Enteral Nutrition in Acute Generalized Peritonitis

Study Overview
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Brief Summary
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Hospitals in South Kivu always have problems supplying artificial enteral nutritional products because of their high cost and low availability in our areas. While the Province has cereals, knowing their nutritional composition would enable the formulation of a nutritional product based on local protein-energy products. Hence the questions below: Can a local cereal-based protein-energy ration be used instead of a costly imported artificial nutritional solution to improve the nutritional status of patients operated on for PAG? What is the tolerance of this early enteral nutrition on the healing and functional recovery of patients compared with an artificial nutritional solution? To answer these questions, a randomized clinical trial has been designed with the following objectives: To formulate an enteral diet using cereals available in our environment with a protein-calorie composition superimposable on the artificial enteral ration, Evaluate the tolerance and advantages of early enteral nutrition with a locally manufactured protein-caloric ration vs. a commercially available artificial nutritional solution in patients undergoing surgery for PAG.

Official Title
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Effects of Early Enteral Nutrition With a Locally Produced Protein-energy Ration Versus a Marketed Nutritional Solution in Patients Operated on for Acute Generalized Peritonitis

Conditions
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Enteral and Supplement Feeds Adverse Reaction, Peritonitis; Acute

Intervention / Treatment
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* Dietary Supplement: study group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient operated for peritonitis with intestinal suture during treatment have a q-SOFA score of 1 to 2 surgeon's agreement to enteral feeding at risk of malnutrition (BMC) Exclusion Criteria: q SOFA score > 2 patients with tare (diabetes, HIV, renal failure)

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>an intervention arm consisting of patients who will receive the locally manufactured protein-energy ration after a laparotomy indicated for generalized acute peritonitis | Dietary Supplement: study group<br>* Patients will receive early enteral locally nutrition postoperatively following surgery for peritonitis<br>|
| Active Comparator: control group<br>patients who will receive the commercially available protein-energy ration after a laparotomy indicated for generalized acute peritonitis | Dietary Supplement: study group<br>* Patients will receive early enteral locally nutrition postoperatively following surgery for peritonitis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of feeding | We will screen complications after feeding | 10 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nutritional surveillance | changes in nutritional status using body mass index, albumin measurement, anthropometric data | 2 days after, 5 days after, 10 days after feeding |