Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000215426
Ethics application status
Approved
Date submitted
10/03/2007
Date registered
20/04/2007
Date last updated
25/03/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomized clinical trial to compare the length of postoperative hospital stay and early morbidity for fast track care versus traditional care after open appendectomy
Scientific title
Randomized clinical trial to compare the length of postoperative hospital stay and early morbidity for fast track care versus traditional care after open appendectomy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Appendectomy 1743 0
Condition category
Condition code
Oral and Gastrointestinal 1834 1834 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fast track protocol consist on
1. preoperative counselling consists of two sessions of 5 minutes duration each: the first after examination and qualification a patient for the appendectomy, and the second before signing a consent

2. early postoperative oral feeding commenced 6 hours after operation and gradually increased from 30 ml of fluids every hour to solid diet as tolerated by a patient
3. opioid-sparing analgesia (paracetamol started 1g per rectum applied immediately after operation and followed by oral 1g 6-8 hourly + indomethacin oral, 25mg 8 hourly, pethidine parenterally, 1mg per kilogram of body weight only if needed as a rescue analgesia

Patients were discharged when passed flatus or stools and tolerate solid diet, and had no complications requiring hospitalization. Patients were observed in the study until discharge from the hospital and were followed up on 7th postoperative day for complications.
Intervention code [1] 1546 0
Treatment: Surgery
Comparator / control treatment
Traditional care protocol (control)
1. postoperative fasting until the patient passes first flatus or stools, or bowel sounds could be heard
2. opioid-based analgesia: pethidine parenterally, 1 mg per kilogram body weight until the patient resumes oral diet
Control group
Active

Outcomes
Primary outcome [1] 2566 0
Length of postoperative hospital stay
Timepoint [1] 2566 0
Measured from the operation to the discharge from the hospital
Primary outcome [2] 2567 0
Morbidity
Timepoint [2] 2567 0
During primary postoperative hospital stay and readmissions, and 7 days after appendectomy
Secondary outcome [1] 4422 0
time to:
bowel sounds timepoints: at 1,2,3* postoperative days
passage either of flatus or stools timepoints: at 1,2,3* postoperative days
tolerance of solid diet timepoints: at 1,2,3* postoperative days and daily until the discharge
facial visual pain score timepoints: at 1,2 postoperative days
* - measuring the outcome variables on the 3rd postoperative was conditional provided the patient had not yet been discharged from the hospital
Timepoint [1] 4422 0

Eligibility
Key inclusion criteria
all consecutive patients who underwent open appendectomy; obtained informed written consent
Minimum age
10 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No consent obtained, age < 10 years, pregnancy Exit criteria: withdrowal of the consent,noncompliance with the protocol.

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)
Allocation was concealed by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by hand drawing the sequence from a box
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/06/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment outside Australia
Country [1] 470 0
Papua New Guinea
State/province [1] 470 0

Funding & Sponsors
Funding source category [1] 1983 0
University
Name [1] 1983 0
Divine Word University
Country [1] 1983 0
Papua New Guinea
Funding source category [2] 1984 0
Hospital
Name [2] 1984 0
Modilon General Hospital
Country [2] 1984 0
Papua New Guinea
Primary sponsor type
University
Name
Divine Word University
Address
Country
Papua New Guinea
Secondary sponsor category [1] 1796 0
Hospital
Name [1] 1796 0
Modilon General Hospital
Address [1] 1796 0
PO Box 2119, Madang 511, Papua New Guinea
Country [1] 1796 0
Papua New Guinea

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3683 0
Research Ethics Committee at Divine Word University
Ethics committee address [1] 3683 0
Madang, Papua New Guinea
Ethics committee country [1] 3683 0
Papua New Guinea
Date submitted for ethics approval [1] 3683 0
Approval date [1] 3683 0
Ethics approval number [1] 3683 0

Summary
Brief summary
The primary aim of the study: to determine if fast track care protocol which consists on early postoperative oral feeding and opioid-sparing analgesia is safe, feasible and beneficial. Based on the earlier studues on fast track protocol after colorectal surgery we hypothetized that it will safe and beneficial after appendectomy
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27480 0
Address 27480 0
Country 27480 0
Phone 27480 0
Fax 27480 0
Email 27480 0
Contact person for public queries
Name 10735 0
Jerzy Kuzma
Address 10735 0
PO Box 483, DWU,
Madang
Country 10735 0
Papua New Guinea
Phone 10735 0
(675) 8522776
Fax 10735 0
(675) 8522812 or 8522853
Email 10735 0
[email protected]
Contact person for scientific queries
Name 1663 0
Jerzy Kuzma
Address 1663 0
PO Box 483
DWU
Madang
Country 1663 0
Papua New Guinea
Phone 1663 0
(675)8522776
Fax 1663 0
(675) 8522812 0r 8522853
Email 1663 0
[email protected]

No information has been provided regarding IPD availability


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
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