Chronic groin pain following open inguinal hernia repair: has consenting practice improved?

Abstract

Introduction

Chronic groin pain following inguinal hernia surgery is a common and potentially debilitating complication, and yet patients are infrequently informed of this risk. This leaves surgeons open to negligence claims, especially given recent changes to case law, which for the first time highlighted the need for a more patient-centred approach to risk disclosure. We investigated how these changes have influenced our consenting practice with respect to the disclosure of this risk.

Methods

We compared how often surgeons discussed the risk of chronic groin pain with adults undergoing elective open unilateral inguinal hernia mesh repairs in 2019 and 2009. The first 50 patients in each of these two years were retrospectively compared. Discussions during the initial consultation and on the day of surgery were assessed by reviewing clinic letters, medical notes and consent forms.

Findings

The risk of chronic pain was discussed with significantly more patients in 2019 than in 2009 (96% v 54%, p<0.0001). Most of these discussions occurred on the day of surgery (92% v 54%, p<0.0001). Only a few patients had these discussions during their initial consultation (18% v 4%, p<0.025).

Conclusions

Discussing the risk of chronic groin pain has improved significantly over the past 10 years. However, these discussions occur mostly on the day of surgery, which gives patients very little time to weigh up the risk. This potentially invalidates the consent they give for surgery. Patients should be given an opportunity to discuss their operative risks in advance of their operation.

Introduction

Inguinal hernia repairs are one of the most commonly performed surgical procedures, with approximately 100,000 carried out in the UK each year.¹ The vast majority are performed through an open approach using a prosthetic mesh.² Although these operations are considered to be straightforward routine day-case procedures, they are not without risk. One of the most serious risks is chronic groin pain, defined as pain persisting beyond 3–6 months.³ Chronic pain is reported by approximately 10–12% of patients and is severe and debilitating in 1–3% of patients.⁴

This risk needs to be discussed with patients so they have realistic expectations and are fully informed before their operation. Most previous studies have shown that disclosure of this risk was poor, with only 14–30% of patients being informed.^5,6 These studies are, however, over 10 years old, and since then there have been significant conceptual changes to risk disclosure before surgery.

Until recently, consent practices and the law have followed a paternalistic approach, whereby a ‘reasonable body of medical opinion’ – the Bolam test – was used as a benchmark for deciding what risks needed to be disclosed. This is despite the General Medical Council’s longstanding advice to discuss risks that patients want or need to know.⁷ The Bolam test has been upheld in several high-profile cases relating to inadequate informed consent where the patient has come to significant harm, including Sidaway v Bethlem Royal Hospital,⁸ Pearce v United Bristol Healthcare NHS Trust⁹ and Chester v Afshar.¹⁰

In 2015 the landmark UK Supreme Court case of Montgomery v Lanarkshire Health Board redefined the standards of disclosure and informed consent.¹¹ In this case, the claimant was not warned of the rare risk of her baby becoming stuck during vaginal delivery and the even rarer subsequent risk of her baby developing hypoxic brain injury (0.1%). Her risk was increased due to her short stature and larger-than-normal baby secondary to the claimant’s diabetes. The alternative option of a Caesarean section to reduce these risks was not discussed. Montgomery won the case and was awarded £5 million. The judges ruled for the first time that doctors should warn patients not only of the risks they thought were important (‘reasonable body of medical opinion’) but also of the risks that may matter to patients themselves, however rare.¹² This ruling created a turning point within the surgical community, and it has been incorporated into the guidance provided by many governing bodies, including the Royal College of Surgeons of England.¹³

We investigate how consenting practice has changed since Montgomery, with respect to the disclosure of chronic groin pain risk following open inguinal hernia repair at our institution. Specifically, we set out to investigate how often this risk was discussed with patients in 2019 compared with 2009, and how the timing of risk discussion has changed over this period.

Methods

We retrospectively studied the first 50 consecutive patients of the calendar year who underwent open inguinal hernia repair using a prosthetic mesh in 2019 and 2009. These patients were identified by our clinical coding team from our general surgical elective lists and included patients under the care of all our general surgical consultants. Patients were excluded if they were aged under 18 years; had recurrent, bilateral or inguinoscrotal hernias; lacked the capacity to give consent; or had the operation performed as an emergency.

A proforma was devised to record how often surgeons discussed the risk of chronic groin pain and any factors that may have influenced this discussion, including the patient’s age, gender and preoperative pain and the seniority of the surgeon having the discussion. There were two main opportunities to have this discussion: during consultations in the outpatient department and on the day of surgery. Documentation of alternative treatment options and whether a leaflet was provided were also recorded. Medical notes, consent forms and electronic clinical letters were reviewed.

