Condition category
Surgery
Date applied
10/04/2010
Date assigned
15/04/2010
Last edited
15/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Paul Redmond

ORCID ID

Contact details

Department of Surgery
Cork University Hospital
Wilton
Cork
-
Ireland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

na

Study information

Scientific title

The benefits of an interactive, individualized online patient pathway for patients undergoing minimally invasive radioguided parathyroidectomy (MIRP). A prospective, double-blinded, randomized clinical trial

Acronym

Study hypothesis

The provision of an online, interactive patient pathway would offer an appropriate means of delivering patient information that would be viewed positively by patients.

Ethics approval

Ethics Committee of University College Cork (Ireland) approved on the 19th Feb 2007 (ref: ECM 4 (q) 06/03/07)

Study design

Prospective double blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Patient education prior to surgery

Intervention

Web based access to information about their hospital process prior to undergoing MIRP.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Anxiety levels 24 hours pre-operatively:
Anxiety was measured the evening before surgery using the anxiety portion of the externally validated Hospital Anxiety and Depression Scale (HADS).

Secondary outcome measures

1. Postoperative pain was scored using a visual analogue pain score and analgesia requirements were assessed according to the World Health Organization (WHO) analgesia ladder 24 hours following surgery.
2. Postoperative assessments of satisfaction with capacity to consent and perception of website utility were measured.

Overall trial start date

19/02/2007

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. All patients undergoing elective MIRP
2. Age over 18
3. Full capacity to consent to both the study and the operation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

64

Participant exclusion criteria

1. Cognitive or visual impairment
2. Lack of access to internet facilities

Recruitment start date

19/02/2007

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Ireland

Trial participating centre

Department of Surgery
Cork
-
Ireland

Sponsor information

Organisation

Cork University Hospital / University College Cork (Ireland)

Sponsor details

c/o Prof Paul Redmond
Department of Surgery
Wilton
Cork
-
Ireland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Cork University Hospital / University College Cork (Ireland) - Investigator led and funded

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