Analysis of Changes in Glucose and Lipid Metabolism in Patients with Clinically Severe Obesity and Type 2 Diabetes Mellitus Undergoing Laparoscopic Sleeve Gastrectomy-Prospective Observational Study.

INTRODUCTION: We still lack studies providing analysis of changes in glucose and lipid metabolism after laparoscopic sleeve gastrectomy (LSG) in patients with type 2 diabetes mellitus (DM2). We aimed to investigate postoperative changes in glucose and lipid metabolism after LSG in patients with DM2. MATERIAL AND METHODS: Prospective, observational study included patients with BMI ≥ 35 kg/m2 and ≤ 50 kg/m2, DM2 < 10 years of duration, who were qualified for LSG. Perioperative 14-day continuous glucose monitoring (CGM) began after preoperative clinical assessment and OGTT, then reassessment 1 and 12 months after LSG. Thirty-three patients in mean age of 45 ± 10 years were included in study (23 females). RESULTS: EBMIL before LSG was 17 ± 11.7%, after 1 month-36.3 ± 12.8%, while after 12 months-66.1 ± 21.7%. Fifty-two percent of the patients had DM2 remission after 12 months. None required then insulin therapy. 16/33 patients initially on oral antidiabetics still required them after 12 months. Significant decrease in HbA1C was observed: 5.96 ± 0.73%; 5.71 ± 0.80; 5.54 ± 0.52%. Same with HOMA-IR: 5.34 ± 2.84; 4.62 ± 3.78; 3.20 ± 1.99. In OGTT, lower increase in blood glucose with lesser insulin concentrations needed to recover glucose homeostasis was observed during follow-ups. Overtime perioperative average glucose concentration in CGM of 5.03 ± 1.09 mmol/L significantly differed after 12 months, 4.60 ± 0.53 (p = 0.042). Significantly higher percentage of glucose concentrations above targeted compartment (3.9-6.7 mmol/L) was observed in perioperative period (7% ± 4%), than in follow-up (4 ± 6% and 2 ± 1%). HDL significantly rose, while triglyceride levels significantly decreased. CONCLUSIONS: Significant improvement in glucose and lipid metabolism was observed 12 months after LSG and changes began 1 month after procedure.

The impact of severe postoperative complications on outcomes of bariatric surgery-multicenter case-matched study.

BACKGROUND: Bariatric surgery has relatively low complication rates, especially severe postoperative complications (defined by Clavien-Dindo classification as types 3 and 4), but these rates cannot be ignored. In other than bariatric surgical disciplines, complications affect not only short-term but also long-term results. In the field of bariatric surgery, this topic has not been extensively studied. OBJECTIVES: The aim of the study was to assess the outcomes of bariatric treatment in patients with obesity and severe postoperative complications in comparison to patients with a noneventful perioperative course. SETTING: Six surgical units at Polish public hospitals. METHODS: We performed a multicenter propensity score matched analysis of 206 patients from 6 Polish surgical units and assessed the outcomes of bariatric procedures. A total of 103 patients with severe postoperative complications (70 laparoscopic sleeve gastrectomy [SG] and 33 with laparoscopic Roux en Y gastric bypass [RYGB]) were compared to 103 patients with no severe complications in terms of peri- and postoperative outcomes. RESULTS: The outcomes of bariatric treatment did not differ between compared groups. Median percentage of total weight loss 12 months after the surgery was 28.8% in the group with complications and 27.9% in patients with no severe complications (P = 0.993). Remission rates of both type 2 diabetes mellitus and arterial hypertension showed no significant difference between SG and RYGB (36% versus 42%, P = 0.927, and 41% versus 46%, P = 0.575. respectively). CONCLUSIONS: The study suggests that severe postoperative complications had no significant influence either on weight loss effects or obesity-related diseases remission.

Quality of Life After Bariatric Surgery-a Systematic Review with Bayesian Network Meta-analysis.

