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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 13 January 2020
Main ID:  ACTRN12616001142426
Date of registration: 22/08/2016
Prospective Registration: No
Primary sponsor: Monash Health
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?
Date of first enrolment: 26/11/2014
Target sample size: 220
Recruitment status: Stopped early
URL:  https://anzctr.org.au/ACTRN12616001142426.aspx
Study type:  Interventional
Study design:  Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;  
Phase:  Not Applicable
Countries of recruitment
Australia
Contacts
Name: Dr Yi Ma   
Address:  Monash Medical Centre 246 Clayton Road Clayton Victoria 3168 Australia
Telephone: +61433719952
Email: rayma1986391@hotmail.com
Affiliation: 
Name: Dr Yi Ma   
Address:  Monash Medical Centre 246 Clayton Road Clayton Victoria 3168 Australia
Telephone: +61433719952
Email: rayma1986391@hotmail.com
Affiliation: 
Key inclusion & exclusion criteria
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

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


Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females
Health Condition(s) or Problem(s) studied
Surgery - Other surgery
Emergency laparoscopic appendicectomy and cholecystectomy;
Emergency laparoscopic appendicectomy and cholecystectomy
Intervention(s)
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.
Primary Outcome(s)
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. [10-14 days post operation]
Secondary Outcome(s)
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.[at the end of trial]
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.[10-14 days post-operation]
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.[4 weeks after Initial follow-up at day 10-14 after operation
]
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. [4 weeks after initial follow-up at day 10-14 after operation]
Secondary ID(s)
Nil known
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Monash Health HREC B
Results
Results available:
Date Posted:
Date Completed:
URL:
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