Early detection of complications after laparoscopic surgery: summary of a safety report from the National Patient Safety Agency
BMJ 2011; 342 doi: https://doi.org/10.1136/bmj.c7221 (Published 19 January 2011) Cite this as: BMJ 2011;342:c7221
All rapid responses
Rapid responses are electronic comments to the editor. They enable our users to debate issues raised in articles published on bmj.com. A rapid response is first posted online. If you need the URL (web address) of an individual response, simply click on the response headline and copy the URL from the browser window. A proportion of responses will, after editing, be published online and in the print journal as letters, which are indexed in PubMed. Rapid responses are not indexed in PubMed and they are not journal articles. The BMJ reserves the right to remove responses which are being wilfully misrepresented as published articles or when it is brought to our attention that a response spreads misinformation.
From March 2022, the word limit for rapid responses will be 600 words not including references and author details. We will no longer post responses that exceed this limit.
The word limit for letters selected from posted responses remains 300 words.
Sir,
The article "Early detection of complications after laparoscopic surgery"
(1) from the National Patient Safety Agency (NSPA) contains masterful
understatement:
"Between April 2005 and April 2010, the NSPA received reports of 11
deaths and 37 serious incidents (SIs) in patients who had deteriorated
after laparoscopic surgery. These incidents are probably greatly under-
reported...."
A survey (2) of 646 members of the Association of Laparoscopic
Surgeons found 31 reports of deaths and 333 significant injuries in the
last year, 90 associated with delayed discharge. Research underpinning the
NPSA paper (3) also analysed the NHSLA database of litigation, revealing
496 claims for injury over 15 years, 327 having been concluded in favour
of the plaintiff. The surgeons' survey is limited by possible double
counting and selective memory, but suggests an incidence of 30 deaths and
at least 3 times as many significant harms annually. The lawyers' data
imply an annual incidence of 22 significant harms. This is probably an
under-estimate; many injured parties will have not made or yet settled
well-founded claims.
These figures are far greater than the NPSA's 2.2 deaths and 7.4
other SIs per year and suggest that only 7-25% of cases were reported to
them. There is little reason to believe that such under-reporting is less
common for other iatrogenic harms. In April 2010, a legally enforceable
duty was placed on hospitals to report all SIs to the NPSA. A prospective
audit of compliance is essential.
Subsequently, the coalition government has made two further,
potentially contradictory commitments:
a) To abolish the NPSA, moving its patient safety functions to the new NHS
Commissioning Board, thereby probably causing planning blight and re-
disorganisation.
b) To ".....require hospitals to be open about mistakes and always tell
patients if something has gone wrong (4)".
Consultations are ongoing at the Department of Health about how and upon
whom this requirement should be enforced. The malpractice insurers,
General Medical Council and Royal Colleges have opposed any legal
sanction, arguing (without evidence) that this already exists, or that it
would encourage cover-ups. The NPSA and NHS LA have been conspicuous by
their absence. A recent parliamentary debate left the government's
position open (5)though the Minister was previously opposed to statutory
duties of candour (Lansley A, personal communication).
This issue is contentious. Insurers fear that costs would rise,
though there is evidence to the contrary. Doctors find it difficult to
admit error, and risk being caught between legal sanctions and bullying by
NHS managers who prioritise reputational risks over patient safety. This
reasonable concern could be alleviated by imposing the duty on management
in the first instance.
Speaking as a doctor (who has inevitably made mistakes) and a patient
(who nearly died of one) most patients welcome candour and are usually
forgiving of errors honestly admitted, but are outraged by evasions or
dishonesty. The present system virtually mandates cover-ups. The better
alternative is an enforceable duty on managers to provide to patients with
copies of any reports of serious incidents sent to the NPSA (or its
successor). This reality check on under-reporting would protect patients
and doctors and promote ethical practice.
1) Lamont T et al. Early detection of complications after
laparoscopic surgery: summary of a safety report from the National Patient
Safety Agency. BMJ?2011;?342:c7221.
