sleeve surgery.
However, the exact incidence of postoperative GERD can vary and depends on
factors such as surgical technique, patient anatomy and postoperative management.
Comparison
of
postoperative
complication
rates,
including
GERD:
Postoperative complications may include, but are not limited to, bleeding, infection,
sleeve stenosis, and GERD recurrence. Comparison of complication rates between
patients with and without mandatory hiatoplasty may provide insight into the
effectiveness of this technique in mitigating specific risks.
Postoperative quality of life analysis: Postoperative quality of life can be
significantly improved after bariatric surgery due to weight loss and improvement of
comorbidities. Specific measures may include, but are not limited to, physical
mobility, self-esteem, relief of symptoms of comorbidities, and overall satisfaction
with the results of surgery.
Evaluation of the safety and technical feasibility of mandatory hiatoplasty: The
integration of hiatoplasty into gastric sleeve surgery should be evaluated in terms of
technical feasibility, safety, and effectiveness in preventing recurrence of hiatal
hernias and GERD. This may involve analysis of complication rates, specific surgical
techniques, and long-term.

14
MATERIALS AND METHODS
Research design
A retrospective case series will be performed.
Universe of study
Electronic clinical records of patients over 18 years of age of indistinct gender who
underwent gastric sleeve with hiatoplasty for obesity or overweight management in a
hospital center specialized in bariatric surgery in Tijuana, Baja California.
Study period
March 2024 - July 2024.
Sample size
To calculate the sample size, the formula for prevalence studies for infinite
populations was used, considering a confidence interval of 95% and a margin of
error of 5%. The formula is presented below:
n= Za/2
2 (p*q)
d2
where,
Za/2 = Z-score of a normal distribution a/2= 1.96
p= 20%
q= 100-р = 70%.
d2 =margin of error= 10
n= a minimum of 275 patients is required
Sampling
Non-probabilistic sampling will be used.
Inclusion and non-inclusion criteria
Inclusion criteria
●
Patients over 18 years of age.
●
Gender indistinct.
●
Overweight, obesity grade I, II, III, super obesity or super-super obesity.

15
●
Underwent gastric sleeve with hiatoplasty for obesity management at a high
volume Tijuana hospital dedicated to bariatric surgery.
Non-inclusion criteria
●
Patient records with incomplete information.
Description of the study
1. This study will be subject to review by the Research and Research Bioethics
Committees of the hospital in question. Since this is a retrospective study, informed
consent is not required.
2. After approval, the electronic clinical records of overweight and obese patients
who meet the inclusion criteria and who underwent bariatric surgery for obesity
management in Tijuana during the study period will be reviewed.
3. The following information of interest will be obtained from the file: age, sex,
comorbidities, BMI, type of procedure, duration of surgery, final bleeding, immediate
postoperative and transoperative complications. Patient follow-up information will
also be obtained, which is obtained both in person for patients who can attend
follow-up consultations and remotely by e-mail after sending a medical questionnaire
and subsequent response from patients who reside in another city or country and
therefore cannot attend their follow-up consultations in person.
4. Finally, the data will be captured in SPSS for statistical analysis.
5. To measure the quality of life of patients and the effectiveness of surgery, the
Bariatric Analysis and Reporting Outcome System (BAROS) scale will be used.
Definition and operationalization of the study variables

16
STATISTICAL ANALYSIS
A database will be created in Excel, which will be downloaded into the statistical
package SPSS v.26 in its MacOS version for data processing.

17
A descriptive analysis will be performed. For qualitative variables with frequencies
and percentages. For quantitative variables, the descriptive analysis will consist of
mean and standard deviation. In case quantitative variables have a non-parametric
distribution, median and interquartile range will be used as descriptive statistics.
ETHICAL CONSIDERATIONS
The present research project was submitted to evaluation by the Local Health
Research and Bioethics Committees for assessment and acceptance.
Since this is a retrospective study and has no bioethical implications as such, article
17 of the regulations of the General Health Law on Health Research will be taken
into consideration, which classifies it as risk-free since the information will be
obtained from clinical records.
Adheres to the Declaration of Helsinki of the World Medical Association.
Establishing Ethical Principles for Medical Research Involving Human Subjects,
adapted by the 8th World Medical Assembly, Helsinki Finland in June 1964. As well
as the last amendment made by the last General Assembly in October 2013, and the
Taipei Declaration on Ethical Considerations on Health Databases and Biobanks that
officially complements the Declaration of Helsinki since 2016; as reported by the
World Medical Assembly.
Absolute confidentiality of the data will be maintained. This is in accordance with the
Federal Law for the Protection of Personal Data, NOM-004-SSA3-2012, of the
clinical file (sections 5.4, 5.5 and 5.7).

18
RESOURCES, FINANCING AND FEASIBILITY
Material resources
●
Printer, sheets, laptop, pens are required.
Human Resources
●
Surgeon: Dr. Alejandro Lopez Ortega
●
Physician Assistant: Dr. Helmut Heribert
●
Methodological Assistants: Dr. Alejandro González Ojeda, Dr. José Aldo
Guzmán Barba, Dr. Isaac Esparza Estrada, Dr. Sergio Jiram Vazquez
Sánchez
Financial resources
Material resources will be provided by the investigators and no additional funding will
be required from the hospitals.

19
SCHEDULE OF ACTIVITIES.
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ANNEXES.

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APPENDIX 2. FOLLOW-UP FORMAT

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