Mario Morino

Laparoscopic surgery versus open surgery for colon cancer: short-term outcomes of a randomised trial.

BACKGROUND The safety and short-term benefits of laparoscopic colectomy for cancer remain debatable. The multicentre COLOR (COlon cancer Laparoscopic or Open Resection) trial was done to assess the safety and benefit of laparoscopic resection compared with open resection for curative treatment of patients with cancer of the right or left colon. METHODS 627 patients were randomly assigned to laparoscopic surgery and 621 patients to open surgery. The primary endpoint was cancer-free survival 3 years after surgery. Secondary outcomes were short-term morbidity and mortality, number of positive resection margins, local recurrence, port-site or wound-site recurrence, metastasis, overall survival, and blood loss during surgery. Analysis was by intention to treat. Here, clinical characteristics, operative findings, and postoperative outcome are reported. FINDINGS Patients assigned laparoscopic resection had less blood loss compared with those assigned open resection (median 100 mL [range 0-2700] vs 175 mL [0-2000], p<0.0001), although laparoscopic surgery lasted 30 min longer than did open surgery (p<0.0001). Conversion to open surgery was needed for 91 (17%) patients undergoing the laparoscopic procedure. Radicality of resection as assessed by number of removed lymph nodes and length of resected oral and aboral bowel did not differ between groups. Laparoscopic colectomy was associated with earlier recovery of bowel function (p<0.0001), need for fewer analgesics, and with a shorter hospital stay (p<0.0001) compared with open colectomy. Morbidity and mortality 28 days after colectomy did not differ between groups. INTERPRETATION Laparoscopic surgery can be used for safe and radical resection of cancer in the right, left, and sigmoid colon.

Survival after laparoscopic surgery versus open surgery for colon cancer : long-term outcome of a randomised clinical trial

BACKGROUND Laparoscopic surgery for colon cancer has been proven safe, but debate continues over whether the available long-term survival data justify implementation of laparoscopic techniques in surgery for colon cancer. The aim of the COlon cancer Laparoscopic or Open Resection (COLOR) trial was to compare 3-year disease-free survival and overall survival after laparoscopic and open resection of solitary colon cancer. METHODS Between March 7, 1997, and March 6, 2003, patients recruited from 29 European hospitals with a solitary cancer of the right or left colon and a body-mass index up to 30 kg/m(2) were randomly assigned to either laparoscopic or open surgery as curative treatment in this non-inferiority randomised trial. Disease-free survival at 3 years after surgery was the primary outcome, with a prespecified non-inferiority boundary at 7% difference between groups. Secondary outcomes were short-term morbidity and mortality, number of positive resection margins, local recurrence, port-site or wound-site recurrence, and blood loss during surgery. Neither patients nor health-care providers were blinded to patient groupings. Analysis was by intention-to-treat. This trial is registered with ClinicalTrials.gov, number NCT00387842. FINDINGS During the recruitment period, 1248 patients were randomly assigned to either open surgery (n=621) or laparoscopic surgery (n=627). 172 were excluded after randomisation, mainly because of the presence of distant metastases or benign disease, leaving 1076 patients eligible for analysis (542 assigned open surgery and 534 assigned laparoscopic surgery). Median follow-up was 53 months (range 0.03-60). Positive resection margins, number of lymph nodes removed, and morbidity and mortality were similar in both groups. The combined 3-year disease-free survival for all stages was 74.2% (95% CI 70.4-78.0) in the laparoscopic group and 76.2% (72.6-79.8) in the open-surgery group (p=0.70 by log-rank test); the difference in disease-free survival after 3 years was 2.0% (95% CI -3.2 to 7.2). The hazard ratio (HR) for disease-free survival (open vs laparoscopic surgery) was 0.92 (95% CI 0.74-1.15). The combined 3-year overall survival for all stages was 81.8% (78.4-85.1) in the laparoscopic group and 84.2% (81.1-87.3) in the open-surgery group (p=0.45 by log-rank test); the difference in overall survival after 3 years was 2.4% (95% CI -2.1 to 7.0; HR 0.95 [0.74-1.22]). INTERPRETATION Our trial could not rule out a difference in disease-free survival at 3 years in favour of open colectomy because the upper limit of the 95% CI for the difference just exceeded the predetermined non-inferiority boundary of 7%. However, the difference in disease-free survival between groups was small and, we believe, clinically acceptable, justifying the implementation of laparoscopic surgery into daily practice. Further studies should address whether laparoscopic surgery is superior to open surgery in this setting.

