Safe and very sound!

▶ Haynes AB, Weiser TG, Berry WR, et al. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med 2009;360:491–9.

▶ Weiser TG, Haynes AB, Dziekan G, et al. Effect of A 19-Item Surgical safety checklist during urgent operations in a global patient population. Ann Surg 2010;251:976–80.

Surgery has become an integral part of global health care, with an estimated 234 million operations performed yearly. Surgical complications are common and often preventable. The authors of these two papers hypothesised that a program to implement a 19-item surgical safety checklist would reduce complications and deaths associated with surgery. The origins of the checklist come, loosely, from the aviation industry where routine safety checks are made prior to and debrief after any flight. In the case of surgery the checks are conducted in the operating theatre prior to and after surgery, and they are similarly designed to improve team communication and consistency of care. The initial study published in 2009 was conducted in non-urgent cases in eight different hospitals around the world (Toronto, Canada; New Delhi, India; Amman, Jordan; Auckland, New Zealand; Manila, Philippines; Ifakara, Tanzania; London, England; and Seattle, WA) These centres representing a variety of economic circumstances and diverse populations of patients participated in the World Health Organisation's Safe Surgery Saves Lives program. The authors collected data on 3955 consecutively enrolled patients (undergoing non-urgent non-cardiac surgery) after the introduction of the Surgical Safety Checklist comparing this with 3733 patients before the checklist was introduced. The rate of death was 1.5% before the checklist was introduced and declined to 0.8% afterward (p=0.003). Inpatient complications occurred in 11.0% of patients at baseline and in 7.0% after introduction of the checklist (p<0.001). In the second paper they went on to look at similar cohorts of patients from the same worldwide centres, this time in an urgent surgical setting (842 patients prior to and 908 after the introduction of the checklist) In this study the complication rate was 18.4% (n=151) at baseline and 11.7% (n=102) after the checklist was introduced (P=0.0001). Death rates dropped from 3.7% to 1.4% following checklist introduction (p=0.0067). Clearly the potential implications of these two papers are enormous. A structured approach in the operating theatre with an initial team briefing, then a simple peri-operative checklist and a post operative debrief appears to significantly reduce surgical complications and mortality. Furthermore, to achieve such results the only real investment required is time and the level of that investment is minimal. So powerful has this message been that many units worldwide (including the UK) have now adopted this approach as mandatory in their theatres. One expects that there will be a number of future publications repeating this work in the coming months and it will be interesting to see how durable and reproducible these findings are.

SONIC trial, but still a lot of surrounding noise…

▶ Colombel JF, Sandborn WJ, Reinisch W, et al. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med 2010;362:1383–95.

Adults who don't respond to first line treatments for Crohn's disease are often started on azathioprine treatment. However, it is unclear if newer anti-tumour necrosis factor (TNF) agents such as infliximab, alone or in combination, are better choices.

To resolve this, SONIC is a randomised double blind trial, comprising 508 adults with moderate or severe Crohn's disease who were given infliximab, azathioprine, or both for 30 weeks (and up to 50 weeks as an extension). These adults had had Crohn's disease for a median of 2 years at randomisation. They had tried systemic steroids, budesonide, or mesalamine without success and none had received azathioprine or infliximab before the trial. The chance of remission without the need for systemic steroids was 56.8% (96/169) in those given drugs, 44.4% (75/169) in those given infliximab alone, and 30% (51/170) in controls given azathioprine. Infliximab was also better at healing mucosal ulcers than azathioprine, and the combination appeared to work best overall. Findings were similar at 26 and 50 weeks. Side effect profiles were comparable in all three groups, and those given the combination had no more opportunistic infections than others. Combining azathioprine with anti-TNF biological agents has been linked to an excess of hepatosplenic T-cell lymphoma in observational studies. But the trial was too small to rule out either of these hazards.

The SONIC trial suggests that infliximab works better for a corticosteroid-free clinical remission, but that both drugs together work in a synergistic fashion. However, this combination could carry a risk of rare but serious side effects. Larger randomised trials, ideally powered for clinical outcomes, are needed to resolve remaining uncertainties.

Colonoscopy in irritable bowel syndrome doesn't change the diagnosis

▶ Chey WD, Nojkov B, Rubenstein JH, et al. The yield of colonoscopy in patients with non-constipated irritable bowel syndrome: Results from a Prospective, Controlled US Trial. Am J Gastroenterol 2010;105:859–65.

Despite recommendations from international management guidelines that clinicians should make a positive diagnosis of irritable bowel syndrome (IBS), without the need of invasive investigation, uncertainty surrounds the diagnosis of IBS for both the patient and the physician.

In this large case-control study, patients presenting with symptoms that met the Rome II criteria for non-constipation-predominant IBS underwent colonoscopy with random left-sided colonic biopsies, and the endoscopic and histological findings were compared to those of healthy asymptomatic individuals undergoing screening colonoscopy for colorectal cancer or polyp surveillance. In total, 466 IBS patients and 451 controls were recruited. Controls were significantly older, and more likely to be male than those with IBS, but were otherwise comparable. Diverticular disease and adenomatous polyps were significantly commoner in controls, and mucosal erythema or ulceration commoner in IBS patients, but there were only 2 (0.4%) cases of inflammatory bowel disease, and 7 (1.5%) cases of microscopic colitis amongst those with IBS.

This study provides reassuring data that demonstrate that organic lower gastrointestinal findings are rare in those with IBS. However, there are some limitations of the study. Firstly, the control group are unlikely to be representative of the general population. Secondly, they were not matched for age and gender to the IBS cases. Thirdly, as all cases and controls did not undergo random colonic biopsy, it is uncertain whether the prevalence of inflammatory bowel disease and microscopic colitis in those with IBS was higher than that of the control population. Finally, as those with IBS only had left sided colonic biopsies performed the true prevalence of these conditions in patients meeting diagnostic criteria for IBS may have been underestimated.

Nevertheless, this study provides novel and useful information for the Gastroenterologist consulting with IBS patients and suggests that the hunt for structural lower gastrointestinal disease in these individuals as a cause for their symptoms is likely to be unsuccessful.

Journals scanned

New England Journal of Medicine, Annals of Surgery, American Journal of Gastroenterology

Reviewers

Mr Alastair Windsor, Dr Neeraj Bala, Dr Alex Ford.