Enhanced Recovery After SurgeryNCT06906289
Resumption of Enteral Feeding After Bowel Anastomosis
A study testing resumption of enteral feeding within 24 hours of surgery and resumption of enteral feeding after 24-48 hours in people with Enhanced Recovery After Surgery and Hospital Stay, Length of Stay in Hospital From Time of Surgery Till Discharge, run by Khyber Teaching Hospital at 1 site in Pakistan.
Trial summary
Resumption of oral feeding after small intestine surgery is a matter of controversy .Some surgeons advocate early resumption while others don't.early feeding is initiated as soon as the patient recovers from effects of anaesthesia, while late resumption is started after 24-48 hours after surgery.Recent studies and… Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Enhanced Recovery After Surgery, Hospital Stay, Length of Stay in Hospital From Time of Surgery Till Discharge, Defecation
- What is being tested?
- resumption of enteral feeding within 24 hours of surgery and resumption of enteral feeding after 24-48 hours
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients undergoing small bowel anastomosis for any indication in elective setting
- Patients of age between 15 to 65 years.
- All genders
Who cannot join
- Patient using glucocorticoids or other immunosuppressive drugs
- non conseting individuals
- Patient having history of gastrectomy
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
Khyber Teaching Hospital
Peshawar, KPK, 25000
Saeed Sarwar, MBBS, +923420973863, saeedkmc2020@gmail.com
About this study
Official title: Comparison of Early Versus Late Resumption of Enteral Feeding After Small Bowel Anastomosis.
Resumption of oral feeding after small intestine surgery is a matter of controversy .Some surgeons advocate early resumption while others don't.early feeding is initiated as soon as the patient recovers from effects of anaesthesia, while late resumption is started after 24-48 hours after surgery.Recent studies and guidelines suggest early feeding. The aim of this study is to compare the early and late resumption of oral feeding.
- Conditions
- Enhanced Recovery After Surgery, Hospital Stay, Length of Stay in Hospital From Time of Surgery Till Discharge, Defecation, Vomiting, Postoperative, Anastomotic Leak, Flatus
- Being tested
- resumption of enteral feeding within 24 hours of surgery, resumption of enteral feeding after 24-48 hours
- Keywords
- Enhanced Recover After Surgery, Hospital Stay, Postoperative vomiting, Anastomotic leak
- Medical subject headings
- Postoperative Nausea and Vomiting, Anastomotic Leak, Flatulence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resumption of enteral feeding within 24 hours of surgeryOther
Patients will be subjected to resumption of enteral feeding within 24 hours of surgery
resumption of enteral feeding after 24-48 hoursOther
Patients will be subjected to late resumption of enteral feeding after 24 to 48 hours of surgery
| Study group | Role | What they receive |
|---|---|---|
| Early group | Experimental | Early group includes patients in whom enteral feeding is resumed within 24 hours once fully conscious from effects of anesthesia Receives: Other: resumption of enteral feeding within 24 hours of surgery; Other: resumption of enteral feeding after 24-48 hours |
| Late group | Experimental | Late group includes patients in whom enteral feeding is started 24-48 hours after recovery from anesthesia Receives: Other: resumption of enteral feeding within 24 hours of surgery; Other: resumption of enteral feeding after 24-48 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to passage of stool/flatus
Time to passage of stool or flatus after surgery ,as reported by the patient or noticed by nurse.Time will be measured in day(s).
Measured: Upto 2 weeks from surgery .From the time of surgery to passage of stool or flatus or death due to any cause, whichever comes first.
Secondary outcomes (2)
Hospital stay
Number of days spent at hospital from time of surgery till discharge from hospital
Measured: Upto 50 weeks postoperatively ,From surgery to discharge or death , whichever comes first.
Vomiting
if vomiting occured or not during time of study.
Measured: Upto 50 weeks postoperatively ,From surgery to discharge or death , whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start1 Oct 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enhanced Recovery After 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khyber Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Saeed Sarwar, Khyber Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906289
- Sponsor's protocol ID
- 806/DME/KMC
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data about patients will not be shared due to confidentiality issues.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Early Versus Late Resumption of Enteral Feeding After Small Bowel Anastomosis.
- ClinicalTrials.gov ID
- NCT06906289
- Acronym / sponsor ID
- 806/DME/KMC
- Conditions
- Enhanced Recovery After Surgery, Hospital Stay, Length of Stay in Hospital From Time of Surgery Till Discharge, Defecation, Vomiting, Postoperative, Anastomotic Leak, Flatus
- Keywords
- Enhanced Recover After Surgery, Hospital Stay, Postoperative vomiting, Anastomotic leak
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Khyber Teaching HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Resumption of oral feeding after small intestine surgery is a matter of controversy .Some surgeons advocate early resumption while others don't.early feeding is initiated as soon as the patient recovers from effects of anaesthesia, while late resumption is started after 24-48 hours after surgery.Recent studies and guidelines suggest early feeding. The aim of this study is to compare the early and late resumption of oral feeding.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early group | Experimental | Other: resumption of enteral feeding within 24 hours of surgery, Other: resumption of enteral feeding after 24-48 hoursEarly group includes patients in whom enteral feeding is resumed within 24 hours once fully conscious from effects of anesthesia |
| Late group | Experimental | Other: resumption of enteral feeding within 24 hours of surgery, Other: resumption of enteral feeding after 24-48 hoursLate group includes patients in whom enteral feeding is started 24-48 hours after recovery from anesthesia |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- All patients undergoing small bowel anastomosis for any indication in elective setting
- Patients of age between 15 to 65 years.
- All genders
Key exclusion criteria (3 listed)
- Patient using glucocorticoids or other immunosuppressive drugs
- non conseting individuals
- Patient having history of gastrectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| resumption of enteral feeding within 24 hours of surgeryPatients will be subjected to resumption of enteral feeding within 24 hours of surgery | Other | Early group, Late group |
| resumption of enteral feeding after 24-48 hoursPatients will be subjected to late resumption of enteral feeding after 24 to 48 hours of surgery | Other | Early group, Late group |
Primary outcome
Time to passage of stool/flatus
Time frame: Upto 2 weeks from surgery .From the time of surgery to passage of stool or flatus or death due to any cause, whichever comes first.
Time to passage of stool or flatus after surgery ,as reported by the patient or noticed by nurse.Time will be measured in day(s).
2 secondary outcomes
Hospital stay
Time frame: Upto 50 weeks postoperatively ,From surgery to discharge or death , whichever comes first.
Vomiting
Time frame: Upto 50 weeks postoperatively ,From surgery to discharge or death , whichever comes first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No. Data about patients will not be shared due to confidentiality issues.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resumption of enteral feeding within 24 hours of surgery and resumption of enteral feeding after 24-48 hours in people with Enhanced Recovery After Surgery and Hospital Stay, Length of Stay in Hospital From Time of Surgery Till Discharge, run by Khyber Teaching Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saeed Sarwar, MBBS (+92342 0973863, saeedkmc2020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to passage of stool/flatus (time frame: Upto 2 weeks from surgery .From the time of surgery to passage of stool or flatus or death due to any cause, whichever comes first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.