Morbidity comparison of sentinel lymph node biopsy versus conventional axillary lymph node dissection for breast cancer patients: results of the sentinella-GIVOM Italian randomised clinical trial.

AIMS: To compare physical morbidity and health-related quality of life (HRQOL) in breast cancer patients who received standard axillary dissection (ALND) or sentinel lymph node biopsy (SLNB), followed by axillary dissection only in the case of sentinel-node positivity, within a randomised clinical trial. PATIENTS AND METHODS: Patients with early breast cancer < or =3cm and clinically negative axilla were randomly allocated to ALND or SLNB. All patients underwent physical examination every 6 months in order to assess any arm-related symptoms. A subset of patients completed the SF-36 quality of life questionnaire and the Psychological General Well Being Index (PGWBI) before randomisation, at 6 and 12 months after surgery and yearly thereafter. Results of the first 24 months are reported. RESULTS: Six-hundred and seventy-seven patients were available for analysis: 341 patients randomised to the ALND group and 336 to the SLNB group. Six months after surgery, the SLNB group had significantly less lymph-oedema, movement restrictions, pain and numbness with respect to the ALND group. Lymph-oedema was also significantly reduced at 12 months and numbness remained significantly less frequent in the SLNB arm at all time points. Three-hundred and ten patients participated in the HRQOL assessment. The mean scores of the PGWB questionnaire general index and anxiety domain were significantly better in the SLNB group than in the ALND group but the difference ceased to be significant at 24 months. CONCLUSIONS: The SLNB is associated with reduced arm morbidity without evidence of a negative impact on psychological well being. While waiting for long-term results of ongoing randomised clinical trials, the SLNB may be proposed for early stage breast cancer patients after adequate information on the expected advantages and the possible risks.

Oral 5-fluorouracil in squamous cell carcinoma of the skin in the aged.

Multiple or recurrent squamous cell skin carcinoma is a rare tumor in the aged. These patients are currently treated with 5-fluorouracil (5-FU) cream as a local chemotherapy; in cases in which the disease progresses, few treatments are available. Two reports deal with the treatment of progressive squamous cell skin carcinoma with systemic 5-FU, but in only eight patients age less than 70 years. We prospectively investigated oral 5-FU therapy in 14 consecutive patients (average age 76 1/2 years) with histologically proven squamous cell skin carcinoma. The disease was aggressive, multiple, or recurrent and had not been eradicated by surgery, radiation therapy, topical 5-FU cream, and non-5-FU chemotherapy. Oral 5-FU was administered as mannitol-coated 5-FU tablets at the daily dose of 175 mg/m2 for 3 weeks every 5 weeks. Toxicity, effectiveness, quality of life, and compliance to therapy were evaluated. Total cycles amounted to 55 (range: 2-6, mean: 4 for each patient) at an average dose intensity of 740 mg/m2/week for from 12 to 36 weeks. Only gastrointestinal toxicity World Health grade I occurred. Quality of life and compliance to therapy were 90%. Therapy induced measurable improvement in nine patients (64.3%): two partial remissions (14.3%), three minimal remissions (21.4%), and four arrests of disease (28.6%) with a median duration of 30+ months. The study ended because of a lack of patients. We can conclude that, if elderly patients require chemotherapy because of progressive multiple or advanced squamous cell skin carcinoma, appreciable results may be obtained with oral 5-FU as a single agent.

A phase II study of oral fluorouracil for gastrointestinal cancer.

Prolonged exposure to 5-fluorouracil (5-FU) is effective for gastrointestinal malignancy (GIM) and it is considered synergistic or additive to concurrent radiotherapy. Oral 5-FU (OF) could represent an easy therapy. The present study prospectively tested the toxicity and effectiveness of OF in GIM by means of 5-FU mannitol-coated tablets (MCT) at 275 or 225 mg/m2/day according to the patients age (65 years cut-off) for a period of 4 weeks every 7 weeks. Also the drug given over 5 days a week for 4 weeks was studied to assess OF toxicity over a time corresponding to that used in standard radiotherapy. Quality of life (LQ) was analyzed. Patients were 27 individuals (20 males), aged 43-70 years, pretreated with radiotherapy (four patients) or i.v. 5-FU-based chemotherapy (five patients), and with progressive malignancy of colorectum (six patients), stomach (five patients), pancreas (four patients) and liver (two patients). The total number of cycles was 91 and 16 patients had more than two cycles. Myelotoxicity was consistently absent; other toxicities greater than WHO grade 1 were: nausea (grade 2 in four patients), diarrhea (grade 2 in six and grade 3 in 11), palmar erithema (grade 2 in one), brown-turning skin (grade 2 in one) and CNS (grade 2 in one). Diarrhea was less frequent (p = 0.007) in gastric and in colorectal than in pancreas and liver cancer patients. In the 10 patients given the drug of 5 days a week, diarrhea was practically absent. LQ was above 90%. Fourteen patients (51%) had total arrest of disease, and 2 among 16 colorectal cancer patients had PR (12.5%). In conclusion, the MCT-OF was tolerated and as effective as the classic i.v. 5-FU at nonmyelosuppressive dose. The MCT-OF dose recommended for further studies is 275 mg/m2/day (or 225 above 65 years) for 4 weeks followed by a 2 week rest period.

