Improved forearm rotation even after early conversion to below-elbow cast for non-reduced diaphyseal both-bones forearm fractures in children: a secondary 7.5-year follow up of a randomized trial.

BACKGROUND AND PURPOSE: previous RCT compared short-term results of above-elbow cast (AEC) with early conversion to below-elbow cast (BEC) in children with non-reduced diaphyseal both-bone forearm fractures. After 7 months both groups had comparable function. Our primary aim was to investigate whether forearm rotation improves or worsens over time. Secondary aims were loss of flexion and extension of the elbow and wrist, patient-reported outcomes measures, grip strength ratio, and radiographic assessment. PATIENTS AND METHODS: We performed long-term follow-up (FU) of a previous RCT. All patients were invited again for the long-term FU measurements. Primary outcome was limitation of forearm rotation. Secondary outcomes were loss of flexion and extension of the elbow and wrist compared with the contralateral forearm, the ABILHAND-Kids questionnaire and the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, grip strength ratio, and radiographic assessment. RESULTS: The mean FU was 7.5 (4.4-9.6) years. Of the initial 47 children, 38 (81%) participated. Rotation improved in both groups over time, with no significant difference in the final forearm rotation: 8° (SD 22) for the AEC group and 8° (SD 15) for the BEC group with a mean difference of 0° (95% confidence interval -13 to 12). Secondary outcomes showed no statistically significant differences. Finally, children < 9 years almost all have full recovery of function. CONCLUSION: Long-term follow-up showed that loss of forearm rotation after a non-reduced diaphyseal both-bone forearm fracture improved significantly compared with that at 7 months, independent of the initial treatment and children aged < 9 will have almost full recovery of function. This substantiates that the remaining growth behaves like a "friend" at long-term follow-up.

Monocyte response after colorectal surgery: A prospective cohort study.

Background: Tumor resection is the common approach in patients with colorectal malignancy. Profound insight into inflammatory changes that accompany the normal post-operative stress response will establish reference parameters useful for identification of putative complications. Alterations in circulating monocytes might be indicative as these cells are considered to be the most responsive leukocytes to trauma. Therefore, the aim of this study is to assess the monocyte subset kinetic and phenotypic changes in response to surgery. Methods: Fifty patients undergoing colorectal tumor resection were included in a multicenter prospective cohort study. Blood samples were collected early in the morning prior to surgery and the next days through postoperative day three for flowcytometric analysis. Leukocyte subtypes were identified and expression of activation stage-related markers by monocyte subsets was quantified. Results: Changes in leukocyte subset composition and monocyte subset phenotypes were most prominent at the first day postoperatively, after which these parameters typically returned to normal or near-normal preoperative values. The immunophenotypic alterations after surgery were most notable in classical and intermediate monocytes. These included up-regulation of activation markers CD64 and CD62L, but down-regulation of HLA-DR and CD54. Markers of de-activation, CD163 and CD206, were consistently increasingly expressed. Discussion/conclusion: The current study gives detailed insight into the peripheral blood leukocyte response after colorectal cancer surgery. This form of short-term stress induces a rapid and significant redistribution of immune cells. Immunophenotypic alterations in monocytes as a response to surgery suggest a mixed profile of cellular activation and de-activation.

Development of a Connected Sensor System in Colorectal Surgery: User-Centered Design Case Study.

