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1.
Langenbecks Arch Surg ; 409(1): 14, 2023 Dec 20.
Article in English | MEDLINE | ID: mdl-38114826

ABSTRACT

PURPOSE: Distal pancreatectomy (DP) is associated with a high complication rate of 30-50% with postoperative pancreatic fistula (POPF) as a dominant contributor. Adequate risk estimation for POPF enables surgeons to use a tailor-made approach. Assessment of the risk of POPF prior to DP can lead to the application of preventive strategies. The current study aims to validate the recently published preoperative and intraoperative distal fistula risk score (D-FRS) in a nationwide cohort. METHODS: This nationwide retrospective Dutch cohort study included all patients after DP for any indication, all of whom were registered in the Dutch Pancreatic Cancer Audit (DPCA) database between 2013 and 2021. The D-FRS was validated by filling in the probability equations with data from this cohort. The predictive capacity of the models was represented by an area under the receiver operating characteristic (AUROC) curve. RESULTS: A total of 896 patients underwent DP of which 152 (17%) developed POPF of whom 144 grade B (95%) and 8 grade C (5%). The preoperative D-FRS, consisting of the variables pancreatic neck thickness and pancreatic duct diameter, showed an AUROC of 0.73 (95%CI 0.68-0.78). The intraoperative D-FRS, comprising pancreatic neck, duct diameter, BMI, operating time, and soft pancreatic aspect, showed an AUROC of 0.69 (95%CI 0.64-0.74). CONCLUSION: The current study is the first nationwide validation of the preoperative and intraoperative D-FRS showing acceptable distinguishing capacity for only the preoperative D-FRS for POPF. Therefore, the preoperative score could improve prevention and mitigation strategies such as drain management, which is currently investigated in the multicenter PANDORINA trial.


Subject(s)
Pancreas , Pancreatic Fistula , Humans , Cohort Studies , Pancreas/surgery , Pancreatectomy/methods , Pancreatic Fistula/etiology , Pancreatic Fistula/prevention & control , Pancreatic Fistula/surgery , Pancreaticoduodenectomy/adverse effects , Postoperative Complications/epidemiology , Postoperative Complications/prevention & control , Postoperative Complications/etiology , Retrospective Studies , Risk Assessment/methods , Risk Factors
2.
Trials ; 24(1): 717, 2023 Nov 09.
Article in English | MEDLINE | ID: mdl-37946272

ABSTRACT

INTRODUCTION: Protein malnutrition after bariatric surgery is a severe complication and leads to significant morbidity. Previous studies have shown that protein intake and physical activity are the most important factors in the preservation of fat-free mass during weight loss. Low protein intake is very common in patients undergoing bariatric surgery despite dietary counseling. Protein powder supplements might help patients to achieve the protein intake recommendations after bariatric surgery and could therefore contribute to preserve fat-free mass. This double-blind randomized placebo-controlled intervention study aims to assess the effect of a daily consumed clear protein powder shake during the first 6 months after bariatric surgery on fat-free mass loss in the first 12 months after laparoscopic Roux-en-Y gastric bypass (LRYGB). METHODS AND ANALYSIS: Inclusion will take place at the outpatient clinic of the bariatric expertise center for obesity of the Maasstad Hospital. Patients will be randomly assigned to either the intervention or control group before surgery. The intervention group will receive a clear protein powder shake of 200 ml containing 20 g of whey protein dissolved in water which should be taken daily during the first 6 months after LRYGB on top of their normal postoperative diet. The control group will receive an isocaloric, clear, placebo shake containing maltodextrine. Postoperative rehabilitation and physiotherapeutical guidance will be standardized and similar in both groups. Also, both groups will receive the same dietary advice from specialized dieticians. The main study parameter is the percentage of fat-free mass loss 6 months after surgery, assessed by multi-frequency bioelectrical impedance analysis (MF-BIA). ETHICS AND DISSEMINATION: The protocol, version 2 (February 20, 2022) has been approved by the Medical Research Ethics Committees United (MEC-U) (NL 80414.100.22). The results of this study will be submitted to peer-reviewed journals. TRIAL REGISTRATION: ClinicalTrials.gov NCT05570474. Registered on October 5, 2022.


Subject(s)
Bariatric Surgery , Gastric Bypass , Obesity, Morbid , Humans , Obesity, Morbid/surgery , Powders , Bariatric Surgery/adverse effects , Gastric Bypass/adverse effects , Gastric Bypass/methods , Dietary Supplements
3.
Front Immunol ; 13: 888278, 2022.
Article in English | MEDLINE | ID: mdl-35860273

ABSTRACT

Morbid obesity is associated with a chronic state of low-grade inflammation, which may lead to accelerated differentiation of T and B cells. These differentiated immune cells are strongly cytotoxic and have an increased pro-inflammatory cytokine producing capacity. Furthermore, the anti-inflammatory function of the T and B cells decreases. The aim of this study was to evaluate the effect of morbid obesity on the subset profile and cytokine producing capacity of T and B cells. Subsequently, we assessed whether bariatric surgery affected the subset profile and cytokine producing capacity of these cells. We determined the proportion of T and B cell subsets and their cytokine producing capacity in peripheral blood collected from 23 morbidly obese patients before and three months after bariatric surgery using flow-cytometry. We compared this with the results of 25 lean controls. Both CD4+ and CD8+ T cells showed a more differentiated subset profile in morbidly obese patients as compared to lean controls, which was not recovered three months after bariatric surgery. The B cell composition of morbidly obese patients after bariatric surgery adjusted towards the profile of lean controls. However, the IL-2 and IFN-γ producing capacity of CD8+ T cells and the IL-2, IFN-γ, TNF-α and IL-10 producing capacity of B cells was not restored three months after bariatric surgery. In conclusion, the data suggest that the immune system has the capacity to recover from the detrimental effects of morbid obesity within three months after bariatric surgery in terms of cell composition; however, this was not seen in terms of cytokine producing capacity. The full restoration of the immune system after bariatric surgery may thus take longer.


