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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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

Study type
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

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

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Not Applicable
Type of endpoint(s)
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 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
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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
Address [1] 290315 0
Country [1] 290315 0
Primary sponsor type
Monash Health
246 Clayton Road
Victoria 3168
Secondary sponsor category [1] 289031 0
Name [1] 289031 0
Address [1] 289031 0
Country [1] 289031 0

Ethics approval
Ethics application status
Ethics committee name [1] 292022 0
Monash Health HREC B
Ethics committee address [1] 292022 0
246 Clayton Road
Victoria 3168
Ethics committee country [1] 292022 0
Date submitted for ethics approval [1] 292022 0
Approval date [1] 292022 0
Ethics approval number [1] 292022 0

Brief summary
In this randomised control trial, we aim to assess the possibility of replacing current outpatient post-operative follow-up after laparoscopic appendicectomy and cholecystectomy with telephone consultation.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 53098 0
Dr Yi Ma
Address 53098 0
Monash Medical Centre
246 Clayton Road
Victoria 3168
Country 53098 0
Phone 53098 0
Fax 53098 0
Email 53098 0
Contact person for public queries
Name 53099 0
Dr Yi Ma
Address 53099 0
Monash Medical Centre
246 Clayton Road
Victoria 3168
Country 53099 0
Phone 53099 0
Fax 53099 0
Email 53099 0
Contact person for scientific queries
Name 53100 0
Dr Yi Ma
Address 53100 0
Monash Medical Centre
246 Clayton Road
Victoria 3168
Country 53100 0
Phone 53100 0
Fax 53100 0
Email 53100 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary