Prospective, randomised, multicentre, open-label trial, designed to evaluate the best timing of closure of the temporary ileostomy (early versus late) in patients who underwent rectal cancer resection and with indication for adjuvant chemotherapy: the STOMAD (STOMa closure before or after ADjuvant therapy) randomised controlled trial.

INTRODUCTION: Temporary ileostomy is a valuable aid in reducing the severity of complications related to rectal cancer surgery. However, it is still unclear what is the best timing of its closure in relation to the feasibility of an adjuvant treatment, especially considering patient-reported outcomes and health system costs. The aim of the study is to compare the results of an early versus late closure strategy in patients with indication to adjuvant chemotherapy after resection for rectal cancer. METHODS AND ANALYSIS: This is a prospective multicentre randomised trial, sponsored by Rete Oncologica Piemonte e Valle d'Aosta (Oncology Network of Piedmont and Aosta Valley-Italy). Patients undergone to rectal cancer surgery with temporary ileostomy, aged >18 years, without evidence of anastomotic leak and with indication to adjuvant chemotherapy will be enrolled in 28 Network centres. An early closure strategy (between 30 and 40 days from rectal surgery) will be compared with a late one (after the end of adjuvant therapy). Primary endpoint will be the compliance to adjuvant chemotherapy with and without ileostomy. Complications associated with stoma closure as well as quality of life, costs and oncological outcomes will be assessed as secondary endpoints. ETHICS AND DISSEMINATION: The trial will engage the Network professional teams in a common effort to improve the treatment of rectal cancer by ensuring the best results in relation to the most correct use of resources. It will take into consideration both the patients' point of view (patient-reported outcome) and the health system perspective (costs analysis). The study has been approved by the Ethical Review Board of Città della Salute e della Scienza Hospital in Turin (Italy). The results of the study will be disseminated by the Network website, medical conferences and peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: NCT04372992.

Laparoscopic ventral hernia repair with composite mesh: Analysis of risk factors for recurrence in 185 patients with 5 years follow-up.

BACKGROUND: Laparoscopic ventral hernia repair is widely used although its clinical indications are often debated. The aim of this study is to describe our surgical experience in order to establish the safety, efficacy, feasibility of laparoscopic ventral hernia repair and to identify the factors that influence the risk of recurrence in a group of patients treated with only one type of prosthetic mesh and by the same surgical team. MATERIALS AND METHODS: Between January 2007 and December 2016, 512 patients were admitted to the General and Urgent Surgery Unit, with diagnosis of ventral hernia. Of these, 244 were operated laparoscopically and 268 in a traditional open surgery. In 244 patients treated by laparoscopy we always used a composite mesh: 185 Parietex™ Composite mesh (Medtronic-Covidien, Minneapolis, USA), the remaining other with other types of prosthetic mesh. The type and size of surgical defects, features of surgical technique, length of hospital stay, rate of conversion, morbidity, mortality, and rate of recurrence at 5 years follow-up were retrospective analysed on the 185 patients who underwent surgery with Parietex™ Composite mesh. RESULTS: We performed 185 laparoscopic ventral hernia repair with Parietex™ Composite mesh: 108 (58%) for incisional hernias and 77 (42%) for primary abdominal wall hernias. Mean age was 58 years (19-80). The mean size of abdominal defect was 5 cm (1,5-18), mean BMI was 30,4 kg/m2 (21-47), mean overlap of the mesh was 5 cm (3-6). The mean operative time was 54 min (30-180) and conversion rate was 3,2%. In 61 patients (33%) we performed a transversus abdominis plane block (T.A.P. block) to reduce postoperative pain. The mean length of hospital stay was 5 days (1-26) (2 days, mean value, in patient with preoperative T.A.P. block). The mortality rate was 0%; overall morbidity was 15,6%. At 5-year follow-up we observed 13 (7%) hernia recurrences. The features of patients with recurrence were as follows: mean age 50 years (19-74), mean ASA Score 3 (2-3), mean BMI 31 kg/m2 (21-44), mean size of hernial defect 7,5 cm (larger diameter), mean overlap 4,5 cm (3-6). CONCLUSIONS: Laparoscopic repair of ventral hernia using composite mesh is an effective and safe procedure particularly suitable in the following cases: median and paramedian defects, diameter of defect between 5 and 15 cm, "swiss cheese" defects, obesity. In our experience the factors related to the patient and the surgical technique that may influence the onset of early or late recurrence as the follows: a defect size >5 cm (W2 of EHS Classification), an overlap of the mesh < 5 cm, a BMI of 30 kg/m2 or superior and the presence of significant comorbidities (ASA score: 3). Finally, we observed that the T.A.P. Block preoperative procedure can lead to reduced the clinical costs through a lower administration of analgesics used and a lower length of stay.