[Ambulatory treatment of postphlebitic ulcers of lower limbs. Physiopathological bases and clinical results]. / Il trattamento ambulatoriale delle ulcere postflebitiche degli arti inferiori. Basi fisiopatologiche e risultati clinici.

Venous ulceration is a troublesome and disabling complication, representing one of the most difficult problems to be treated by the vascular surgeon. Venous insufficiency is a widespread condition, the prevalence of venous ulceration being 0.5 - 1 per cent in European populations. Although all venous ulcers will heal if the limb is elevated above heart level for an extended period of time, patients need a safe, effective, not disabling and quick therapy. Hence, the competent vascular surgeon must be familiar with venous pathophysiology and possess a thorough understanding of the treatment options available for a discouraged patient in need of an acceptable and effective approach. The aim of the present study was to assess the efficacy and the speed of healing of venous ulcer using an outpatient ambulatory treatment protocol. This protocol consisted of elastic compression bandage allowing deambulation, local dressing using lyophilized heterologous collagen (Condress, Gentili) and systemic profibrinolytic drugs. Exclusion criteria were coexisting arterial insufficiency, ulcer area greater than 25 cm2, coexisting disabling diseases (congestive cardiac failure, hepatic insufficiency, malignancy). From December 1990 to June 1993, 37 patients affected by venous ulcer were treated, according to the aforementioned protocol, at the Surgical Department of Montecchio Maggiore Hospital (VI). There were 16 male and 21 female patients, mean age was 66 years (range 59-91). Results show the complete healing of the venous ulcer in 94.5% of patients; mean time for ulcer healing was 128 days (range 45-91). The Authors conclude that the outpatient ambulatory treatment protocol is safe, quick, and effective for the therapy of chronic venous ulcer; once obtained the healing of the ulcer, elastic compressive bandage with elastic stockings is mandatory to prevent recurrences.

[A rare case of accessory choledochus associated with diverticulum of the common bile duct]. / Un raro caso di coledoco accessorio associato a diverticolo della via biliare principale.

The Authors report on a rare congenital anomaly of the biliary tract characterized by an accessory choledochus, which drained the inferior paramedian segments of the liver. Such anomalous duct emerged from the hepatic hilum right behind the cystic artery, the cystic duct and the gallbladder to join the primary choledochus few millimeters from the papilla of Vater. At the point of junction, in the posterior aspect of the II duodenal portion, a choledochal diverticulum containing cholesterin and bilirubin stones was also present. Surgery was indicated by the onset of a pseudo-obstructive syndrome followed by jaundice. At laparotomy the exact diagnosis was possible. The intervention consisted in a choledochotomy and duodenotomy with tube drainage and exeresis of the choledochal cyst containing the stones.

[Laparoscopic appendectomy in clinical practice. Aesthetic and functional advantages]. / Appendicectomia per via videolaparoscopica nella pratica clinica. Vantaggi estetici e funzionali.

The mortality rate following traditional (open) surgical appendectomy has declined over the past 60 years to almost zero. Many surgeons question the utility of laparoscopic surgery for appendicitis as the appendix can often be removed through a small incision and the degree of trauma to the patient may be minimal. However, some patients suffer wound infection, prolonged hospitalization and delay in returning to full normal activity. Moreover, postoperative adhesions have been recorded in as many as 63 per cent of cases. Although recent studies have shown that laparoscopic appendectomy is safe and feasible, controversies still exist concerning indications and limits of the procedure. The aim of the present study is to clarify the advantages of the laparoscopic technique in performing appendectomy for both acute and chronic appendicitis. The Authors report on their experience of laparoscopic appendectomy performed at the Surgical Department of Montecchio Maggiore Hospital (VI) from July 1992 to December 1992. Ten laparoscopic appendectomies were performed in 8 female and 2 male patients with a mean age of 19 years (range 14-31). There were no conversions to laparotomy; mean operative time was 57 minutes (range 28-92). As far as the position of trocars is concerned, the Authors utilize a particular technique which presents an aesthetic advantage but requires the use of an endolaparoscopic stapler (Multifire Endo GIA 30 Autosuture). There was no mortality; the postoperative course was uneventful in all cases. Patients were discharged from the hospital the day after laparoscopic intervention. Follow up showed no postoperative pain, short bed stay at home and fast return to full activity; functional and aesthetic results were most satisfactory.(ABSTRACT TRUNCATED AT 250 WORDS)

[Subclavian steal syndrome. Clinical aspects and therapeutic problems]. / Sindrome da furto della succlavia. Aspetti clinici e problemi terapeutici.

