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Background The efficacy and safety outcomes of laparoscopy-assisted distal gastrectomy (LADG) with D2 lymph node dissection for locally advanced gastric cancer remain unclear. Therefore, we conducted a randomized, controlled phase II trial to confirm the feasibility of LADG in terms of technical safety, and short-term surgical outcomes were investigated. Methods Eligibility criteria included pre-operatively diagnosed advanced gastric cancer that could be treated by distal gastrectomy with D2 lymph node dissection; MP, SS, and SE without involvement of other organs; and N0–2 and M0. Patients aged 20–80 years were pre-operatively randomized. Results In total, 180 patients were registered and randomized to the open (89 patients) and laparoscopic arms (91 patients). Among 91 patients in the laparoscopic arm, 86 underwent laparoscopic gastrectomy according to the study protocol. Regarding the primary endpoint of the phase II trial, the proportion of patients with either anastomotic leakage or pancreatic fistula was 4.7 % (4/86). The grade 3 or higher morbidity rate, including systemic and local complications, was 5.8 %. Conversion to open surgery was required for 1 patient (1.2 %), without any intra-operative complication. The post-operative mortality rate was 0, and no patient required readmission for surgical complications within 6 months after initial discharge. Conclusions The technical safety of LADG with D2 lymph node dissection for locally advanced gastric cancer was demonstrated. A phase III trial to confirm the non-inferiority of this procedure to open gastrectomy in terms of long-term outcomes is ongoing. Registered Number: UMIN 000003420 ( www.umin.ac.jp/ctr/ ).

Observational studies suggest that bariatric–metabolic surgery might greatly improve non-alcoholic steatohepatitis (NASH). However, the efficacy of surgery on NASH has not yet been compared with the effects of lifestyle interventions and medical therapy in a randomised trial. We did a multicentre, open-label, randomised trial at three major hospitals in Rome, Italy. We included participants aged 25–70 years with obesity (BMI 30–55 kg/m2), with or without type 2 diabetes, with histologically confirmed NASH. We randomly assigned (1:1:1) participants to lifestyle modification plus best medical care, Roux-en-Y gastric bypass, or sleeve gastrectomy. The primary endpoint of the study was histological resolution of NASH without worsening of fibrosis at 1-year follow-up. This study is registered at ClinicalTrials.gov, NCT03524365. Between April 15, 2019, and June 21, 2021, we biopsy screened 431 participants; of these, 103 (24%) did not have histological NASH and 40 (9%) declined to participate. We randomly assigned 288 (67%) participants with biopsy-proven NASH to lifestyle modification plus best medical care (n=96 [33%]), Roux-en-Y gastric bypass (n=96 [33%]), or sleeve gastrectomy (n=96 [33%]). In the intention-to-treat analysis, the percentage of participants who met the primary endpoint was significantly higher in the Roux-en-Y gastric bypass group (54 [56%]) and sleeve gastrectomy group (55 [57%]) compared with lifestyle modification (15 [16%]; p<0·0001). The calculated probability of NASH resolution was 3·60 times greater (95% CI 2·19–5·92; p<0·0001) in the Roux-en-Y gastric bypass group and 3·67 times greater (2·23–6·02; p<0·0001) in the sleeve gastrectomy group compared with in the lifestyle modification group. In the per protocol analysis (236 [82%] participants who completed the trial), the primary endpoint was met in 54 (70%) of 77 participants in the Roux-en-Y gastric bypass group and 55 (70%) of 79 participants in the sleeve gastrectomy group, compared with 15 (19%) of 80 in the lifestyle modification group (p<0·0001). No deaths or life-threatening complications were reported in this study. Severe adverse events occurred in ten (6%) participants who had bariatric-metabolic surgery, but these participants did not require re-operations and severe adverse events were resolved with medical or endoscopic management. Bariatric-metabolic surgery is more effective than lifestyle interventions and optimised medical therapy in the treatment of NASH. Fondazione Policlinico Universitario A Gemelli, Policlinico Universitario Umberto I and S Camillo Hospital, Rome, Italy.