Continuous data are presented as median and interquartile range as appropriate. The chi-squared test for categorical data and the unpaired t-test for continuous variables were used to evaluate the differences between the groups. The statistical significance for all tests used was set at p<0.05. Analyses were performed using GraphPad Prism version 7.00 for Windows, GraphPad Software, La Jolla, CA, USA (www.graphpad.com).

Findings

Patients from 2019 and 2009 were equally matched for age (66.5 years v 65.5 years), male gender (n=44 v 44), preoperative pain (n=33 v 24), and the seniority of the surgeon discussing operative risk in the outpatient department (consultant, 25 v 34; registrar, 24 v 15; senior house officer, 1 v 1) and on the day of surgery (consultant, 15 v 10; registrar, 22 v 26; senior house officer, 13 v 14) (Table 1).

Table 1.

Patient characteristics in 2019 and 2009

	2019 (n=50)	2009 (n=50)	p
Age (median, range) (years)	66.5 (54.5–73.5)	65.5 (47.0–75.0)	0.189
Male (n)	44	44
Preoperative pain (n)	33	24	0.069
Seniority of surgeon (initial consultation)
Consultant (n)	25	34	0.10
Registrar (n)	24	15
Senior house officer (n)	1	1
Seniority of surgeon (day of surgery)
Consultant (n)	15	10	0.50
Registrar (n)	22	26
Senior house officer (n)	13	14

The risk of chronic pain was discussed with significantly more patients in 2019 than in 2009 (96% v 54%, p<0.0001). Most of these discussions occurred on the day of surgery (92% v 54%) rather than at the initial consultation (18% v 4%). Only a small number of patients were informed of the risk of chronic pain on both occasions in 2019 (14%) and in 2009 (4%) (Table 2, Fig 1).

Table 2.

Timing of discussion of risk of chronic groin pain

	2019	2009	p
Day of surgery or initial consultation (n, %)	48 (96)	27 (54)	<0.0001
Day of surgery (n, %)	46 (92)	27 (54)	<0.0001
Initial consultation (n, %)	9 (18)	2 (4)	0.025
Both visits (n, %)	7 (14)	2 (4)	0.08

Figure 1.

Timing of discussion of risk of chronic groin pain

A number of clinic letters documented that ‘risks were discussed’ without detailing the specific complication of chronic pain (28% of patients in 2019, 12% of patients in 2009). Risk discussions were evidenced by documentation in clinic letters or on consent forms, but not in clinical notes. None of the consent forms were completed in clinic. Information leaflets were given to only 2% of patients in 2019 and to none in 2009.

Alternatives to open inguinal hernia surgery were discussed on only a few occasions. Nonoperative options were discussed with 24% of patients in 2019 and 2% of patients in 2009. A laparoscopic approach was discussed with 14% patients in 2019 and 4% patients in 2009.

Many surgeons did not have the opportunity to discuss operative risks and alternative options before the day of surgery with the patients that they themselves would later operate on. In 2019 and 2009, 78% and 56% of patients respectively were not seen by their operating surgeon until the day of surgery.

Discussion

Chronic groin pain following an open inguinal hernia mesh repair can be highly debilitating and can have a profound impact on a person’s life. Early studies in 2008 and 2009 revealed that disclosure of this risk was poor, with only 14–30% of patients being informed.^5,6 This was marginally better in the study carried out in 2016–17, which revealed that 64% of patients were informed.¹⁴ Our study revealed that in 2009, around the time of the earlier studies, chronic groin pain was discussed with only 54% of patients; this had improved significantly by 2019, when 96% of patients were informed (p<0.0001).

The reason for this improvement is likely to be multifactorial. The Montgomery case was a significant turning point in case law. It reinforced the consent guidelines written by the General Medical Council and became integrated in those written by specialist bodies, including the Royal College of Surgeons of England. It is also likely that awareness of this risk among surgeons improved with increased research over the past 10 years. Additionally, there have been increasing media reports in recent years and heightened public concern about the relationship of prosthetic meshes and the development of chronic pain. Although many of these reports relate to use in vaginal prolapse surgery, there are growing reports in the media relating to inguinal hernia surgery. This may have prompted a more thorough consenting process for patients in 2019.

