Trends and safety of bariatric revisional surgery in Italy: multicenter, prospective, observational study.

BACKGROUND: Revisional bariatric surgery (RBS) represents a further solution for patients who experience inadequate weight loss (IWL) following primary bariatric surgery (BS) or significant weight regain (WR) following initial satisfactory response. RBS guidelines are lacking; however, an increased trend in further BS offerings has been reported recently. OBJECTIVE: Analyze trend, mortality, complication, readmission, and reoperation rates for any reason at 30 days after RBS in Italy. SETTING: Ten Italian high-volume BS centers (university hospitals and private centers). METHODS: Prospective, observational, multicenter study enrolling patients undergoing RBS between October 1, 2021, and March 31, 2022, registering reasons for RBS, technique, mortality, intraoperative and perioperative complications, readmissions, and reinterventions for any reason. Patients undergoing RBS during the same calendar interval in 2016-2020 were considered control patients. RESULTS: A total of 220 patients were enrolled and compared with 560 control-group patients. Mortality was .45% versus .35% (n.s), with an overall mortality of .25%, while open surgery or conversion to open surgery was registered in 1%. No difference was found for mortality, morbidity, complications, readmission (1.3%), and reoperation rates (2.2%). IWL/WR was the most frequent cause, followed by gastroesophageal reflux disease; Roux-en-Y gastric bypass was the most used revisional procedure (56%). Sleeve gastrectomy was the most revised procedure in the study group, while gastric banding was the most revised in the control group. RBS represents up to 9% of the total BS in the Italian participating centers. CONCLUSIONS: Laparoscopy represents the standard approach for RBS, which appears safe. Current Italian trends show a shift toward sleeve gastrectomy being the most revised procedure and Roux-en-Y gastric bypass being the most frequent revisional procedure.

Biosimilar epoetin α is as effective as originator epoetin-α plus liposomal iron (Sideral®), vitamin B12 and folates in patients with refractory anemia: A retrospective real-life approach.

Several biosimilar versions of recombinant human erythropoietin are currently approved for use in Europe, including a biosimilar epoetin-α. The aim of this the study was to verify that biosimilar epoetin-α is similar in terms of efficacy, safety and cost to originator epoetin-α for the treatment of refractory anemia in patients with myelodysplastic syndrome. A total of 92 patients with myelodysplasia and refractory anemia were investigated. The patients received either originator (group A) or biosimilar (group B) epoetin-α. In addition, they received liposomal iron (Sideral®), calcium levofolinate and vitamin B12. Moreover, the median monthly overall costs were calculated for each group. The results demonstrated that hemoglobin (Hb) levels increased by 1 g/dl after a median time of 5 weeks in group A and 4 weeks in group B. In group A, a Hb level of >12 g/dl was achieved after 12 weeks, while in group B after 10.5 weeks. The median cost of therapy was 1,536 euros/month in group A and 1,354 euros/month in group B. A total of 5 patients required transfusion support in group A and 7 in group B. In conclusion, biosimilar epoetin-α appears to be comparable to originator epoetin-α in terms of efficacy and safety for the treatment of refractory anemia.

Laparoscopic colostomy for acute left colon obstruction caused by diverticular disease in high risk patient: A case report.

INTRODUCTION: The colostomy is often necessary in complicated divertcular disease. The laparoscopic colostomy is not widely used for the treatment of complicated diverticular disease. Its use in patients with high operative risk is still on debate. The aim of this case report was to present the benefits of laparoscopic colostomy in patients with high peri-and postoperative risk factors. PRESENTATION OF CASE: We present a case of 76-year-old female admitted to emergency unit for left colonic obstruction. The patient had a past history of liver cirrhosis HCV-related with a severe malnutrition, hypertrophic cardiomyopathy, diverticular disease, hiatal ernia, previous appendectomy. Patient was classified according to their preoperative risk ASA 3 (classification of the American society of Anestesia-ASA score). Contrast-enhanced abdominal CT revealed a marked thickening in the sigmoid colon and a marked circumferential stenosis in the sigmoid colon in absence of neoplasm, and/or abscess. The laparoscopic procedure is proposed as first intention. DISCUSSION: The operation time was 50min, and the hospital stay was 4 days. Post operative complications grade I according to the Clavien Dindo Classification. CONCLUSIONS: Laparoscopic colostomy is safe and feasible procedure in experienced hands. It is associated with low morbidity and short stay in hospital and should be considered a good alternative to a laparotomy.

Laparoscopic sleeve gastrectomy as a revisional procedure for failed laparoscopic gastric banding with a "2-step approach": a multicenter study.

