COMPARATIVE OUTCOME OF EARLY AND STANDARD ORAL FEEDING AFTER EMERGENCY BOWEL SURGERY
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDr Hamail Khanum
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Early oral feeding
Other interventionLiquid 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
Standard oral feeding
Other interventionStandard 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).
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Group A with early oral feeding (ERAS)Experimental treatment 1 intervention
Group B: Group B with standard oral feedingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Hospital stay
Duration from day of surgery till discharge following discharge criteria
Time frame
10 Days2
Feed tolerance
Tolerance to oral feeding will be evaluated by monitoring for vomiting within the first 24 hours after initiating a regular diet
Time frame
24 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dr Hamail Khanum
Lead sponsor
Gulab Devi Hospital
Sponsor institution
Source ClinicalTrials.gov