Subject(s)
Bariatric Surgery , Obesity, Morbid , B-Lymphocytes , CD8-Positive T-Lymphocytes , Cytokines , Humans , Interleukin-2 , Obesity, Morbid/surgery
4.
Br J Surg ; 108(11): 1371-1379, 2021 11 11.
Article in English | MEDLINE | ID: mdl-34608941

ABSTRACT

BACKGROUND: Despite the fact that primary percutaneous catheter drainage has become standard practice, some patients with pancreatic fistula after pancreatoduodenectomy ultimately undergo a relaparotomy. The aim of this study was to compare completion pancreatectomy with a pancreas-preserving procedure in patients undergoing relaparotomy for pancreatic fistula after pancreatoduodenectomy. METHODS: This retrospective cohort study of nine institutions included patients who underwent relaparotomy for pancreatic fistula after pancreatoduodenectomy from 2005-2018. Furthermore, a systematic review and meta-analysis were performed according to the PRISMA guidelines. RESULTS: From 4877 patients undergoing pancreatoduodenectomy, 786 (16 per cent) developed a pancreatic fistula grade B/C and 162 (3 per cent) underwent a relaparotomy for pancreatic fistula. Of these patients, 36 (22 per cent) underwent a completion pancreatectomy and 126 (78 per cent) a pancreas-preserving procedure. Mortality was higher after completion pancreatectomy (20 (56 per cent) versus 40 patients (32 per cent); P = 0.009), which remained after adjusting for sex, age, BMI, ASA score, previous reintervention, and organ failure in the 24 h before relaparotomy (adjusted odds ratio 2.55, 95 per cent c.i. 1.07 to 6.08). The proportion of additional reinterventions was not different between groups (23 (64 per cent) versus 84 patients (67 per cent); P = 0.756). The meta-analysis including 33 studies evaluating 745 patients, confirmed the association between completion pancreatectomy and mortality (Mantel-Haenszel random-effects model: odds ratio 1.99, 95 per cent c.i. 1.03 to 3.84). CONCLUSION: Based on the current data, a pancreas-preserving procedure seems preferable to completion pancreatectomy in patients in whom a relaparotomy is deemed necessary for pancreatic fistula after pancreatoduodenectomy.


Subject(s)
Drainage/methods , Laparotomy/methods , Pancreatectomy/methods , Pancreatic Fistula/surgery , Pancreaticoduodenectomy/adverse effects , Postoperative Complications/surgery , Cohort Studies , Global Health , Humans , Incidence , Intraoperative Period , Multicenter Studies as Topic , Pancreatic Fistula/epidemiology , Pancreatic Fistula/etiology , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Reoperation , Survival Rate/trends
5.
Updates Surg ; 73(4): 1391-1397, 2021 Aug.
Article in English | MEDLINE | ID: mdl-33770412

ABSTRACT

Drain Amylase level are routinely determined to diagnose pancreatic fistula after Pancreatocoduodenectomy. Consensus is lacking regarding the cut-off value of amylase to diagnosis clinically relevant postoperative pancreatic fistulae (POPF). The present study proposes a model based on Amylase Value in the Drain (AVD) measured in the first three postoperative days to predict a POPF. Amylase cut-offs were selected from a previous published systematic review and the accuracy were validated in a multicentre database from 12 centres in 2 countries. The present study defined POPF the 2016 ISGPS criteria (3 times the upper limit of normal serum amylase). A learning machine method was used to correlate AVD with the diagnosis of POPF. Overall, 454 (27%) of 1638 patients developed POPF. Machine learning excluded a clinically relevant postoperative pancreatic fistulae with an AUC of 0.962 (95% CI 0.940-0.984) in the first five postoperative days. An AVD at a cut-off of 270 U/L in 2 days in the first three postoperative days excluded a POPF with an AUC of 0.869 (CI 0.81-0.90, p < 0.0001). A single AVD in the first three postoperative days may not exclude POPF after pancreatoduodenectomy. The levels should be monitored until day 3 and have two negative values before removing the drain. In the group with a positive level, the drain should be kept in and AVD monitored until postoperative day five.


