BioEnterics Intragastric Balloon (BIB): a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients.

BACKGROUND: The BioEnterics Intragastric Balloon (BIB) System in association with restricted diet has been used for the short-term treatment of morbid obesity. Aim of this study was to evaluate the real, short term, efficacy of the BIB for weight reduction in morbidly obese patients by using a prospective, double-blind, randomised, sham-controlled, crossover study. METHODS: Patients were recruited from January 2003 to December 2003. After selection, they were randomly allocated into two groups: BIB followed by sham procedure after 3 months (Group A), and sham procedure followed by BIB after 3 months (Group B). All endoscopic procedures were performed under unconscious intravenous sedation. The BioEnterics Intragastric Balloon (Inamed Health; Santa Barbara, CA, USA) was filled by using saline (500 ml) and methylene blue (10 ml). Patients were discharged with omeprazole therapy and diet (1000 kcal). Patients were followed up weekly by a physician blinded to randomisation. In both groups mortality, complications, BMI, BMI reduction and %EWL were considered. Data were expressed as mean +/- s.d., except as otherwise indicated. Statistical analysis was performed by means of Student's t-test, Fisher's exact test or chi (2) with Yates correction; P < 0.05 was considered significant. RESULTS: A total of 32 patients were selected and entered the study (8M/24F; mean age: 36.2 +/- 5.6 years, range 25-50 years; mean BMI 43.7+/-1.5 kg/m(2), range 40-45 kg/m(2); mean %EW: 43.1 +/- 13.1, range: 35-65). All patients completed the study. Mortality was absent. Complications related to endoscopy, balloon placement and removal were absent. Mean time of BIB positioning was 15 +/- 2 min, range 10-20 min. After the first 3 months of the study, in Group A patients the mean BMI significantly (P < 0.001) lowered from 43.5 +/- 1.1 to 38.0 +/- 2.6 kg/m(2), while in Group B patients the decrease was not significant (from 43.6 +/- 1.8 to 43.1 +/- 2.8 kg/m(2)). The mean %EWL was significantly higher in Group A than in Group B (34.0 +/- 4.8 vs 2.1 +/- 1%; P < 0.001). After crossover, at the end of the following 3 months, the BMI lowered from 38.0 +/- 2.6 to 37.1 +/- 3.4 kg/m(2) and from 43.1 +/- 2.8 to 38.8 +/- 3.1 kg/m(2) in Groups A and B, respectively. CONCLUSIONS: The results of this study show that treatment of obese patients with BioEnterics Intragastric Balloon is a safe and effective procedure. In association with appropriate diet it is significantly effective in weight reduction when compared to sham procedure plus diet. The BIB procedure can play a role in weight reduction in morbidly obese patients or in the preoperative treatment of bariatric patients.

[Laparoscopic inguinal hernia repair "IPOM" with Dual-Mesh]. / Ernioplastica inguinale laparoscopica "IPOM" con Dual-Mesh.

The authors report their experience on laparoscopic hernioplasty using the Intraperitoneal Onlay Mesh Repair (IPOM) in 56 patients. 34 patients had a bilateral hernia, 6 of which were recurrent and 22 had a monolateral hernia, of which 9 had recurrent hernia. Overall, a total of 90 hernias were treated. The hernia repair was performed utilizing "GORE-TEX DualMesh Plus biomaterial with holes" in the first 32 cases and the latest "...Corduroy" type in the remaining 24 cases. The prostheses were fixed with titanium spiral tacks (Protack, AutoSuture, Tyco Healthcare). No intraoperative complications occurred and no conversion was necessary. Five minor post-operative complications (5.5%), 2 seromas and 3 transient paresthesias, were observed. Four patients (7.1%) needed analgesics after the first 24 hours. Mean hospital stay was 36 hours, with a minimum of 24 and a maximum of 48. Mean resumption of normal activity was 8 days with return to work within two weeks. At an average 18 months follow-up, 3 recurrences were recorded (3.3%). The results of this study as well as the meta-analysis of the series presented in the Literature, indicate that the IPOM may be a feasible, safe and effective procedure in the treatment of recurrent and bilateral hernias or when a hernia repair is performed during other laparoscopic procedures. The IPOM has infact been shown to be faster and easier than the other more commonly performed laparoscopic hernioplasties (TAPP and TEP). These data may also suggest to utilize this technique in particular cases of primitive hernia such as very active young males or heavy duty workers. However the limited series and the short follow-up ask for randomized prospective long term studies to definitely ascertain the true incidence of recurrence and therefore the effectiveness of this attractive procedure.

Laparoscopic cholecystectomy and intraoperative endoscopic sphincterotomy in the treatment of cholecysto-choledocholithiasis.