BackgroundAlthough laparoscopic surgery has been recommended as an optional therapy for patients with early gastric cancer, whether patients with locally advanced gastric cancer (AGC) could benefit from laparoscopy-assisted distal gastrectomy (LADG) with D2 lymphadenectomy remains elusive due to a lack of comprehensive clinical data. To evaluate the efficacy of LADG, we conducted a multi-institutional randomized controlled trial to compare laparoscopy-assisted versus open distal gastrectomy (ODG) for AGC in North China.MethodsIn this RCT, after patients were enrolled according to the eligibility criteria, they were preoperatively assigned to LADG or ODG arm randomly with a 1:1 allocation ratio. The primary endpoint was the morbidity and mortality within 30 postoperative days to evaluate the surgical safety of LADG. The secondary endpoint was 3-year disease-free survival. This trial was registered at ClinicalTrial.gov as NCT02464215.ResultsBetween March 2014 and August 2017, a total of 446 patients with cT2-4aN0-3M0 (AJCC 7th staging system) were enrolled. Of these, 222 patients underwent LADG and 220 patients underwent ODG were included in the modified intention-to-treat analysis. The compliance rate of D2 lymph node dissection was identical between the LADG and ODG arms (99.5%, P = 1.000). No significant difference was observed regarding the overall postoperative complication rate in two groups (LADG 13.1%, ODG 17.7%, P = 0.174). No operation-related death occurred in both arms.ConclusionsThis trial confirmed that LADG performed by credentialed surgeons was safe and feasible for patients with AGC compared with conventional ODG.

Purpose Bariatric surgery is a treatment for morbid obesity. Different surgical procedures have been described in order to obtain excess weight loss (EWL), but currently laparoscopic sleeve gastrectomy is the most commonly performed procedure throughout the world. Reducing abdominal wall trauma and increasing the aesthetic result are important goals for all bariatric surgeons. We conducted a randomized, controlled trial in order to assess if the three-trocar sleeve gastrectomy can be safely carried out or should be abandoned. Materials and Methods From September 2016 to February 2017, 90 patients were enrolled in our trial. Each patients was evaluated by a multidisciplinary team before surgery. Two groups were created after application of the inclusion and exclusion criteria. The primary endpoint was to define the features of early post-operative complications of patients in group 1 (the three-trocar technique—the experimental group) compared to group 2 (five-trocar technique—the control group). The secondary endpoints were to evaluate any differences between the two groups concerning post-operative pain and patients’ satisfaction with the aesthetic results. Results There was no difference between the two groups concerning age, sex distribution, weight, and BMI. The rate of co-morbidities was similar in both groups. Operative time was inferior in the control group, but patient satisfaction was better in the three-trocar sleeve gastrectomy group. Conclusions The three-trocar sleeve gastrectomy can be safely carried out with a modest increase in operative time, without additional early surgical complications and with a greater patient aesthetic satisfaction. Trial Registration researchregistry2386.

Introduction Laparoscopic sleeve gastrectomy is one of the most common techniques in bariatric surgery, but there is no consensus on the optimal distance from the pylorus to start the gastric transection. The aim of this study is to determine the differences in gastric emptying, gastric distension and metabolic response between two starting distances. Material and Methods This is a prospective randomised study of 60 patients (30 patients with the section at 3 cm and 30 patients at 8 cm from the pylorus). We calculate at 6 and 12 months from surgery gastric emptying by scintigraphy (T1/2 min), gastric volume by CT scan (cc) and metabolic response by blood sample analysis (glucose, HbA1c, insulin, HOMA-IR, GLP-1, GIP and C-peptide). Results Gastric emptying increases the speed significantly in both groups but is greater in the 3-cm group ( p  < 0.05). Dividing groups into type 2 diabetic patients and non-diabetic patients, the speed in non-diabetic patients is significantly higher for the 3-cm group. Residual volume increases significantly in both groups, and there are no differences between them. One year after surgery, there are significant improvements in the hyperinsulinaemia in the patients of the 3-cm group with respect to the 8-cm group, but only in diabetic patients. No differences between groups are found regarding changes in GLP-1 or GIP. Conclusions Gastric emptying is faster in patients with antrum resection. The distance does not influence the gastric emptying of diabetic patients. Other mechanisms may explain metabolic response besides GLP-1 and its association with improvements in diabetes via gastric emptying.

