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Completed

NCT Number: NCT04024189

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Christie NHS Foundation Trust

Manchester, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Survey

Other

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

Primary outcomes

  1. 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.

    Time frame: 6 weeks

    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

  2. Patients views and feelings regarding their experiences in relation to support from healthcare professionals was assessed using a study specific patient questionnaire.

    Time frame: 6 week

    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.

Sponsors and collaborators

Lead sponsor

The Christie NHS Foundation Trust

Other

Registry information

Official study title

Audit of Informed Consent of Patients Undergoing Surgery

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 18, 2019
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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