BACKGROUND: A single-stage minimally invasive procedure would be optimal for management of cholecysto-choledocholithiasis. Two alternative strategies are available: management by laparoscopy alone or a combined laparoscopic-endoscopic approach. This study evaluates the results of the latter procedure. METHODS: From June 1993 to September 1997, 1400 patients with symptomatic biliary stone disease were evaluated for laparoscopic cholecystectomy. Intraoperative cholangiography was performed on the basis of a preoperative suspicion of bile duct stones; bile duct stone treatment was by intraoperative endoscopic retrograde sphincterotomy. RESULTS: Intraoperative cholangiography was performed because of a preoperative suspicion of a bile duct abnormality in 141 of 1400 patients (10%) undergoing laparoscopic cholecystectomy because of biliary stone disease. Of those 141 patients, 54 (38.3%) presented with pathologic findings (bile duct stone [52] and papillary stenosis [2]); all 54 underwent intraoperative endoscopic sphincterotomy. Complete clearance of the ductal stones was achieved in 43 patients (82.7%) by intraoperative sphincterotomy, and in 9 patients by an additional postoperative endoscopic procedure. Laparoscopic cholecystectomy was carried out in all cases. There were no conversions to an open operation. Postoperative course in the uncomplicated cases was comparable to that for laparoscopic cholecystectomy alone. The postoperative complication rate was 5.6% and mortality 1.8%. Mean hospital stay was 3.3 days (range 2 to 16). At a mean 38 months follow-up, no complications related to the laparoscopic-endoscopic procedure were observed. CONCLUSION: The intraoperative combined laparoscopic-endoscopic approach seems to be a feasible and effective management of cholecysto-choledocholithiasis, saving patients a subsequent invasive procedure.

Laparoscopic resection of solitary gastric schwannoma.

We report a case of successful laparoscopic resection of a solitary schwannoma of the gastric fundus performed on emergency. The patient was a 52-year-old man who presented with an upper gastrointestinal hemorrhage. At admission, the endoscopy and hydro-CT scan showed a submucosal tumor, 2.5 cm in maximum diameter, with an area of central ulceration arising from the anterior wall of the gastric fundus. A wedge laparoscopic resection of the gastric wall was performed under endoscopic guidance. The defect in the anterior wall was repaired in part by linear stapler and in part using a continuous suture. The postoperative recovery was uneventful and the patient was discharged on the 4th postoperative day. Laparoscopic approach represents a safe and efficient approach for the treatment of benign tumors of the stomach, also on emergency basis.

111In-pentetreotide detection of gastrinoma before and after surgery.

Eighteen patients with Zollinger-Ellison syndrome were studied with 111In-pentetreotide SPECT in order to localize gastrinoma, the tumour responsible for this pathology. NMR imaging was also carried out. Eight patients were operated. 111In-pentetreotide was reinjected 4 hours before operation and the radioactivity of the excised tumours counted. The nature of the withdrawn tissues was assessed by immunohistochemistry (chromogranina A). The scintigraphy was repeated 3-6 months after surgery. 111In pentetreotide SPECT was more sensitive than NMR. It was also absolutely specific because all the radioactive tumours excised showed positive chromogranin A staining. The radioactivity/gram counted in gastrinomas exceeded 10 fold the hepatic and biliary radioactivity and 20-100 folds the radioactivity of blood and omentum. In all the operated patients but three, the scintigraphy performed after surgery did not detect tumours. However complete eradication did not occur, because though 3-6 months after surgery the gastrinemia was significantly lower with respect to pre-surgery results it did not return to normal values in all patients but two.

Minimally invasive approach for the treatment of idiopathic varicocele.

Laparoscopic ligation of the spermatic veins represents a new approach for the treatment of the idiopathic varicocele. This procedure was performed in 28 consecutive patients. The diagnosis was based on physical examination and Doppler ultrasonography. The indications for surgery were (a) infertility and abnormal semen analyses (15 patients), (b) scrotal pain (six patients), and (c) psychological reasons (seven patients). One patient underwent concomitant hernioplasty. Two cases presented with a recurrence after 6 and 12 months, respectively. The mean operative time was 34 +/- 11 min in unilateral cases and 47 +/- 9 min in bilateral cases. In one patient with left inguinal hernia and varicocele, the operative time was 70 min. All patients were discharged the day after operation without antibiotics and analgesics and resumed normal activity within 5 to 9 days, depending on age and occupation. Postoperative semen analyses (at 12 months' follow-up) were obtained from seven patients and demonstrated an improvement in semen motility (preoperative 40% versus postoperative 56%). This study confirms that laparoscopic treatment of varicocele is safe, minimally invasive, and, according to National Health Service fees, less costly than radiological occlusion procedures.

