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A question of consent

01 September 2012

A 45-year-old woman, Ms B, suffered from severe heartburn and was referred to consultant general surgeon Mr X. He undertook an upper gastro-intestinal endoscopy, which demonstrated erosive oesophagitis above a large sliding hiatus hernia.

Ms B’s symptoms were not controlled with maximal medical therapy and therefore Mr X recommended anti-reflux surgery. He subsequently performed a laparoscopic fundoplication, but Ms B continued to have significant reflux symptoms and was unhappy with the results of her operation.

At two years after the initial surgery, Ms B was desperate for further intervention but had now started smoking and had put weight on to the point that her BMI > 40.

A further consultation with Mr X resulted in a repeat endoscopy, a barium swallow, oesophageal manometry and 24-hour pH monitoring. These investigations demonstrated a recurrent hiatus hernia with a breakdown in the fundoplication resulting in marked recurrent gastro-oesophageal reflux disease.

Ms B agreed to a further revision laparoscopic fundoplication but Mr X was unable to complete the procedure laprascopically due to the presence of multiple adhesions. Mr X decided against an immediate conversion to open surgery as he had not discussed this with the patient or documented it on her consent form.

Three days later, after further discussion with Ms B and completion of a more detailed consent form, Mr X performed a laparotomy and a difficult revision anti-reflux operation requiring partial resection of the gastric fundus. Ms B developed a severe abdominal wound infection and experienced a stormy and prolonged postoperative recovery.

There then followed several readmissions, culminating in a major plastic surgical procedure to reconstruct her abdominal wall. Ms B made a claim against Mr X, alleging negligence in the management of her case. Expert opinion was obtained and there was agreement that the indication for revision anti-reflux surgery and preoperative work-up had been satisfactory.

However, the process of consent was criticised in several areas. The failure to warn Ms B of the possibility of an open conversion was felt to be a significant failing, causing a three-day delay and requiring another operation and anaesthetic. There was also no evidence of any preoperative discussion regarding the risks of infection or gastric resection, even before the second procedure.

It was additionally felt that Mr X should have given more consideration to Ms B’s high BMI and smoking habits as potentially reversible risk factors for postoperative complications. The case was settled for a moderate amount.

Learning points

  • The process of consent for any operation should be a detailed conversation between clinician and patient with documented evidence. The incidence and potential impact of any common and potentially serious complications should always be discussed and documented.
  • Patients should be made aware of any aspect of their health or lifestyle that may adversely affect the outcome of an operation, particularly where action could be taken to optimise such conditions before surgery. In this case, preoperative weight loss and smoking cessation may have averted or lessened the extent of the subsequent complications.
  • Postoperative infection is not necessarily a sign of negligence or substandard care. In this case, although some responsibility for the infection could be attributed to the patient’s body habitus and smoking, it was the failure by the surgeon to specifically warn Ms B of this risk that may have constituted substandard care in the quality of consent taken.
  • Any laparoscopic operation, no matter how minor, may not go to plan, necessitating an open conversion. Patients should always be made aware of this with any consent form clearly reflecting the discussion.
  • Consent for procedures should be a personalised discussion so that the information given to patients includes not only the general and procedure-specific risks, but is also tailored to the specifi c values held by the individual patient. With revision anti-reflux surgery, adhesions and scarring from the original surgery may increase the risk of damage to organs such as the liver, spleen or stomach (as in this case) with a variety of clinical consequences, including resection. Mr X should have warned Ms B about this.