Early Feeding Versus Conventional Feeding

January 13, 2023 updated by: Sajid Ali,FCPS, DHQ mardan

Effectiveness of Early Feeding Versus Conventional Feeding After Stoma Reversal in Adult Surgical Surgical Practices

The goal of this clinical trial is to compare early feeding vs conventional feeding after stoma reversal. The main question it aims to answer are:

• whether it is beneficial to start oral feeding within 12hrs after stoma reversal

Participants will be randomly assigned two groups either early feeding or conventional group

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Kpk
      • Mardan, Kpk, Pakistan, 25300
        • DHQ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • having ileostomy
  • no peritonitis
  • intestinal obstruction

Exclusion Criteria:

  • uncontrolled diabetes
  • uncontrolled hypertension
  • sepsis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: early feeding group
after stoma reversal in patients in this group oral feeding was started with in 12 hrs after surgery
Other: early feeding
oral feeding within 12hours after stoma reversal
Active Comparator: conventional feeding group
after stoma reversal in patients in this group oral feeding was started 48hrs after surgery
Procedure: conventional feeding
oral feeding after 48hours of NBM after stoma reversal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the outcome of early versus conventional oral feeding in stoma reversal in terms of postoperative ileus
Time Frame: 5days
comparison of post-op anastomotic leakage hospital stay wound infection
5days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DHQ mardan

Collaborators

DHQ HOSPITAL MARDAN

Investigators

  • Principal Investigator: sajid khan, fcps, DHQ mardan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2020

Primary Completion (Actual)

June 10, 2022

Study Completion (Actual)

July 10, 2022

Study Registration Dates

First Submitted

December 26, 2022

First Submitted That Met QC Criteria

December 26, 2022

First Posted (Actual)

January 11, 2023

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 278-41

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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