Outcome of laparoscopic gastric bypass in obese and diabetic patients: when surgery fails.

BACKGROUND: The beneficial effects of bariatric surgery on diabetes and obesity have been widely demonstrated in the literature. The aim of our study was to evaluate the rate of failure of laparoscopic gastric bypass both in terms of weight loss and metabolic remission after one follow-up year. METHODS: A longitudinal, multicenter prospective study was carried out on 771 patients affected by pathological obesity. The following parameters were recorded for each patient before surgery: anthropometric, metabolic, social, smoking habits and previous failure of other bariatric procedures. After 1 follow-up year, final weight, final Body Mass Index (BMI), final percentage of lost excess body weight and percentage of lost BMI were evaluated. RESULTS: Statistical analysis showed a correlation between BMI>50 kg/m2, presence of metabolic syndrome, presence of diabetes, gastric pouch volume greater than 60 mL and failure of weight loss outcome. Statistical analysis of metabolic failure has recognized a high preoperative glycated hemoglobin percentage (HbA1c%) value as a statistically significant negative predictive factor. CONCLUSIONS: Bariatric Surgery is the most effective treatment for weight loss and metabolic improvement. However, in our study, surgery did not achieve the expected outcome in patients with specific metabolic, anthropometric and surgical characteristics (BMI>50 kg/m2, presence of metabolic syndrome, presence of T2DM with high preoperative HbA1c% level and gastric pouch volume greater than 60 mL).

Preoperative Predictive Factors of Successful Weight Loss and Glycaemic Control 1 Year After Gastric Bypass for Morbid Obesity.

BACKGROUND: Gastric bypass (GBP) is one of the most effective surgical procedures to treat morbid obesity and the related comorbidities. This study aimed at identifying preoperative predictors of successful weight loss and type 2 diabetes mellitus (T2DM) remission 1 year after GBP. METHODS: Prospective longitudinal study of 771 patients who underwent GBP was performed at four Italian centres between November 2011 and May 2013 with 1-year follow-up. Preoperative anthropometric, metabolic and social parameters, the surgical technique and the previous failed bariatric procedures were analyzed. Weight, the body mass index (BMI), the percentage of excess weight lost (% EWL), the percentage of excess BMI lost (% BMIL) and glycated haemoglobin (HbA1c) were recorded at follow-up. RESULTS: Univariate and multivariate analysis showed that BMI <50 kg/m(2) (p = 0.006) and dyslipidaemia (p = 0.05) were predictive factors of successful weight loss. Multivariate analysis of surgical technique showed significant weight loss in patients with a small gastric pouch (p < 0.001); the lengths of alimentary and biliary loops showed no statistical significance. All diabetic patients had a significant reduction of HbA1c (p < 0.001) after surgery. BMI ≥ 50 kg/m(2) (p = 0.02) and low level of preoperative HbA1c (p < 0.01) were independent risk factors of T2DM remission after surgery. CONCLUSIONS: This study provides a useful tool for making more accurate predictions of best results in terms of weight loss and metabolic improvement.