Enteral Nutrition in Acute Generalized Peritonitis

NCT ID: NCT05997745

Last Updated: 2023-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-20

Study Completion Date

2023-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Enteral and Supplement Feeds Adverse Reaction Peritonitis; Acute

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

study group

Intervention Type DIETARY_SUPPLEMENT

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

control group

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

Group Type ACTIVE_COMPARATOR

study group

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

study group

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Université Evangélique enAfrique

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

JEAN PAUL CIKWANINE, MASTER

Role: CONTACT

+243990860491

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.