Pre-made consent for elective inguinal hernia repair: the need for standardisation-a survey of all UK NHS Trusts.

PURPOSE: Elective inguinal hernia repair (IHR) is one of the most commonly performed operations in the UK. As with all procedures, informed consent is essential. Pre-made consent forms have been suggested to improve consenting practice. This study aimed to assess the usage and quality of pre-made hernia-specific consent forms (PCF) in the UK.

METHODS: A freedom of information request was sent to all UK NHS Trusts asking: (1) does the trust perform IHRs; (2) do they have a PCF; and (3) to send a copy. Complications lists on received forms were reviewed and compared to those listed on the British Hernia Society (BHS) "patient information" webpage.

RESULTS: 157/185 Trusts (85%) responded. 117/157 (75%) perform IHRs; 16/117 (14%) use PCFs. The number of reported risks was variable (range 4-18), as was the content of each form (28 different risks were listed). Quoted percentage risks were inconsistent (e.g. recurrence range < 1-5%). The frequency of each BHS-quoted risk was (open/laparoscopic): Bleeding 62/75%; infection 85/92%; seroma 31/42%; damage to testicular blood supply 69/75%; damage to abdominal contents NA/25%; haematoma 62/67%; venous thromboembolism 54/50%; recurrence 85/83%; chronic pain 77/58%; mesh infection 23/8%. Zero forms contained all BHS-quoted risks.

CONCLUSIONS: Whilst the consent form only provides documentation of the consent process, this study suggests that PCFs do not improve the quality of consent as both the type and likelihood of quoted complications were highly variable between Trusts. As follow-up for elective procedures is rare, it is unlikely that this variability reflects actual measured outcomes.