OBJECTIVE: Comprehensive analysis and comparison of HRQoL following different bariatric interventions through systematic review with network meta-analysis. BACKGROUND: Different types of bariatric surgeries have been developed throughout the years. Apart from weight loss and comorbidities remission, improvement of health-related quality of life (HRQoL) is an important outcome of metabolic surgery. METHODS: MEDLINE, EMBASE, and Scopus databases have been searched up to April 2020. Inclusion criteria to the analysis were (1) study with at least 2 arms comparing bariatric surgeries; (2) reporting of HRQoL with a validated tool; (3) follow-up period of 1, 2, 3, or 5 years. Network meta-analysis was conducted using Bayesian statistics. The primary outcome was HRQoL. RESULTS: Forty-seven studies were included in the analysis involving 26,629 patients and 11 different surgeries such as sleeve gastrectomy (LSG), gastric bypass (LRYGB), one anastomosis gastric bypass (OAGB), and other. At 1 year, there was significant difference in HRQoL in favor of LSG, LRYGB, and OAG compared with lifestyle intervention (SMD: 0.44; 95% CrI 0.2 to 0.68 for LSG, SMD: 0.56; 95% CrI 0.31 to 0.8 for LRYGB; and SMD: 0.43; 95% CrI 0.06 to 0.8 for OAGB). At 5 years, LSG, LRYGB, and OAGB showed better HRQoL compared to control (SMD: 0.92; 95% CrI 0.58 to 1.26, SMD: 1.27; 95% CrI 0.94 to 1.61, and SMD: 1.01; 95% CrI 0.63 to 1.4, respectively). CONCLUSIONS: LSG and LRYGB may lead to better HRQoL across most follow-up time points. Long-term analysis shows that bariatric intervention results in better HRQoL than non-surgical interventions.

Type 2 Diabetes Remission 5 Years After Laparoscopic Sleeve Gastrectomy: Multicenter Cohort Study.

PURPOSE: Bariatric surgery is no longer considered only as a weight loss surgery but also a way of treating obesity-related comorbidities such as type 2 diabetes mellitus (T2DM). Short-term T2DM remissions in patients undergoing laparoscopic sleeve gastrectomy (LSG) have been shown, but there are very few reports on the mid-term results. We aimed to assess the remission rate of T2DM in obese patients after LSG throughout 5-year follow-up. MATERIALS AND METHODOLOGY: We performed a retrospective multicenter cohort analysis of 240 patients who underwent LSG. We assessed the remission rate of T2DM 1 year and 5 years after surgery. RESULTS: Forty-six percent of patients achieved T2DM remission 5 years after LSG. The remission group had better weight loss results (median% of total weight loss 5 years after: 30.1% (22.9-37.0) vs 23.0% (13.7-30.2), p < 0.001) and were significantly younger than the no remission group (43 (38-52) vs 52 (44-58) years, p < 0.001). Duration of T2DM was significantly shorter (2 (1-5) vs 5 (3-10) years, p < 0.001) with less insulin requirement and less diabetes-related complications (7.2% vs 19.8%, p < 0.001) and significantly lower median DiaRem score (4.0 (IQR 2.0-6.0) vs 12.0 (IQR 5.0-16.0), p < 0.001). Preoperative body mass index (BMI) had no effect on remission. CONCLUSIONS: Our study suggests that diabetes remission after laparoscopic sleeve gastrectomy occurs frequently, and in the 5-year follow-up, it may remain at the level of 46%. We identified the age of patients, duration, and severity of T2DM as factors affecting mid-term diabetes remission. Nevertheless, further well-designed trials are needed to support our findings.

Laparoscopic versus open liver resections of posterolateral liver segments - a systematic review and meta-analysis.

INTRODUCTION: Laparoscopic resection has become an accepted approach to liver tumour surgery. However, it is considered difficult, especially in unfavourably located lesions. AIM: To compare the outcomes of laparoscopic (LLR) and open liver resection (OLR) of posterolateral segments. MATERIAL AND METHODS: We searched the PubMed, EMBASE, and Scopus databases from inception to 30 September 2019. Full text articles and conference abstracts were included for further analysis. This review follows the PRISMA guidelines. RESULTS: From 643 articles, 15 studies (N = 1196 patients) were included in the meta-analysis. All of them were non-randomised. Our findings showed that LLR had significantly lowered overall morbidity compared to OLR (MD = 0.66; 95% CI: 0.51-0.86; p = 0.002). Length of hospital stay (MD = 2.48; 95% CI: -3.87, -1.08; p < 0.001) was also shorter in the LLR group. Operative time (MD = 55.65; 95% CI: 24.14-87.16; p < 0.001) was significantly shorter in the OLR group. In terms of blood loss, major complications, R0 resection rates, and resection margin, there were no significant differences. CONCLUSIONS: Our meta-analysis showed that the laparoscopic approach to resections of posterolateral liver segments is beneficial. However, the results are based on non-randomised trials, and further research is needed to fully establish their clinical application.

The fragility of statistically significant results from clinical nutrition randomized controlled trials.