Subject(s)
Pancreatic Fistula , Pancreaticoduodenectomy , Amylases , Drainage , Humans , Pancreas/surgery , Pancreatic Fistula/diagnosis , Pancreatic Fistula/etiology , Pancreatic Fistula/surgery , Pancreaticoduodenectomy/adverse effects , Postoperative Complications/diagnosis , Postoperative Complications/surgery , Risk Factors
6.
Eur J Surg Oncol ; 47(3 Pt B): 708-716, 2021 03.
Article in English | MEDLINE | ID: mdl-33323293

ABSTRACT

INTRODUCTION: First, this study aimed to assess the prognostic value of different definitions for resection margin status on disease-free survival (DFS) and overall survival (OS) in pancreatic ductal adenocarcinoma (PDAC). Second, preoperative predictors of direct margin involvement were identified. MATERIALS AND METHODS: This nationwide observational cohort study included all patients who underwent upfront PDAC resection (2014-2016), as registered in the prospective Dutch Pancreatic Cancer Audit. Patients were subdivided into three groups: R0 (≥1 mm margin clearance), R1 (<1 mm margin clearance) or R1 (direct margin involvement). Survival was compared using multivariable Cox regression analysis. Logistic regression with baseline variables was performed to identify preoperative predictors of R1 (direct). RESULTS: 595 patients with a median OS of 18 months (IQR 10-32 months) months were analysed. R0 (≥1 mm) was achieved in 277 patients (47%), R1 (<1 mm) in 146 patients (24%) and R1 (direct) in 172 patients (29%). R1 (direct) was associated with a worse OS, as compared with both R0 (≥1 mm) (hazard ratio (HR) 1.35 [95% and confidence interval (CI) 1.08-1.70); P < 0.01) and R1 (<1 mm) (HR 1.29 [95%CI 1.01-1.67]; P < 0.05). No OS difference was found between R0 (≥1 mm) and R1 (<1 mm) (HR 1.05 [95% CI 0.82-1.34]; P = 0.71). Preoperative predictors associated with an increased risk of R1 (direct) included age, male sex, performance score 2-4, and venous or arterial tumour involvement. CONCLUSION: Resection margin clearance of <1 mm, but without direct margin involvement, does not affect survival, as compared with a margin clearance of ≥1 mm. Given that any vascular tumour involvement on preoperative imaging was associated with an increased risk of R1 (direct) resection with upfront surgery, neoadjuvant therapy might be considered in these patients.


Subject(s)
Carcinoma, Pancreatic Ductal/surgery , Margins of Excision , Pancreatic Neoplasms/surgery , Aged , Carcinoma, Pancreatic Ductal/pathology , Cohort Studies , Disease-Free Survival , Female , Humans , Logistic Models , Male , Middle Aged , Multivariate Analysis , Netherlands , Pancreatic Neoplasms/pathology , Prognosis , Proportional Hazards Models , Survival Rate
7.
Trials ; 21(1): 334, 2020 Apr 16.
Article in English | MEDLINE | ID: mdl-32299515

ABSTRACT

BACKGROUND: Pancreatic cancer has a very poor prognosis. Best practices for the use of chemotherapy, enzyme replacement therapy, and biliary drainage have been identified but their implementation in daily clinical practice is often suboptimal. We hypothesized that a nationwide program to enhance implementation of these best practices in pancreatic cancer care would improve survival and quality of life. METHODS/DESIGN: PACAP-1 is a nationwide multicenter stepped-wedge cluster randomized controlled superiority trial. In a per-center stepwise and randomized manner, best practices in pancreatic cancer care regarding the use of (neo)adjuvant and palliative chemotherapy, pancreatic enzyme replacement therapy, and metal biliary stents are implemented in all 17 Dutch pancreatic centers and their regional referral networks during a 6-week initiation period. Per pancreatic center, one multidisciplinary team functions as reference for the other centers in the network. Key best practices were identified from the literature, 3 years of data from existing nationwide registries within the Dutch Pancreatic Cancer Project (PACAP), and national expert meetings. The best practices follow the Dutch guideline on pancreatic cancer and the current state of the literature, and can be executed within daily clinical practice. The implementation process includes monitoring, return visits, and provider feedback in combination with education and reminders. Patient outcomes and compliance are monitored within the PACAP registries. Primary outcome is 1-year overall survival (for all disease stages). Secondary outcomes include quality of life, 3- and 5-year overall survival, and guideline compliance. An improvement of 10% in 1-year overall survival is considered clinically relevant. A 25-month study duration was chosen, which provides 80% statistical power for a mortality reduction of 10.0% in the 17 pancreatic cancer centers, with a required sample size of 2142 patients, corresponding to a 6.6% mortality reduction and 4769 patients nationwide. DISCUSSION: The PACAP-1 trial is designed to evaluate whether a nationwide program for enhanced implementation of best practices in pancreatic cancer care can improve 1-year overall survival and quality of life. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03513705. Trial opened for accrual on 22th May 2018.


Subject(s)
Carcinoma, Pancreatic Ductal/mortality , Carcinoma, Pancreatic Ductal/therapy , Health Plan Implementation , Pancreatic Neoplasms/mortality , Pancreatic Neoplasms/therapy , Quality of Life , Adolescent , Adult , Aged , Aged, 80 and over , Biliary Tract Surgical Procedures , Carcinoma, Pancreatic Ductal/epidemiology , Child , Child, Preschool , Cluster Analysis , Drainage , Enzyme Replacement Therapy , Female , Humans , Infant , Infant, Newborn , Male , Middle Aged , Multicenter Studies as Topic , Neoadjuvant Therapy , Netherlands/epidemiology , Palliative Care , Pancreatic Neoplasms/epidemiology , Pancreaticoduodenectomy , Patient Compliance , Randomized Controlled Trials as Topic , Stents , Treatment Outcome , Young Adult
8.
Pancreatology ; 19(6): 888-896, 2019 Sep.
Article in English | MEDLINE | ID: mdl-31378583

