The risks of laparoscopic surgery
A sharp rise in the number of laparoscopic procedures has been mirrored by a rise in high claims resulting from laparoscopic injury. Sarah Whitehouse looks at the risks
The benefits of laparoscopic surgery are clear but when complications occur, they tend to be serious.
In 2010, the highest laparoscopic surgery settlement MPS experienced was for more than R11 million, for a laparoscopic Nissen fundoplication with complications. Between one third and one half of all major complications occur at the time of surgical entry. Postoperatively, complications from otherwise successful laparoscopic procedures include incisional hernias, wound infections and/or haematoma and adhesion formation.1
What types of claims are associated with laparoscopic surgery?
Patients make a claim against surgeons for a variety of reasons. Many claims arise out of or include an allegation of a lack of training. As with any clinical practice, it is important to act within the limits of your own competence and be able to prove that you are sufficiently qualified.
In some instances, a laparotomy may be a more appropriate form of treatment, rather than a laparoscopy, and complications may arise as a result of the wrong choice of surgery. Make sure that it is accepted clinical practice to perform a certain procedure laparoscopically in cases similar to yours.
Claims may also be made because of a delay in recognising complications postoperatively. Such cases can be difficult to defend, particularly if the patient’s medical records do not document that they have been closely monitored and any deterioration in their condition managed in a timely and appropriate fashion.
To underestimate the importance of keeping good medical records is to potentially deal a severely damaging blow to your career
Managing expectations
Managing patient expectations and ensuring that they are fully informed of the risks and benefits of laparoscopic surgery is essential. The HPCSA, in Seeking Patients’ Informed Consent: The Ethical Considerations, states that during the consent process, you should provide the patient with information including: “The purpose of a proposed investigation or treatment; details of the procedures or therapies involved, including subsidiary treatment such as methods of pain relief; how the patient should prepare for the procedure; and details of what the patient might experience during or after the procedure, including common and serious side effects.”2
You must warn patients explicitly about the risks with laparoscopic surgery, says Dr Graham Howarth, MPS Head of Medical Services (Africa). “With laparoscopic surgery, patients go into theatre expecting small-scale surgery to take place, but if there are complications and the patient has to have a laparotomy, and they are not warned that this could be a possibility before the procedure, they could be left very shocked and make a claim.”
Although patients tend to think of laparoscopic surgery as minor surgery, it is major surgery with the potential for major complications – visceral injury and bleeding, injury to the bowel, or injury to the bladder.
What’s more, the public’s view of laparoscopic surgery as something minor is enhanced by the fact that patients are usually discharged the following day, or sometimes even the same day as surgery.
Once all the relevant risks and benefits have been discussed, it is important to check back that the patient understands the procedure. A signed consent form does not in itself prove valid consent to treatment – the important factors will always be the quality, extent and accuracy of the information given beforehand.
Make sure that discussions around patient expectations are reflected in the patient’s notes. Dr Howarth says: “If there are no notes, it is difficult to say that such a conversation has taken place.”
A signed consent form does not in itself prove valid consent to treatment – the important factors will always be the quality, extent and accuracy of the information given beforehand
Box 1: Risk management recommendations
Prior to performing a new laparoscopic surgery procedure, appropriate training is necessary. Document the indications in support of the performance of the laparoscopic procedure when evaluating patients for surgery. If contraindications are present, document specific reasons why the benefits of surgery outweigh the risks.
Obtain a patient’s informed consent for the procedure and document this. Verbally discuss informed consent with the patient to ensure that all questions are addressed.
Verbally discuss informed consent with the patient to ensure that all questions are addressed
Check the surgical equipment is present, fully functioning and is sterile. Evaluate the patient for injuries or complications prior to the conclusion of the procedure. Promptly treat or document any complications as soon as they arise.
Preoperative, operative and postoperative notes should be timely, detailed, clear and factual with no abbreviations that could be misinterpreted.
If the surgery is being done on an outpatient basis, be sure that the patient and/or caregiver is educated to recognise complications and know to report them to the surgeon, and document this.
Physician Insurers Association of America, Laparoscopic Injury Study, p17 (2000)
Postoperative vigilance and care
Often, technical problems that occur during a procedure may go unnoticed until a patient becomes seriously unwell. The Physician Insurers Association of America found in a study of laparoscopic cholecystectomy cases that a failure to recognise complications until after the procedure was reported in more than 70% of claims.3
Failing to detect complications promptly is compounded by the fact that there often seems to be reluctance amongst surgeons to respond appropriately and/or efficiently when complications become apparent postoperatively. Professor Leon Snyman, Associate Professor in Obstetrics and Gynaecology at the University of Pretoria, and an expert on gynaecological laparoscopic surgery, says: “Unlike a laparotomy, where patients should be seen to improve on a daily basis, in laparoscopic surgery they should be improving on an hourly basis.”