Cerebrovascular disease is a leading cause of morbidity and mortality in Italy. Although atherosclerotic involvement of the carotid artery is more prevalent, some patients suffer from stenosis of the subclavian artery, usually proximal to the origin of the vertebral artery. Neurological symptoms result from reversed flow in the vertebral artery, so-called "subclavian-steal". This collateral pathway may rob the posterior circulation of perfusion to the degree of producing episodes of vertebrobasilar insufficiency. The authors have therefore reviewed their experience with this disease and present their findings, therapeutic procedures and short-term results. During 1990 four patients affected by "subclavian-steal syndrome" were observed at the Surgical Department of Montecchio Maggiore Hospital (VI). Two patients were operated on and axillo-axillary bypass operations were performed (with a 5 mm Gore-tex graft). The goal of surgical treatment is to alleviate cerebrovascular symptomatology by restoring flow to the subclavian artery distal to the occlusion. Axillo-axillary bypass offers distinct advantages over the alternative methods such as transthoracic procedures or carotid-subclavian bypass. Axillo-axillary bypass is a technically simple procedure with very good results and minimal complications. It avoids sternotomy, thoracotomy and clavicular resections: the carotid artery is not involved in the procedure. The authors conclude that axillo-axillary bypass is a cheap, safe and effective treatment for symptomatic subclavian artery insufficiency.

[Cholecystectomy via video laparoscopy: the whys of a choice]. / Colecistectomia per via videolaparoscopica: i perché di una scelta.

The management of calculous disease of the gallbladder has undergone significant change during the last decade. Recent years have seen the development of alternative methods for the treatment of biliary stones including dissolution therapy, endoscopic and percutaneous extraction, extracorporeal shock wave lithotripsy. Yet, despite these technologic advances, most surgeons have continued to consider cholecystectomy the safest, most effective and the only curative procedure. Open cholecystectomy, performed in the same fashion for more than a century has demonstrated low morbidity and minimal mortality rates. However, the operation does incur sizable expense in terms of hospitalization, cosmetic appearance and time lost from work. Laparoscopic cholecystectomy quickly emerged as an alternative to open cholecystectomy. The authors report their experience of laparoscopic cholecystectomy performed at the Surgical Department of Montecchio Maggiore Hospital (VI). Twenty-eight patients were operated on: in all but one laparoscopic cholecystectomy was successfully completed; in one case a fistula between gallbladder and the common bile duct led to T-tube drainage insertion via a laparotomy. In one patient laparoscopic cholecystectomy was performed after an endoscopic retrograde cholangio-sphincterotomy for associated stones of the common bile duct. Mean operative time was 69 minutes (range 46-210). Morbidity and mortality were 0%; maximal hospital stay was 48 hours. These data confirm that laparoscopic cholecystectomy may be considered the treatment of choice for stone disease of the gallbladder and it should enter into the cultural and technical background of a general surgeon.

[Role of surgery in the therapy of peptic ulcer after arrival of H2-blocking drugs]. / Il ruolo della chirurgia nella terapia dell'ulcera peptica dopo l'avvento dei farmaci H2-bloccanti.

This retrospective study was undertaken to determine if the advent of H2-blockers has altered the surgical treatment and the outcome of patients with peptic ulcer disease. The records of patients undergoing surgery for peptic ulcer disease at Montecchio Maggiore Hospital, Vicenza (Italy), from 1968 to 1977 (group A) and from 1979 to 1989 (group B) were reviewed. Data recorded included, ulcer location, surgical procedures (emergency or elective), indications for emergency surgery (perforation, bleeding). Statistical analysis was performed by means of the chi-square test. From 1968 to 1989, 15.810 surgical operations were performed: the indication was peptic ulcer disease in 398 cases (2.51%). The percentage of surgical operations performed for peptic ulcer was 3.54% in group A and 1.55% in group B. A marked decline in surgery for peptic ulcer was noted in group B, concerning both elective and emergency surgery; surgical interventions strongly decreased for both duodenal and gastric ulcer. This study demonstrates that H2-blockers have definitely altered the surgical treatment for peptic ulcer disease.