BACKGROUND & AIMS: Recently, a parameter called "Fragility index" (FI) has been proposed, which measures how many events the statistical significance relies on. The lower the FI the more "fragile" the results, and thus more care should be taken when interpreting the results. Our aim in this study was to check FI of nutritional trials. METHODS: We conducted a systematic review of human clinical nutrition RCTs that report statistically significant dichotomous primary outcomes. We searched the EMBASE, MEDLINE, and Scopus databases. The FI of primary outcomes using the Fisher exact test was calculated and checked the correlations of FI with the number of randomised trials, the p-value of primary outcomes, the publication date, the journal impact factor and the number of patients lost to follow-up. RESULTS: The initial database search revealed 5790 articles, 37 of which were included in qualitative synthesis. The median (IQR) FI for all studies was 1 (1-3). 28 studies (75.7%) had an FI lower or equal to 2, and in 12 (32.43%) articles, the FI was lower than the number of patients lost to follow-up. No correlations were found between FI and the study characteristics (number of randomized patients, p value of primary outcome, event ratio in experimental group, event ratio in control group, publication date, journal impact factor, lost to follow-up). CONCLUSION: The results of RCTs in nutritional research often rely on a small number of events or patients. The number of patients lost to follow-up is frequently higher than the FI calculation. Formulating recommendations based on RCTs should be done with caution and FI may be used as auxiliary parameter when assessing the robustness of their findings.

Meta-analysis of short- and long-term outcomes after pure laparoscopic versus open liver surgery in hepatocellular carcinoma patients.

BACKGROUND: The advantages of laparoscopy are widely known. Nevertheless, its legitimacy in liver surgery is often questioned because of the uncertain value associated with minimally invasive methods. Our main goal was to compare the outcomes of pure laparoscopic (LLR) and open liver resection (OLR) in patients with hepatocellular carcinoma. METHODS: We searched EMBASE, MEDLINE, Web of Science, and The Cochrane Library databases to find eligible studies. The most recent search was performed on December 1, 2017. Studies were regarded as suitable if they reported morbidity in patients undergoing LLR versus OLR. Extracted data were pooled and subsequently used in a meta-analysis with a random-effects model. Clinical applicability of results was evaluated using predictive intervals. Review was reported following the PRISMA guidelines. RESULTS: From 2085 articles, forty-three studies (N = 5100 patients) were included in the meta-analysis. Our findings showed that LLR had lower overall morbidity than OLR (15.59% vs. 29.88%, p < 0.001). Moreover, major morbidity was reduced in the LLR group (3.78% vs. 8.69%, p < 0.001). There were no differences between groups in terms of mortality (1.58% vs. 2.96%, p = 0.05) and both 3- and 5-year overall survival (68.97% vs. 68.12%, p = 0.41) and disease-free survival (46.57% vs. 44.84%, p = 0.46). CONCLUSIONS: The meta-analysis showed that LLR is beneficial in terms of overall morbidity and non-procedure-specific complications. That being said, these results are based on non-randomized trials. For these reasons, we are calling for randomization in upcoming studies. Systematic review registration: PROSPERO registration number CRD42018084576.

Transanal total mesorectal excision for low rectal cancer: a case-matched study comparing TaTME versus standard laparoscopic TME.

BACKGROUND: Transanal total mesorectal excision (TaTME) is emerging as a novel alternative to laparoscopic total mesorectal excision (LaTME). The aim of this study was to compare clinical and pathological results from these two techniques in patients undergoing rectal resections because of low rectal cancer. MATERIALS AND METHODS: Thirty-five patients undergoing TaTME were matched with 35 patients operated on using LaTME. Composite primary endpoint (complete TME, negative circumferential resection margin [pCRM], and distal resection margin [pDRM]) was used to assess pathological quality specimens. Secondary outcomes included operative and postoperative parameters (operative time, total blood loss, postoperative morbidity, length of stay, 30-day mortality). RESULTS: Composite primary endpoint was achieved by 85% of subjects in the TaTME group and 82% of subjects in the LaTME group (P=0.66). Mean pCRM was 1.1±1.29 vs 0.99±0.78 mm (P=0.25). Distal pDRM was 1.57±0.92 and 1.98±1.22 cm (P=0.15). In the TaTME and LaTME groups, respectively, complete mesorectal excision was achieved in 89% and 83% of subjects, while excision was nearly complete for the remaining 11% and 17% (P=0.23). CONCLUSION: TaTME appears to be a noninferior alternative to laparoscopic surgery. TaTME allows for quality retrieval of surgical specimens with comparable clinical outcomes with LaTME.

Postoperative complications are associated with worse survival after laparoscopic surgery for non-metastatic colorectal cancer - interim analysis of 3-year overall survival.