Differential effect of stress on gastric somatostatin, prostaglandin E and gastrin release in the rat.

BACKGROUND: The relationship between gastric mucosal damage induced by stress, peptides present in the gastric mucosa and is not clear. Aim of this study was to determine whether cold-restraint stress affected the release of gastric somatostatin, gastrin and in the isolated perfused stomach preparation. METHODS: Male Sprague-Dawley rats were used, 12 cold-restraint stressed and 12 unstressed controls. 4 additional unstressed rats were treated with aspirin (100 mg/kg p.o.). After 30 minutes, isolated stomachs were perfused for 50 minutes with Krebs-Ringer buffer added with isoproterenol or carbamylcholine plus somatostatin-14 or carbamylcholine alone, somatostatin, gastrin and prostaglandin E2 release in the portal vein effluent were measured by radioimmuno-assay. Histology of the gastric mucosa was obtained from a further 4 stressed and 4 unstressed rats. RESULTS: In the stomach from stressed animals, the somatostatin response to isoproterenol and the prostaglandin E2 response to carbamylcholine plus somatostatin were significantly lower than in the controls, whereas gastrin response to carbamylcholine was enhanced by stress. Treatment with aspirin abolished the prostaglandin E2 response to stimulation. Gastric mucosa histology from stressed and unstressed animals showed no significant lesions. CONCLUSIONS: The inhibition of gastric somatostatin and prostaglandins release coupled to an enhanced acid stimulatory influence appear to antidate gastric mucosal injury and should play a role in the stress ulcer genesis.

Embarazo en la adolescencia: edad ginecológica y resultados perinatales / Pregnancy in the adolescence: gynecological age and perinatals results

Se comparó la incidencia de bajo peso en los recién nacidos de madres aolescentes, presentación pelviana, cesárea y fórceps, en un grupo de 119 madres primigestas de edad cronológica menor o igual a 16 años y 0 a 2 años de edad ginecológica versus otro grupo de 119 madres primigestas de igual edad cronológica que el anterior y con 3 y 4 años de edad ginecológica. Del estudio se excluyeron las madres no primigestas, las que presentaron embarazo gemelar o muerte fetal intrauterina. No se han encontrado diferencias estadisticamente significativas para ninguna de las variables estudiadas en ambos grupos. Tampoco hubo diferencia significativa entre el promedio de los pesos de los recién nacidos

Embarazo en la adolescencia: edad ginecológica y resultados perinatales / Pregnancy in the adolescence: gynecological age and perinatals results

Se comparó la incidencia de bajo peso en los recién nacidos de madres aolescentes, presentación pelviana, cesárea y fórceps, en un grupo de 119 madres primigestas de edad cronológica menor o igual a 16 años y 0 a 2 años de edad ginecológica versus otro grupo de 119 madres primigestas de igual edad cronológica que el anterior y con 3 y 4 años de edad ginecológica. Del estudio se excluyeron las madres no primigestas, las que presentaron embarazo gemelar o muerte fetal intrauterina. No se han encontrado diferencias estadisticamente significativas para ninguna de las variables estudiadas en ambos grupos. Tampoco hubo diferencia significativa entre el promedio de los pesos de los recién nacidos(AU)

[Echographic and ERCP-manometric study of gallbladder and Oddi's sphincter behavior in biliary colic in patients with cholelithiasis. Effects of cerulein]. / Studio ecografico e CPRE-manometrico del comportamento della colecisti e dello sfintere di Oddi in corso di colica biliare in pazienti con colelitiasi. Effetto della ceruleina.

In a previous study, we have shown that caerulein relieves biliary colic pain in gallstone patients. This study was initiated to determine gallbladder and sphincter of Oddi behaviour during biliary colic and their response to caerulein. In 10 gallstone patients gallbladder volume was measured by real-time ultrasonography during a biliary colic episode and 72 hours after cessation of pain, before and after caerulein administration. Basal sphincter of Oddi pressure was determined by CPRE manometry in 10 gallstone patients during biliary colic and three days after cessation of pain, before and after caerulein. The results of this study show that, during biliary colic, gallbladder volume is 8 times greater than in the post-colic state. Basal sphincter of Oddi pressure was also significantly higher during biliary colic than in the post-colic state. Caerulein relieved in all cases the biliary colic pain while reducing gallbladder volume and decreasing the sphincter of Oddi.

Sequential endoscopic-laparoscopic treatment of cholecystocholedocholithiasis.

