Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001142426
Ethics application status
Approved
Date submitted
26/11/2014
Date registered
22/08/2016
Date last updated
23/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is telephone consultation a safe, satisfactory and cost-effective alternative to outpatient review for follow up post emergency laparoscopic appendicectomy and cholecystectomy?
Scientific title
In patients who have received emergency laparoscopic appendicectomy or cholecystectomy, is telephone consultation at 10-14 days after operation more effective than outpatient clinic review in terms of patient satisfaction level, follow-up attendance rate, complication rate and cost?
Secondary ID [1] 285747 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MORPH protocol
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emergency laparoscopic appendicectomy and cholecystectomy 293634 0
Condition category
Condition code
Surgery 293929 293929 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Post-operative review by telephone consultation at day 10-14 after operation. Telephone consultation will be performed by surgical registrars or interns within a duration of 15 minutes.
Intervention code [1] 290704 0
Treatment: Other
Comparator / control treatment
post-operative follow-up in outpatient clinic setting at 10-14 days after operation. The outpatient review will be done by surgical registrars or interns within 15 minutes.
Control group
Active

Outcomes
Primary outcome [1] 293699 0
follow-up attendance rate. In outpatient review group, attendance will be defined by completion of post-operative review in clinic. In telephone consultation group, attendance will be defined by answering the follow-up telephone call and completing the review questionnaire.
Timepoint [1] 293699 0
10-14 days post operation
Secondary outcome [1] 311619 0
Patient satisfaction.

The outcome will be assessed in a "yes" or "no" manner. The percentage of patients who are satisfied with the review method will then be compared between the two groups.
Timepoint [1] 311619 0
4 weeks after initial follow-up at day 10-14 after operation
Secondary outcome [2] 311620 0
Complication rate

The major theoretical concern with telephone review includes missing significant post-operative complications and poor communication. Although neither of these has been reported in the literature, they can potentially happen.

In order to assess this, the patients will be asked about their progress 4 weeks after their initial follow-up. Any ongoing operation related issue or contact with medical service will be noted. In addition, patient will be asked about any concerns of communication during this survey.

A non-validated satisfaction survey was designed specifically for this study.
Timepoint [2] 311620 0
4 weeks after Initial follow-up at day 10-14 after operation
Secondary outcome [3] 311621 0
GP satisfaction rate

Again, the outcome will be assessed in a "yes" or "no" manner. The percentage of general practitioner who are satisfied with the review method will then be compared between the two groups.
Timepoint [3] 311621 0
at the end of trial
Secondary outcome [4] 311622 0
cost of consultation

Estimated cost of single session of outpatient clinic review can be obtained from Finance department of Monash Health. Cost of telephone consultation can be calculated from the hourly salary of registrar or intern and the duration of telephone contact.
Timepoint [4] 311622 0
10-14 days post-operation

Eligibility
Key inclusion criteria
1. All patient must be admitted under ASU
2.Emergency laparoscopic cholecystectomy or appendicectomy
3. >18yo
4. Speaks and understand English
5. consented for study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Intra-operative/post-operative complications
-Return to theatre
-Return to HDU
-Not medically fit by day 5 post-op
-Drain tube in situ on discharge
2. Choledocholithiasis
3. Patient received interventional radiological procedure

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)
Eligible patients will be identified by surgical registrars on ASU. Once participants agree to participate in the trial, informed consent will be obtained and participant will be allocated to either telephone consultation or outpatient review.

Allocation concealment is achieved by the use of sealed opaque envelopes, which contains the participant's allocation number and follow-up method. Once participant is recruited into the study, the surgical registrar will open one of the envelops and inform the participant about their allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
On discharge of the participant from inpatient service, the patient will receive an envelope with their allocation detail. The ward clerk will book the patient for relevant review based on the allocation.

Sequence was generated randomly using a randomisation table created by computer software (computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Likely single-variance analysis as no obvious confounder can be identified

A sample size of 220 has been calculated based on the assumption of a 50% reduction in "Do Not Attend" rate for participants at post-operative review. This will produce a power of 88%.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
Other reasons
currently 178 participants recruited, preliminary data analysis showed statistical significance with sufficient power. We believe that this is enough to address the clinical question without further recruitment
Date of first participant enrolment
Anticipated
Actual
26/11/2014
Date of last participant enrolment
Anticipated
Actual
2/03/2016
Date of last data collection
Anticipated
26/03/2015
Actual
4/05/2016
Sample size
Target
220
Accrual to date
Final
178
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6517 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 6518 0
Dandenong Hospital - Dandenong
Recruitment postcode(s) [1] 14083 0
3168 - Clayton
Recruitment postcode(s) [2] 14084 0
3175 - Dandenong

Funding & Sponsors
Funding source category [1] 290315 0
Self funded/Unfunded
Name [1] 290315 0
Country [1] 290315 0
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Road
Clayton
Victoria 3168
Country
Australia
Secondary sponsor category [1] 289031 0
None
Name [1] 289031 0
Address [1] 289031 0
Country [1] 289031 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292022 0
Monash Health HREC B
Ethics committee address [1] 292022 0
Ethics committee country [1] 292022 0
Australia
Date submitted for ethics approval [1] 292022 0
18/08/2014
Approval date [1] 292022 0
18/09/2014
Ethics approval number [1] 292022 0
14224B

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

Contacts
Principal investigator
Name 53098 0
Dr Yi Ma
Address 53098 0
Monash Medical Centre
246 Clayton Road
Clayton
Victoria 3168
Country 53098 0
Australia
Phone 53098 0
+61433719952
Fax 53098 0
Email 53098 0
[email protected]
Contact person for public queries
Name 53099 0
Yi Ma
Address 53099 0
Monash Medical Centre
246 Clayton Road
Clayton
Victoria 3168
Country 53099 0
Australia
Phone 53099 0
+61433719952
Fax 53099 0
Email 53099 0
[email protected]
Contact person for scientific queries
Name 53100 0
Yi Ma
Address 53100 0
Monash Medical Centre
246 Clayton Road
Clayton
Victoria 3168
Country 53100 0
Australia
Phone 53100 0
+61433719952
Fax 53100 0
Email 53100 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
No additional documents have been identified.