Chimney Trial : study protocol for a randomized controlled trial

Background Parastomal hernias (PSHs) are common, troubling the lives of people with permanent colostomy. In previous studies, retromuscular keyhole mesh placement has been the most-used technique for PSH prevention but results have been controversial. Additionally, surgical treatment of PSHs is associated with a high rate of complications and recurrences. Therefore, it is crucial to find the most effective way to prevent PSHs in the first place without an increased risk of complications. Due to a lack of adequate research, there is no clear evidence or recommendations on which mesh or technique is best to prevent PSHs. Methods/design The Chimney Trial is a Nordic, prospective, randomized controlled, multicenter trial designed to compare the feasibility and the potential benefits of specifically designed, intra-abdominal onlay mesh (DynaMesh (R)-Parastomal, FEG Textiltechnik GmbH, Aachen, Germany) against controls with permanent colostomy without mesh. The primary outcome of the Chimney Trial is the incidence of a PSH detected by a computerized tomography (CT) scan at 12-month follow-up. Secondary outcomes are the rate of clinically detected PSHs, surgical-site infection as defined by the Centers for Disease Control and Prevention (CDC), complications as defined by the Clavien-Dindo classification, the reoperation rate, operative time, length of stay, quality of life as measured by the RAND-36 survey and colostomy impact score, and both direct and indirect costs. For each group, 102 patients were enrolled at attending hospitals and randomized at a ratio of 1:1 by browser-based software to receive a preventive mesh or a conventional colostomy without a mesh. Patients will be followed for 1 month and at 1, 3, and 5 years after the operation for long-term results and complications. Discussion The Chimney Trial aims to provide level-I evidence on PSH prevention.Peer reviewe

Surgical site infection after gastrointestinal surgery in high-income, middle-income, and low-income countries: a prospective, international, multicentre cohort study

Background: Surgical site infection (SSI) is one of the most common infections associated with health care, but its importance as a global health priority is not fully understood. We quantified the burden of SSI after gastrointestinal surgery in countries in all parts of the world. Methods: This international, prospective, multicentre cohort study included consecutive patients undergoing elective or emergency gastrointestinal resection within 2-week time periods at any health-care facility in any country. Countries with participating centres were stratified into high-income, middle-income, and low-income groups according to the UN's Human Development Index (HDI). Data variables from the GlobalSurg 1 study and other studies that have been found to affect the likelihood of SSI were entered into risk adjustment models. The primary outcome measure was the 30-day SSI incidence (defined by US Centers for Disease Control and Prevention criteria for superficial and deep incisional SSI). Relationships with explanatory variables were examined using Bayesian multilevel logistic regression models. This trial is registered with ClinicalTrials.gov, number NCT02662231. Findings: Between Jan 4, 2016, and July 31, 2016, 13 265 records were submitted for analysis. 12 539 patients from 343 hospitals in 66 countries were included. 7339 (58·5%) patient were from high-HDI countries (193 hospitals in 30 countries), 3918 (31·2%) patients were from middle-HDI countries (82 hospitals in 18 countries), and 1282 (10·2%) patients were from low-HDI countries (68 hospitals in 18 countries). In total, 1538 (12·3%) patients had SSI within 30 days of surgery. The incidence of SSI varied between countries with high (691 [9·4%] of 7339 patients), middle (549 [14·0%] of 3918 patients), and low (298 [23·2%] of 1282) HDI (p < 0·001). The highest SSI incidence in each HDI group was after dirty surgery (102 [17·8%] of 574 patients in high-HDI countries; 74 [31·4%] of 236 patients in middle-HDI countries; 72 [39·8%] of 181 patients in low-HDI countries). Following risk factor adjustment, patients in low-HDI countries were at greatest risk of SSI (adjusted odds ratio 1·60, 95% credible interval 1·05–2·37; p=0·030). 132 (21·6%) of 610 patients with an SSI and a microbiology culture result had an infection that was resistant to the prophylactic antibiotic used. Resistant infections were detected in 49 (16·6%) of 295 patients in high-HDI countries, in 37 (19·8%) of 187 patients in middle-HDI countries, and in 46 (35·9%) of 128 patients in low-HDI countries (p < 0·001). Interpretation: Countries with a low HDI carry a disproportionately greater burden of SSI than countries with a middle or high HDI and might have higher rates of antibiotic resistance. In view of WHO recommendations on SSI prevention that highlight the absence of high-quality interventional research, urgent, pragmatic, randomised trials based in LMICs are needed to assess measures aiming to reduce this preventable complication

