Plain English Summary
Background and study aims
The return of patients for surgery is not always optimal and this wastes valuable theatre time in a setting where this resource is in high demand by every gynaecological unit. Usually patients are booked into a gynaecological elective surgery book. The patients are expected to return on a particular date before the surgery. An appointment card is given to the patient as a reminder and the patient's outpatient card is kept in the hospital. The aim of this study is to find out whether reminding women using a text message increases the number of patients returning for gynaecological surgery.
Who can participate?
Women scheduled to undergo surgery with a waiting list of at least 1 month
What does the study involve?
Between 48-72 hours after joining the study, all participants are sent a text confirming that they have been booked for gynaecological surgery. Participants are randomly allocated 3-10 days after joining the study into intervention and control groups. The intervention group receive another reminder text 48-72 hours before the date of arrival to hospital for the scheduled surgery. Just after the expected day of return for surgery, the researchers find out if the participants in both groups have returned for surgery.
What are the possible benefits and risks of participating?
This study is new and innovative since no study of this kind has been done on gynaecological patients, certainly not in South Africa. At the end of this study a higher number of patients are expected to return for gynaecological surgery. This would optimize all theatre time available. There are no risks involved for the patients. They receive the same level of care if decided not to take part or withdraw from the study.
Where is the study run from?
Chris Hani Baragwanath Hospital (South Africa)
When is the study starting and how long is it expected to run for?
May to December 2011
Who is funding the study?
Chris Hani Baragwanath Hospital (South Africa)
Who is the main contact?
Dr Johannes Potgieter
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A study of women reminded by short message service for elective gynaecological surgery: a single-blind, randomized controlled trial
Acronym
Study hypothesis
The return of patients for surgery is not always optimal and this wastes valuable theatre time in a setting where this resource is in high demand by every gynaecological unit. By doing this study the researcher would like to point out a gap or show an innovation in improving patient compliance by using telemedicine in the middle income country. This proposed study is new and innovative since no study of this kind has been done on gynaecological patients, certainly not in South Africa. At the end of this study the researcher expects a better number of patients returning for gynaecological surgery. This would optimize all theatre time available.
Ethics approval
Human Research Ethics Committee (Medical), University of Witwatersrand, 25/03/2011, ref: M110317
Study design
Single-blind randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Telemedicine for gynaecological surgery
Intervention
Women recruited for the study as above will be allocated study numbers after they have been recruited. These numbers will be randomised 3 to 10 days after recruitment to intervention and control groups in blocks of ten, to ensure a more-or-less equal spread of intervention and control participants.
The random numbers will be generated by the researchers supervisor (who will not be involved with recruitment), and issued by telephone (or SMS) to the researcher for each study number. The researcher will then know which of the participants will receive a reminder SMS (intervention group). Between 48 and 72 hours before the expected date of arrival back to hospital for gynaecological surgery, intervention group participants will receive an SMS from the researcher reminding them of the return date for operation.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
At or just after the expected day of return for surgery for each participant (in both intervention and control groups), the researcher will find out from the gynaecological wards if the participant has returned for surgery
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/05/2011
Overall trial end date
31/12/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Women scheduled to undergo surgery with a waiting list of at least 1 month
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
50-60
Participant exclusion criteria
1. Women who do not have mobile phones and women who object to receiving SMS communications from the hospitals on their mobile phones
2. Age less than 18 years
3. Inability to comprehend English SMSs
4. Refusal to participate in the trial
Recruitment start date
01/05/2011
Recruitment end date
31/12/2011
Locations
Countries of recruitment
South Africa
Trial participating centre
Chris Hani Baragwanath Hospital
2013
South Africa
Sponsor information
Organisation
Chris Hani Baragwanath Hospital (South Africa)
Sponsor details
Department of Obstetrics and Gynaecology Syndicate
R68 Old Potchefstroom Road
PO Bertsham
Johannesburg
2013
South Africa
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Investigator initiated and funded (South Africa)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Department of Obstetrics and Gynaecology Syndicate, Chris Hani Baragwanath Hospital (funding cost for ISRCTN registration)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list