Title

Current status of the postoperative fistula in the gastrointestinal tract. A multi-centric and multi-national study. ¨FISTULA DAY¨

Keywords

Abdominal sepsis, anastomotic leak, enteroatmospheric fistula, enterocutaneus fistula, hostile abdomen, anastomotic dehiscense, intestinal anastomosis, intestinal perforation, intestinal failure.

Backround

The enteroatmospheric fistulas and enterocutaneous fistulas are usually the result of an intestinal leak.

Even though the close follow up of the patient is a cornerstone in the early diagnosis of the intestinal leak, there is evidence that when the treating physician is thinking of a possible diagnosis  on an earlier manner  highly impacts evolution.

Current treatment actually depends on the moment in which the diagnosis is made, which makes the treatment quite varied and with total absence of a standardized criteria.

In recent years, the American society of parenteral and enteral nutrition  and the Latin American federation of enteral and parenteral nutrition collaborated as a unit to edit the ASPEN-FELANPE clinical guidelines where  the entero-cutaneous fistulas was consistently described as <500ml or >500ml effluent, however, as of today, there is no such thing as a generalized and broadly implemented classification for fistulas or intestinal leaks.

Treatment and surgical techniques that are being implemented are based on series of case reports as well as retrospective series with a staggering amount of method flaws.

There is enough evidence to demonstrate that the failure to achieve an early and accurate diagnosis of intestinal leaks and intestinal fistulas is a common denominator in such patients.

Justification

As of today there are no global cross-sectional surveys to describe the prevalence of the gastrointestinal leak/fistula.

The study intends to generate new epidemiological data about how frequent the problem is, how  the diagnosis and treatment approaches differ from one country to another or a major hospital center from another, as well as the risk factors, and the level of standardization that current managements have.

The study intends to propose unified and standardize criteria for diagnosis as well as for treatment. Disregarding the country of origin.

Bibliographic analysis

Multiple studies about intestinal leaks and fistulas have been presented through out the years, looking to identify risk factors, affected population, incidence and morbidity for this disease, however, there are few in which the standardization of treatment is mentioned.  The few published studies, which attempt to approach a standardization of treatment, tend to have a poor methodology in their elaboration. For this study protocol, studies which have been published in the last ten years that talk about intestinal leaks and or fistulas, incidence, risk factors, diagnostic methods and treatment were reviewed, very few from the mentioned above have attempted to establish a standardization of specific treatment.

Objectivs

General:

  • Identify the prevalence of the postoperative gastrointestinal leaks/fistulas.

Specifics:

  • Analyze the diversity in the diagnosis which is frequently described as fistula.
  • Evaluate the co-occurrence of nutritional risk or malnutrition in patients diagnosed with postoperative
  • Propose a standardized classification of the diagnosis clustered by scenarios.
  • Report 30-day and 60-day outcomes of the included patients with a leak/fistula with timing relative to initial diagnosis of the leak/fistula.
  • Describe the current management of the postoperative gastrointestinal leaks/fistulas.
Hypothesis

The prevalence of the postoperative gastrointestinal fistulas continues to be elevated and the clinical entity difficult to diagnosis and treatments are variable.

Methodology

Environment of the study:

2nd and 3rd level Hospitals, Latin America, Europe, North America, Asia

Population to be studied:

All in-hospital patients with a diagnosis of gastrointestinal leak/fistula.

Inclusion criteria:

Adult hospitalized patients the public and private sector admitted with leak/fistula and history of gastrointestinal anastomosis or a repair of gastrointestinal perforation will be included.

Exclusion criteria:

Patients in intensive care units for other reasons, medical patients, psychiatry  admissions, , pediatric patient population wil be excluded, patients being managed as out-patients.

Sample size and sampling procedures:

Every patient with a diagnosis of gastro-intestinal leak or anastomosis  admitted in none primary care hospitals meaning general hospitals and highly specialized hospitals in North America, Latin America, Europe, Asia.

Design of the study:

Cross-sectional, descriptive, analytic, point prevalence survey.

 

Variables

Variable

Concept Definition Operational definition Type of variable

Mesuring scale

Age Amount of time that person has lived, starting from the day of birth. Patient´s age at the admission to the hospital. Discreet quantitative. Years
Sex Biological condition that differentiates male and female. Male or female, confirmed by an official document. Nominal

Qualitative.

Female

Male

In-hospital

stay

Amount of days a patient remains in the hospital. Amount of time since the hospital admission Discreet quantitative Capture the exact amount of days
Comorbidities Adjacent Clinical situation the patient suffers from coupled to the current diagnosis. Clinical situation which may or may not compromise the patient´s progress in a direct or indirect manner. Discreet qualitative

 

YES

NO

Primary diagnosis

 

Main reason why the patient is being hospitalized Clinical situation which drives the patient to be admitted to the hospital. Binary i.e;:  abdominal hernia.  Yes/no
Intestinal fistula

 

 

Abnormal communication between two epithelial surfaces. Abnormal communication between two surfaces. Binary

 

yes/ no
Intestinal leak Abnormal content discharge from a portion of the gastrointestinal tract. Clinical condition that causes sepsis, secondary to the abnormal  content discharge from the gastrointestinal tract, most common in the first days of treatment.

