Luigi Basso

Cesarean section and hernia repair: simultaneous approach

Aim:  Hernias of the abdominal wall occurring during pregnancy are usually treated a few weeks after delivery. The aim of this study was to retrospectively evaluate the clinical outcome of inguinal or umbilical hernioplasty performed at the time of the cesarean section, and to compare the outcome of this group with a control population, who received a cesarean section alone.

Extent of lymphadenectomy and perioperative therapies: two open issues in gastric cancer.

Gastric cancer is one of the leading causes of death for cancer worldwide, although geographical variations in incidence exist. Over the last decades, its incidence and mortality have gradually decreased in Western countries, while these have increased, or remained stable, in the other world regions. Gastric cancer is often diagnosed at an advanced stage, with the only notable exception of Japan, where nationwide screening programs are enforced, due to local high incidence. Curative- intent surgery (i.e., gastrectomy, total or partial, and lymphadenectomy) remains the cornerstone of treatment of gastric cancer. Much has been debated about the extent of lymph node dissection and, although it is a valuable contribution to staging and cure, operative treatment only represents one aspect of overall effective management, as the risk of both locoregional and distant recurrences are high, and bear a poor prognosis. As a matter of fact, surgery, as a single modality treatment, has probably achieved its maximum efficacy for local control and survival, while other accompanying nonsurgical treatment modalities have to be taken into account, although their role is still the subject of considerable debate. The authors in this review present an update on the outcome of treatment of gastric cancer in relation to the extent of lymphadenectomy and of various nonsurgical preoperative, intraoperative, and postoperative strategies.

IS THERE A CAUSAL CONNECTION BETWEEN BILE ACIDS AND COLORECTAL CANCER

Bile acid composition was assessed in 50 patients with colorectal cancer as compared to that in a control group of 50 subjects. The two groups were age- and sex-matched. The overall bile acid values were similar in both groups, while the relative concentrations of primary and secondary bile acids were different, a significant increase in the patients with colorectal cancer being observed. This finding thus seems to confirm the existence of a link between colorectal cancer and cholelithiasis. Both conditions share common risk factors, such as alterations in cholesterol metabolism and bile acid composition.

Screening of Helicobacter pylori infection after gastrectomy for cancer or peptic ulcer: Results of a cohort study

BACKGROUND Gastric cancer commonly follows a long-standing inflammation, mainly due to Helicobacter pylori (HP) infection. After resection, the stump develops precancerous alterations. DESIGN Prospective study of patients undergoing endoscopy from April 1, 2000, through March 31, 2006. SETTING University departments of Surgery and Experimental Medicine and Pathology. PATIENTS One hundred eighty-seven patients receiving upper gastrointestinal tract endoscopy many years after surgery for duodenal ulcer or gastric cancer. Ten to 12 postoperative endoscopic biopsy samples were taken from the remnant stomach. MAIN OUTCOME MEASURE The risk of gastric cancer precursor lesions associated with HP infection. RESULTS The gastric cancer precursor lesions were more common in the entire HP-positive population (odds ratio [OR], 2.37; 95% confidence interval [CI], 1.25-4.49; P = .007). However, HP-positive patients undergoing resection for cancer had a higher risk of the precursor lesions compared with HP-negative patients in the same diagnostic group (OR, 4.20; 95% CI, 1.10-15.96) and all patients undergoing resection for duodenal ulcer (OR, 1.59; 95% CI, 0.44-5.73). CONCLUSION The results of this investigation support the role of HP in gastric carcinogenesis and suggest that the HP eradication therapy might prevent the development of metachronous gastric cancer after gastric resection.

Bilateral ovarian mucinous cystadenoma in an adolescent presenting as abdominal compartment syndrome

an invasive adenocarcinoma originating in a tubulovillous adenoma. A subsequently performed sigmoidectomy revealed no residual tumour. In the pathology report, there was a description of an extensive black area in the mucosa and the serosa of the colon. The black colour was caused by the used Indian ink. Retrospectively, it is clear that the black lesions were spots of Indian ink derived from the intial marking of the resected adenoma. The pigmentation was probably not due to spilling but rather to migrating macrophages who absorbed the Indian ink and died on their journey. This case illustrates that ‘‘tissue is still the issue’’. In doubtful cases it is mandatory to take a biopsy.

