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Bitter lessons
ARTICLES
22 Latini R, Tognoni G, Maggioni AP, et al. Clinical effects of early ACE inhibitor treatment for acute myocardial infarction are similar in the presence and absence of aspirin: meta-analysis of individual data from early 96,000 randomized patients. J Am Coll Cardiol 2000; 35: 1801–07. 23 Flather MD, Yusuf S, Kober L, et al. Long-term ACE-inhibitor therapy in patients with heart failure or left ventricular dysfunction: a systematic overview of data from individual patients. Lancet 2000; 355: 1575–81. 24 Yusuf S, Wittes J, Probstfield J, Tyroler A. Analysis and interpretation
of treatment effects in subgroups of patients in randomized clinical trials. JAMA 1991; 266: 93–98. 25 Yusuf S, Collins R, Peto R. Why do we need some large, simple randomized trials? Stat Med 1984; 3: 409–20. 26 Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst 1959; 22: 719–48. 27 Yusuf S, Peto R, Lewis J, Collins R, Sleight P. Beta-blockade during and after myocardial infarction: an overview of the randomized trials. Prog Cardiovasc Dis 1985; 27: 335–71.
Uses of error Bitter lessons Federico Bozzetti I once operated on a 70-year-old woman with an advanced gastric cancer, who was enrolled in a randomised clinical trial, which compared the standard reconstruction after total gastrectomy (the Roux-en-Y procedure) with a more hazardous and delicate reconstruction (the interposed loop procedure). The higher risk of this reconstruction was due to the fact that a loop of jejunum had to be isolated on its vascular pedicle, anastomosed proximally to the oesophagus and distally to the duodenum. My previous experience with total gastrectomy consisted of several dozen cases, most of which I had done with the standard Roux-en-Y reconstruction. This patient was randomised to an interposed loop procedure, and had an early postoperative dehiscence of the oesophago-jejunal anastomosis which was impossible to repair despite three subsequent operations. Finally, to prevent a lethal peritonitis, we had to remove the interposed loop, close the oesophageal stump in the lower
mediastinum, close the duodenal stump, and construct a cervical oesophagostomy and a feeding jejunostomy. The patient survived all the surgical trauma and postoperative complications but finally died, some months later, without ever leaving the hospital, with a massive bronchoenteric fistula caused by recurrent tumour growth. There was no apparent error in the surgical technique at the first operation, and the dehiscence was probably caused by arterial ischaemia from postoperative hypotension or microvascular thrombosis. Subsequent operations were correctly planned and performed. The major error was made at my desk when I decided to enrol the patient in this trial, even though she met all the eligibility criteria. Basically, I did not reason that any mild benefit in nutritional status potentially gained in the interposed loop arm would never compensate for the excess morbidity of a surgical procedure which was intrinsically more hazardous.
Oncologia Chirurgica Generale, Istituto Nazionale per lo Studio e la Cura dei Tumori, 20133 Milan, Italy (F Bozzetti MD)
THE LANCET • Vol 360 • October 5, 2002 • www.thelancet.com
1043
For personal use. Only reproduce with permission from The Lancet Publishing Group.
22 Latini R, Tognoni G, Maggioni AP, et al. Clinical effects of early ACE inhibitor treatment for acute myocardial infarction are similar in the presence and absence of aspirin: meta-analysis of individual data from early 96,000 randomized patients. J Am Coll Cardiol 2000; 35: 1801–07. 23 Flather MD, Yusuf S, Kober L, et al. Long-term ACE-inhibitor therapy in patients with heart failure or left ventricular dysfunction: a systematic overview of data from individual patients. Lancet 2000; 355: 1575–81. 24 Yusuf S, Wittes J, Probstfield J, Tyroler A. Analysis and interpretation
of treatment effects in subgroups of patients in randomized clinical trials. JAMA 1991; 266: 93–98. 25 Yusuf S, Collins R, Peto R. Why do we need some large, simple randomized trials? Stat Med 1984; 3: 409–20. 26 Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst 1959; 22: 719–48. 27 Yusuf S, Peto R, Lewis J, Collins R, Sleight P. Beta-blockade during and after myocardial infarction: an overview of the randomized trials. Prog Cardiovasc Dis 1985; 27: 335–71.
Uses of error Bitter lessons Federico Bozzetti I once operated on a 70-year-old woman with an advanced gastric cancer, who was enrolled in a randomised clinical trial, which compared the standard reconstruction after total gastrectomy (the Roux-en-Y procedure) with a more hazardous and delicate reconstruction (the interposed loop procedure). The higher risk of this reconstruction was due to the fact that a loop of jejunum had to be isolated on its vascular pedicle, anastomosed proximally to the oesophagus and distally to the duodenum. My previous experience with total gastrectomy consisted of several dozen cases, most of which I had done with the standard Roux-en-Y reconstruction. This patient was randomised to an interposed loop procedure, and had an early postoperative dehiscence of the oesophago-jejunal anastomosis which was impossible to repair despite three subsequent operations. Finally, to prevent a lethal peritonitis, we had to remove the interposed loop, close the oesophageal stump in the lower
mediastinum, close the duodenal stump, and construct a cervical oesophagostomy and a feeding jejunostomy. The patient survived all the surgical trauma and postoperative complications but finally died, some months later, without ever leaving the hospital, with a massive bronchoenteric fistula caused by recurrent tumour growth. There was no apparent error in the surgical technique at the first operation, and the dehiscence was probably caused by arterial ischaemia from postoperative hypotension or microvascular thrombosis. Subsequent operations were correctly planned and performed. The major error was made at my desk when I decided to enrol the patient in this trial, even though she met all the eligibility criteria. Basically, I did not reason that any mild benefit in nutritional status potentially gained in the interposed loop arm would never compensate for the excess morbidity of a surgical procedure which was intrinsically more hazardous.
Oncologia Chirurgica Generale, Istituto Nazionale per lo Studio e la Cura dei Tumori, 20133 Milan, Italy (F Bozzetti MD)
THE LANCET • Vol 360 • October 5, 2002 • www.thelancet.com
1043
For personal use. Only reproduce with permission from The Lancet Publishing Group.