Randomized clinical trial of prevention of seroma formation after mastectomy by local methylprednisolone injection.

BACKGROUND: Seroma formation, the most prevalent postoperative complication after mastectomy, is an inflammatory process that is potentially preventable via local steroid administration. This study investigated the effect of local steroid administration on seroma formation. METHODS: This was a double-blind randomized placebo-controlled intervention study of a single dose of 80 mg methylprednisolone versus saline on seroma formation after mastectomy. Patients were further classified according to the surgical axillary procedure: mastectomy with sentinel lymph node biopsy (M + SLNB) or mastectomy with level I-II axillary lymph node dissection (M + ALND). Treatments were administered into the wound cavity via the drain orifice following removal of the drain on the first day after surgery. The primary endpoint was seroma formation; secondary endpoints included the frequency of side-effects and complications. RESULTS: A total of 212 women scheduled for mastectomy for primary breast cancer were included. After M + SLNB, 32 (46 per cent) of 69 women developed a seroma in the methylprednisolone group, compared with 52 (78 per cent) of 67 in the saline group (P < 0.001). The mean cumulative seroma volume in the intention-to-treat population for the first 10 and 30 days was significantly lower in the methylprednisolone group (24 ml versus 127 ml in the saline group, and 177 versus 328 ml respectively) (P < 0.001). After M + ALND, similar proportions of patients developed a seroma in the methylprednisolone (35 of 37, 95 per cent) and saline (34 of 36, 94 per cent) groups, and methylprednisolone administration had no significant effect on seroma formation. No differences in infection rate were observed. CONCLUSION: Methylprednisolone administered into the wound cavity on the first day after M + SLNB exerted a highly significant preventive effect against seroma formation during the next 30 days. This effect was not seen in the M + ALND group. Future studies may clarify whether higher or repeated methylprednisolone doses increase the efficacy.

Multifocality as a prognostic factor in breast cancer patients registered in Danish Breast Cancer Cooperative Group (DBCG) 1996-2001.

The purpose of this study was to investigate the prognostic influence of multifocality in breast cancer patients. In a cohort of 7196 patients there were 945 patients with multifocality. We found no prognostic influence of multifocality on overall survival when controlling for known prognostic factors. We found a small but significant influence on disease-free survival (HR=1.16 [1.03-1.31]) and a strong correlation between multifocality and known prognostic factors. This was in accordance with an earlier study done on a smaller population and in a different period of time [Pedersen L, Gunnarsdottir KA, Rasmussen BB, Moeller S, Lanng C. The prognostic influence of multifocality in breast cancer patients. Breast 2004;13:188-193].

Assessment of clinical palpation of the axilla as a criterion for performing the sentinel node procedure in breast cancer.

AIMS: Clinically palpable lymph nodes (LNs) are regarded as a contraindication for performing the sentinel node (SN) procedure. Many studies have shown, however, that clinical assessment of axillary LNs is inaccurate. This study evaluated the reliability of clinical axillary LN assessment by experts and assessed whether inaccuracy can be related to LN size. METHODS: Three hundred and one consecutive breast cancer patients undergoing either axillary dissection or SN were studied prospectively. RESULTS: The risk of having metastasis to the LN was 40.4% if the preoperative clinical assessment was "non-palpable LN", 61.5% if the assessment was "palpable but benign LN" and 84.4% if it was "suspicious LN". There were no clinically significant differences in mean size either when the LN was palpable versus non-palpable, or when the LN had metastasis or not. CONCLUSIONS: The clinical assessment of axillary LNs as a criterion for offering the SN procedure is of little value.

Lipoma of the breast: a diagnostic dilemma.

Lipoma of the breast often causes diagnostic and therapeutic uncertainty. Clinically it may be difficult to distinguish a lipoma from other conditions. Fine-needle aspiration cytology (FNAC) is often not helpful. Both mammography and ultrasound scanning are often negative. For the present study, 108 women with a clinical diagnosis of lipoma were enrolled prospectively. The clinical diagnosis of lipoma was found to be incorrect in 25.0% of these cases. Mammography and ultrasound revealed a lipoma in only 3.0% and 21.0%, respectively. FNAC revealed only fat cells in 74.0% of cases. In all, only 9 patients (11.4%) fulfilled the triple diagnostic criteria, theoretically making tumour excision mandatory in the remaining cases. Our proposal for management is for any clinical diagnosis of lipoma to be confirmed by either FNAC revealing fat cells or a core biopsy consistent with a lipoma. The mammogram and the ultrasound need not necessarily demonstrate a lipoma, but obviously must not show anything to raise the suspicion of malignancy at the site. If these criteria are met it is not necessary to excise the tumour.