Therapeutic approaches to patients with pilonidal sinus based on specific clinical characteristics

Controversies exist about the optimal treatment for patients with pilonidal disease. Our therapeutic approach to patients with this condition has been conservative treatment. Surgery was performed only after failure of conservative treatment. Surgery consisted of excision of the sinus and primary closure in patients of female sex and with sinus of small dimensions. Excision and Limberg flap was performed in male patients with a large sinus. Conservative treatment was successful in almost 50% of the patients. Excision and Limberg flap reconstruction had fewer recurrences than excision and primary closure; however, patients were less satisfied from an aesthetic point of view. Therapeutic approach to patients with pilonidal sinus should be modified according to the clinical conditions of the patient and anatomic characteristics of sinus.

It's got four wheels but is it a 'Ferrari' or a 'Fiat Bambino'? A critical reappraisal of evidence-based medicine.

It is obviously the case [1–3] that evidence-based medicine (EBM) relies on facts, whereby experimental evidence prevails over other knowledge. Thus, scientific conclusions, for example from randomized controlled trials (RCTs), can be reached regardless of theory, artefacts or observer-dependent bias. While extremely valuable and helpful in many clinical situations, EBM has its weaknesses. The definition of ‘evidence’ may be ambiguous and can exclude important information. In EBM various degrees of ‘evidence’ are classified according to the method used for its collection. Some types of study, such as a RCT, are generally believed to be less ‘vulnerable’ to error and are therefore accepted as being of ‘higher quality’, but ironically RCTs and meta-analyses have never been scientifically proven to be more reliable than other methods of research. The definition of ‘high-quality evidence’ may exclude the information necessary to address many medical questions. Thus EBM does not provide any means of integrating other important forms of medical knowledge such as may come from clinical experience or the individual patient. It is interesting to note that the concept of EBM is not ‘evidence-based’ and has never been found to meet its own empirical tests for evaluating its effectiveness. If we consider that the aim of EBM should be the optimization of medical care by basing decisions on ‘statistically valid’ clinical studies, it is a paradox that there is no scientific ‘evidence’, as defined by EBM, that meets its own criteria. It may be inappropriate to apply EBM to individual patients because of differences in clinical circumstances and individual laboratory data. Many diseases are rare, and their variants, which may include many subsets of patients, will always be beyond ‘evidence’. This difficulty may also apply to common conditions such as constipation, where evidence cannot be applied to each individual owing to the heterogeneity of the disorder. For example, such patients can be divided according to type, age, gender, parity, concomitant disease etc. There is the danger that EBM may fracture the doctor–patient relationship, which is one of the keystones of care, thus limiting the right of the patient to receive the best treatment for his or her particular pathology. It is of further concern that EBM might be used indiscriminately by hospital managers as a powerful and dangerous weapon to reduce health-care costs. They might ask ‘Are we sure that an expensive Whipple procedure for pancreatic cancer translates into a real benefit for the patient? Is survival prolonged? What is the evidence base?’. Yet, if medically indicated, wouldn’t we all offer it to our patients, because the operation can indeed help some, albeit a few? It is also the case that EBM applied indiscriminately could dramatically increase the cost of health care, for example if it were ‘proven’ by the evidence that an unnecessarily expensive therapy was slightly more effective than another effective, yet cheaper, treatment. Not all scientific evidence is made accessible to the public, and this factor can strongly limit the effectiveness of any approach. The most obvious bias is the frequent failure to publish negative results, especially in the case of commercially sponsored clinical trials [4]. Another factor is the type of trial, whereby those that are considered ‘gold standard’, such as a large RCT, may be very expensive so the degree of funding can itself influence what gets investigated and published. Evidence-based medicine has different grades of ‘evidence’ (I to III in the USA; A to D in the UK) and ‘recommendations’ (A to D) [5]. Effectively, saying that for a certain procedure ‘there is EBM’ without necessarily taking into any account whether the evidence or recommendations, adds up to no more than saying that all cars have four wheels, ignoring whether they are Ferraris or Fiat Bambinos. Used correctly, EBM is extremely valuable in clinical practice, but when applied blindly and in ignorance of the specific clinical context it may be misleading and even incorrect.

