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

NCT ID: NCT07047729

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-06
• Study Completion Date: 2025-09-06

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).

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.

Conditions

Bowel Surgery; Emergency Abdominal Surgery; ERAS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A with early oral feeding (ERAS)

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.

Group Type: EXPERIMENTAL

Early oral feeding

Intervention Type: 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 B with standard oral feeding

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.

Group Type: EXPERIMENTAL

Standard oral feeding

Intervention Type: 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).

Interventions

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

Intervention Type: 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).

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr Hamail Khanum

OTHER

Sponsor Role: lead

Responsible Party

Dr Hamail Khanum

Consultant

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Professor Dr Maratab Ali, MBBS FCPS

Role: STUDY_DIRECTOR

Gulab Devi Hospital

Locations

Gulab Devi Hospital Lahore

Lahore, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Dr Umnah Noor, MBBS

Role: CONTACT

umnahnoor@gmail.com

+923414498885

Dr Hamail Khanum, MBBS

Role: CONTACT

hamailkhanum@gmail.com

+923235511997

Facility Contacts

Prof Dr Maratab Ali, MBBS, FCPS

Role: primary

maratabali@hotmail.com

+923009416942

Other Identifiers

20

Identifier Type: -

Identifier Source: org_study_id