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

NCT07047729 | Recruiting

• 1 other identifier: 20
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Bowel Surgery; Emergency Abdominal Surgery; ERAS

Outcome Measures

Primary Outcomes (2)

• Hospital stay

  Duration from day of surgery till discharge following discharge criteria

  10 Days

• Feed tolerance

  Tolerance to oral feeding will be evaluated by monitoring for vomiting within the first 24 hours after initiating a regular diet

  24 hours

Study Arms (2)

Group A with early oral feeding (ERAS)

EXPERIMENTAL

Group A (early 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. Tolerance to oral feeding will be evaluated by monitoring for vomiting within the first 24 hours after initiating a regular diet. 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.

Other: Early oral feeding

Group B with standard oral feeding

EXPERIMENTAL

Group B (standard oral feeding), consisting of 30 patients. 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. 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.

Other: Standard oral feeding

Interventions

Early oral feeding OTHER

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

Group A with early oral feeding (ERAS)

Standard oral feeding OTHER

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).

Group B with standard oral feeding

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Dr Hamail Khanum: lead

Study Sites (1)

Gulab Devi Hospital Lahore

Lahore, Punjab Province, 05307, Pakistan

RECRUITING

Study Officials

• Professor Dr Maratab Ali, MBBS FCPS

  Gulab Devi Hospital

  STUDY DIRECTOR

Central Study Contacts

Dr Umnah Noor, MBBS

CONTACT

+923414498885; umnahnoor@gmail.com

Dr Hamail Khanum, MBBS

CONTACT

+923235511997; hamailkhanum@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: March 6, 2025
• Primary Completion: September 6, 2025
• Study Completion: September 6, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)