Introduction Bariatric surgery is the only treatment option that achieves sustained weight loss in obese patients and that also has positive effects on obesity-related comorbidities. Laparoscopic sleeve gastrectomy (LSG) seems to achieve equal weight loss as laparoscopic Roux-en-Y gastric bypass (LRYGB), but there is still much debate about the quality of life (QOL) after LSG, mainly concerning the association with gastroesophageal reflux. Our hypothesis is that QOL after LSG is comparable with QOL after LRYGB. Materials and Methods Between February 2013 and February 2014, 150 patients were randomized to undergo either LSG or LRYGB in our clinic. Differences in QOL were compared between groups by using multiple QOL questionnaires at follow-up moments preoperatively and 2 and 12 months after surgery. Results After 12 months of follow-up, 128 patients had returned the questionnaires. Most QOL questionnaires showed significant improvement in scores between the preoperative moment and after 12 months of follow-up. The Gastroesophageal Reflux Disease Questionnaire (GerdQ) score deteriorated in the LSG group after 2 months, but recovered again after 12 months. After 2 months of follow-up, the mean GerdQ score was 6.95 ± 2.14 in the LSG group versus 5.50 ± 1.49 in the LRYGB group ( p  < 0.001). After 1 year, the mean GerdQ score was 6.63 ± 2.26 in the LSG group and 5.60 ± 1.07 in the LRYGB group ( p  = 0.001). Conclusion This randomized controlled trial shows that patients who underwent LSG have significantly higher GerdQ scores at both 2 and 12 months postoperatively than patients who underwent LRYGB, whereas overall QOL did not differ significantly.

Introduction Inadequate weight loss (IWL)/weight regain (WR) and gastro-esophageal reflux disease (GERD), unresponsive to medical management, are two most common indications for conversion of sleeve gastrectomy (SG) to Roux-en-Y gastric bypass (RYGB). This study reports detailed outcomes of conversion of SG to RYGB for these two indications separately. Methods We interrogated our prospectively maintained database to identify patients who underwent a conversion of their SG to RYGB in our unit. Outcomes in patients converted for IWL/WR and those converted for GERD were evaluated separately. Results We carried out 22 SG to RYGB in our unit between Aug 2012 and April 2015 with a mean follow-up of 16 months. Indication for conversion was GERD in 10/22 (45.5%) patients and IWL/WR in 11/22 (50.0%) patients. Patients undergoing conversion for GERD were significantly lighter (BMI 30.5) than those converted for IWL/WR (BMI 43.3) at the time of conversion. The conversion was very effective for GERD with 100% patients reporting improvement in symptoms, and 80% patients were able to stop their antacid medications. IWL/WR group achieved a further BMI drop of 2.5 points 2 years after surgery (final BMI 40.8) in comparison with 2.0 points BMI drop achieved by the GERD group (final BMI 28.5). Conclusion This study demonstrates that conversion of SG to RYGB is effective for GERD symptoms but not for further weight loss, which was modest in both groups. Future studies need to examine the best revisional procedure for IWL/WR after SG.

IntroductionBariatric surgeries are the only effective long-term treatment in obese patients. The innovation of laparoscopic gastric plication (LGP) raised some questions about its effectiveness compared to traditionally used techniques such as laparoscopic sleeve gastrectomy (LSG). We tried to answer some of these questions.Materials and MethodsWe investigated 70 patients in a randomized clinical trial (IRCT2013123012294N5) from 2012 to 2015. Thirty-five patients were randomly assigned to each LSG or LGP group, using sealed envelope method. The body mass index (BMI) reduction and the percentage of excess weight loss (%EWL) along with %total body weight loss (%TWL) were primary endpoint and were assessed at follow-up periods. We recorded postoperative complications, as well.ResultsTwo-year follow-up rate was 100%. There were no statistically significant differences between the two groups in means of preoperative BMI. Also, postoperative follow-ups were not suggestive for a significant difference in BMI (all p values > 0.05). The mean %EWL at follow-ups showed no significant difference at any point, except for 3 and 6 months after surgery (p value = 0.002 and 0.017, respectively). This finding was confirmed by %TWL trend in 12 months after surgery. LSG patients were readmitted more than LGP patients (seven cases vs one case, p value = 0.024). Postoperative complications such as nausea and vomiting, hair loss, iron deficiency, vitamin D deficiency, and cholelithiasis were not different between the two groups. There was one death in the LGP group due to pulmonary thromboembolism.ConclusionsLGP showed to be efficient regarding %EWL and %TWL reduction in short-term follow-ups with comparable postoperative complications to LSG.

