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Recruiting NCT07047729

COMPARATIVE OUTCOME OF EARLY AND STANDARD ORAL FEEDING AFTER EMERGENCY BOWEL SURGERY

No phase Interventional Bowel Surgery Emergency Abdominal Surgery ERAS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Early oral feeding, Standard oral feeding.
Who it may be relevant to
Registry conditions: Bowel Surgery, Emergency Abdominal Surgery, ERAS. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Informed consent will be obtained from patients or their legal representatives in cases where the patient is unconscious. Patient information, including names, ages, gender, smoking history, comorbidities, and the indication for emergency surgical procedures, will be documented. All surgical procedures will follow standard protocols and will be conducted by a single surgical team led by at least two consultants, each with more than five years of experience. All 60 patients will be randomly allocated into two groups using a random number table: Group A (early oral feeding), consisting of 30 patients, and Group B (standard oral feeding), consisting of 30 patients. In Group A, a liquid diet will be initiated within 24 hours after surgery and, if well-tolerated without vomiting, will transition to a regular diet over the subsequent 24 hours. On the other hand, in Group B, a standard diet (late feeding), including liquid filtrates, will only be introduced after the resolution of the ileus, during which these patients will remain NPO (nothing by mouth).

Detailed description

Informed consent will be obtained from patients or their legal representatives in cases where the patient is unconscious. Patient information, including names, ages, gender, smoking history, comorbidities, and the indication for emergency surgical procedures, will be documented. All surgical procedures will follow standard protocols and will be conducted by a single surgical team led by at least two consultants, each with more than five years of experience. All 60 patients will be randomly allocated into two groups using a random number table: Group A (early oral feeding), consisting of 30 patients, and Group B (standard oral feeding), consisting of 30 patients. In Group A, a liquid diet will be initiated within 24 hours after surgery and, if well-tolerated without vomiting, will transition to a regular diet over the subsequent 24 hours. On the other hand, in Group B, a standard diet (late feeding), including liquid filtrates, will only be introduced after the resolution of the ileus, during which these patients will remain NPO (nothing by mouth). Tolerance to oral feeding will be evaluated by monitoring for vomiting within the first 24 hours after initiating a regular diet, and this evaluation will be conducted by the researcher herself. Patients will be discharged from the hospital once they have tolerated a regular diet for at least 24 hours and the duration of hospital stay will be noted as well. All data will be documented on a predefined proforma. Other variables like febrile episode and need for additional NPO will also be recorded.

Interventions

  • Other Early oral feeding
    Liquid diet will be initiated within 24 hours after surgery and, if well-tolerated without vomiting, will transition to a regular diet over the subsequent 24 hours
  • Other Standard oral feeding
    Standard diet (late feeding), including liquid filtrates, will only be introduced after the resolution of the ileus, during which these patients will remain NPO (nothing by mouth).

Primary outcome measures

  • Hospital stay [Time frame: 10 Days]
  • Feed tolerance [Time frame: 24 hours]

Eligibility criteria

Inclusion criteria

  • Either Gender
  • Requiring emergency surgery due to conditions such as obstructive bowel disease, GI perforation, colorectal surgery, blunt abdominal trauma (resulting from falls or roadside accidents), and penetrating abdominal trauma (involving firearm injuries and stab wounds).

Exclusion criteria

  • Patients with terminal cancer need palliative surgery (as their focus is on comfort care rather than surgical intervention).
  • Patients who had undergone surgery within the past 30 days (to avoid potential complications associated with recent surgical procedures).
  • Patients receive regular renal replacement therapy (to prevent additional stress on their medical condition).
  • Pregnant women (as surgical interventions may pose risks to both the mother and the unborn child).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Gulab Devi Hospital Lahore — Lahore

Identifiers

NCT: NCT07047729 · 20

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