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NCT04024189 Clinical Trial

Patient Experience of Consent for Cancer Surgery in Light of Recent Changes to UK Law- a Questionnaire Study

Patient Satisfaction Clinical Trial

Official title:
Audit of Informed Consent of Patients Undergoing Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04024189
Other study ID # 18/2117
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2018
Est. completion date August 10, 2018

Study information
Verified date July 2019
Source The Christie NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Since the 2015 Montgomery vs Lanarkshire Health Board ruling, the consent process in the UK has had to change. In practice, this means that doctors must ask themselves whether the patient knows about the material risks of the treatment being proposed, alternatives to the treatment, and whether reasonable care has been taken to ensure the patient actually knows this. This study aims to determine patients' perspectives of consent for major cancer surgery in light of the Lanarkshire ruling.

Description:

A patient satisfaction survey was administered to patients who had undergone urological, gynaecological, colorectal, and plastic surgical procedures at a specialised cancer centre where changes to consent processes in light of the Lanarkshire ruling had been implemented.

Recruitment information / eligibility
Status Completed
Enrollment 39
Est. completion date August 10, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- All patients who have been admitted and undergone surgery within a 6 week period between April - June 2018.

Exclusion Criteria:

- Any patient who could not complete the survey questionnaire i.e. English was not their first language or to unwell to complete.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Survey
Patients were given a questionnaire/survey to complete in respect of their satisfaction of the consent process for their surgical procedure

Locations
Country Name City State
United Kingdom The Christie NHS Foundation Trust Manchester

Sponsors (1)
Lead Sponsor Collaborator
The Christie NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patients understanding of the risks associated with the procedure they will be having and the alternatives available to them was assessed using a study specific questionnaire. Was the patient made aware by the clinical care team of the risks associated with their procedure and the alternatives available to them. Were they able to make an informed choice. This will be measured using a patient questionnaire 6 weeks
Primary Patients views and feelings regarding their experiences in relation to support from healthcare professionals was assessed using a study specific patient questionnaire. Did patients feel that healthcare professionals provided them with sufficient information and support to make an informed decision in respect of their procedure. This will be measured using a questionnaire completed by patients. 6 week
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