BACKGROUND: Laparoscopic sleeve gastrectomy (LSG) has been proposed as an alternative revisional procedure for failed/complicated gastric banding. This is a retrospective cohort study of a prospectively maintained database of revisional LSG after band removal for insufficient weight loss and/or band-related complications, using a 2-step approach. The outcomes were compared with a control group of primary LSG. The study was conducted at a university hospital (Sapienza University of Rome-Polo Pontino, Icot, Latina, Italy) and 2 community general hospitals (Hospital Andosilla Civita Castellana, Viterbo, Italy and Hospital Villa D'Agri, Potenza, Italy). METHODS: A total of 76 revisional LSG procedures was recorded; a control group of 279 LSG patients was selected. The primary endpoint was to compare the perioperative complication rate between the revisional versus the control group. Secondary endpoints were operative time, conversion rate, postoperative length of stay and percentage excess weight loss (%EWL) at 6, 12, and 24 months. RESULTS: The indications for band removal were inadequate weight loss (47 patients), slippage (10 patients), erosion (7 patients), and pouch dilation (12 patients). All procedures were completed laparoscopically. The median operative time was 78 minutes for the revision LSG and 65 minutes for the control LSG (P<.05). In the revision group, the overall complication rate was 17.1%, and the median postoperative length of stay was 4 days; in the control group, the overall complication rate was 10.7%, and the median postoperative length of stay was 3. No complications requiring reoperation or readmission occurred in the revision group. In the control group, there were 5 cases of major complications. All the patients completed the follow-up. A total of 56 patients in the revision group and 184 patients in the control group were followed-up for at least 24 months. The %EWL at 6, 12, and 24 months was 46.5%, 66.4%, and 78.5%, respectively, in the revision group, and 49.8%, 78.2%, and 78%, respectively, in the control group. CONCLUSION: Results confirmed that LSG, performed in 2 steps, is an effective revision procedure for failed or complicated laparoscopic adjustable gastric banding with good perioperative outcomes and 2-year weight loss.

Combined endo-laparoscopic approach in a patient with a duodenal foreign body and bowel obstruction.

We report the successful removal of an intraduodenal foreign body (f.b.) by endo-laparoscopic rendezvous, in a 67-year-old patient with mental disorders and duodenal occlusion by a large peach seed impacted in the duodenum. During a first endoscopic diagnostic evaluation it was possible to retract the peach seed into the stomach and have a confirmation of a stenosis of the second portion of the duodenum. Otherwise, the endoscopic procedure failed during removal out of the esophagus due to the large size of the f.b., and a second treatment in general anesthesia was planned. A 4 cm anterior gastrotomy was than performed by laparoscopy, and with a real endo-laparoscopic rendezvous, the peach seed out of the stomach was positioned, avoiding any intra-gastric surgical manouver and directly passing from Dormia basket into laparoscopic plastic retrieval bag. The gastrotomy was than closed with a single cartridge of a linear stapler and reinforced with an oversewn suture.

Improvement in health-related quality of life in first year after laparoscopic adjustable gastric banding.

BACKGROUND: We analyzed the health-related quality of life (HRQOL) and its determinants in the first year after laparoscopic adjustable gastric banding (LAGB). The setting was 10 Italian public and private bariatric surgery centers. METHODS: Data collected in an ongoing, prospective, 3-year multicenter Italian study on the changes in HRQOL after LAGB were used. HRQOL was investigated using the Medical Outcomes Study Short-Form 36 questionnaire. Hunger, satiety, and the self-perceived effects of LAGB were recorded. RESULTS: A total of 334 patients were enrolled. The follow-up rate was 92.2%. The percentage of excess weight loss was 39.6% ± 25.8%, with very few side effects or complications. Hunger in the morning (0-10 scale) was 4.5 ± 2.7 before surgery and 3.8 ± 2.4 after 1 year (P <.001). Satiety after a meal (0-10 scale) was 7.1 ± 2.7 before surgery and 8.2 ± 1.9 at 1 year (P <.001). The self-perceived effect of LAGB on caloric intake (0-10 scale) was 8.4 ± 1.9 after 1 year. The scores for the 8 Medical Outcomes Study Short-Form 36 subscales were significantly improved after surgery. The physical component summary score was 52.6 ± 11.9 at baseline and 79.1 ± 15.6 after 1 year (P <.001). The corresponding mental component summary scores were 52.2 ± 12.3 and 76.5 ± 17.2 (P <.001). Greater physical component summary improvement was independently associated with a low initial physical component summary (P <.001), high satiety (P = .002), a high percentage of excess weight loss (P = .013), and a high self-perceived effect of the LAGB (P = .026). Greater mental component summary improvement was associated with a low initial mental component summary (P <.001), high satiety (P <.001), a low frequency of heartburn (P = .004), and a high percentage of excess weight loss (P = .012). CONCLUSIONS: Significant improvements in HRQOL were observed in the first year after LAGB. A poor baseline HRQOL, a high efficacy of the banding in eating control, and better weight loss might influence HRQOL changes.