ABSTRACT

BACKGROUND: Abdominal drainage and the timing of drain removal in patients undergoing pancreatic resection are under debate. Early drain removal after pancreatic resection has been reported to be safe with a low risk for clinical relevant postoperative pancreatic fistula (CR-POPF) when drain amylase on POD1 is < 5000U/L. The aim of this study was to validate this algorithm in a large national cohort. METHODS: Patients registered in the Dutch Pancreatic Cancer Audit (2014-2016) who underwent pancreatoduodenectomy, distal pancreatectomy or enucleation were analysed. Data on post-operative drain amylase levels, drain removal, postoperative pancreatic fistulae were collected. Univariate and multivariate analysis using a logistic regression model were performed. The primary outcome measure was grade B/C pancreatic fistula (CR-POPF). RESULTS: Among 1402 included patients, 433 patients with a drain fluid amylase level of <5000U/L on POD1, 7% developed a CR-POPF. For patients with an amylase level >5000U/L the CR-POPF rate was 28%. When using a cut-off point of 2000U/L or 1000U/L during POD1-3, the CR-POPF rates were 6% and 5% respectively. For patients with an amylase level of >2000U/L and >1000UL during POD 1-3 the CR-POPF rates were 26% and 22% respectively (n = 223). Drain removal on POD4 or thereafter was associated with more complications (p = 0.004). Drain amylase level was shown to be the most statistically significant predicting factor for CR-POPF (Wald = 49.7; p < 0.001). CONCLUSION: Our data support early drain removal after pancreatic resection. However, a cut-off of 5000U/L drain amylase on POD1 was associated with a relatively high CR-POPF rate of 7%. A cut-off point of 1000U/L during POD1-3 resulted in 5% CR-POPF and might be a safer alternative.


Subject(s)
Drainage/methods , Pancreas/surgery , Abdomen , Aged , Algorithms , Amylases/analysis , Device Removal/statistics & numerical data , Female , Humans , Male , Middle Aged , Netherlands , Pancreatectomy , Pancreatic Neoplasms/surgery , Pancreaticoduodenectomy , Reference Values , Treatment Outcome
9.
Eur J Surg Oncol ; 45(10): 1906-1911, 2019 Oct.
Article in English | MEDLINE | ID: mdl-31186205

ABSTRACT

INTRODUCTION: Locally advanced pancreatic cancer (LAPC) is found in 35% of patients with pancreatic cancer. However, these patients often have occult metastatic disease. Patients with occult metastases are unlikely to benefit from locoregional treatments. This study evaluated the yield of occult metastases during staging laparoscopy in patients with LAPC. METHODS: Between January 2013 and January 2017 all patients with LAPC underwent a staging laparoscopy after a recent tri-phasic CT-scan of the chest and abdomen. Data were retrospectively reviewed from a prospectively maintained database. Univariate and multivariable logistic regression analysis was conducted to predict metastasis found at laparoscopy. RESULTS: A total of 91 (41% male, median age 64 years) LAPC patients were included. The median time between CT-scan and staging laparoscopy was 21 days. During staging laparoscopy metastases were found in 17 patients (19%, 95% CI: 12%-28%). Seven (8%) patients had liver-only, 9 (10%) patients peritoneal-only, and 1 (1%) patient both liver and peritoneal metastases. Univariate logistic regression analysis showed that CEA (OR 1.056, 95% CI 1.007-1.107, p = 0.02) was the only preoperative predictor for occult metastases. In a multivariable logistic regression analysis of the preoperative risk factors again only CEA was an independent predictor for occult metastatic disease (p = 0.03). Patients with a CEA above 5 µg/L had a risk of occult metastasis of 91%. FOLFIRINOX was given to 69 (76%) of the patients with a median number of cycles of 8. Subsequent radiotherapy was given to 44 (48%) patients after the FOLFIRINOX treatment. Six (14%) patients underwent a resection after FOLFIRINOX and radiotherapy. The overall 1-year survival was 53% in patients without occult metastasis versus 29% with occult metastasis (p = 0.11). The 1-year OS for patients that completed FOLFIRINOX and radiotherapy was 84%. CONCLUSION: The yield of staging laparoscopy for occult intrahepatic or peritoneal metastases in patients with locally advanced pancreatic cancer was 19%. Staging laparoscopy is recomended for patients with LAPC for accurate staging to determine optimal treatment.


Subject(s)
Laparoscopy/methods , Neoplasm Staging/methods , Pancreatic Neoplasms/diagnosis , Aged , Female , Follow-Up Studies , Humans , Male , Middle Aged , Neoplasm Metastasis , Pancreatic Neoplasms/secondary , Predictive Value of Tests , Retrospective Studies , Tomography, X-Ray Computed
10.
Int J Obes (Lond) ; 43(11): 2189-2199, 2019 11.
Article in English | MEDLINE | ID: mdl-30979972

