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Trial registered on ANZCTR


Registration number
ACTRN12619001574134
Ethics application status
Approved
Date submitted
24/10/2019
Date registered
14/11/2019
Date last updated
14/11/2019
Date data sharing statement initially provided
14/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Preferred Method of Post-Operative Follow Up After Uncomplicated Laparoscopic Surgery
Scientific title
The Efficacy and Acceptability of Telemedicine versus In-Person Follow up after Uncomplicated Laparoscopic Surgery.
Secondary ID [1] 299637 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Appendicitis 314953 0
Umbilical hernia 314954 0
Inguinal hernia 314955 0
Cholecystitis 314956 0
Biliary colic 314958 0
Condition category
Condition code
Surgery 313300 313300 0 0
Surgical techniques
Oral and Gastrointestinal 313371 313371 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Scheduled telephone call at the three-week post-operative time point completed by the general surgical doctor. There is no time limit for the telephone call, however the duration of the conversation is recorded.
A case report form is recorded to capture each patient's
(a) histopathology results
(b) length of consultation
(c) post-operative progression (fevers, pain, pain relief method, tenderness, wound healing, discharge, return to activities, return to work, exercise)
(d) General (bowels, stools, diet, urination, any concerns)
(e) Safe to discharge patient? if no, patient is booked in for an in clinic appointment
(f) Patient Satisfaction Questionnaire
Intervention code [1] 315956 0
Treatment: Other
Comparator / control treatment
Scheduled in patient appointment in hospital at the three-week post-surgery completed by the general surgery doctor.

A case report form is recorded to capture each patient's
(a) histopathology results
(b) length of consultation, approximately, 10 - 15 minutes.
(c) method of transport, cost to travel to clinic and time taken off from work to attend appointment
(d) post-operative progression (fevers, pain, pain relief method, tenderness, wound healing, discharge, return to activities, return to work, exercise)
(e) General (bowels, stools, diet, urination, any concerns)
(f) Safe to discharge patient? if no, patient is booked in for an in clinic appointment
(g) Patient Satisfaction Questionnaire
Control group
Active

Outcomes
Primary outcome [1] 321781 0
To determine if patient satisfaction with postoperative care with telephone follow up is non-inferior to clinic follow up.

Likert scale, patient satisfaction questionnaire adapted from: Gray, R., Sut, M., Badger, S. & Harvey, C. Post-operative telephone review is cost-effective and acceptable to patients. The Ulster medical journal 79, 76 (2010). This is completed immediately after their consultation.
Timepoint [1] 321781 0
3-8 weeks post-operation when patients have their post-telephone review or clinic appointment.
Secondary outcome [1] 376181 0
- To determine if telephone post-operative follow up is a safe alternative to clinic post-operative follow up visits.

Safety is assessed by reviewing that patients in the telephone arm did not have any post-operative issues as patients compared in the clinic arm. If complications arise, patients are advised to return for clinic review or visit their local general practitioner. A further 3 month follow up phone call is to be provided for patients for both arms as a safety measure to ensure no complications were missed.
Timepoint [1] 376181 0
At 3 weeks-8 post-operation, at their consultation review.
Secondary outcome [2] 376485 0
- To determine if telephone or clinic follow up visits are preferred based on differing demographics (i.e., age, distance travelled)

Patient's age and postcode, method of transport is to be recorded at their consultation review.

Timepoint [2] 376485 0
At 3 weeks-8 post-operation, at their consultation review.
Secondary outcome [3] 376486 0
- To determine the length of visit differences between telephone and clinic follow up.

The start and end time of a telephone or clinic review is to be recorded the case report form for each patient.
Timepoint [3] 376486 0
At 3 weeks-8 post-operation, at their consultation review.

Eligibility
Key inclusion criteria
St Vincent's Melbourne Public Hospital Patients undergoing:
Laparoscopic appendectomy
Laparoscopic cholecystectomy
Laparoscopic/open inguinal hernia repair
Laparoscopic/open umbilical hernia repair

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients unable to give consent themselves must be excluded from the study
Patients requiring an interpreter should be excluded from the study
Any patients without a phone number
Any Clavien Dindo 3 and above complication
Prisoners
Overseas patients
Patients who cannot attend an appointment within 3- 8 weeks post-surgery.

Procedure specific exclusions:
Laparoscopic Appendectomy:-
Patients identified as having a perforated appendix associated with four - quadrant pus
Laparoscopic Cholecystectomy:-
Any procedure starting as laparoscopic but converted to open
Laparoscopic or Open Umbilical/Inguinal Hernia Repair:-
Hernia defect identified as being in the scrotum and containing bowel is to be excluded (for inguinal hernia) – Giant ilioscrotal

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 central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15040 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 28327 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 304111 0
Hospital
Name [1] 304111 0
St Vincent's Hospital Melbourne Research Endowment Fund
Address [1] 304111 0
41 Victoria Parade
Fitzroy Victoria 3065
Country [1] 304111 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne Research Endowment Fund
Address
41 Victoria Parade
Fitzroy Victoria 3065
Country
Australia
Secondary sponsor category [1] 304329 0
None
Name [1] 304329 0
Address [1] 304329 0
Country [1] 304329 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304600 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 304600 0
Research Governance Unit
Level 5, Building E (Aikenhead Building)
27 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [1] 304600 0
Australia
Date submitted for ethics approval [1] 304600 0
15/11/2017
Approval date [1] 304600 0
09/10/2018
Ethics approval number [1] 304600 0
LRR 062/18

Summary
Brief summary
This randomised controlled trial aims to investigate the efficacy and acceptability of telemedicine vs. traditional in-person follow-up for patients undergoing uncomplicated general surgical procedures. These general surgical procedures include appendectomies, umbilical and inguinal hernia repairs, and cholecystectomies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97534 0
Mr Brett Knowles
Address 97534 0
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy VIC 3065
Country 97534 0
Australia
Phone 97534 0
+61 3 9231 2211
Fax 97534 0
Email 97534 0
brett.knowles@svha.org.au
Contact person for public queries
Name 97535 0
Dr Lynn Chong
Address 97535 0
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy VIC 3065
Country 97535 0
Australia
Phone 97535 0
+61 3 9231 2074
Fax 97535 0
Email 97535 0
lynn.chong@svha.org.au
Contact person for scientific queries
Name 97536 0
Mr Brett Knowles
Address 97536 0
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy VIC 3065
Country 97536 0
Australia
Phone 97536 0
+61 3 9231 2211
Fax 97536 0
Email 97536 0
brett.knowles@svha.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 5464 0
Ethical approval
Citation [1] 5464 0
Link [1] 5464 0
Email [1] 5464 0
Other [1] 5464 0
Summary results
No Results