BACKGROUND: A successful innovative medical device is not only technically challenging to develop but must also be readily usable to be integrated into health care professionals' daily practice. Through a user-centered design (UCD) approach, usability can be improved. However, this type of approach is not widely implemented from the early stages of medical device development. OBJECTIVE: The case study presented here shows how UCD may be applied at the very early stage of the design of a disruptive medical device used in a complex hospital environment, while no functional device is available yet. The device under study is a connected sensor system to detect colorectal anastomotic leakage, the most detrimental complication following colorectal surgery, which has a high medical cost. We also aimed to provide usability guidelines for the initial design of other innovative medical devices. METHODS: UCD was implemented by actively involving health care professionals and all the industrial partners of the project. The methodology was conducted in 2 European hospitals: Grenoble-Alpes University Hospital (France) and Erasmus Medical Center Rotterdam (the Netherlands). A total of 6 elective colorectal procedures and 5 ward shifts were observed. In total, 4 workshops were conducted with project partners and clinicians. A formative evaluation was performed based on 5 usability tests using nonfunctional prototype systems. The case study was completed within 12 months. RESULTS: Functional specifications were defined for the various components of the medical device: device weight, size, design, device attachment, and display module. These specifications consider the future integration of the medical device into current clinical practice (for use in an operating room and patient follow-up inside the hospital) and interactions between surgeons, nurses, nurse assistants, and patients. By avoiding irrelevant technical development, this approach helps to promote cost-effective design. CONCLUSIONS: This paper presents the successful deployment over 12 months of a UCD methodology for the design of an innovative medical device during its early development phase. To help in reusing this methodology to design other innovative medical devices, we suggested best practices based on this case.

Laparoscopic peritoneal lavage versus sigmoidectomy for perforated diverticulitis with purulent peritonitis: three-year follow-up of the randomised LOLA trial.

BACKGROUND: This study aimed to compare laparoscopic lavage and sigmoidectomy as treatment for perforated diverticulitis with purulent peritonitis during a 36 month follow-up of the LOLA trial. METHODS: Within the LOLA arm of the international, multicentre LADIES trial, patients with perforated diverticulitis with purulent peritonitis were randomised between laparoscopic lavage and sigmoidectomy. Outcomes were collected up to 36 months. The primary outcome of the present study was cumulative morbidity and mortality. Secondary outcomes included reoperations (including stoma reversals), stoma rates, and sigmoidectomy rates in the lavage group. RESULTS: Long-term follow-up was recorded in 77 of the 88 originally included patients, 39 were randomised to sigmoidectomy (51%) and 38 to laparoscopic lavage (49%). After 36 months, overall cumulative morbidity (sigmoidectomy 28/39 (72%) versus lavage 32/38 (84%), p = 0·272) and mortality (sigmoidectomy 7/39 (18%) versus lavage 6/38 (16%), p = 1·000) did not differ. The number of patients who underwent a reoperation was significantly lower for lavage compared to sigmoidectomy (sigmoidectomy 27/39 (69%) versus lavage 17/38 (45%), p = 0·039). After 36 months, patients alive with stoma in situ was lower in the lavage group (proportion calculated from the Kaplan-Meier life table, sigmoidectomy 17% vs lavage 11%, log-rank p = 0·0268). Eventually, 17 of 38 (45%) patients allocated to lavage underwent sigmoidectomy. CONCLUSION: Long-term outcomes showed that laparoscopic lavage was associated with less patients who underwent reoperations and lower stoma rates in patients alive after 36 months compared to sigmoidectomy. No differences were found in terms of cumulative morbidity or mortality. Patient selection should be improved to reduce risk for short-term complications after which lavage could still be a valuable treatment option.

Hartmann's procedure versus sigmoidectomy with primary anastomosis for perforated diverticulitis with purulent or fecal peritonitis: Three-year follow-up of a randomised controlled trial.

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 long-term stoma free rate, overall hospitalization and parastomal hernias.

Do We Need to Stabilize All Reduced Metaphyseal Both-bone Forearm Fractures in Children with K-wires?

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 follow-up 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 5-year 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? METHODS: We analyzed the extended minimum 5-year follow-up of a randomized controlled trial in which children with a reduced metaphyseal both-bone forearm fracture were randomized to either an above-elbow cast (casting group) or fixation with K-wires and an above-elbow cast (K-wire group). Between January 2006 and December 2010, 128 patients were included in the original randomized controlled trial: 67 in the casting group and 61 in the K-wire group. For the current study, based on an a priori calculation, it was determined that, with an anticipated mean limitation in prosupination (forearm rotation) of 7° ± 7° in the casting group and 3° ± 5° in the K-wire group, a power of 80% and a significance of 0.05, the two groups should consist of 50 patients each. Between January 2014 and May 2016, 82% (105 of 128) of patients were included, with a mean follow-up of 6.8 ± 1.4 years: 54 in the casting group and 51 in the K-wire group. At trauma, patients had a mean age of 9 ± 3 years and had mean angulations of the radius and ulna of 25° ± 14° and 23° ± 18°, respectively. The primary result was limitation in forearm rotation. Secondary outcome measures were radiologic assessment, patient-reported outcome measures (QuickDASH and ABILHAND-kids), handgrip strength, and VAS score for cosmetic appearance. Assessments were performed by the first author (unblinded). Multivariable logistic regression analysis was performed to analyze which factors led to a clinically relevant limitation in forearm rotation. RESULTS: There was a mean limitation in forearm rotation of 5° ± 11° in the casting group and 5° ± 8° in the K-wire group, with a mean difference of 0.3° (95% CI -3° to 4°; p = 0.86). Malunions occurred more often in the casting group than in the K-wire group: 19% (13 of 67) versus 7% (4 of 61) with an odds ratio of 0.22 for K-wiring (95% CI 0.06 to 0.80; p = 0.02). In patients in whom a malunion occurred (malunion group), there was a mean limitation in forearm rotation of 6° ± 16° versus 5° ± 9° in patients who did not have a malunion (acceptable alignment group), with a mean difference 0.8° (95% CI -5° to 7°; p = 0.87). Factors associated with a limited forearm rotation ≥ 20° were a malunion after above-elbow casting (OR 5.2 [95% CI 1.0 to 27]; p = 0.045) and a refracture (OR 7.1 [95% CI 1.4 to 37]; p = 0.02). CONCLUSION: At a minimum of 5 years after injury, in children with a reduced metaphyseal both-bone forearm fracture, there were no differences in forearm rotation, patient-reported outcome measures, or radiographic parameters between patients treated with only an above-elbow cast compared with those treated with additional K-wire fixation. Redisplacements occurred more often if treated by an above-elbow cast alone. If fracture redisplacement is not treated promptly, this leads to a malunion, which is a risk factor for a clinically relevant (≥ 20°) limitation in forearm rotation at minimum 5-year follow-up. Children with metaphyseal both-bone forearm fractures can be treated with closed reduction and casting without additional K-wire fixation. Nevertheless, a clinician should inform parents and patient about the high risk of fracture redisplacement (and therefore malunion), with risk for limited forearm rotation if left untreated. Weekly radiographic monitoring is essential. If redisplacement occurs, remanipulation and fixation with K-wires should be considered based on gender, age, and direction of angulation. Future research is required to establish the influence of (skeletal) age, gender, and the direction of malunion angulation on clinical outcome. LEVEL OF EVIDENCE: Level I, therapeutic study.

Calcification of the Aorta-Iliac Trajectory as a Risk Factor for Anastomotic Leakage in Colorectal Surgery: Individual Patient Data Meta-Analysis and Systematic Review.

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.

Below-elbow cast sufficient for treatment of minimally displaced metaphyseal both-bone fractures of the distal forearm in children: long-term results of a randomized controlled multicenter trial.

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.

Matrix metalloproteinase-9 in relation to patients with complications after colorectal surgery: a systematic review.

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.

Arterial calcification is a risk factor for anastomotic leakage after esophagectomy: A systematic review and meta-analysis.

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 I2-test. RESULTS: From the 456 articles retrieved, seven studies were selected including 1.860 patients. The median (range) of anastomotic leakage was 17.2% (12.7-24.8). Meta-analysis showed a statistically significant association between increased calcium score and anastomotic leakage for the thoracic aorta (OR 2.18(CI 1.42-3.34)), celiac axis (OR 1.62(CI 1.15-2.29)) and right post-celiac axis (common hepatic, gastroduodenal and right gastroepiploic arteries) (OR 2.69(CI 1.27-5.72)). Heterogeneity was observed for analysis on calcification of the thoracic aorta and celiac axis (I2 = 71% and 59%, respectively) but not for the right branches of the celiac axis (I2 = 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.

Sigmoid resection with primary anastomosis versus the Hartmann's procedure for perforated diverticulitis with purulent or fecal peritonitis: a systematic review and meta-analysis.

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, PA was 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.