Laparoscopic Liver Resection for Malignant Liver Tumors: Preliminary Results of a Multicenter European Study

ObjectiveTo assess the feasibility, safety, and outcome of laparoscopic liver resection for malignant liver tumors. Summary Background DataThe precise role of laparoscopy in resection of liver malignancies (hepatocellular carcinoma [HCC] and liver metastases) remains controversial despite an increasing number of publications reporting laparoscopic resection of benign liver tumors. MethodsA retrospective study was performed in 11 surgical centers in Europe regarding their experience with laparoscopic resection of liver malignancies. Detailed questionnaires were sent to each surgeon focusing on patient characteristics, clinical data, type and characteristics of the tumor, technical details of the operation, and early and late clinical outcome. All patients had radiologic investigations at follow-up to exclude disease recurrence. ResultsFrom February 1994 to December 2000, 37 patients with malignant liver tumors were included in this study. Ten patients had HCC, including 9 with cirrhotic liver, and 27 patients had liver metastases. The mean tumor size was 3.3 cm, and 89% of the tumors were located in the left lobe or in the anterior segments of the right liver. Liver procedures included 12 wedge resections, 9 segmentectomies, 14 bisegmentectomies (including 13 left lateral segmentectomies), and 2 major hepatectomies. The transfusion rate, the use of pedicular clamping, the conversion rate (13.5% in the whole series), and the complication rate were significantly greater in patients with HCC. There were no deaths. Postoperative complications occurred in eight patients (22%). The surgical margin was less than 1 cm in 30% of the patients. During a mean follow-up of 14 months, the 2-year disease-free survival was 44% for patients with HCC and 53% for patients having hepatic metastases from colorectal cancer. No port-site metastases were observed during follow-up. ConclusionsIn patients with small malignant tumors, located in the left lateral segments or in the anterior segments of the right liver, laparoscopic resection is feasible and safe. The complication rate is low, except in patients with HCC on cirrhotic liver. By using laparoscopic ultrasound, a 1-cm free surgical margin should be routinely obtained. The late outcome needs to be evaluated in expert centers.

E.A.E.S. multicenter prospective randomized trial comparing two-stage vs single-stage management of patients with gallstone disease and ductal calculi.

