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Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
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Trial registered on ANZCTR
Registration number
ACTRN12625000914460
Ethics application status
Approved
Date submitted
27/05/2025
Date registered
22/08/2025
Date last updated
22/08/2025
Date data sharing statement initially provided
22/08/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Postoperative effect of chewing gum on paediatric stoma reversal: A Randomized Controlled Trial
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Scientific title
Postoperative Impact of chewing gum on paediatric stoma reversal: A Randomized Controlled Trial
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Secondary ID [1]
314524
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nil
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Universal Trial Number (UTN)
The Universal Trial Number (UTN) is U1111-1323-2760
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
pediatric stomas
337618
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colostomy
337619
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ileostomy
337620
0
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post operative ileus
337621
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Condition category
Condition code
Surgery
333953
333953
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0
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Other surgery
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Oral and Gastrointestinal
333954
333954
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
In this study ,we will use hilal bubble gum which is a standard company manufacturing standard gums nationally. There will 2 arms.one arm will receive chewing gum 24 hours post operatively(intervention) every 3 hours, for 3 days. After every 3hours mother or care giver is advised to collect amount of un used gum, which will be recorded every 12 hours. Gum will be provided free of cost. while another arm will not receive it. Same age and disease groups will be selected for the study.
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Intervention code [1]
331160
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Treatment: Surgery
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Comparator / control treatment
The group not receiving chewing is control group.
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Control group
Active
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Outcomes
Primary outcome [1]
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To determine duration of POST OPERATIVE ILEUS in both groups.
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Assessment method [1]
341605
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data will be collected regarding passage of stool or flatus every 4 hourly postoperatively.
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Timepoint [1]
341605
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every 4 hours after intervention till return of bowel function in form of passage of flatus or stool.
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Secondary outcome [1]
448055
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length of hospital stay
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Assessment method [1]
448055
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it is assessed by physical visit of data collector to patient and interacting with care giver.
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Timepoint [1]
448055
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This will be around the time of discharge from the hospital. These data will include • Morbidity • Postoperative recovery course • Length of hospital stay • time to full enteral feeds
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Eligibility
Key inclusion criteria
children planned for stoma reversal, older than 7 years and less than 18 years.
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Minimum age
7
Years
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
i. patients with documented allergies to the contents of chewing gum.
ii. Patients with a diagnosis of diabetes mellitus disease at the time of surgery.
iii. Patients who will be unconscious or unable to chew gum after 24 hours post-surgery.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomization by computer.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerized sequence generation
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
31/08/2025
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Actual
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Date of last participant enrolment
Anticipated
31/08/2026
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Actual
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Date of last data collection
Anticipated
31/08/2026
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
27087
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Pakistan
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State/province [1]
27087
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khyber pukhtoon khwa
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Funding & Sponsors
Funding source category [1]
319076
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Charities/Societies/Foundations
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Name [1]
319076
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Aftab welfare trust
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Address [1]
319076
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Country [1]
319076
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Pakistan
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Primary sponsor type
Charities/Societies/Foundations
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Name
Aftab welfare trust
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Address
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Country
Pakistan
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Secondary sponsor category [1]
321536
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Individual
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Name [1]
321536
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Muhammad Kabir, senior registrar,saidu group of teaching hospital swat.
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Address [1]
321536
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Country [1]
321536
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Pakistan
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317673
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Ethical review board Saidu Medical Colledge
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Ethics committee address [1]
317673
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Ethical review board ,2nd floor ,Saidu medical college ,Saidu sharif swat. Po box no 19200.
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Ethics committee country [1]
317673
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Pakistan
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Date submitted for ethics approval [1]
317673
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03/02/2025
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Approval date [1]
317673
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18/02/2025
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Ethics approval number [1]
317673
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Summary
Brief summary
This study assess the role of chewing gum in pediatric post operative ileus(POI) following stoma closure.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
141770
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Dr Muhammad kabir
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Address
141770
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senior registarar,pediatric surgery unit,saidub group of teaching hospital swat,KPK,Pakistan.post code.19200
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Country
141770
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Pakistan
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Phone
141770
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+92 03425668673
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Fax
141770
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Email
141770
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[email protected]
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Contact person for public queries
Name
141771
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muhammad kabir
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Address
141771
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senior registarar,pediatric surgery unit,saidub group of teaching hospital swat,KPK,Pakistan.post code.19200
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Country
141771
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Pakistan
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Phone
141771
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+923425668673
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Fax
141771
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Email
141771
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[email protected]
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Contact person for scientific queries
Name
141772
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muhammad kabir
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Address
141772
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senior registarar,pediatric surgery unit,saidub group of teaching hospital swat,KPK,Pakistan.post code.19200
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Country
141772
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Pakistan
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Phone
141772
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+92 03425668673
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Fax
141772
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Email
141772
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Anyone
Conditions for requesting access:
•
No requirements
What individual participant data might be shared?
•
De-identified individual participant data:
•
All outcomes data
•
Published results
What types of analyses could be done with individual participant data?
•
Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of:
3
years
Where can requests to access individual participant data be made, or data be obtained directly?
•
Email of trial custodian, sponsor or committee:
[email protected]
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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