The relationship between industry and surgical practice

Sir Iain Chalmers, one of the founders of the Cochrane Collaboration, some years ago stated that he did not ‘blame industry for trying to get away with anything that is normally considered to be its primary purpose, which is to make profits and look after its shareholders’ interests. It is our profession that has colluded in all of this and been prepared to go along with it – we are the people to blame because we need not have stood for it’ [1]. While on the one hand the public demands scientifically more and more advanced treatments, on the other many industries try to exploit the prosperous business of healthcare by introducing new devices. While these should be scientifically validated for efficacy, safety and need, certain factors might bias or prematurely encourage their validation. Patients have now wide access to technology and information through the Internet. Their expectations of healthcare are technologically advanced. They seek painless and ‘magic’ solutions to their problems, even if effective cheaper and time-honoured treatments already exist. Medicine is competitive and coloproctology is no exception. Surgeons, especially at a personal level, may be urged to employ technical innovations simply to prove that they are ‘in fashion’ and technologically up-to-date. Manufacturers invest huge funds in research and development of new drugs and devices and, as a consequence, they may be reluctant to accept or publicly disclose a negative outcome. Because of this, most studies testing new devices and medications end up publishing only positive and convenient results. In an attempt to limit this, the editors of most medical journals now specifically ask prospective contributors, on submission of a paper for publication, to disclose whether they have any conflict of interest [2], defined as ‘situations where the disparity between the interests of the patient and those of the physician... may unknowingly affect the sound judgment of the physician’ [3]. This is one reason why submission of papers now requires more and more forms to complete, sometimes by each individual author. Regardless of forms and statements, however, moral integrity is probably still the only or most effective way to avoid bogus, biased and ‘fawning’ publishing. Some scientists have tried to report the possible negative outcome of their sponsored research against the interest of their own sponsors but have had to face huge editorial, professional and even legal opposition. The story of Dr Betty Dong, a clinical pharmacist at the University of California at San Francisco (UCSF) is a famous example. Between 1987 and 1990 Dr Dong was financed by Boots Pharmaceuticals, to compare Synthroid (levothyroxine, at the time manufactured by Boots) with cheaper generic medications. In 1995 Boots was taken over by BASF A.G., which then started marketing Synthroid through its subsidiary Knoll Pharmaceuticals. Up to Dr Dong’s study, Synthroid was considered to have superior bioavailability, but she discovered that generic drugs were just as good and effective and if these had been used in practice the annual expenditure in the USA of

Letter: experience of 3711 stapled haemorrhoidectomy operations (Br J Surg 2006; 93: 226–230)

356 million per year would have been saved [4]. When Dr Dong tried to publish her findings in the Journal of the American Medical Association (JAMA), Boots (and later Knoll Pharmaceuticals) threatened to take legal action and Dr Dong had to withdraw her manuscript from the JAMA just 1 week before publication. Boots then published an incomplete ‘convenient’ version of the findings in ‘friendly’ journals, under their own control, while excluding Dr Dong and threatening to sue her. Two UCSF investigations subsequently failed to find any wrongdoing by Dr Dong and concluded that her study was rigorously conducted in line with the protocol with only very minor deviations, which are in any case always to be expected in any clinical trial. UCSF labelled Boots’s handling of Dr Dong ‘harassment’ and ‘deceptive and self-serving’, considering suppression of the manuscript to be an infringement of academic freedom. The clinical pharmacist was basically left alone in her battle for the truth, but eventually in 1996 Dr Dong’s story became ‘public’ and was exposed in the Wall Street Journal [5]. Soon after publication of the paper, the Food and Drug Administration, which had been loosely involved from 1994, concluded that Boots/Knoll had violated the Federal Food, Drug and Cosmetic Act. Dr Dong’s paper was at last published in JAMA in April 1997 after a delay of 7 years [6]. In November 1997, the manufacturer (which had become Knoll Pharmaceuticals) was required to pay around

Cyanoacrylate glue in the treatment of ano-rectal fistulas

100 million to settle legal actions accusing the company of having cheated its patients. This was probably no disaster for the company since a profit of