Enteral Nutrition in Acute Generalized Peritonitis

NCT05997745 | Unknown

• 1 other identifier: 002
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Enteral and Supplement Feeds Adverse Reaction; Peritonitis; Acute

Outcome Measures

Primary Outcomes (1)

• Tolerability of feeding

  We will screen complications after feeding

  10 days after surgery

Secondary Outcomes (1)

• nutritional surveillance

  2 days after, 5 days after, 10 days after feeding

Study Arms (2)

study group

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

patients who will receive the commercially available protein-energy ration after a laparotomy indicated for generalized acute peritonitis

Dietary Supplement: study group

Interventions

study group DIETARY_SUPPLEMENT

Patients will receive early enteral locally nutrition postoperatively following surgery for peritonitis

control group; study group

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• q SOFA score \> 2
• patients with tare (diabetes, HIV, renal failure)

Sponsors & Collaborators

• Université Evangélique enAfrique: lead

MeSH Terms

Conditions

Peritonitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases

Central Study Contacts

JEAN PAUL CIKWANINE, MASTER

CONTACT

+243990860491; jpcikwa1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 18, 2023
• Study Start: August 20, 2023
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: August 18, 2023

Record last verified: 2023-07