[Round ligament suspension in laparoscopic hepatic surgery: technical advantages]. / La sospensione del legamento rotondo in chirurgia epatica laparoscopica: vantaggi tecnici.

Transabdominal suspension sutures are generally described in different laparoscopic surgical techniques. During the different phases of the surgical procedure, this solution permits the surgeon to achieve better exposure of the "target organ" or adequate stabilisation of it without adding more ports and instruments. In a limited working space, the use of many instruments may interfere with the surgeon's movements. In the present paper, we present the use of suspension sutures of the round ligament in different hepatic surgical techniques performed laparoscopically in our department of surgery, analysing the technical advantages.

Role of a minimally invasive approach in the management of laparoscopic adjustable gastric banding postoperative complications.

HYPOTHESIS: Complications after laparoscopic adjustable gastric banding as treatment for morbid obesity may require a major reintervention. A minimally invasive approach represents an attractive management alternative for such complications. DESIGN: Prospective case series. SETTING: Major academic medical and surgical center. PATIENTS: From January 1996 to July 2003, 47 patients who had undergone laparoscopic adjustable gastric banding were operated on again. Considering the causes for reoperation, the patients were divided into 4 groups: group A had major complications (n = 26); group B, minor complications (n= 11); group C, psychological problems (n=6); and group D, insufficient weight loss (n=4). INTERVENTIONS: Forty-three procedures, 38 using general anesthesia (groups A, C, and D) and 5 using local anesthesia (group B), were performed. MAIN OUTCOME MEASURES: Feasibility, safety, and effectiveness of a minimally invasive approach in the treatment of laparoscopic adjustable gastric banding complications. RESULTS: In group A, 9 of 10 patients with irreversible gastric pouch dilatation and 15 of 16 with intragastric band migrations were treated laparoscopically. In group B, 5 ports were substituted and 2 reconnections of the catheter-port system were performed. In group C, 6 laparoscopic band removals were carried out. In group D, 4 laparoscopic revision procedures for insufficient weight loss were performed. The operative mortality was nil. The most frequent cause of reoperation was intragastric migration (37.2%). A minimally invasive approach was adopted in 94.7% of cases. CONCLUSION: Laparoscopy is safe and effective, even as a second operative procedure.

Different plasma ghrelin levels after laparoscopic gastric bypass and adjustable gastric banding in morbid obese subjects.

Gastric bypass has been reported to be associated with markedly suppressed plasma ghrelin levels, suggesting that it is one of the possible weight-reducing factors related to this procedure. The aim of this study was the evaluation of plasma ghrelin levels in patients who had undergone laparoscopic Roux-en-Y gastric bypass (LRYGBP) and laparoscopic adjustable silicone gastric banding (LASGB). Normoweight, obese subjects and patients who had undergone total gastrectomy were used as controls. In this cross-sectional study, we selected 10 subjects who underwent LASGB, 11 subjects with LRYGBP, 10 obese subjects, eight patients with total gastrectomy, and eight normoweight subjects. Plasma ghrelin, insulin, and glucose profiles were determined before and after breakfast and lunch. Obese subjects showed a ghrelin plasma level significantly lower than normoweight subjects (407.3 +/- 21.6 vs. 813 +/- 72.4 pg/ml, P < 0.01). Patients with LRYGBP showed baseline ghrelin levels lower than LASGB (213.5 +/- 73.9 vs. 314.2 +/- 84.3 pg/ml, P = 0.04). Both groups of patients who underwent bariatric surgical procedures also had ghrelin lower than normoweight and obese subjects (P < 0.01 and P < 0.05, respectively). Patients with total gastrectomy showed plasmatic ghrelin levels extremely lower than those in all other groups (32.6 +/- 18.7 pg/ml, P < 0.001 for all). The ghrelin profile in both groups of subjects who underwent LRYGBP and LASGB did not show any meal-related changes as observed in obese and normoweight control groups. Significant difference in plasma ghrelin levels between LRYGBP and LASGB was found, suggesting that both procedures could induce weight loss by different mechanisms in which ghrelin could be involved.

Accuracy of laparoscopy in the diagnosis and staging of lymphoproliferative diseases.