ABSTRACT

BACKGROUND: Obesity adversely affects health and is associated with subclinical systemic inflammation and features of accelerated aging, including the T-cell immune system. The presence of metabolic syndrome (MetS) may accelerate, while bariatric surgery might reverse these phenomena. To examine the effects of MetS and bariatric surgery on T-cell aging, we measured relative telomere length (RTL) and T-cell differentiation status in obese patients before and after bariatric surgery. METHODS: WHO II/III classified obese patients scheduled for bariatric surgery were included: 41 without MetS and 67 with MetS. RTL and T-cell differentiation status were measured in circulating CD4+ and CD8+ T cells via flow cytometry. T-cell characteristics were compared between patients with and without MetS prior to and at 3, 6, and 12 months after surgery considering effects of age, cytomegalovirus-serostatus, and weight loss. RESULTS: Thymic output, represented by numbers of CD31-expressing naive T cells, showed an age-related decline in patients with MetS. MetS significantly enhanced CD8+ T-cell differentiation. Patients with MetS had significant lower CD4+ RTL than patients without MetS. Within the first 6 months after bariatric surgery, RTL increased in CD4+ T cells after which it decreased at month 12. A decline in both thymic output and more differentiated T cells was seen following bariatric surgery, more pronounced in the MetS group and showing an association with percentage of body weight loss. CONCLUSIONS: In obese patients, MetS results in attrition of RTL and accelerated T-cell differentiation. Bariatric surgery temporarily reverses these effects. These data suggest that MetS is a risk factor for accelerated aging of T cells and that MetS should be a more prominent factor in the decision making for eligibility for bariatric surgery.


Subject(s)
Bariatric Surgery , Cellular Senescence/physiology , Obesity , T-Lymphocytes/physiology , Telomere/physiology , Adolescent , Adult , Female , Humans , Male , Metabolic Syndrome , Middle Aged , Obesity/metabolism , Obesity/physiopathology , Obesity/surgery , Prospective Studies , Young Adult
11.
J Gastrointest Surg ; 23(12): 2327-2337, 2019 12.
Article in English | MEDLINE | ID: mdl-30820797

ABSTRACT

BACKGROUND: Radical gastrectomy is the cornerstone of the treatment of gastric cancer. For tumors invading the pancreas, en-bloc partial pancreatectomy may be needed for a radical resection. The aim of this study was to evaluate the outcome of gastrectomies with partial pancreatectomy for gastric cancer. METHODS: Patients who underwent gastrectomy with or without partial pancreatectomy for gastric or gastro-oesophageal junction cancer between 2011 and 2015 were selected from the Dutch Upper GI Cancer Audit (DUCA). Outcomes were resection margin (pR0) and Clavien-Dindo grade ≥ III postoperative complications and survival. The association between partial pancreatectomy and postoperative complications was analyzed with multivariable logistic regression. Overall survival of patients with partial pancreatectomy was estimated using the Kaplan-Meier method. RESULTS: Of 1966 patients that underwent gastrectomy, 55 patients (2.8%) underwent en-bloc partial pancreatectomy. A pR0 resection was achieved in 45 of 55 patients (82% versus 85% in the group without additional resection, P = 0.82). Clavien-Dindo grade ≥ III complications occurred in 21 of 55 patients (38% versus 17%, P < 0.001). Median overall survival [95% confidence interval] was 15 [6.8-23.2] months. For patients with and without perioperative systemic therapy, median survival was 20 [12.3-27.7] and 10 [5.7-14.3] months, and for patients with pR0 and pR1 resection, it was 20 [11.8-28.3] and 5 [2.4-7.6] months, respectively. CONCLUSIONS: Gastrectomy with partial pancreatectomy is not only associated with a pR0 resection rate of 82% but also with increased postoperative morbidity. It should only be performed if a pR0 resection is feasible.


Subject(s)
Gastrectomy/adverse effects , Pancreatectomy/adverse effects , Postoperative Complications/epidemiology , Stomach Neoplasms/surgery , Adult , Aged , Esophagogastric Junction/pathology , Female , Humans , Male , Middle Aged , Neoplasm Staging , Netherlands , Pancreas/pathology , Retrospective Studies , Stomach Neoplasms/mortality , Stomach Neoplasms/pathology , Survival Rate , Treatment Outcome
12.
BMC Obes ; 5: 36, 2018.
Article in English | MEDLINE | ID: mdl-30524741

ABSTRACT

BACKGROUND: Tranexamic acid reduces blood loss associated with various surgical procedures. Postoperative bleeding caused by dissection or bleeding of the enteric staple lines is a well-known complication following bariatric surgery. Reoperation in order to restore hemostasis is frequently necessary (up to 2.5% in literature). The effect of conservative therapy using tranexamic acid for postoperative hemorrhage after bariatric surgery is still very much a novel technique. The aim is to present our results (reoperation rate and thrombo-embolic complication rate) of tranexamic acid therapy for postoperative bleeding after bariatric surgery in comparison to those in existing literature. METHODS: We retrospectively reviewed 1388 patients who underwent bariatric surgery (laparoscopic gastric bypass or laparoscopic gastric sleeve). Use of tranexamic acid, reoperation rate, transfusion rate and rate of thrombo-embolic complications were reviewed. RESULTS: Forty-five of 1388 (3.2%) total patients experienced significant hemorrhage after bariatric surgery. Tranexamic acid was administered in 44 of these patients. A failure of the treatment with tranexamic acid was observed in four patients. The incidence of reoperation was 0.4% for the entire population. No thrombo-embolic complications were registered for patients receiving tranexamic acid. CONCLUSION: These findings suggest that the administration of tranexamic acid appears to be safe in reducing the reoperation rate for bleeding after bariatric surgery.