Preoperative common bile duct (CBD) clearance with endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic sphincterotomy (ES) is routinely performed in many centers where laparoscopic cholecystectomy (LC) is the procedure of choice for the treatment of cholelithiasis. The purpose of this study was to evaluate prospectively the results of the sequential endoscopic-laparoscopic management in patients with gallstones and suspected CBD stones. From November 1990 to May 1993, 700 consecutive patients were evaluated for LC. Preoperative workup included clinical history and physical examination; serum levels of bilirubin, alkaline phosphatase, and amylase; and ultrasonography. Preoperative ERCP was indicated in cases with previous or present jaundice or acute pancreatitis, altered liver or pancreatic blood tests, dilated CBD (> 6 mm) and CBD stones at ultrasonography. If CDB pathology was confirmed, ES was performed and treatment attempted. All patients were assigned to undergo LC within 48 h. Morbidity, mortality, hospital stay, and disability were recorded. Of 700 patients, 49 (7%) underwent ERCP. In 26 patients (54.2%), CBD stones were identified; ES was performed and stone extraction succeeded in 22 patients (84.6%). Two patients with intrahepatic stones were successfully treated with a percutaneous transhepatic approach and then underwent surgery. Two patients with cholecystocholedochal fistula underwent open surgery. In two cases ERCP showed a papillary stenosis, which was treated with ES. Of 44 patients, 35 (79.5%) underwent LC within 48 h. The overall morbidity (ERCP/ES plus LC) was 10.4%. No mortality occurred. The mean hospital stay was 4.5 days. Return to normal activities occurred within 11 days after LC. This sequential approach resulted in a safe and effective treatment of cholecystocholedocholithiasis and a decrease in the overall costs.

[Computed tomography patterns in patients treated with laparoscopic Nissen fundoplication for gastroesophageal reflux]. / Quadri con tomografia computerizzata nei pazienti sottoposti a intervento di fundoplicatio secondo Nissen per via laparoscopica per reflusso gastroesofageo.

This work was aimed at investigating the CT anatomy in patients submitted to Nissen's fundoplication. Forty patients (mean age: 61 years) with peptic esophagitis (9 patients), refractory gastroesophageal (GE) reflux (11 patients) and hiatal hernia (20 patients) were examined. CT studies were performed with a third generation unit (CT Pace, General Electric, USA) with the patients in the prone position, after Gastrovison (Schering) and barium paste administration. In 34 patients, CT demonstrated surgery-related anatomical changes, such as the presence of a soft tissue mass at the distal third of the esophagus. In 4 patients, functional incompetence of the fundoplication (3 patients) and a recurrent hyatal hernia (1 patient) were demonstrated. In conclusion, CT studies performed with a dedicated technique permitted the accurate assessment of the anatomy of the GE junction after Nissen's fundoplication. In our study, CT demonstrated the presence of postoperative fluid collections and specific signs related to fundoplication incompetence. Our results suggest a possible application of CT to the postoperative follow-up of the patients submitted to Nissen's fundoplication, with a complementary role that of to endoscopy and functional exams.

Laparoscopic excision of posterior gastric wall leiomyoma.

The development of laparoscopic surgery has suggested new technical procedures for the treatment of several pathologies. Herein we report a case of laparoscopic excision of a posterior gastric wall leiomyoma. The technique reproduces that used in conventional surgery but with a transgastric approach, and the advantages of minimally invasive surgery are maintained. This laparoscopic approach may be considered an alternative strategy for surgical treatment of benign tumors of the stomach.

Somatostatin receptor localization of pancreatic endocrine tumors.

Gastroenteropancreatic endocrine tumors are difficult to localize. At the same time the tumor is localized, though, there is an opportunity for cure or to remove tumor tissue. In this study we have prospectively examined the ability of 111In-octreotide scintigraphy, magnetic resonance imaging (MRI), and computed tomography (CT) to localize tumor lesions in 24 patients with a biochemical or histologic diagnosis of neuroendocrine tumor. In eight patients a surgical assessment of the imaging results was prospectively performed. Planar and abdominal single-photon emission tomography (SPET) images acquired 4 and 24 hours after 180 to 220 MBq of 111In-octreotide injection were evaluated and compared with conventional imaging techniques. SPET scintigraphy visualized more presumed tumor lesions (n = 39) than conventional imaging studies (MRI,n = 25; CT,n = 13); 23 of 24 patients had positive octreotide scintigraphy, 17 of 24 had positive MRI-scans, and 12 of 24 patients had positive CT scans. It was concluded that 111In-octreotide scintigraphy combined with conventional imaging improves the preoperative localization of presumably tumorous lesions in patients with gastroenterohepatic endocrine tumors.

