The validity of informed consent for inguinal hernia surgery
Research type
Research Study
Full title
The validity of informed consent for inguinal hernia surgery
IRAS ID
59936
Contact name
Stephen Kirk
Contact email
Sponsor organisation
South Eastern Health and Social Care Trust
Research summary
Patients' knowledge and understanding after "informed" consent is not formally assessed, and therefore the validity of informed consent is unclear. It is also unclear if patient factors affect the validity of informed consent as only one research study has examined factors which may impact on informed consent. It is important for doctors to know if consent is informed and what patient factors may affect validity of consent. If a greater understanding of informed consent was possible, strategies to improve the validity of informed consent could be employed. Patients could be given tailored information to improve their understanding of potential treatments and ensure that consent is truly informed.
Inguinal hernia repair is a commonly performed procedure with well documented risks and benefits. Factors which we think may impact on validity of consent include age, sex, anxiety, medical history, memory, intelligence quotient (IQ), personality, health locus of control, education and level of deprivation.
The study will be conducted in the hospitals of the South Eastern Health and Social Care Trust and will last for 12 months. All patients referred with inguinal hernia aged 18 and over will be elligible for inclusion. All participants will attend a Specialist Hernia Clinic, where they will be diagnosed, consented and complete an initial questionnaire and all assessments. In addition to patients proceeding to surgery, those patients who decline to have surgery or are felt to be unsuitable for surgery will also be included. Further information will be posted to the patient prior to surgery. On attendance for surgery a further questionnaire will be completed and consent confirmed. A further questionnaire will be completed by telephone review 6 weeks and 6 months after surgery.
Results will be distributed to patients within a 6 month period after study completion.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
14/NW/1188
Date of REC Opinion
15 Aug 2014
REC opinion
Further Information Favourable Opinion