13.
Br J Surg ; 105(12): 1630-1638, 2018 11.
Article in English | MEDLINE | ID: mdl-29947418

ABSTRACT

BACKGROUND: After neoadjuvant chemoradiotherapy (nCRT) plus surgery for oesophageal cancer, 29 per cent of patients have a pathologically complete response in the resection specimen. Active surveillance after nCRT (instead of standard oesophagectomy) may improve health-related quality of life (HRQoL), but patients need to undergo frequent diagnostic tests and it is unknown whether survival is worse than that after standard oesophagectomy. Factors that influence patients' preferences, and trade-offs that patients are willing to make in their choice between surgery and active surveillance were investigated here. METHODS: A prospective discrete-choice experiment was conducted. Patients with oesophageal cancer completed questionnaires 4-6 weeks after nCRT, before surgery. Patients' preferences were quantified using scenarios based on five aspects: 5-year overall survival, short-term HRQoL, long-term HRQoL, the risk that oesophagectomy is still necessary, and the frequency of clinical examinations using endoscopy and PET-CT. Panel latent class analysis was used. RESULTS: Some 100 of 104 patients (96·2 per cent) responded. All aspects, except the frequency of clinical examinations, influenced patients' preferences. Five-year overall survival, the chance that oesophagectomy is still necessary and long-term HRQoL were the most important attributes. On average, based on calculation of the indifference point between standard surgery and active surveillance, patients were willing to trade off 16 per cent 5-year overall survival to reduce the risk that oesophagectomy is necessary from 100 per cent (standard surgery) to 35 per cent (active surveillance). CONCLUSION: Patients are willing to trade off substantial 5-year survival to achieve a reduction in the risk that oesophagectomy is necessary.


Subject(s)
Chemoradiotherapy, Adjuvant/psychology , Esophageal Neoplasms/therapy , Patient Preference , Aged , Chemoradiotherapy, Adjuvant/mortality , Esophageal Neoplasms/mortality , Esophageal Neoplasms/psychology , Esophagectomy/psychology , Female , Humans , Male , Middle Aged , Neoadjuvant Therapy/mortality , Neoadjuvant Therapy/psychology , Netherlands/epidemiology , Prospective Studies , Quality of Life , Surveys and Questionnaires , Survival Analysis
14.
Biomaterials ; 109: 32-39, 2016 12.
Article in English | MEDLINE | ID: mdl-27662579

ABSTRACT

Macrophages play a key role in the foreign body response. In this study it was investigated whether obesity affects the acute response of macrophages to biomaterials in vitro and whether this response is associated with biomarkers in blood. CD14 + monocytes were isolated from blood from obese and age and gender matched lean persons. Monocyte subsets were determined based on CD14 and CD16 on their surface. C-reactive protein (CRP) was measured in peripheral blood. The response of monocyte-derived macrophages to polypropylene (PP), polylactic acid (PLA), polyethylene terephthalate (PET) monofilament, and PET-multifilament (mPET) in culture was based on cytokine production. More IL-6 (for PET), less CCL18 (all materials) and IL-1ra (for PLA) was produced by macrophages from obese patients than lean subjects. Body mass index, serum CRP and to a lesser extend percentages of monocyte subtypes correlated with IL-6, TNFα, CCL18, and IL-1ra production. Taken together, monocyte-derived macrophages of obese patients respond more pro-inflammatory and less anti-inflammatory to biomaterials than macrophages from lean subjects, depending on the material. These results are a step towards personalized medicine for the development of a model or even a blood test to decide which biomaterial might be suitable for each patient.


Subject(s)
Biocompatible Materials/adverse effects , Macrophages/drug effects , Monocytes/pathology , Obesity/pathology , Adult , Biomarkers/metabolism , C-Reactive Protein/metabolism , Case-Control Studies , Cells, Cultured , Cytokines/metabolism , Female , Foreign-Body Reaction/blood , Humans , Interleukin 1 Receptor Antagonist Protein/metabolism , Interleukin-6/metabolism , Macrophages/metabolism , Male , Middle Aged , Obesity/blood , Polyesters/adverse effects , Polyethylene Terephthalates/adverse effects , Polypropylenes/adverse effects , Tumor Necrosis Factor-alpha/metabolism
15.
Colorectal Dis ; 18(8): 785-92, 2016 Aug.
Article in English | MEDLINE | ID: mdl-26788679

ABSTRACT

AIM: This study used a national registry to compare the outcome after a low Hartmann's procedure (LHP), defined as removal of most of the rectum to leave a short anorectal stump and an end colostomy, and low anterior resection (LA) with or without a diverting ileostomy (DI) in rectal cancer patients all of whom had received preoperative neoadjuvant radiotherapy (RT). METHOD: Patients who underwent LHP or LA with or without DI for rectal cancer after RT between 2009 and 2013 were identified from the Dutch Surgical Colorectal Audit. The postoperative outcome was compared between the three groups and risk of complications, reoperation and mortality were analysed in a multivariable model. RESULTS: The study included 4288 patients were included, of whom 27.8% underwent LHP, 20.2% LA and 52.0% LA with DI. Thirty-day mortality was higher after LHP (3.2% vs 1.3% and 1.3% for LA with or without DI, P < 0.001), but LHP was not an independent predictor of mortality in multivariable analysis. LHP and LA with DI were associated with a lower rate of abdominal infective complications (6.5% and 10.1% vs 16.2%, P < 0.001) and reoperation (7.3% and 8.1% vs 16.5%, P < 0.001). In multivariable analysis, LHP (OR 0.35, 95% CI 0.26-0.47) and LA with DI (OR 0.43, 95% CI 0.33-0.54) were associated with a lower risk of reoperation than LA alone. LHP was associated with a lower risk of any postoperative complication than LA with or without DI (OR 0.81, 95% CI 0.66-0.98). CONCLUSION: LHP and LA with DI were associated with fewer infective complications and reoperations than LA alone. The rate of any complication was less after LHR than LA with or without DI.