The prognostic influence of multifocality in breast cancer patients.

The aim of this study was to investigate whether multifocality (MF) is a factor that has significant effect on overall survival when controlling for known prognostic factors. A cohort of 929 breast cancer patients operated between 1985 and 1990 was investigated. Of these, 158 (17%) patients had MF tumors and 771 had unifocal tumors. To investigate whether MF is an independent prognostic factor for overall survival in breast cancer, a Cox regression model was applied. Only tumor size, positive lymph nodes, histologic grade and receptor status had a significant effect on overall survival in the multivariate analysis. We found a positive correlation between tumor size and MF and between the number of positive lymph nodes and MF. In conclusion, MF had no significant effect on overall survival besides that which can be explained by other prognostic factors.

[Differences in definitions of irritable bowel syndrome]. / Forskelle i colon irritabile-definitioner.

Irritable bowel syndrome is inconsistently defined. The resulting difference in study populations may impede general application of results from one study to another. The aim of this study was to evaluate the consistency of various definitions. At a follow-up of a sex-and age-stratified randomly selected cohort, participants filled in a questionnaire about abdominal symptoms. Questions categorized the participants according to five different definitions of irritable bowel syndrome:1) two Manning criteria,2) Rome criteria,3) consensus report by Drossman,4) definition by Talley and 5) definition by Kay. The participation rate was 64.4%. Manning and Rome criteria were consistent with a kappa value of 0.72. Consistency was also present comparing definitions of Drossman. Tallay and Kay (kappa values of 0.60-0.66) All other comparisons had kappa values below 0.42. It is concluded that variations in study population selected by different definitions of Irritable Bowel Syndrome are so large that they impede general application of any results. There is a need for an international agreement on a definition of irritable bowel syndrome.

Irritable bowel syndrome: which definitions are consistent?

OBJECTIVES: Irritable bowel syndrome is inconsistently defined in international literature. Consequently, the resulting differences in study populations may impede any general application of results from one study to another. The aim of this study was to evaluate the consistency of various definitions of irritable bowel syndrome. DESIGN: By means of a questionnaire concerning abdominal symptoms, subjects were categorized as having IBS according to five definitions: (1) two positive Manning criteria; (2) the Rome criteria; (3) a consensus report by Drossman; (4) definition by Talley; and (5) a newly suggested definition by Kay. SETTING: The study was carried out as part of a cohort study of 4122 Danes at the Centre of Preventive Medicine (former the Glostrup Population Studies), Glostrup County Hospital, Denmark. MAIN OUTCOMES MEASURES: Kappa coefficients comparing the irritable bowel populations as defined by the above five definitions. RESULTS: The participation rate was 64.4%. Manning and Rome criteria of irritable bowel syndrome were consistent with a Kappa value of 0.72. A substantial degree of consistency was also present comparing definitions of Drossman, Talley and Kay (kappa, 0.60-0.62). All other comparisons had kappa values below 0.42. CONCLUSION: Variations in study populations selected by different definitions of irritable bowel syndrome are so large that they impede the general application of any results. There is a need for international agreement on consistent use of one definition of irritable bowel syndrome.

[CT in preoperative assessment of renal tumors?]. / CT ved praeoperativ vurdering af nyretumorer?

The value of CT-scanning as part of the preoperative morphological investigation of patients with renal tumours was calculated in a material of 28 patients. In eight patients, operative treatment was not found to be indicated. In the 20 patients in whom operation was undertaken, the operative and histological findings were compared with the findings on CT-scanning. In cases of disagreement, the CT-scanning findings were reassessed. It was found that interpretation of the CT-scan was accurate in 40% of the cases while minor disagreements were present in 25% but these did not have any significance for the indications for operation. In the remaining 35% considerable disagreement was found between the CT-scan and the operative or histological findings such as invasion of neighbouring organs, cysts interpreted as solid tumours with necrosis and as regards interpretation of the retroperitoneal glands. The present authors consider that CT-scanning provides an important supplement to the conventional morphological investigation of renal tumours with intravenous urography and radiography of the thorax. CT-scanning appears to be preferable to ultrasonic scanning in cases which are difficult to review and where expert interpretation of ultrasonic findings is not available. In addition, routine preoperative biopsy of the tumour guided by ultrasound is recommended together with peroperative biopsy for freeze microscopic examination prior to nephrectomy.

Gastrocolic fistula resulting from chronic pancreatitis.

Gastrocolic fistulas are rare, and are usually seen as complications of peptic ulcer or malignancy of the stomach and large intestine. We have described a case resulting from chronic relapsing pancreatitis. The patient was successfully treated with excision of the fistula and closure of the gastric and colonic wall.

