NCT06906289

Brief 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 guidelines suggest early feeding. The aim of this study is to compare the early and late resumption of oral feeding.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 2, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

1.2 years

First QC Date

March 19, 2025

Last Update Submit

March 25, 2025

Conditions

Keywords

Enhanced Recover After SurgeryHospital StayPostoperative vomitingAnastomotic leak

Outcome Measures

Primary Outcomes (1)

  • 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).

    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

    Upto 50 weeks postoperatively ,From surgery to discharge or death , whichever comes first.

  • Vomiting

    Upto 50 weeks postoperatively ,From surgery to discharge or death , whichever comes first.

Study Arms (2)

Early group

EXPERIMENTAL

Early group includes patients in whom enteral feeding is resumed within 24 hours once fully conscious from effects of anesthesia

Other: resumption of enteral feeding within 24 hours of surgeryOther: 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

Other: resumption of enteral feeding within 24 hours of surgeryOther: resumption of enteral feeding after 24-48 hours

Interventions

Patients will be subjected to resumption of enteral feeding within 24 hours of surgery

Early groupLate group

Patients will be subjected to late resumption of enteral feeding after 24 to 48 hours of surgery

Early groupLate group

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients undergoing small bowel anastomosis for any indication in elective setting
  • Patients of age between 15 to 65 years.
  • All genders

You may not qualify if:

  • Patient using glucocorticoids or other immunosuppressive drugs
  • non conseting individuals
  • Patient having history of gastrectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khyber Teaching Hospital

Peshawar, KPK, 25000, Pakistan

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and VomitingAnastomotic LeakFlatulence

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Central Study Contacts

Saeed Sarwar, MBBS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 19, 2025

First Posted

April 2, 2025

Study Start

October 1, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

April 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Data about patients will not be shared due to confidentiality issues.

Locations