Main
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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:
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ANZCTR |
Last refreshed on:
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13 January 2020 |
Main ID: |
ACTRN12616001142426 |
Date of registration:
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22/08/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Is telephone consultation a safe, satisfactory and cost-effective alternative to outpatient review for follow up post emergency laparoscopic appendicectomy and cholecystectomy?
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Scientific title:
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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:
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26/11/2014 |
Target sample size:
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220 |
Recruitment status: |
Stopped early |
URL:
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https://anzctr.org.au/ACTRN12616001142426.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Contacts
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Name:
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Dr Yi Ma
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Address:
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Monash Medical Centre
246 Clayton Road
Clayton
Victoria 3168
Australia |
Telephone:
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+61433719952 |
Email:
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rayma1986391@hotmail.com |
Affiliation:
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Name:
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Dr Yi Ma
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Address:
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Monash Medical Centre
246 Clayton Road
Clayton
Victoria 3168
Australia |
Telephone:
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+61433719952 |
Email:
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rayma1986391@hotmail.com |
Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Surgery - Other surgery
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Emergency laparoscopic appendicectomy and cholecystectomy; Emergency laparoscopic appendicectomy and cholecystectomy
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Intervention(s)
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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.
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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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]
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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
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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]
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Secondary ID(s)
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Nil known
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
Monash Health HREC B
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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