 

Binary

 

Yes/No
Gastrointestinal anastomosis Surgical conection between two portions of the gastrointestinal tract. The site of surgical repair Binary Yes/ NO
Body mass index Weight (kg)/height (m2) Weight/Size Binary Capture the actual
Fasting Deprived from food and beverage. Due to the patient´s current condition, the doctor prescribed  deprivation from food and beverage (NPO). Binary

Continuos

YES/ NO

 

Number of days

 

 

Body weight

 

Body mass (kg) Body mass (kg) measured by scale. Continuous Number expressed in kilograms.
Height Designates an individual´s height, which is determined by genetic and environmental factor Height measured  in centimeters Quantitative

Continuos

Number expressed in

Centimeters

 

Albumin

Biomarker from the blood test results. Biomarker from the blood test results. Continuous g/L
Types of nutrition Types and forms of the nutritional support

and caloric contribution

Parenteral Nutrition

Enteral Nutrition

Oral Diet

Oral Supplements

Binary

 

 

continuous

Type of feeding: yes/no

 

Caloric intake:

Kcal/day; kcal/kg body weight/day

Protein intake:

g/day; g/kg body weight/day

Nutritional needs Amount of calories necessary to obtain an adequate nutritional balance. Necessary  caloric contribution though different nutritional courses to obtain an adequate nutritional balance. Continuous

 

 

To compare actual intake to goal intake

 

Ocreotide

 

 

Octapeptide derived from somatostatin with an action mechanism that excels somatostatin Drug derived from somatostatin that has similar effects but with a more prolonged action spectrum. Binary

continuous

yes/no

 

 

 

dose

Temporary abdominal closure Clinical situation in which the abdomen is not completely closed. Surgical management takes place as a damage control measure, such as intraabdominal infections or  prevention of elevated intrabdominal pressure Binary

 

What type of temporary abdominal closure was used?

 

Was temporary closure implemented?

 

 

 

Reoperation

Surgical intervention in an individual who had prior surgical repair. Acute Surgical intervention to an individual who had already been previously intervened. Binary yes/no

 

Intensive Care Unit Admission from the general hospital ward to an intensive care unit. Usually for hemodynamic instability or their risk to develop such instability Binary

Continuous

Admitted

Not admitted

 

Number of ICU days

Fistula discharge Amount of fluid discharged. Daily average of fistula effluent. Continuous Number of milliliters.
Data capture

Hospitals and health professionals will be invited to share the required data from patients that fall under the diagnosis of intestinal fistula/leak and are in-hospital at the time of the given date which will be previously selected. The information will be entered into an online platform (Redcap) using a patient identification code but not including unique patient identifiers.

Participating sites will join the survey only after obtaining regulatory approval at their site. Data will be stored on a password-protected server and downloaded to complete the analysis by the research team.

Data analysis

The acquired data will be analyzed using measures of central tendency and standard deviations, using RedCap. Statistical models predicting the development of leak or fistula (high versus low-output ECF) will be developed using logistic regression. P<0.05 will be considered statistically significant.

Limitations of the study

Technological difficulties from the hospitals that don’t have internet access at the given date. Data entry will be made by volunteers, and may not have complete accuracy.

Ethical values applied to this study

Due to the cross-sectional nature of this study, patients’ care will not be intervened upon in any way.  It is unlikely that the ethics reviewers at individual sites will require signed informed consent, but sites must evaluate this individually. The biggest risk may be loss of confidentiality. However, with the use of patient identification codes, not names, addresses or hospital identification codes, this risk minimizes.

Research team's experience on the subject

FELANPE more than 20 years involved in the education and training of clinical nutrition in Latin America.

Dr. Arturo Vergara (Fundación Sta. Fé, Colombia)

Dr.  Manuel Cadena (Fundación Sta. Fé, Colombia)

Dr. Antonio Campos Campos (Brazil)

Dr. Isabel Correia (Brazil)

Dr. Humberto Arenas (México) UFI

Dr. Roberto Anaya (México) UFI

Dr. Juan Fco. García Morales (México) UFI

Dr. Diego Arenas (México) UFI

Dra. Dolores Rodriguez (Ecuador)

Dra. Sarita Betancourt (Ecuador

Dr. Daren Heyland (Canada)

  1. Charlene Compherc (USA)

Dra. Francisca Joly (France)

Available human resources to achieve the project's completion

FELANPE (Latin America)

Latin American surgery societies and academies

ASPEN (Usa y Canadá)

ESPEN(Europa)

PENSA (Asia)

Surgical associated infectious diseases  of Latin America (SISLA)

Nursing Associations and societies

FELAC

Glossary

2nd level: patients in this type of institution have a higher level of complexity than a primary care clinic, this includes pediatrics, obstetrics and gynecology, general surgery and internal medicine, as well as complementary diagnostic services and treatment.

3rd level: This hospital is a social organization, with the purpose of promoting clinical research and formal education. It has a highly specialized staff, as well as the technical resource to develop activities of protection, recovery and rehabilitation with the culture of prevention. Emergency services, patient care 24 hours a day, 364 days a year. With a minimum capacity of 20 hospitalized patients.

Enterocutaneous fistula: established communication between the intestinal epithelium and the skin. It favors the exit of the intraluminal material towards the outer surface and was usually preceded by a digestive leak or an intestinal inflammatory process that favored the loss of the continuity of the visceral wall

Enteroatmospheric Fistula: Loss of the continuity of the visceral wall which is open towards the atmosphere without adhering to the skin. They are usually formed in the context of a hostile abdomen; The intestinal mucosa is evolved in an islet of granulation tissue with the open abdomen. It is usually very difficult to control.

Leak: leakage of digestive tract material, given by a loss of the continuity of the digestive wall secondary to lesions, anastomotic dehiscence and / or raphia intestinalis, which causes localized intra-abdominal infection (abscess) or it may cause diffuse peritonitis.

Adults: Patients above the age of 14 years 11 months.

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