The incidence of clinically significant anastomotic leaks (AL) after upper gastrointestinal (GI) surgery is approximately 4 % - 20 %, and the associated mortality can be as high as 80 % . Nutritional support is a key component of therapy in such cases, related to high prevalence of malnutrition and nil per month required for leak treatment. In the prophylactic setting, before the occurrence of any AL, a literature review based on seven randomised trials showed that enteral nutrition (EN) is associated with shorter hospital stay, lower incidence of severe of infectious complications, lower severity of complications and decreased cost compared to parenteral nutrition (TPN) following major upper GI surgery . In the curative setting, after the AL occurrence, very few evidence is available. Only one randomized clinical trial suggested the superiority of EN versus TPN after pancreatic surgery with a increase of the 30-day fistula closure rate from 37% in the TPN group to 60% in the EN group . This sole randomised study available did not include all postoperative upper GI AL (PUGIAL) that can occur after esophageal, gastric, duodenal, pancreatic surgery (including obesity surgery), whereas the concept of enteral nutritional support is highly relevant for all these situations. However surgeons are usually reluctant to provide EN in case of AL. A randomized study suggested the feasibility of EN in 47 patients with upper GI AL but no randomized study to date has been designed to test the superiority of EN versus TPN in PUGIAL. The study aim is to demonstrate the superiority of EN versus TPN to accelerate AL healing after upper GI surgery. Hypothesis: EN increases the 30-day fistula closure rate in PUGIAL, allowing better HRQOL without increasing morbi-mortality.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
administration of enteral nutrition
administration of parenteral nutrition
Hôpital Claude Huriez, CHU
Lille, France
30-day fistula closure rate
Fistula closure will be defined as an output of no fluid for at least 48 hours in wound or drainage AND absence of any fluid collection on imaging (Computed Tomography scan with injection of contrast product).
Time frame: 30 days after randomization
6-month fistula closure rate
Percentage of patients having their fistula closed according to the definition above within 6 months after randomization
Time frame: at 6 months after randomization
Time to first fistula closure
Time to first fistula closure defined as time in days from randomization to first AL closure within 6 months after randomization
Time frame: at 6 months after randomization
Treatment-related complications
number of patients presenting at least one complication related to the nutritional support (catheter related infection or thrombosis, tube related complication)
Time frame: longitudinal evaluation during all the study duration (from randomization to 6 months)
Postoperative mortality rate
rate of death after operation
Time frame: at 30 days after randomization
Postoperative morbidity rate
rate of patients with a Clavien-Dindo grade 3-4-5 complications
Time frame: at 30 days after randomization
Weight
in kg
Time frame: longitudinal evaluation during all the study duration (from randomization to 6 months)
Albumin and prealbumin
in g/L
Time frame: longitudinal evaluation during all the study duration (from randomization to 6 months)
C reactive protein
mg/L
Time frame: longitudinal evaluation during all the study duration (from randomization to 6 months)
Grip test
muscular strength
Time frame: longitudinal evaluation during all the study duration (from randomization to 6 months)
Length of hospital stay in healthcare structure
Length of hospital stay in healthcare structure (including home hospitalization) based on the number of days of hospitalization
Time frame: from the randomization until the end of hospitalization, up to 6 months
Short form questionnaire 36 (SF-36)
Patient's Health-related quality of life (HRQOL) score. The SF-36 includes a single-item measure of health transition or change. he SF-36® Health Survey items and scales were constructed using the Likert method of summated ratings.4 Answers to each question are scored (some items need to be recoded). These scores are then summed to produce raw scale scores for each health concept which are then transformed to a 0 - 100 scale. Thie higher the score is, the better the quality of life is.
Time frame: at inclusion, day 30, day 60, 3 months and 6 months
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