Enteral Nutrition in Acute Generalized Peritonitis

Not Applicable

Not yet recruiting

• Conditions: Enteral and Supplement Feeds Adverse Reaction; Peritonitis; Acute
• Interventions: Dietary Supplement: study group

• Registration Number: NCT05997745
• Lead Sponsor: Université Evangélique enAfrique

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-08-07
• Study First Submitted QC: 2023-08-11
• Last Update Submitted: 2023-08-11
• Study First Posted: 2023-08-18
• Last Update Posted: 2023-08-18
• Study Start: 2023-08-20
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 76

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	study group	an intervention arm consisting of patients who will receive the locally manufactured protein-energy ration after a laparotomy indicated for generalized acute peritonitis
control group	study group	patients who will receive the commercially available protein-energy ration after a laparotomy indicated for generalized acute peritonitis

Primary Outcome Measures

Name	Time	Method
Tolerability of feeding	10 days after surgery	We will screen complications after feeding

Secondary Outcome Measures

Name	Time	Method
nutritional surveillance	2 days after, 5 days after, 10 days after feeding	changes in nutritional status using body mass index, albumin measurement, anthropometric data