Unlike a laparotomy, where patients should be seen to improve on a daily basis, in laparoscopic surgery they should be improving on an hourly basis
Time is almost concertinaed in laparoscopic surgery – improvements, and deterioration, in a patient’s condition happen quickly. It is important that you ensure the patient is monitored frequently, and this is recorded. If there is no note in the patient’s records of these checks, it makes defending a claim very difficult.
The complication itself may not be the result of a negligent act, eg, a perforated bowel, but if a surgeon adopts a wait-and-see approach, or sits on the problem and manages it with painkillers and antibiotics, this could result in a negligence claim. If a patient has been discharged and contacts their surgeon complaining of pain, they are often advised to take paracetamol, wait, and ring back if the pain persists into the next day. Often, this might be too late. The response may then have to be surgical – which often involves the big jump to a laparotomy.
When taking informed consent for a procedure, you should ensure that patients are educated about the possible risk of postoperative complications, and warned of the signs to look out for so that they know when to seek treatment once they have been discharged from hospital.
There should also be clear guidelines for the patient to know who to contact should there be a problem out of hours, so that they know to go to their surgeon rather than another doctor. This helps to ensure continuity of care.
Case study
Mrs F, a 45-year-old accountant, was referred to Dr M with a clinical history of biliary colic. An ultrasound confirmed the presence of several stones. Mrs F was fully consented for a laparoscopic cholecystectomy and booked in for surgery in five weeks’ time.
During the procedure, Dr M divided what he thought was the cystic artery and duct. He documented that inflammation was partially obliterating Calot’s triangle. Apart from this, the procedure was uneventful.
Mrs F was not eager to mobilise following recovery from the general anaesthetic, seeming generally listless and complaining of pain.
The next day, she refused breakfast, saying she had no appetite and felt nauseous. Later in the day, she developed some respiratory symptoms with cough, moderate grade temperature and bilateral consolidation of both lung bases. Her condition then deteriorated very quickly and she became tachycardic and tachypnoeic.
She was transferred to ICU, where she was intubated and ventilated. Minimal yellowish fluid was noticed in her abdominal drain. Within the next few days, her renal function deteriorated, her white cell count became very high and her Hb dropped to 7g/dl. She had several episodes of melaena. An abdominal ultrasound revealed a multiloculated collection in the right upper quadrant; 300ml of clear orange fluid was drained.
All attempts to stabilise her situation and take her back to theatre were unsuccessful, and Mrs F died in ICU three weeks after surgery.4
All attempts to stabilise her situation and take her back to theatre were unsuccessful
The postmortem examination confirmed that the cause of death was septicaemic shock due to peritonitis, as a consequence of the common bile duct being damaged.
Learning points
- Damage to the common bile duct is the most common complication in laparoscopic cholecystectomy. This is often due to inflammation, which makes it difficult to distinguish the common bile duct from the cystic duct. This is encountered in about 5% of cases.
- The signs and symptoms of complications in patients who have had laparoscopic surgery are often subtle, so careful postoperative observation is vital.
- The Association of Laparoscopic Surgeons of Great Britain and Ireland (ALSGBI) recommends taking the following precautions during surgery:
- Maintain the best possible vision at all times.
- Avoid the use of sharp instruments unless absolutely necessary.
- Take extreme care with the use of diathermy, or ultrasonic devices (remember that the tip of the instrument may remain hot even if the power has been switched off).
- Check that the bowel has not been injured during access.
- Before leaving the abdominal cavity take care to check all areas where injury to tissue or bleeding may have occurred.
- Inspect all cannulation sites after withdrawal of the cannula at the conclusion of the operation. (Lightly place a finger over the skin wound at the time of inspection so that any bleeding will run into the abdominal cavity and be seen easily.)
- Where necessary, use a drain.5
- Finally, ensure that all patients are given appropriate contact details and instructed to contact the hospital, rather than their GP or another hospital, if any problems occur.
Unless otherwise stated, facts have been altered to preserve confidentiality.
References
- Makai G and Isaacson K, Complications of Gynaecologic Laparoscopy, Clinical Obstetrics and Gynaecology Vol 52 no 3 401-411 (2009)
- HPCSA, Seeking Patients’ Informed Consent: The Ethical Considerations para 3.1.3 (2007)
- Physician Insurers Association of America, Laparoscopic Injury Study p10 (2000)
- Lalanda M, Anthony S, Through the keyhole, Casebook, 15 (1) (2007)
- Kapadia CR and McMahon MJ, Recognition, Management and Prevention of Abdominal Complications of Laparoscopic Surgery, ALS Clinical Guidelines, (ALSGBI).