Although these improvements in 2019 at first glance appear pleasing, they do not fully reflect the ideal process of informed consent. One of the key issues highlighted for the first time by our study concerns the timing of information disclosure. The vast majority of patients studied in 2019 and 2009 were counselled on the risks on the day of surgery (92% and 54%, respectively) rather than at their initial specialist outpatient consultations (18% and 4%, respectively). The small number of patients being informed of the risk during their initial consultation could be explained by the time pressures that exist in these busy environments, which leave very little time for meaningful discussion of operative risk. It is also possible that our study underestimated the number of patients who were informed of this risk during their initial consultation. Only patients who had specific documentation of ‘chronic pain’ on their clinic letters or clinical notes were considered to have had this discussion. Many more patients had documentation on their clinic letters that ‘risks were discussed’ (28% in 2019 v 12% in 2009) without elaborating on the details. It is possible that chronic pain was discussed in these cases but simply not documented. It is well known that written documentation often does not reflect what has been discussed with patients.^15,16

The Royal College of Surgeons of England has developed clear guidance on the timing of information disclosure since Montgomery. It advises that the process of consent ‘should begin well in advance of the treatment’ so that patients have enough time to make an informed decision.¹³ Waiting until the day of surgery runs the risk of the patient giving consent under pressure, without fully appreciating the true nature of this potential complication. The patient may feel they cannot refuse and are at the point of no return, especially as personal commitments and alternative arrangements have been made. Gaining consent while under duress would potentially invalidate consent.¹⁷ The judges in the Montgomery case stated that ‘even those doctors who ... are more hurried are obliged to pause and engage in the discussion which the law requires’. Being too busy in the outpatient clinic is not a justifiable excuse.

These time constraints are not the only factor that impacts the consent process in the outpatient department. Booking patients on to a pooled operating list, which is common practice in the UK for patients undergoing routine inguinal hernia repairs, may also cause problems. These pooled lists allow surgeons to operate on patients who they have not seen before, and therefore the surgeons have not had the opportunity to discuss the operative risks before the day of surgery. At our institution, 78% of patients in 2019 and 56% of patients in 2009 were not seen by their operating surgeon at the initial outpatient appointment. This may compromise their consent, most obviously so if the previous surgeon did not discuss the risk of chronic pain. On a subtler note, some surgeons may have a particular operative approach, such as routine sacrifice of the ilioinguinal nerve, the pros and cons of which may not be discussed if the patient sees a different surgeon. Failure to inform the patient that a different surgeon will be operating may invalidate their consent and lead to a negligent claim, as in the case of Jones v Exeter NHS Foundation Trust.¹⁸

Failure to gain high-quality informed consent may lead to wide-ranging consequences, with the patient being centrally affected. In the event that the patient develops chronic pain (even if mild and manageable) without being informed of this risk, the patient may believe that this was an unexpected complication and that they have received poor care, raising a complaint and potentially seeking recompense. Although there may be a legitimate reason for a negligence claim other than ‘failure to inform’, this does not excuse poor consenting practice. Some patients may elect not to have surgery based on the risks. As such, all patients should be offered alternative treatment options. In the case of inguinal hernia repairs, the patient should be offered a nonoperative approach as well as a laparoscopic approach if suitable. In our study, only a few patients were offered these alternative options.

Poor consenting practice has been reported to account for 10% of all complaints and 6% of all malpractice claims.¹⁹ The cost to the NHS is increasing every year, with figures from NHS Resolution (formerly the NHS Litigation Authority) showing that ‘failure to warn’ cost the NHS £51.5 million in 2017–18.²⁰ It is unknown how much of this relates specifically to chronic groin pain after inguinal hernia surgery. Of all negligence claims related to inguinal hernia surgery, the development of chronic pain was one of the most common reasons for a claim, accounting for 18–31% of cases.^21–23 Whether ‘failure to warn’ of this risk was central to these cases remains unclear. It has, however, been shown that chronic pain was not an independent predictor for a successful claim, meaning that with better, more thorough counselling on this risk, the number of negligence claims can be minimised.²³

To help improve risk disclosure during the consent process, prepared consent forms listing all risks have been developed and shown to be highly effective.^24–26 Following the Montgomery case, however, this scripted approach to information delivery has been described as an ‘ethically and legally dubious practice’, because it does not involve the patient–doctor dialogue central to the consent process.²⁷ In addition, the generality of these consent forms runs the risk of not allowing consent to be tailored to a particular patient. The same can be said for written and electronic information resources that are now widely available: these may all be used as an adjunct to the consent process, but they cannot replace a clear timely discussion with the patient.

Conclusions

Chronic groin pain after open inguinal hernia surgery is common, potentially debilitating, and of increasing public concern and media interest. Care should be taken to appropriately inform patients of this risk. Failure to do so, especially in the post-Montgomery era, is increasingly likely to result in a negligent claim. Although many of our patients were informed of this risk, this was typically done only on the day of surgery. Obtaining a patient’s consent just before their operation may put them under duress, invalidating their consent. To help avoid this, more effort needs to be made to discuss the risk in advance of the operation. The obvious time would be during the initial outpatient appointment, despite the well-known time pressures that exist. This discussion needs to be documented clearly. We recommend this be done in the clinic letter, which can be sent to the patient for their perusal. With the addition of an information leaflet and a formal second discussion on the day of surgery, this will form a good body of evidence that every effort was made to fully inform the patient of the risk.