Bowel SurgeryNCT07047729
COMPARATIVE OUTCOME OF EARLY AND STANDARD ORAL FEEDING AFTER EMERGENCY BOWEL SURGERY
A study testing Early oral feeding and Standard oral feeding in people with Bowel Surgery and Emergency Abdominal Surgery, run by Dr Hamail Khanum at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Surgery, Emergency Abdominal Surgery, ERAS
- What is being tested?
- Early oral feeding and Standard oral feeding
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Mar 2025to 6 Sep 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Gulab Devi Hospital Lahore
Lahore, Punjab Province, 05307
Prof Dr Maratab Ali, MBBS, FCPS, +923009416942, maratabali@hotmail.com
About this study
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).
Read the 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
- Being tested
- Early oral feeding, Standard oral feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early oral feedingOther
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
Standard oral feedingOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard oral feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital stay
Duration from day of surgery till discharge following discharge criteria
Measured: 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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start6 Mar 2025
- Primary completion6 Sep 2025 (estimated)
- Study completion6 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Hamail Khanum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Hamail Khanum, Gulab Devi Hospital
- Investigators
- Professor Dr Maratab Ali, MBBS FCPS, Study director, Gulab Devi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047729
- Sponsor's protocol ID
- 20
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No