Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001312538
Ethics application status
Approved
Date submitted
24/07/2024
Date registered
29/10/2024
Date last updated
29/10/2024
Date data sharing statement initially provided
29/10/2024
Date results provided
29/10/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of Mono therapy with' piperacillin/tazobactam 'and multiple drugs therapy for the treatment of perforated appendix in children.
Scientific title
Evaluate the effectiveness of mono therapy with piperacillin/tazobactam and multiple drugs therapy for the treatment of perforated appendix in children: ( from 4 years till 13 years) A randomised control trial.
Secondary ID [1] 312600 0
none
Universal Trial Number (UTN)
none
Trial acronym
none
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
wound infection 334526 0
intra abdominal collection
 334528 0
adhesion obstruction 334533 0
Condition category
Condition code
Surgery 331142 331142 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Research was conducted in Mayo Hospital Lahore Pediatric Surgery Ward
Two groups were made
Group A received monotherapy with piperacillin / tazobactam 100 mg/ kg 8 hourly intravenous for 7 days
Group B received multi drug therapy which included Meropenem 20 mg/kg 8 hourly intravenous and Metronidazole 7.5mg / kg 8 hourly intravenous for 7 days. These drugs started postoperative one day after surgery
Intervention code [1] 329112 0
Treatment: Drugs
Comparator / control treatment
Group B,receiving multi drug therapy was taken as comparator
Control group
Active

Outcomes
Primary outcome [1] 338892 0
wound infection
Timepoint [1] 338892 0
daily during first week post surgery
Secondary outcome [1] 437823 0
intra abdominal collection
Timepoint [1] 437823 0
3 days post surgery
Secondary outcome [2] 438977 0
Adhesion Obstruction
Timepoint [2] 438977 0
6 months post surgery

Eligibility
Key inclusion criteria
Patient having perforated appendix
Age from 4 to 13 years
Given informed consent
Included in this study
Minimum age
4 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
none

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All data was entered and analyzed using SPSS version 23. The quantitative variables were given as mean + /- standard deviation. The qualitative variables were given in frequency and percentage. Comparison was done using Chi square test. p-value < 0.05 will be considered significant

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
25/12/2023
Date of last participant enrolment
Anticipated
Actual
24/06/2024
Date of last data collection
Anticipated
25/12/2024
Actual
Sample size
Target
74
Accrual to date
Final
74
Recruitment outside Australia
Country [1] 26524 0
Pakistan
State/province [1] 26524 0
Punjab

Funding & Sponsors
Funding source category [1] 317027 0
Self funded/Unfunded
Name [1] 317027 0
Dr Nadir Aman
Country [1] 317027 0
Pakistan
Primary sponsor type
Individual
Name
Dr Nadir Aman Resident pediatric surgery mayo hospital lahore pakistan
Address
Country
Pakistan
Secondary sponsor category [1] 319277 0
Individual
Name [1] 319277 0
Dr Mariam rafique resident trainy in pediatric surgery unit mayo hospital Lahore
Address [1] 319277 0
Country [1] 319277 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315784 0
Institutional review board king Edward medical university nila gumbad new anar Kali Lahore Pakistan
Ethics committee address [1] 315784 0
Ethics committee country [1] 315784 0
Pakistan
Date submitted for ethics approval [1] 315784 0
15/09/2023
Approval date [1] 315784 0
24/10/2023
Ethics approval number [1] 315784 0
512

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135782 0
Dr Nadir Aman
Address 135782 0
Pediatric surgery unit mayo hospital Lahore Pakistan near anar kali
Country 135782 0
Pakistan
Phone 135782 0
+92428500478
Fax 135782 0
Email 135782 0
[email protected]
Contact person for public queries
Name 135783 0
Nadir Aman
Address 135783 0
Pediatric surgery unit mayo hospital Lahore Pakistan near anar kali street 567
Country 135783 0
Pakistan
Phone 135783 0
+92428500478
Fax 135783 0
Email 135783 0
[email protected]
Contact person for scientific queries
Name 135784 0
Nadir Aman
Address 135784 0
Pediatric surgery unit mayo hospital Lahore near anar kali street 567
Country 135784 0
Pakistan
Phone 135784 0
+92428500478
Fax 135784 0
Email 135784 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24015Ethical approval24-10-2923 [email protected] 388181-(Uploaded-24-07-2024-04-36-00)-Photo to PDF_2024-07-23_22-59-02.pdf



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.