Minimally invasive approach in Mirizzi's syndrome.

During a 4-year period (November 1990-September 1994), 1152 patients underwent laparoscopic cholecystectomy (LC). In five (0.4%) patients a cholecysto-choledochal fistula (Mirizzi's syndrome type II) was diagnosed and a minimally invasive treatment (endoscopy-laparoscopy-interventional radiology) was attempted. The first two cases were converted to open surgery probably because of severe anatomical distortion and inadequate confidence in performing a laparoscopic choledochal repair. The last three patients were successfully treated by minimally invasive procedures. These data indicate that a minimally invasive treatment can be safely attempted through a multi-disciplinary approach in Mirizzi's syndrome.

Complications after laparoscopic cholecystectomy. Coordinated radiologic, endoscopic, and surgical treatment.

The diagnostic and therapeutic approaches used for patients referred for bile duct injuries and other major complications after laparoscopic cholecystectomy (LC) were reviewed and the results of a coordinated radiologic, endoscopic, and surgical approach were assessed. From April 1991 to October 1993, 23 patients were observed. Seven patients had biliary strictures, five had biliary lesions, five presented with retained common bile duct (CBD) stones, and one had a minor cystic duct leak. Five patients had miscellaneous abdominal fluid collections; in addition, biloma or bile ascites were present in 10/23 cases. Correct definition of iatrogenic lesions was mainly made by endoscopic retrograde cholangiography (ERCP) (n = 15), associated in six cases also with percutaneous cholangiography (PTC). "Minimally invasive" treatment included the full range of endoscopic and interventional radiological procedures. Six patients with biliary strictures, one patient with a biliary lesion, all five patients with residual CBD stones, and four patients with abdominal collections were treated by "minimally invasive" techniques: Therefore, laparotomy was avoided in 70% of cases (16/23 patients). Open surgery was necessary in 7/23 patients (30%), because of ductal lesion (n = 4), ductal stricture by endoloop (n = 1), iliac artery injury (n = 1), and phlegmon of gallbladder bed (n = 1). It appears that careful assessment of complications after LC is mandatory and often requires the combined use of ERCP/PTC and cross-sectional imaging.(ABSTRACT TRUNCATED AT 250 WORDS)

[Laparoscopic ultrasonography in laparoscopic surgery and diagnosis]. / Ecografia laparoscopica in chirurgia e diagnostica laparoscopica.

The authors report their experience with 101 patients examined with laparoscopic ultrasound (LU) using a dedicated 7.5-MHz linear probe which can be introduced through the 10-mm surgical trocars. In the patients undergoing laparoscopic cholecystectomy (77 cases), LU adequately demonstrated gallbladder wall and contents in all cases and visualized the main bile duct in 93.5% of cases; stones of the CBD or cystic duct were demonstrated in two cases. The liver was studied in 18 patients undergoing diagnostic laparoscopy or laparoscopic colonic resection: secondary lesions were identified in two cases, while benign lesions (cysts or angiomas) were seen in 6 cases. In the patients operated on for colonic resection (8 cases), LU was successfully used to localize the enteric tract affected by the tumor and to mark safety margins for excision. The technical features of the exam are reported and the main imaging findings discussed. The authors conclude that LU is a safe method which is easy to perform and does not significantly increase the operating time; the indications of this laparoscopic application of ultrasound are not yet defined but the application area will certainly widen in the future, as operative and diagnostic laparoscopy are more and more frequently used by surgeons.

Estrogens, androgens, and EGF receptor expression in gastric carcinoma induced by N-methyl-N'-nitro-N-nitrosoguanidine.

Complex and conflicting relationships between epidermal growth factor (EGF), estrogens (E), androgens (A), and related receptors (EGF-R, E-R, A-R) have been reported in different biological situations associated with cell proliferation. There is also evidence that EGF and sex hormone receptors may be involved in normal and neoplastic growth of the gastrointestinal mucosa. In this study, we investigated the behavior of EGF receptors and sex hormone and related receptors, during N-methyl-N'-nitro-N-nitrosoguanidine (NG)-induced gastric carcinogenesis in Sprague-Dawley male rats. Four groups of 15 rats each (10 NG-treated and five controls) were sacrificed after 1, 20, 30, and 40 weeks of treatment. Gastric tissue from each rat was processed for receptor status (number and affinity) and proliferative activity. A significant and progressive decrease of A-R and EGF-R was observed starting from the 20th week, while no change of E-R occurred throughout the experiment. Cell proliferation in the gastric mucosa of NG-treated rats increased after 30 weeks of treatment. These data indicate that NG treatment is able to modify the receptor status of gastric mucosa in rats.