Laparoscopy seems to be playing an emerging role in the management of lymphoproliferative diseases. The aim of this study was to prospectively analyze personal experience evaluating the role and limits of laparoscopy in the management of lymphomas. From July 1993 to December 2000, 131 consecutive patients were referred to our institution for primary diagnosis (group A, n = 70), suspected relapse (reassessment) (group B, n = 54), or staging/restaging of lymphoproliferative diseases (group C, n = 7). Diagnostic and/or operative laparoscopy was performed in all patients. To assess the accuracy of laparoscopy, the results were analyzed according to the indications for surgery. In all, 128 procedures were completed laparoscopically (95.5%). Conversion was required in 7 cases (5.1%). Causes of the conversions were severe obesity (body mass index 62.5), uncontrolled intraoperative bleeding (HIV+), nondiagnostic tissue sampling (2 cases), perisplenic inflammation and perisplenic abscesses (3 cases). The results of this study highlight the safety of diagnostic and staging laparoscopy and laparoscopic splenectomy in patients with lymphoproliferative diseases (major complications 2.9%, perioperative mortality 0%). In all, 96.4% of patients from group A and 100% of patients from group B were treated on the basis of laparoscopic findings. No false negative diagnosis occurred. Laparoscopy may become the "gold standard" in the management of lymphoproliferative disease in the following settings: for the differential diagnosis of hepatic and/or splenic focal lesions; when percutaneous needle biopsy fails and/or genetic analysis is needed for therapeutic decision; for the primary diagnosis and abdominal staging of patients with diffuse retroperitoneal lymphadenopathy in the absence of peripheral lymphadenopathy; for cases of abdominal restaging after concurrent chemoradiotherapy and in cases of suspected relapse when percutaneous biopsy is not technically possible; and for patients with lymphoproliferative disease when splenectomy is required. Marked splenomegaly with perisplenic inflammatory reaction and lymphadenopathy in HIV+ patients should be considered possible causes of failure of the laparoscopic approach.

[Laparoscopic splenectomy: analysis of 60 consecutive cases]. / La splenectomia laparoscopica: analisi di 60 casi consecutivi.

The purpose of the study was to analyze the results of 60 patients who were candidates for laparoscopic splenectomy. Over the period from May 1994 to May 2001, 60 patients were candidates for splenectomy. Laparoscopy was contraindicated in 3 cases because of ASA III and marked splenomegaly (2 cases) and previous gastric resection (1 case). The procedure was indicated for benign disease in 38 cases and for malignant disease in the remainder. Fifty-three procedures were completed laparoscopically (92.9%). Conversion proved necessary in 4 patients (6.7%) due to large incisional hernia, perisplenic abscess, bleeding of major splenic vessels at the hilum and marked splenomegaly (2 cases of lymphoma). The mean operative time was 200 min for the malignancies and 110 min for the benign conditions (P < 0.05). Major morbidity occurred in 5 cases (8.7%). No deaths were registered. The mean postoperative hospital stay was 7.5 days for patients with malignancies and 5.2 days for patients with benign disease (P < 0.05). Laparoscopic splenectomy was safe and effective in patients with benign disease, even in cases of marked splenomegaly. The morbidity rate was significantly higher in lymphoma patients than in patients with benign haematological disorders.

Modifications of metabolic and cardiovascular risk factors after weight loss induced by laparoscopic gastric banding.

BACKGROUND: The well-known inverse relation between life expectancy and BMI, particularly in morbid obesity, is presumably in large part due to multiple cardiovascular and metabolic comorbidities. Severely obese patients treated with laparoscopic adjustable silicone gastric banding (LASGB) were evaluated for such risk factors before and 1 year after LASGB. METHODS: 130 individuals (age 20-66, BMI 34-59 kg/m2) who underwent LASGB between 1996 and 2000 were studied; 50 of them were available for reevaluation 12 months after surgery. The presence and severity of diabetes (DM), hypertension (HTN), hypercholesterolemia (HC) and hypertriglyceridemia (HT) were assessed before and after surgery. In 18 of them erythrocyte sedimentation rate (ESR) were also measured. RESULTS: Comorbidities were highly prevalent at the initial evaluation: DM 10%, HTN 32%, HC 37%, HT 27%. In the subgroup reevaluated after surgery, prevalence of DM decreased from 15% to 6%, HTN from 37% to 25%, HC from 36% to 25%, and HT from 29% to 13%, with an average BMI loss from 44.1 to 35.9. ESR decreased from a preoperative value of 36.7 +/- 22.6 mm/hr to 18.3 +/- 11.9 mm/hr at 1 year (p < 0.001). CONCLUSION: Morbidly obese subjects respond to LASGB with an impressive reduction of comorbidities which is sustained for at least 1 year, well after the initial acute negative energy balance and when weight tends to stabilize. The high prevalence of elevated ESR, which has been considered a strong predictor of coronary mortality, confirms previous reports of its association with obesity, and the clear tendency to normalization with weight loss may represent a further element contributing to lower morbidity.