Subject(s)
Anastomosis, Surgical/methods , Colon/surgery , Ileostomy/methods , Postoperative Complications/epidemiology , Rectal Neoplasms/surgery , Rectum/surgery , Registries , Abdominal Abscess/epidemiology , Aged , Aged, 80 and over , Anastomotic Leak/epidemiology , Digestive System Surgical Procedures/methods , Female , Hospital Mortality , Humans , Male , Middle Aged , Multivariate Analysis , Neoadjuvant Therapy , Netherlands/epidemiology , Radiotherapy , Rectal Neoplasms/pathology , Reoperation , Retrospective Studies , Surgical Wound Infection/epidemiology , Treatment Outcome
16.
Gut ; 65(12): 1981-1987, 2016 12.
Article in English | MEDLINE | ID: mdl-26306760

ABSTRACT

INTRODUCTION: In pancreatic cancer, preoperative biliary drainage (PBD) increases complications compared with surgery without PBD, demonstrated by a recent randomised controlled trial (RCT). This outcome might be related to the plastic endoprosthesis used. Metal stents may reduce the PBD-related complications risk. METHODS: A prospective multicentre cohort study was performed including patients with obstructive jaundice due to pancreatic cancer, scheduled to undergo PBD before surgery. This cohort was added to the earlier RCT (ISRCTN31939699). The RCT protocol was adhered to, except PBD was performed with a fully covered self-expandable metal stent (FCSEMS). This FCSEMS cohort was compared with the RCT's plastic stent cohort. PBD-related complications were the primary outcome. Three-group comparison of overall complications including early surgery patients was performed. RESULTS: 53 patients underwent PBD with FCSEMS compared with 102 patients treated with plastic stents. Patients' characteristics did not differ. PBD-related complication rates were 24% in the FCSEMS group vs 46% in the plastic stent group (relative risk of plastic stent use 1.9, 95% CI 1.1 to 3.2, p=0.011). Stent-related complications (occlusion and exchange) were 6% vs 31%. Surgical complications did not differ, 40% vs 47%. Overall complication rates for the FCSEMS, plastic stent and early surgery groups were 51% vs 74% vs 39%. CONCLUSIONS: For PBD in pancreatic cancer, FCSEMS yield a better outcome compared with plastic stents. Although early surgery without PBD remains the treatment of choice, FCSEMS should be preferred over plastic stents whenever PBD is indicated. TRIAL REGISTRATION NUMBER: Dutch Trial Registry (NTR3142).


Subject(s)
Drainage , Jaundice, Obstructive/therapy , Metals , Pancreatic Neoplasms/therapy , Plastics , Preoperative Care , Stents , Cholangiopancreatography, Endoscopic Retrograde , Drainage/methods , Humans , Jaundice, Obstructive/etiology , Netherlands , Pancreatic Neoplasms/complications , Pancreatic Neoplasms/pathology , Pancreaticoduodenectomy , Plastics/adverse effects , Prospective Studies , Stents/adverse effects , Treatment Outcome
17.
Eur J Surg Oncol ; 39(10): 1063-70, 2013 Oct.
Article in English | MEDLINE | ID: mdl-23871573

ABSTRACT

INTRODUCTION: In 2009, the nationwide Dutch Surgical Colorectal Audit (DSCA) was initiated by the Association of Surgeons of the Netherlands (ASN) to monitor, evaluate and improve colorectal cancer care. The DSCA is currently widely used as a blueprint for the initiation of other audits, coordinated by the Dutch Institute for Clinical Auditing (DICA). This article illustrates key elements of the DSCA and results of three years of auditing. METHODS: Key elements include: a leading role of the professional association with integration of the audit in the national quality assurance policy; web-based registration by medical specialists; weekly updated online feedback to participants; annual external data verification with other data sources; improvement projects. RESULTS: In two years, all Dutch hospitals participated in the audit. Case-ascertainment was 92% in 2010 and 95% in 2011. External data verification by comparison with the Netherlands Cancer Registry (NCR) showed high concordance of data items. Within three years, guideline compliance for diagnostics, preoperative multidisciplinary meetings and standardised reporting increased; complication-, re-intervention and postoperative mortality rates decreased significantly. DISCUSSION: The success of the DSCA is the result of effective surgical collaboration. The leading role of the ASN in conducting the audit resulted in full participation of all colorectal surgeons in the Netherlands. By integrating the audit into the ASNs' quality assurance policy, it could be used to set national quality standards. Future challenges include reduction of administrative burden; expansion to a multidisciplinary registration; and addition of financial information and patient reported outcomes to the audit data.