AbstractBackground: The current management of patients with gallstone disease and ductal calculi consists of endoscopic stone extraction (ESE) followed by laparoscopic cholecystectomy (LC). Following the advent of techniques of laparoscopic ductal stone clearance, an alternative single-stage laparoscopic treatment was introduced for these patients. The European Association of Endoscopic Surgery (E.A.E.S.) set up a ductal stone trial to compare the relative efficacy and outcome of these two management options. Methods: A prospective randomized controlled clinical trial compared two management options. Group A (n= 150) received preoperative endoscopic retrograde cholangiography (ERC) with ESE followed by LC during the same hospital admission, and group B (n= 150) received single-stage laparoscopic management. Results: There were no significant differences between the two groups in the clinical demographic details and the pretreatment biochemical findings. In group A, 14 of 150 patients received single-stage treatment; in group B, 17 of 150 were managed by the two-stage approach (protocol violation = 31/300, 10%). In group A patients managed in accordance with randomization, ERC was successful in 129/136 (95%) and preoperative ESE succeeded in 82/98 (84%) with ductal calculi detected by the ERC. Two patients had malignancies and one refused surgery. Thus, 133 patients underwent surgery. Of this group, 116 had LC only and 17 had LC and attempted laparoscopic duct exploration. There were eight conversions to open surgery (6%), 17 complications for both stages (12.8%), and two postoperative deaths (1.5%). In group B patients managed in accordance with randomization, intraoperative cholangiography was successful in 132/133 (99%). Twenty-one (16%) had normal findings, ductal calculi were found in 109, and other pathology was noted in two (periampullary cancer, severe pancreatitis). These two patients and one other (who had gross adhesion in the triangle of Calot) were converted at the start of the procedure. Transcystic ductal stone clearance was successful in 45 of 56 patients (80%), and laparoscopic direct common duct (CBD) exploration was successful in 47 of 55 patients (85%). This group includes 53 patients who underwent primary direct exploration and two failed attempts at transcystic extraction. The conversion rate was 13%. Postoperative complications were encountered in 21 patients (15.8%), and one patient died of a major myocardial infarction (0.75%). The one postoperative death and the 10/11 biliary complications occurred in the laparoscopic supraduodenal CBD exploration subgroup. The conversion rate was higher in group B (17 vs eight; p= 0.08). Laparotomy in the postoperative period was required in three patients in group A and four patients in group B. The group B patients were in hospital for 3 days less than patients who had two-stage management (median, 6.0, IQR = 4.25–12 vs median, 9.0, IQR = 5.5–14; p < 0.05). Conclusions: The results demonstrate equivalent success rates and patient morbidity for the two management options but a significantly shorter hospital stay with the single-stage laparoscopic treatment. The findings indicate that in fit patients (ASA I and II), single-stage laparoscopic treatment is the better option, and preoperative ESE should be confined to poor-risk patients—i.e., those with cholangitis or severe pancreatitis.

Laparoscopic total mesorectal excision: a consecutive series of 100 patients.

ObjectiveTo analyze total mesorectal excision (TME) for rectal cancer by the laparoscopic approach during a prospective nonrandomized trial. Summary Background DataImproved local control and survival rates in the treatment of rectal cancer have been reported after TME. MethodsThe authors conducted a prospective consecutive series of 100 laparoscopic TMEs for low and mid-rectal tumors. All patients had a sphincter-saving procedure. Case selection, surgical technique, and clinical and oncologic results were reviewed. ResultsThe distal limit of rectal neoplasm was on average 6.1 (range 3–12) cm from the anal verge. The mean operative time was 250 (range 110–540) minutes. The conversion rate was 12%. Excluding the patient who stayed 104 days after a severe fistula and reoperation, the mean postoperative stay was 12.05 (range 5–53) days. The 30-day mortality was 2% and the overall postoperative morbidity was 36%, including 17 anastomotic leaks. Of 87 malignant cases, 70 (80.4%) had a minimum follow-up of 12 months, with a median follow-up of 45.7 (range 12–72) months. During this period 18.5% (13/70) died of cancer and 8.5% (6/70) are alive with metastatic disease. The port-site metastasis rate was 1.4% (1/70): a rectal cancer stage IV presented with a parietal recurrence at 17 months after surgery. The locoregional pelvic recurrence rate was 4.2% (3/70): three rectal cancers stage III at 19, 13, and 7 postoperative months. ConclusionsLaparoscopic TME is a feasible but technically demanding procedure (12% conversion rate). This series confirms the safety of the procedure, while oncologic results are at present comparable to the open published series with the limitation of a short follow-up period. Further studies and possibly randomized series will be necessary to evaluate long-term clinical outcome in cancer patients.

Obesity surgery: Evidence-based guidelines of the European Association for Endoscopic Surgery (EAES)

