Condition category
Not Applicable
Date applied
03/07/2011
Date assigned
29/07/2011
Last edited
04/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

Trial website

Contact information

Type

Scientific

Primary contact

Dr Johannes Potgieter

ORCID ID

Contact details

16 Whispering Leaves
Doncaster Rd
New Market
Alberton
Alberton
1449
South Africa

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 approved on 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

Screening

Patient information sheet

Not available in web format, please use the contact details below 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 researcher’s 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 measures

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

Eligibility

Participant inclusion criteria

The study population will be all women scheduled to undergo surgery with a waiting list of at least one 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

16 Whispering Leaves
Alberton
1449
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

http://www.chrishanibaragwanathhospital.co.za/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes