Purpose The optimal surgical approach for perforated diverticulitis with purulent or fecal peritonitis (Hinchey grade III or IV) remains debated. In recent years, accumulating evidence comparing sigmoid resection with primary anastomosis (PA) with the Hartmann's procedure (HP) was presented. Therefore, the aim was to provide an updated and extensive synthesis of the available evidence. Methods A systematic search in Embase, MEDLINE, Cochrane, and Web of Science databases was performed. Studies comparing PA to HP for adult patients with Hinchey III or IV diverticulitis were included. Data on mortality, morbidity, stoma reversal, and patient-reported and cost-related outcomes were extracted. Random effects models were used to pool data and estimate odds ratios (ORs). Results From a total of 1560 articles, four randomized controlled trials and ten observational studies were identified, reporting on 1066 Hinchey III/IV patients. Based on trial outcomes, PAwas found to be favorable over HP in terms of stoma reversal rates (OR 2.62, 95% CI 1.29, 5.31) and reversal-related morbidity (OR 0.33, 95% CI 0.16, 0.69). No differences in mortality (OR 0.83, 95% CI 0.32, 2.19), morbidity (OR 0.99, 95% CI 0.65, 1.51), and reintervention rates (OR 0.90, 95% CI 0.39, 2.11) after the index procedure were demonstrated. Data on patient-reported and cost-related outcomes were scarce, as well as outcomes in PA patients with or without ileostomy construction and Hinchey IV patients. Conclusion Although between-study heterogeneity needs to be taken into account, the present results indicate that primary anastomosis seems to be the preferred option over Hartmann's procedure in selected patients with Hinchey III or IV diverticulitis.
Purpose Anastomotic leakage (AL) is the most severe complication following colorectal resection and is associated with increased mortality. The main group of enzymes responsible for collagen and protein degradation in the extracellular matrix is matrix metalloproteinases. The literature is conflicting regarding anastomotic leakage and the degradation of extracellular collagen by matrix metalloproteinase-9 (MMP-9). In this systematic review, the possible correlation between anastomotic leakage after colorectal surgery and MMP-9 activity is investigated. Methods Embase, MEDLINE, Cochrane, and Web of Science databases were searched up to 3 February 2020. All published articles that reported on the relationship between MMP-9 and anastomotic leakage were selected. Both human and animal studies were found eligible. The correlation between MMP-9 expression and anastomotic leakage after colorectal surgery. Results Seven human studies and five animal studies were included for analysis. The human studies were subdivided into those assessing MMP-9 in peritoneal drain fluid, intestinal biopsies, and blood samples. Five out of seven human studies reported elevated levels of MMP-9 in patients with anastomotic leakage on different postoperative moments. The animal studies demonstrated that MMP-9 activity was highest in the direct vicinity of an anastomosis. Moreover, MMP-9 activity was significantly reduced in areas further proximally and distally from the anastomosis and was nearly or completely absent in uninjured tissue. Conclusion Current literature shows some relation between MMP-9 activity and colorectal AL, but the evidence is inconsistent. Innovative techniques should further investigate the value of MMP-9 as a clinical biomarker for early detection, prevention, or treatment of AL.
Background: Leakage of the esophago-gastrostomy after esophagectomy with gastric tube reconstruction is a serious complication. Anastomotic leakage occurs in up to 20% of patients and a compromised perfusion of the gastric tube is thought to play an important role. This meta-analysis aimed to investigate whether arterial calcification is a risk factor for anastomotic leakage in esophageal surgery. Method: Embase, Medline, PubMed, Cochrane databases and Google scholar databases were systematically searched for studies that assessed arterial calcification of the thoracic aorta, celiac axis including its branches, or the superior mesenteric artery in patients that underwent esophagectomy with gastric tube reconstruction. The degree of calcification was classified as absent, minor or major. A "random-effects model" was used to calculate pooled Odds Ratios (OR) and 95% confidence intervals (CI). Heterogeneity was assessed using the Q-test and I 2-test. Results: From the 456 articles retrieved, seven studies were selected including 1.860 patients. The median (range) of anastomotic leakage was 17.2% (12.7e24.8). Meta-analysis showed a statistically significant association between increased calcium score and anastomotic leakage for the thoracic aorta (OR 2.18(CI 1.42e3.34)), celiac axis (OR 1.62(CI 1.15e2.29)) and right post-celiac axis (common hepatic, gastroduodenal and right gastroepiploic arteries) (OR 2.69(CI 1.27e5.72)). Heterogeneity was observed for analysis on calcification of the thoracic aorta and celiac axis (I 2 ¼ 71% and 59%, respectively) but not for the right branches of the celiac axis (I 2 ¼ 0%). Conclusion: This meta-analysis, including good quality studies, showed a statistically significant association between arterial calcification and anastomotic leakage in patients who underwent esophagectomy with gastric tube reconstruction.
Background:The aim of the present study is to present the three years follow-up a randomised controlled trial that compared Hartmann's Procedure (HP) with sigmoidectomy with primary anastomosis (with or without defunctioning ileostomy) (PA) in a randomised design to determine the optimal treatment strategy for perforated diverticulitis with purulent or fecal peritonitis. Methods: Data were prospectively gathered for the first 12 months after randomization and retrospectively collected up to 36 months. The primary long-term endpoint was stoma free rate 36 months after the index procedure. Secondary outcomes were patients with a stoma at 36 months, percentage of stoma reversals, related reinterventions, parastomal/incisional hernia rates, total in hospital days including all readmissions regardless their relation to the intervention, overall morbidity and mortality. Results: Three years follow-up was completed in 119 of the originally 130 included patients, with 57 (48%) in the PA-group and 62 (52%) patients in the HP-group. 36 months stoma free rate was significantly better for patients undergoing PA compared with HP (PA 92% vs HP 81%, hazard ratio 2.326 [95% CI 1.538-3.517]; log-rank p < 0⋅0001). Stoma reversal rates did not significantly differ (PA 31/40(78%) versus HP 45/61(74%), p = 0.814). Overall cumulative morbidity (PA 21/57(36%) versus HP 30/62(48%), p = 0.266) and mortality (PA 6/57(11%) versus HP 7/62 (11%), p = 1.000) did not differ between groups. However, more parastomal hernias occurred in the HP-group (HP 10/62(16%) vs PA 1/57(2%), p = 0.009) and the mean total in hospital days after three years follow-up was significantly lower in the PA-group compared to the HP-group (PA 14 days (IQR 9.5-22.5) versus HP 17 days (IQR 12.5-27.5)), p = 0.025). Conclusion: Long-term results showed that in haemodynamically stable, immunocompetent patients primary anastomosis is superior to Hartmann's procedure as treatment for perforated diverticulitis with respect to longterm stoma free rate, overall hospitalization and parastomal hernias.
Background and purpose — We have previously shown that children with minimally displaced metaphyseal both-bone forearm fractures, who were treated with a below-elbow cast (BEC) instead of an above-elbow cast (AEC), experienced more comfort, less interference in daily activities, and similar functional outcomes at 7 months’ follow-up (FU). This study evaluates outcomes at 7 years’ follow-up. Patients and methods — A secondary analysis was performed of the 7 years’ follow-up data from our RCT. Primary outcome was loss of forearm rotation compared with the contralateral forearm. Secondary outcomes were patient-reported outcome measures (PROMs) consisting of the ABILHAND-kids and the DASH questionnaire, grip strength, radiological assessment, and cosmetic appearance. Results — The mean length of FU was 7.3 years (5.9–8.7). Of the initial 66 children who were included in the RCT, 51 children were evaluated at long-term FU. Loss of forearm rotation and secondary outcomes were similar in the 2 treatment groups. Interpretation — We suggest that children with minimally displaced metaphyseal both-bone forearm fractures should be treated with a below-elbow cast.