INTRODUCTION: Postoperative morbidity after colorectal resections for cancer remains a significant problem. Data on the influence of complications on survival after laparoscopic colorectal resection are still limited. AIM: To analyze the impact of postoperative complications on long-term survival after radical laparoscopic resection for colorectal cancer. MATERIAL AND METHODS: Two hundred and sixty-five consecutive non-metastatic colorectal cancer patients undergoing laparoscopic colorectal resection for cancer were included in the analysis. The entire study group was divided into two subgroups based on the occurrence of postoperative complications. Group 1 included patients without postoperative morbidity and group 2 included patients with complications. The primary outcome was overall survival. RESULTS: Median follow-up was 45 (IQR: 34-55) months. Group 1 consisted of 187 (70.5%) patients and group 2 comprised 78 (29.5%) patients. Studied groups were comparable in terms of sex, age, body mass index, ASA class, cancer staging, localization of the tumor and operative time. Patients in group 1 had significantly better overall 3-year survival compared to those with complications (84.9% vs. 69.8%, p = 0.022). Kaplan-Meier curves showed significantly improved survival rates in patients without complications compared with complicated cases. The Cox proportional multivariate model showed that postoperative complications (HR = 2.83; 95% CI: 1.35-5.92; p = 0.0058) and AJCC III (HR = 3.17; 95% CI: 1.52-6.6; p = 0.0021) were independent predictors of worse survival after laparoscopic colorectal cancer surgery. CONCLUSIONS: Our analysis of interim results after 3 years confirms that complications after laparoscopic colorectal cancer surgery have an impact on survival. For this reason, these patients should be carefully monitored after surgery aiming at early detection of recurrence.

The Safety of Selective Use of Splenic Flexure Mobilization in Sigmoid and Rectal Resections-Systematic Review and Meta-Analysis.

BACKGROUND: According to traditional textbooks on surgery, splenic flexure mobilization is suggested as a mandatory part of open rectal resection. However, its use in minimally invasive access seems to be limited. This stage of the procedure is considered difficult in the laparoscopic approach. The aim of this study was to systematically review literature on flexure mobilization and perform meta-analysis. METHODS: A systematic review of the literature was performed using the Medline, Embase and Scopus databases to identify all eligible studies that compared patients undergoing rectal or sigmoid resection with or without splenic flexure mobilization. INCLUSION CRITERIA: (1) comparison of groups of patients with and without mobilization and (2) reports on overall morbidity, anastomotic leakage, operative time, length of specimen, number of harvested lymph nodes, or length of hospital stay. The outcomes of interest were: operative time, conversion rate, number of lymph nodes harvested, overall morbidity, mortality, leakage rate, reoperation rate, and length of stay. RESULTS: Initial search yielded 2282 studies. In the end, we included 10 studies in the meta-analysis. Splenic flexure is associated with longer operative time (95% confidence interval (CI) 23.61⁻41.25; p < 0.001) and higher rate of anastomotic leakage (risk ratios (RR): 1.02; 95% CI 1.10⁻3.35; p = 0.02), however the length of hospital stay is shorter by 0.42 days. There were no differences in remaining outcomes. CONCLUSIONS: Not mobilizing the splenic flexure results in a significantly shorter operative time and a longer length of stay. Further research is required to establish whether flexure mobilization is required in minimally invasive surgery.

Pancreatoduodenectomy for pancreatic head tumors in the elderly - Systematic review and meta-analysis.

The age at which patients are undergoing pancreatoduodenectomy is increasing worldwide. The data on the outcome of this surgical procedure in the elderly is constantly expanding. This meta-analysis aims to assess the safety of pancreatoduodenectomy in elderly population, primarily focusing on morbidity and mortality. We searched the Medline, Embase and Cochrane databases to identify eligible studies. The most recent search was performed on 10th April 2017. Inclusion criteria were: (1) comparison of the characteristics and perioperative outcomes of older patients versus younger patients undergoing pancreatoduodenectomy; (2) objective evaluation of mortality or overall morbidity; and (3), publication in English. Exclusion criteria were: (1) a lack of comparative data; (2) a lack of primary outcomes or insufficient data to analyze; (3) a focus on procedures other than pancreatoduodenectomy; or (4), the impossibility of extraction of data specifically concerning pancreatoduodenectomy. Primary outcomes were overall morbidity and mortality. Secondary outcomes analyzed postoperative complications, R0 rate and length of hospital stay. 45 eligible studies were chosen, with a combined total of 21,295 patients. Older patients compared to younger patients had a higher risk of death (2.26% vs. 4.54%; RR: 2.23; 95% CI 1.74-2.87) and a higher complication rate (47.23% vs. 39.35%; RR: 1.17; 95% CI 1.12-1.24). There were no differences in pancreatic fistula occurrence (p = 0.27), bile leakage (p = 0.81), postoperative hemorrhage (p = 0.08), or R0 rate (p = 0.92). Our review confirms, that in the case of pancreatoduodenectomy, advanced age is a risk factor for increased non-surgical morbidity and, by extension, higher mortality.