Background Data on adherence to postoperative lifestyle recommendations by bariatric patients are scarce. Thus, the aim of this study was to evaluate adherence to selected recommendations during the first year following laparoscopic sleeve gastrectomy (LSG) surgery. Methods A prospective cohort study with 12 months of follow-up on 100 LSG patients was conducted. Data were collected at baseline and at 3 (M3), 6 (M6), and 12 (M12) months post-surgery and included anthropometrics, biochemical tests, food intake, food tolerance, common surgery-related side effects, physical activity (PA), supplementation, and number of follow-up meetings with a dietitian. Results Data were available for 77 patients (57.1% women, mean age 43.1 ± 9.3 years and preoperative BMI 42.1 ± 4.8 kg/m 2 ). Only a minority of the patients adhered to the recommended protein intake ≥60 g/day at all time points (≤40.3%) and ≥6 meetings with a dietitian at M12 (41.6%). Half of the patients performed ≥150 min/week of PA at all time points (≤50.6%) as recommended. PA of ≥150 min/week was associated with better lipid and glucose changes at M6 and M12 ( P  ≤ 0.044). Most of the patients adhered to the recommended supplementation at all time points (≥57.1%). Adherence to supplementation at M12 was significantly associated with higher serum levels of folic acid, iron, hemoglobin, and vitamins D and B12 ( P  ≤ 0.056 for all). Adherence to all recommendations was not significantly associated with excess weight loss ≥60% at M12 ( P  ≥ 0.195 for all). Conclusion Bariatric patients have medium to high adherence to the major lifestyle recommendations during the first year following LSG; however, adherence to those recommendations was not related to better weight loss at short-term follow-up. Adherence to recommended supplementation was associated with better micronutrient status 1 year postoperatively.

Background Adenocarcinoma of the gastroesophageal junction (GEJ) Siewert type II can be resected by transthoracic esophagectomy or transhiatal extended gastrectomy. Both allow for a complete tumor resection, yet there is an ongoing controversy about which surgical approach is superior with regards to quality of life, oncological outcomes and survival. While some studies suggest a better oncological outcome after transthoracic esophagectomy, others favor transhiatal extended gastrectomy for a better postoperative quality of life. To date, only retrospective studies are available, showing ambiguous results. Methods This study is a multinational, multicenter, randomized, clinical superiority trial. Patients ( n = 262) with a GEJ type II tumor resectable by both transthoracic esophagectomy and transhiatal extended gastrectomy will be enrolled in the trial. Type II tumors are defined as tumors with their midpoint between ≤1 cm proximal and ≤ 2 cm distal of the top of gastric folds on preoperative endoscopy. Patients will be included in one of the participating European sites and are randomized to either transthoracic esophagectomy or transhiatal extended gastrectomy. The trial is powered to show superiority for esophagectomy with regards to the primary efficacy endpoint overall survival. Key secondary endpoints are complete resection (R0), number and localization of tumor infiltrated lymph nodes at dissection, post-operative complications, disease-free survival, quality of life and cost-effectiveness. Postoperative survival and quality of life will be followed-up for 24 months after discharge. Further survival follow-up will be conducted as quarterly phone calls up to 60 months. Discussion To date, as level 1 evidence is lacking, there is no consensus on which surgery is superior and both surgeries are used to treat GEJ type II carcinoma worldwide. The CARDIA trial is the first randomized trial to compare transthoracic esophagectomy versus transhiatal extended gastrectomy in patients with GEJ type II tumors. Several quality control measures were implemented in the protocol to ensure data reliability and increase the trial’s significance. It is hypothesized that esophagectomy allows for a higher rate of radical resections and a more complete mediastinal lymph node dissection, resulting in a longer overall survival, while still providing an acceptable quality of life and cost-effectiveness. Trial registration The trial was registered on August 2nd 2019 at the German Clinical Trials Register under the trial-ID DRKS00016923 .