2) Association of Surgeons of Great Britain and Ireland. Survey of
injuries associated with laparoscopic surgery. 2010.
www.asgbi.org.uk/en/members/asgbi_surveys.cfm.
3) NPSA. Rapid Response Report: Laparoscopic surgery: Failure to
recognise post-operative deterioration. NPSA/2010/RRR016.
http://www.nelm.nhs.uk/en/NeLM-Area/News/2010---September/27/NPSA-rapid-
response-report-Failure-to-recognise-post-operative-deterioration-
following-laparoscopic-surgery
4) HM Government. The Coalition: our programme for government.
http://www.direct.gov.uk/prod_consum_dg/groups/dg_digitalassets/@dg/@en/documents/digitalasset/dg_187876.pdf
5) Candour in Health Care (Westminster Hall debate, 1/12/2010).
http://www.publications.parliament.uk/pa/cm201011/cmhansrd/cm101201/hall...
Competing interests: FWA suffered a laparoscopic perforation at an elective procedure. This was left untreated until post-op day 7, resulting in a sub-total excisional laparostomy, a cardiac arrest and six months convalescence. He is an unpaid member of the Department of Health working party cited above.
This article1, form the NPSA team, was extremely helpful in listing
the symptoms and signs that would alert health professionals to the
possibility of a laparoscopic-related complication. It is equally
important that patients are similarly educated on these post-operative
symptoms, and this information ought to be documented at peri-operative
consent and contained within patient information leaflets as an expected
level of good medical practice.
Delays in the recognition and management of laparoscopic
complications undoubtedly compound morbidity. Whilst 'major' symptoms
(such as abdominal distension, pyrexia and shock) may be predictive of
laparoscopic-related complication, they tend to be late-stage sequelae.
Clinicians need to be aware of subtle 'minor' presentation symptoms (e.g.
mild abdominal pain, dyspepsia, nausea, constipation) which often do not
appreciably impact on the patient's general health and represent early-
onset sequelae. Clinicians need to maintain a low threshold for further
investigation when confronted with a patient re-presenting shortly after
laparoscopic surgery. As a rule of thumb, and perhaps considered as a
'safety rule', clinicians should assume laparoscopic-related complication
until proven otherwise in any patient who is not demonstrating progressive
improvement after laparoscopic surgery. Such a rule encompasses both
'major' and 'minor' type presentation symptoms and would facilitate
earlier senior clinician involvement, recognition and intervention.
Laparoscopy performed in the abdomen is not solely performed by
general surgeons. I am concerned that NPSA 1 may have missed a golden
opportunity to involve other 'stakeholders' (e.g. gynaecologists,
urologists) when drafting this safety alert. Ultimately, most laparoscopic
complications are not specific to the particular type of operation, or
specialty-specific, and relate to common mechanisms (such as injury at the
time of laparoscopic entry 2 or delayed-onset diathermy bowel
injuries).Wider multi-specialty consultation would have led to greater
dissemination of this important safety alert message and improved patient
safety awareness.
1. Lamont T, Watts F, Panesar S, Macfie J, Matthew D. Early detection
of complications after laparoscopic surgery: summary of a safety report
from the National Patient Safety Agency.BMJ. 2011 Jan 19;342:c7221.
2. Varma R, Gupta JK. Laparoscopic entry techniques: clinical
guideline, national survey, and medicolegal ramifications. Surg Endosc.
2008 Dec;22(12):2686-97.
Competing interests: No competing interests
Consent 24 Hours before the operation:how feassible?
Sir,
With the development of day Surgery all patients come in on the
morning of the surgery and even with best intentions in the world there is
insufficient time to take full informed consent. Rightly or wrongly, days
of patients coming in the day before the surgery are just a distant
memory.
Ideally, fully informed consent should be obtained a week before the
surgery and patients should be given written information too. This would
allow patients to digest the information, ask any questions that they may
have and indeed change their mind if they wish to. This is something akin
to the 'cooling off period' that is used in the commercial world.
Competing interests: No competing interests