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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04803422




Registration number
NCT04803422
Ethics application status
Date submitted
27/02/2021
Date registered
17/03/2021

Titles & IDs
Public title
Per Oral Versus Intravenous Postoperative Antibiotics After Surgery for Complicated Appendicitis.
Scientific title
Per Oral Versus Intravenous Postoperative Antibiotics After Surgery for Complicated Appendicitis: A Cluster Randomized Cluster Crossover Non-Inferiority Study.
Secondary ID [1] 0 0
P-2021-27
Universal Trial Number (UTN)
Trial acronym
PIPA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Complicated Appendicitis 0 0
Condition category
Condition code
Surgery 0 0 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Antibiotic

Active comparator: Arm 1- Postoperative Course - Pre-or intraoperative antibiotics (both uncomplicated and complicated) appendicits: Single-dose inj. Metronidazole and Pipperacillin/Tazobactam. In case of allergy to penicillin: Single-dose inj. Metronidazole and intravenous inj. Cefuroxim.

First 6 month: Tablet Amoxicillin/Clavulanic Acid and Tablet Metronidazole.In case of allergy to Penicillin: Tablet Metronidazole and Tablet Ciprofloxacillin.

Last 6 month: Intravenous Metronidazole and Intravenous Pipperacillin / Tazobactam. In case of allergy to penicillin: Intravenous Metronidazole and Intravenous Cefuroxim.

Active comparator: Arm 2 - Postoperative Course - Pre-or intraoperative antibiotics (both uncomplicated and complicated) appendicits: Single-dose inj. Metronidazole and Pipperacillin/Tazobactam. In case of allergy to penicillin: Single-dose inj. Metronidazole and intravenous inj. Cefuroxim.

First 6 month: Intravenous Metronidazole and Intravenous Pipperacillin / Tazobactam. In case of allergy to penicillin: Intravenous Metronidazole and Intravenous Cefuroxim.

Last 6 month: Tablet Amoxicillin/Clavulanic Acid and Tablet Metronidazole.In case of allergy to Penicillin: Tablet Metronidazole and Tablet Ciprofloxacillin.


Treatment: Drugs: Antibiotic
The study aims to test whether oral antibiotics is non-inferior compared to intravenous antibiotics.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Intra-abdominal abscess
Timepoint [1] 0 0
Assessed at postoperative day 30
Secondary outcome [1] 0 0
postoperative stay
Timepoint [1] 0 0
The event is assessed at postoperative day 30. The event is determnied beginning from the time the surgery ends till the time the patient is discharged from the hospital.
Secondary outcome [2] 0 0
Complications according to Clavien-Dindo Classifcation
Timepoint [2] 0 0
Assessed at postoperative day 30
Secondary outcome [3] 0 0
Costs
Timepoint [3] 0 0
Assessed at postoperative day 30. Data for both in- and outpatient costs will be extracted from the Danish Health Authority
Secondary outcome [4] 0 0
Wound infection
Timepoint [4] 0 0
Assessed postoperative day 30

Eligibility
Key inclusion criteria
* On cluster level, hospitals with emergency surgical admissions performing laparoscopic appendectomies are eligible for inclusion.
* On an individual level, participants are eligible for inclusion if they undergo a laparoscopic appendectomy for appendicitis (both uncomplicated and complicated), are = 18 years of age, and provide a signed written consent form.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Exclusion criteria are specifically related to the therapy and individual participants will be excluded if they undergo any other procedures than laparoscopic appendectomy during index surgery.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2024
Sample size
Target
Accrual to date
Final
3193
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Slagelse

Funding & Sponsors
Primary sponsor type
Other
Name
Zealand University Hospital
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04803422