Is the laparoscopic approach for rectal cancer superior to open surgery? A systematic review and meta-analysis on short-term surgical outcomes.

INTRODUCTION: Over the past years the incidence of colorectal cancers has increased worldwide. Currently it is the most common gastrointestinal malignancy worldwide. The laparoscopic approach has become the gold standard for surgical treatment. However, a recently published meta-analysis showed no difference in short- and long-term oncological outcomes of laparoscopy for treating rectal cancer. AIM: To assess current literature on short-term outcomes of rectal cancer treatment using laparoscopic surgery in comparison to the open approach. MATERIAL AND METHODS: We performed a systematic review and meta-analysis according to the PRISMA guidelines. The primary outcomes of interest were morbidity and short-term complications. RESULTS: We identified 4,328 potential references. In the end we included 13 randomized controlled trials (RCTs). We did not find any significant differences in terms of morbidity, haemorrhage, ureter injury, anastomotic leakage, mortality, intra-abdominal abscess or postoperative ileus. We found significant differences in the rate of surgical site infections, operative time, blood loss, length of hospital stay and time to first bowel movement. CONCLUSIONS: This systematic review based on available RCTs confirms that laparoscopic rectal cancer surgery is associated with short-term outcomes comparable to the open approach. Moreover, in some aspects it provides better results (e.g. functional postoperative recovery, lower rate of surgical site infections (SSIs)). The quality of evidence is high; therefore in our opinion it is very unlikely that future trials will alter these results, and for this reason the laparoscopic approach can be considered the gold standard for the treatment of the majority of patients.

Defunctioning ileostomy reduces leakage rate in rectal cancer surgery - systematic review and meta-analysis.

OBJECTIVES: The role of a defunctioning ileostomy in every anterior rectal resection with total mesorectal excision (TME) is still controversial. In this study, we aimed to review the current literature to determine the impact of ileostomy creation on postoperative outcomes in patients undergoing anterior rectal resection with TME. METHODS: MEDLINE, Embase and Cochrane Library were searched for eligible studies. We analyzed data up to October 2017. Eligible studies had to compare patients with vs. without a defunctioning ileostomy in rectal cancer surgery and comprise data on anastomotic leakage in both groups. The primary outcome was anastomotic leakage. Secondary outcomes included the complication rate, mortality, reoperation rate, length of hospital stay and 30-day readmission. RESULTS: Initial search yielded 1,966 articles. Thorough evaluation resulted in 13 eligible articles which were analyzed. Leakage rate (RR = 0.43, 95% CI 0.28-0.67) and the number of reoperations (RR = 0.62, 95% CI 0.40-0.94) were significantly lower in the defunctioning stoma group. Morbidity was significantly higher in the stoma group (RR = 1.32, 95% CI 1.05-1.65). Analysis of mortality, length of hospital stay and readmission rate did not show any significant differences. CONCLUSION: A defunctioning ileostomy may decrease the anastomotic leakage rate, additionally significantly reducing the risk of reoperations but it may also increase the overall complication rate. The presence of the protective stoma has no effect on mortality, length of hospital stay and readmission rate.

Primary tumor resection in stage IV unresectable colorectal cancer: what has changed?

Most current guidelines do not recommend primary tumor resection in stage IV unresectable colorectal cancer. Rapid chemotherapy development over the last decade has substantially changed the decision making. However, results of recently published trials and meta-analyses suggest that primary tumor resection may in fact be beneficial, principally in terms of prolonged survival. Additional factors, such as use of minimally invasive approach or protocols of enhanced recovery after surgery, affect clinical outcomes as well, but are often neglected when discussing the state of the art in this area. There are still no randomized studies determining the legitimacy of upfront surgery in asymptomatic patients. Also, quality of life also plays an important role in choosing appropriate treatment. Having said that, there is no data that would prove whether primary tumor resection has an advantage on that issue. With all the uncertainty, currently decision making in unresectable stage IV colorectal cancer is primarily up to clinicians' knowledge, common sense and patients' preferences.