ANZCTR - Registration

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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

12/04/2022

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]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Appendicitis

Umbilical hernia

Inguinal hernia

Cholecystitis

Biliary colic

Condition category

Condition code

Surgery

Surgical techniques

Oral and Gastrointestinal

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]

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]

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]

3-8 weeks post-operation when patients have their post-telephone review or clinic appointment.

Secondary outcome [1]

- 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]

At 3 weeks-8 post-operation, at their consultation review.

Secondary outcome [2]

- 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]

At 3 weeks-8 post-operation, at their consultation review.

Secondary outcome [3]

- 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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Stopped early

Data analysis

Data collected is being analysed

Reason for early stopping/withdrawal

Other reasons/comments

Other reasons

COVID-19 pandemic required all outpatient appointments to be switched to telehealth only.

Date of first participant enrolment

Anticipated

21/11/2019

Actual

2/12/2019

Date of last participant enrolment

Anticipated

19/11/2020

Actual

12/03/2020

Date of last data collection

Anticipated

31/12/2020

Actual

Sample size

Target

200

Accrual to date

Final

140

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment postcode(s) [1]

3065 - Fitzroy

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

St Vincent's Hospital Melbourne Research Endowment Fund

Address [1]

41 Victoria Parade
Fitzroy Victoria 3065

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent's Hospital Melbourne Human Research Ethics Committee

Ethics committee address [1]

Research Governance Unit
Level 5, Building E (Aikenhead Building)
27 Victoria Parade
Fitzroy VIC 3065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/11/2017

Approval date [1]

09/10/2018

Ethics approval number [1]

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

Mr Brett Knowles

Address

St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy VIC 3065

Country

Australia

Phone

+61 3 9231 2211

Fax

[email protected]

Contact person for public queries

Name

Lynn Chong

Address

St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy VIC 3065

Country

Australia

Phone

+61 3 9231 2074

Fax

[email protected]

Contact person for scientific queries

Name

Brett Knowles

Address

St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy VIC 3065

Country

Australia

Phone

+61 3 9231 2211

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
5464	Ethical approval					378619-(Uploaded-24-10-2019-18-56-27)-Study-related document.pdf

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.

Trial Review

Documents added manually

Documents added automatically