BackgroundThe increasing prevalence of morbid obesity together with the development of laparoscopic approaches has led to a steep rise in the number of bariatric operations. These guidelines intend to define the comparative effectivness and surrounding circumstances of the various types of obesity surgery.MethodsA consensus panel representing the fields of general/endoscopic surgery, nutrition and epidemiology convened to agree on specific questions in obesity surgery. Databases were systematically searched for clinical trial results in order to produce evidence-based recommendations. Following two days of discussion by the experts and a plenary discussion, the final statements were issued.RecommendationsAfter the patient’s multidisciplinary evaluation, obesity surgery should be considered in adults with a documented BMI greater than or equal to 35 and related comorbidity, or a BMI of at least 40. In addition to standard laboratory testing, chest radiography, electrocardiography, spirometry, and abdominal ultrasonography, the preoperative evaluation of obesity surgery patients also includes upper gastrointestinal endoscopy or radiologic evaluation with a barium meal. Psychiatric consultation and polysomnography can safely be restricted to patients with clinical symptoms on preoperative screening. Adjustable gastric banding (GB), vertical banded gastroplasty (VBG), Roux-en-Y gastric bypass (RYGB) and biliopancreatic diversion (BPD) are all effective in the treatment of morbid obesity, but differ in degree of weight loss and range of complications. The choice of procedure therefore should be tailored to the individual situation. There is evidence that a laparoscopic approach is advantageous for LAGB, VBG, and GB (and probably also for BPD). Antibiotic and antithromboembolic prophylaxis should be used routinely. Patients should be seen 3 to 8 times during the first postoperative year, 1 to 4 times during the second year and once or twice a year thereafter. Outcome assessment after surgery should include weight loss and maintainance, nutritional status, comorbidities and quality-of-life.

Primary treatment of hepatocellular carcinoma by arterial chemoembolization

Two hundred and ninety-one patients with hepatocellular carcinoma were treated by chemoembolization (CE), using ethiodized oil, doxorubicin, and a gelatin sponge. Patients with thrombosis of either the portal vein or a main branch were excluded. The mortality rate in the first 2 months after treatment was 7% in noncirrhotic patients, 2.8% in patients with class A cirrhosis, 8% in patients with class B cirrhosis, and 37% in patients with class C cirrhosis. The tumor diameter remained the same in 55.3% of patients, was reduced by up to 50% in 20% of the patients, was reduced by more than 50% in 7.3% of the patients, and almost completely disappeared in 1.8% of the patients. The diameter of the tumor increased in 15.6% of patients. Forty-three patients underwent a resection or transplantation after chemoembolization. Histologic examination of the specimens revealed significant necrosis of the tumor. The long-term survival rate at 2 years was 49% for class A cirrhotics, 29% for class B cirrhotics, and 9% for class C cirrhotics. Complications included cholecystitis (10%), vasculitis (14%), renal decompensation (13%), an increase in ascites (14%), and jaundice (12%). Chemoembolization is an effective and safe initial treatment for hepatocellular carcinoma. It is effective in producing tumor necrosis and reducing the size of the tumor. Improvement in survival was noted when patients who underwent chemoembolization were compared with an historical series of untreated patients, and resection and transplantation are kept as options.

Laparoscopic vs open hepatic resection: a comparative study.

Background: Although the feasibility of minor laparoscopic liver resections (LLR) has been demonstrated, data comparing the open vs the laparoscopic approach to liver resection are lacking. Methods: We compared 30 LLR with 30 open liver resections (OLR) in a pair-matched analysis. The indications for resection were malignant disease in 47% of the LLR and 83% of the OLR. The average size of the lesions was 42 mm for LLR and 41 mm for OLR. Five wedge resections, 12 segmentectomies, and 13 bisegmentectomies were performed in each group. Results: The conversion rate for LLR was nil. The mean operative time was 148 min for LLR and 142 min for OLR. Mean blood loss was minimal in the LLR group (320 vs 479 ml; p < 0.05). Postoperative complications occurred in 6.6% of the patients in each group; there were no deaths. The mean postoperative hospital stay was shorter for LLR patients (6.4 vs 8.7 days; p < 0.05). In tumors, the resection margin was <1 cm in 43% of the LLR patients and 40% of the OLR patients (p = NS). Conclusions: Minor LLR of the anterior segments has the same rates of mortality and morbidity as OLR. However, the laparoscopic approach reduces blood loss and postoperative hospital stay.

