NCT05680428

Brief Summary

The goal of this clinical trial is to compare early feeding vs conventional feeding after stoma reversal. The main question it aims to answer are: • whether it is beneficial to start oral feeding within 12hrs after stoma reversal Participants will be randomly assigned two groups either early feeding or conventional group

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 10, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

2.4 years

First QC Date

December 26, 2022

Last Update Submit

January 13, 2023

Conditions

Ileostomy - Stoma

Outcome Measures

Primary Outcomes (1)

  • To evaluate the outcome of early versus conventional oral feeding in stoma reversal in terms of postoperative ileus

    comparison of post-op anastomotic leakage hospital stay wound infection

    5days

Study Arms (2)

early feeding group

EXPERIMENTAL

after stoma reversal in patients in this group oral feeding was started with in 12 hrs after surgery

Other: early feeding

conventional feeding group

ACTIVE COMPARATOR

after stoma reversal in patients in this group oral feeding was started 48hrs after surgery

Procedure: conventional feeding

Interventions

early feedingOTHER

oral feeding within 12hours after stoma reversal

early feeding group
conventional feedingPROCEDURE

oral feeding after 48hours of NBM after stoma reversal

conventional feeding group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • having ileostomy
  • no peritonitis
  • intestinal obstruction

You may not qualify if:

  • uncontrolled diabetes
  • uncontrolled hypertension
  • sepsis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DHQ

Mardan, Kpk, 25300, Pakistan

Location

Study Officials

  • sajid khan, fcps

    DHQ mardan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
consultant General Surgeon

Study Record Dates

First Submitted

December 26, 2022

First Posted

January 11, 2023

Study Start

January 10, 2020

Primary Completion

June 10, 2022

Study Completion

July 10, 2022

Last Updated

January 18, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)