Intraperitoneal granulomatous foreign body reaction after accidental perforation of the abdominal wall. Case report.

After an accidental perforation by a wooden stake of the abdominal wall and distal ileum a 28-year-old man developed an aggressive granulomatous foreign body reaction of the greater omentum with high fever and abdominal pain. The patient was cured by omental resection and prednisone treatment.

Perforated gastric ulcer.

A retrospective study is presented of 297 patients operated upon for perforated benign gastric ulcer in Denmark from 1975 to 1984. Male:female ratio was 0.9:1, mean age 64.2 years. The numbers of gastric and prepyloric perforations were almost equal (156:141), but gastric perforations were more frequent in elderly women and prepyloric perforations in younger men. Simple closure was performed in 83 per cent of the patients, gastric resection in 14 per cent and simple closure and vagotomy in 3 per cent. The postoperative mortality rate was 21 per cent and was related to the high proportion of elderly patients with concurrent diseases and delayed treatment.

Seasonal periodicity of perforated gastric ulcer.

The seasonal periodicity of perforated peptic ulcer of the stomach was analysed among 296 patients operated at seven departments of gastrointestinal surgery in Denmark between 1975 and 1984. Admissions were significantly higher in August and September with a tendency, although not significant, in March also. This pattern was unaffected by age and sex.

Gastrocolic fistulas.

Sixteen patients were treated for gastrocolic fistula arising as a complication of peptic ulcer (11 cases), colonic perforation (2), gastric cancer (1), colonic cancer (1) or pancreatitis (1). The predominant symptoms were diarrhoea, weight loss and abdominal pain. Barium meal and barium enema were the most reliable means of diagnosis, and no fistula was gastroscopically demonstrable. A one-stage en bloc resection of the involved gastrocolic region was performed in eight cases. Other operations were simple excision (3), gastric resection with closure of the colonic wall (2) and colectomy with closure of the gastric wall (2). In one case cure was achieved with cimetidine, without surgical intervention. Four patients died postoperatively and two had recurrence of fistula.

The aminoterminal propeptide of type III procollagen and basement membrane components in serum during wound healing in man.

The aim of this study was to investigate if the serum concentrations of antigens related to basement membrane components and to the interstitial type III collagen reflect the sequential and transitional synthesis of basement membranes and of type III collagen in wound granulation tissue. The aminoterminal propeptide of type III collagen, the 7S domain of type IV collagen and the P1 fragment of laminin were determined in 11, 10 and 6 patients, respectively, during wound healing following intraabdominal surgery. No change was observed in the type III propeptide level at the first postoperative day. During further follow-up (mean 71 days, range 21-155 days), the propeptide levels showed a transitional increase, with a maximum at day 10. A sequential pattern was observed in the increase of the serum concentrations, as the maximum increase of the basement related antigens in serum occurred within the first 7 postoperative days. This is in accordance with observations of an early formation of basement membranes in blood vessels, preceding deposition of interstitial collagens in granulation tissue. The results support the assumption that the serum concentrations of connective tissue related antigens may be valuable markers of wound healing in man.

Peritoneal lavage in the diagnosis of acute peritonitis.

The study was aimed at determining the value of peritoneal lavage as an aid in the diagnosis of acute peritonitis when the diagnosis could not be made by ordinary clinical criteria. Thirty patients were studied prospectively. Twenty-five of the patients were suspected of having peritonitis but doubt existed because of an unreliable history or equivocal or confusing abdominal signs. Five remaining patients were comatose and an intraabdominal source of sepsis needed to be excluded. The technique of lavage and criteria for diagnosis have been presented herein. There were 10 true-positive results, no false-positive results, 19 true-negative results, and one false-negative result (positive predictive value 100 percent, confidence level 95 percent). There were no complications due to the test. Peritoneal lavage is a useful method of diagnosing or excluding peritonitis in patients with confusing abdominal signs. Negative results of laparotomy or prolonged observation may thus be obviated in such patients.

Screening for Campylobacter pyloridis in patients with upper dyspepsia and the relation to inflammation of the human gastric antrum.

Campylobacter pyloridis, a recently detected microorganism, was isolated from gastric antral mucosa in 58% of 119 consecutive patients with upper dyspepsia. There was a highly significant correlation between the presence of Campylobacter pyloridis and antral inflammation and a close relation to prepyloric and duodenal ulcer. There was no significant correlation with the severity or type of inflammation. This microorganism, which seems to be as common in Denmark as in other parts of the world, is considered a possible cause of gastroduodenal disease.