Laparoscopic liver resection of benign liver tumors: Results of a multicenter European experience

Objective: The objective of this study was to assess the feasibility, safety, and outcome of laparoscopic liver resection for benign liver tumors in a multicenter setting. Background: Despite restrictive, tailored indications for resection in benign liver tumors, an increasing number of articles have been published concerning laparoscopic liver resection of these tumors. Methods: A retrospective study was performed in 18 surgical centres in Europe regarding their experience with laparoscopic resection of benign liver tumors. Detailed standardized questionnaires were used that focused on patients characteristics, clinical data, type and characteristics of the tumor, technical details of the operation, and early and late clinical outcome. Results: From March 1992 to September 2000, 87 patients suffering from benign liver tumor were included in this study: 48 patients with focal nodular hyperplasia (55%), 17 patients with liver cell adenoma (21%), 13 patients with hemangioma (15%), 3 patients with hamartoma (3%), 3 patients with hydatid liver cysts (3%), 2 patients with adult polycystic liver disease (APLD) (2%), and 1 patient with liver cystadenoma (1%). The mean size of the tumor was 6 cm, and 95% of the tumors were located in the left liver lobe or in the anterior segments of the right liver. Liver procedures included 38 wedge resections, 25 segmentectomies, 21 bisegmentectomies (including 20 left lateral segmentectomies), and 3 major hepatectomies. There were 9 conversions to an open approach (10%) due to bleeding in 45% of the patients. Five patients (6%) received autologous blood transfusion. There was no postoperative mortality, and the postoperative complication rate was low (5%). The mean postoperative hospital stay was 5 days (range, 2–13 days). At a mean follow-up of 13 months (median, 10 months; range, 2–58 months), all patients are alive without disease recurrence, except for the 2 patients with APLD. Conclusions: Laparoscopic resection of benign liver tumors is feasible and safe for selected patients with small tumors located in the left lateral segments or in the anterior segments of the right liver. Despite the use of a laparoscopic approach, selective indications for resection of benign liver tumors should remain unchanged. When performed by expert liver and laparoscopic surgeons in selected patients and tumors, laparoscopic resection of benign liver tumor is a promising technique.

Mortality after bariatric surgery: analysis of 13,871 morbidly obese patients from a national registry.

Objective:To define mortality rates and risk factors of different bariatric procedures and to identify strategies to reduce the surgical risk in patients undergoing bariatric surgery. Summary Background Data:Postoperative mortality is a rare event after bariatric surgery. Therefore, comprehensive data on mortality are lacking in the literature. Methods:A retrospective analysis of a large prospective database was carried out. The Italian Society of Obesity Surgery runs a National Registry on bariatric surgery where all procedures performed by members of the Society should be included prospectively. This Registry represents at present the largest database on bariatric surgery worldwide. Results:Between January 1996 and January 2006, 13,871 bariatric surgical procedures were included: 6122 adjustable silicone gastric bandings (ASGB), 4215 vertical banded gastroplasties (VBG), 1106 gastric bypasses, 1988 biliopancreatic diversions (BPD), 303 biliointestinal bypasses, and 137 various procedures. Sixty day mortality was 0.25%. The type of surgical procedure significantly influenced (P < 0.001) mortality risk: 0.1% ASGB, 0.15% VBG, 0.54% gastric bypasses, 0.8% BPD. Pulmonary embolism represented the most common cause of death (38.2%) and was significantly higher in the BPD group (0.4% vs. 0.07% VBG and 0.03% ASGB). Other causes of mortality were the following: cardiac failure 17.6%, intestinal leak 17.6%, respiratory failure 11.8%, and 1 case each of acute pancreatitis, cerebral ischemia, bleeding gastric ulcer, intestinal ischemia, and internal hernia. Therefore, 29.4% of patients died as a result of a direct technical complication of the procedure. Additional significant risk factors included open surgery (P < 0.001), prolonged operative time (P < 0.05), preoperative hypertension (P < 0.01) or diabetes (P < 0.05), and case load per Center (P < 0.01). Conclusions:Mortality after bariatric surgery is a rare event. It is influenced by different risk factors including type of surgery, open surgery, prolonged operative time, comorbidities, and volume of activity. In defining the best bariatric procedure for each patient the different mortality risks should be taken into account. Choice of the procedure, prevention, early diagnosis, and therapy for cardiovascular complications may reduce postoperative mortality.