Low risk of complications in patients with first-time acute uncomplicated diverticulitis

First-time acute uncomplicated diverticulitis (AUD) has been considered to have an increased risk of complication, but the level of evidence is low. The aim of the present study was to evaluate the risk of complications in patients with first-time AUD and in patients with a history of diverticulitis. This paper is a population-based retrospective study at Vastmanland's Hospital, VasterA&lt;yen&gt;s, Sweden, where all patients were identified with a diagnosis of colonic diverticular disease ICD-10 K57.0-9 from January 2010 to December 2014. The records of all patients were surveyed and patients with a computed tomography (CT)-verified AUD were included. Complications defined as CT-verified abscess, perforation, colonic obstruction, fistula, or sepsis within 1 month from the diagnosis of AUD were registered. Of 809 patients with AUD, 642 (79%) had first-time AUD and 167 (21%) had a previous history of AUD with no differences in demographic or clinical characteristics. In total, 16 (2%) patients developed a complication within 1 month irrespective of whether they had a previous history of diverticulitis (P = 0.345). In the binary logistic regression analysis, first-time diverticulitis was not associated with increased risk of complications (OR 1.58; CI 0.52-4.81). The rate of antibiotic therapy was about 7-10% during the time period and outpatient management increased from 7% in 2010 to 61% in 2014. The risk for development of complications is low in AUD with no difference between patients with first-time or recurrent diverticulitis. This result strengthens existing evidence on the benign disease course of AUD

Hartmann’s procedure in rectal cancer: a population-based study of postoperative complications

Hartmann's procedure for rectal cancer patients is increasingly performed but few studies have reported the postoperative outcome. The purpose was to report postoperative complications and analyse risk factors in rectal cancer patients operated with Hartmann's procedure. To describe the selection and postoperative complication patterns, all bowel-resected rectal cancer patients were included. Population-based data were from the county of Vastmanland, Sweden. All rectal cancer patients operated with an elective bowel resection between 1996 and 2012 were included. Demographics and postoperative complications were prospectively registered and data retrospectively analysed. Of the 624 patients included, 396 (64 %) were operated with an anterior resection, 159 (25 %) with an abdominoperineal excision and 69 (11 %) a Hartmann's procedure of which 90 % were low Hartmann's. Patients operated with a Hartmann's procedure were significantly older, had higher ASA-score, poorer WHO performance score and lower serum albumin levels. Operative time for Hartmann's procedure was a median of 49 and 99 min shorter than after anterior resection and abdominoperineal excision, respectively, and entailed less bleeding. Complications related to the pelvic and perineal dissections were more common after abdominoperineal excision compared with anterior resection and Hartmann's procedure (32 vs. 9 and 13 %, p &lt; 0.001). Few rectal cancer patients, operated with Hartmann's procedure, developed pelvic complications despite a higher age, more co-morbidities, metastases in different localities and functional inferiority when compared with the patients operated with anterior resection or abdominoperineal excision. Hartmann's procedure is a valid alternative procedure in the old and frail rectal cancer patient.</p