Background Short-term follow-up studies have shown that reduced metaphyseal both-bone forearm fractures in children should be treated with K-wires to prevent redisplacement and inferior functional results. Minimum 5-year follow-up studies are limited. Range of motion, patient-reported outcome measures, and radiographic parameters at minimum 5-year followup should be evaluated because they could change insights into how to treat pediatric metaphyseal forearm fractures.Questions/purposes (1) Does K-wire stabilization of reduced metaphyseal both-bone forearm fractures in children provide better forearm rotation at minimum 5year follow-up? (2) Do malunions (untreated redisplaced fractures) of reduced metaphyseal both-bone forearm fractures in children induce worse functional results? (3) Which factors lead to limited forearm rotation at minimum 5-year follow-up?Each author certifies that there are no funding or commercial associations (consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article related to the author or any immediate family members. All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request. Clinical Orthopaedics and Related Research® neither advocates nor endorses the use of any treatment, drug, or device. Readers are encouraged to always seek additional information, including FDA approval status, of any drug or device before clinical use. Ethical approval for this study was obtained from METC Zuidwest Holland (number 41839.098.12).
BACKGROUND A successful innovative medical device is not only technically challenging to develop, but must also be readily usable for it to be integrated into healthcare professionals’ practice. Usability is studied and enhanced via a user-centred approach, the advantages of which have been demonstrated. However, this type of approach is not widely implemented from the early stages of medical device development. OBJECTIVE This case study presents a user-centred approach applied to the design of a connected sensor system to detect Colorectal Anastomotic Leakage (CAL) at an early stage. CAL is the most detrimental complication following colorectal surgery. METHODS User-Centred Design (UCD) was implemented by actively involving healthcare professionals and all the industrial partners of the project. The methodology was conducted in two European hospitals: Grenoble University Hospital (France) and Erasmus Medical Centre Rotterdam (the Netherlands). Six elective colorectal procedures and five ward shifts were observed. Four workshops were run with project partners. Formative evaluation was carried out based on five usability tests with non-functional prototypes. The case study was completed within 12 months. RESULTS Functional specifications were defined for the various components of the medical device. These specifications take into account the future integration of the medical device in current practice, as well as interactions between surgeons, nurses, nurse assistants, and patients. CONCLUSIONS The UCD methodology was relevant in the early stages of development of this innovative medical device. The results improved the functional specifications of the device by considering the context of use. The implementation of the methodology in a hospital environment is discussed, as is the utility of presenting future users with a non-functional device. By avoiding irrelevant technical development, this approach helps promote cost-effective design.
Objective: The purpose of this review is to evaluate the relevance of vascular calcification as a potential risk factor for anastomotic leakage in colorectal surgery. Method: The Embase, Medline, PubMed, and Cochrane databases and Google Scholar were systematically searched. Studies that assessed calcification of the aorta-iliac trajectory in patients who underwent colorectal surgery were included. An independent patient data meta-analysis was performed as follows: based on the heterogeneity of the study population, a “random-effects model” or “fixed-effects model” was used to perform a multivariable logistic regression and calculate pooled Odds Ratios (OR) and 95% confidence intervals (CI). Heterogeneity was assessed using the Q-test and I2-test. Results: From a total of 457 articles retrieved, eight fell within the scope of the review, with a total of 2010 patients. Anastomotic leakage was found at a mean rate of 11.1% (SD 4.9%). In these eight studies, four different calcification scoring methods were used, which made a single structured meta-analysis not feasible. Therefore, an independent patient data meta-analysis on the most frequently used calcification scoring method was performed, including three studies with a total of 396 patients. After multivariable analyses, no significant association was found between anastomotic leakage and the amount of calcification in the aorta-iliac trajectory. The remaining three scoring methods were evaluated. In four of the five studies, vascular calcification was associated with anastomotic leakage after colorectal surgery. Conclusion: In contrast to previous studies, an individual patient data meta-analysis found no association between calcification and anastomotic leakage in colorectal surgery after multivariable analysis that considered a single calcification measurement method. In addition, this study demonstrated several scoring methods for arterial calcification and the need for a standardized technique. Therefore, the authors would recommend prospective studies using a calcification scoring method that includes grade of stenosis due to its potential to preoperatively improve perfusion by endovascular treatment.
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