Subject(s)
Colorectal Neoplasms/surgery , Colorectal Surgery , Medical Audit/methods , Colorectal Neoplasms/epidemiology , Humans , Netherlands/epidemiology , Postoperative Complications/epidemiology , Quality Assurance, Health Care , Registries
18.
J Gastrointest Surg ; 17(8): 1471-6, 2013 Aug.
Article in English | MEDLINE | ID: mdl-23733362

ABSTRACT

INTRODUCTION: Abscess formation and perforation are complications of acute appendicitis that lead to localized or generalized peritonitis. The long-term implications of complicated appendectomy remain largely unknown. MATERIALS AND METHODS: In the present study, it was investigated whether patients with complicated appendicitis experienced more abdominal complaints after long-term follow-up when compared to uncomplicated cases. In addition, the influence of operation technique (open versus laparoscopic) was studied. A retrospective analysis of 1,481 appendectomies for acute appendicitis was performed in two centers from January 2000 until January 2006. Demographic data, operative reports, intraoperatively adhesions and complications, abdominal pain, and satisfaction were monitored. In total, 1,433 patients were invited to fill out a questionnaire with a median follow-up of 7.1 years. Questionnaires of 526 (37 %) patients were suitable for analysis. RESULTS: Perforation, abdominal abscesses, or adhesions at initial operation did not result in more abdominal complaints when compared to appendectomy for uncomplicated acute appendicitis. Additionally, no significant differences in abdominal complaints were seen between laparoscopic and open techniques. CONCLUSION: In conclusion, the results of our study show that after follow-up of 7 years, the incidence of abdominal complaints was not influenced by operative technique or whether acute appendicitis was complicated or not. This finding does not support a causative role for adhesions with regard to chronic abdominal complaints. Our data enables surgeons to inform their patients about the long-term results of appendectomy, whether it was complicated or not.


Subject(s)
Abdominal Abscess/complications , Abdominal Pain/etiology , Appendectomy/adverse effects , Appendicitis/complications , Peritonitis/complications , Tissue Adhesions/complications , Abdominal Abscess/etiology , Adult , Appendectomy/methods , Appendicitis/surgery , Chronic Pain/etiology , Female , Follow-Up Studies , Humans , Male , Peritonitis/etiology , Retrospective Studies , Surveys and Questionnaires , Time Factors , Tissue Adhesions/etiology
19.
Tech Coloproctol ; 16(5): 363-8, 2012 Oct.
Article in English | MEDLINE | ID: mdl-22752330

ABSTRACT

BACKGROUND: Treatment of perforated diverticulitis depends on disease severity classified according to Hinchey's preoperative classification. This study assessed the accuracy of preoperative staging of perforated diverticulitis by computerized tomography (CT) scanning. METHODS: All patients who presented with perforated diverticulitis between 1999 and 2009 in two teaching hospitals of Rotterdam, the Netherlands, and in addition had a preoperative CT scan within 24 h before emergency surgery were included. Two radiologists reviewed all CT scans and were asked to classify the severity of the disease according to the Hinchey classification. The CT classification was compared to Hinchey's classification at surgery. RESULTS: Seventy-five patients were included, 48 of whom (64 %) were classified Hinchey 3 or 4 perforated diverticulitis during surgery. The positive predictive value of preoperative CT scanning for different stages of perforated diverticulitis ranged from 45 to 89 %, and accuracy was between 71 and 92 %. The combination of a large amount of free intra-abdominal air and fluid was strongly associated with Hinchey 3 or 4 and therefore represented a reliable indicator for required surgical treatment. CONCLUSIONS: The accuracy of predicting Hinchey's classification by preoperative CT scanning is not very high. Nonetheless, free intra-abdominal air in combination with diffuse fluid is a reliable indication for surgery as it is strongly associated with perforated diverticulitis with generalized peritonitis. In 42 % of cases, Hinchey 3 perforated diverticulitis is falsely classified as Hinchey 1 or 2 by CT scanning.


Subject(s)
Diverticulitis, Colonic/diagnostic imaging , Intestinal Perforation/diagnostic imaging , Tomography, X-Ray Computed , Adult , Aged , Aged, 80 and over , Ascitic Fluid/diagnostic imaging , Diverticulitis, Colonic/classification , Diverticulitis, Colonic/surgery , Female , Humans , Intestinal Perforation/classification , Intestinal Perforation/surgery , Male , Middle Aged , Pneumoperitoneum/diagnostic imaging , Pneumoperitoneum/etiology , Predictive Value of Tests , Severity of Illness Index , Young Adult
20.
BMJ Qual Saf ; 21(6): 481-9, 2012 Jun.
Article in English | MEDLINE | ID: mdl-22491528

ABSTRACT

OBJECTIVE: To determine if composite measures based on process indicators are consistent with short-term outcome indicators in surgical colorectal cancer care. DESIGN: Longitudinal analysis of consistency between composite measures based on process indicators and outcome indicators for 85 Dutch hospitals. SETTING: The Dutch Surgical Colorectal Audit database, the Netherlands. PARTICIPANTS: 4732 elective patients with colon carcinoma and 2239 with rectum carcinoma treated in 85 hospitals were included in the analyses. MAIN OUTCOME MEASURES: All available process indicators were aggregated into five different composite measures. The association of the different composite measures with risk-adjusted postoperative mortality and morbidity was analysed at the patient and hospital level. RESULTS: At the patient level, only one of the composite measures was negatively associated with morbidity for rectum carcinoma. At the hospital level, a strong negative association was found between composite measures and hospital mortality and morbidity rates for rectum carcinoma (p<0.05), and hospital morbidity rates for colon carcinoma. CONCLUSIONS: For individual patients, a high score on the composite measures based on process indicators is not associated with better short-term outcome. However, at the hospital level, a good score on the composite measures based on process indicators was consistent with more favourable risk-adjusted short-term outcome rates.


Subject(s)
Colorectal Neoplasms/surgery , Outcome Assessment, Health Care , Quality Assurance, Health Care/methods , Quality Indicators, Health Care , Surgical Procedures, Operative/standards , Databases, Factual , Female , Hospitals, Public , Humans , Longitudinal Studies , Male , Netherlands
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