Risk factors for small bowel obstruction after open rectal cancer resection

Abstract Background Small bowel obstruction (SBO) is observed in around 10% of patients with prior open abdominal surgery. Rectal resection causes the highest readmission rates. The aim of this study was to investigate risk factors for readmission for SBO and causes for SBO in patients who needed surgery following rectal cancer surgery. Methods A population-based registry with prospectively gathered data on 752 consecutive patients with rectal cancer who underwent open pelvic surgery between January 1996 and January 2017 was used. Univariable and multivariable regression analysis was performed, and the risk of SBO was assessed. Results In total, 84 patients (11%) developed SBO after a median follow-up time of 48 months. Of these patients, 57% developed SBO during the 1st year after rectal cancer surgery. Surgery for SBO was performed in 32 patients (4.3%), and the cause of SBO was stoma-related in one-fourth of these patients. In the univariable analysis previous RT and re-laparotomy were found as risk factors for readmission for SBO. Re-laparotomy was an independent risk factor for readmission for SBO (OR 2.824, CI 1.129–7.065, P = 0.026) in the multivariable analysis, but not for surgery for SBO. Rectal resection without anastomoses, splenic flexors mobilization, intraoperative bleeding, operative time were not found as risk factors for SBO. Conclusions One-tenth of rectal cancer patients who had open surgery developed SBO, most commonly within the 1st postoperative year. The risk of SBO is greatest in patients with complications after rectal cancer resection that result in a re-laparotomy. </jats:sec

Increased accuracy in diagnosing diverticulitis using predictive clinical factors

Background: The aim of this study was to identify clinical factors leading to increased diagnostic accuracy for acute colonic diverticulitis. Methods: Patients with clinical suspicion of acute colonic diverticulitis verified with computed tomography (CT) from two hospitals in Sweden between 9 January 2017 and 31 October 2017 were prospectively included. Symptoms, comorbidities, and laboratory results were documented. Candidate variables were analyzed using logistic regression, and the final variable set that yielded the most accurate predictions was identified using least absolute shrinkage and selection operator regression and evaluated using the area under the receiver operating characteristic (ROC) curve. Results: In total, 146 patients were included (73% women; median age 68 years; age range, 50-94 years). The clinical diagnostic accuracy was 70.5%. In the multiple logistic regression analysis, gender (female vs male odds ratio [OR]: 4.82; confidence interval [CI], 1.56-14.91), age (OR, 0.92; 95% CI, 0.87-0.98), pain on the lower left side of the abdomen (OR, 15.14; 95% CI, 2.65-86.58), and absence of vomiting (OR, 14.02; 95% CI, 2.90-67.88) were statistically significant and associated with the diagnosis of CT-verified diverticulitis. With seven predictors (age, gender, urinary symptoms, nausea, temperature, C-reactive protein, and pain left lower side), the area under the ROC curve was 0.82, and a formula was developed for calculating a risk score. Conclusion: We present a scoring system using common clinical variables that can be applied to patients with clinical suspicion of colonic diverticulitis to increase the diagnostic accuracy. The developed scoring system is available for free of charge at https://phille-wagner.shinyapps.io/Diverticulitis_risk_model/

A Deep Neural Network-Based Decision Support Tool for the Detection of Lymph Node Metastases in Colorectal Cancer Specimens

The identification of lymph node metastases in colorectal cancer (CRC) specimens is crucial for the planning of postoperative treatment and can be a time-consuming task for pathologists. In this study, we developed a deep neural network (DNN) algorithm for the detection of metastatic CRC in digitized histologic sections of lymph nodes and evaluated its performance as a diagnostic support tool. First, the DNN algorithm was trained using pixel-level annotations of cancerous areas on 758 whole slide images (360 with cancerous areas). The algorithm's performance was evaluated on 74 whole slide images (43 with cancerous areas). Second, the algorithm was evaluated as a decision support tool on 288 whole slide images covering 1517 lymph node sections, randomized in 16 batches. Two senior pathologists (C.K. and C.O.) assessed each batch with and without the help of the algorithm in a 2 x 2 crossover design, with a washout period of 1 month in between. The time needed for the evaluation of each node section was recorded. The DNN algorithm achieved a median pixel-level accuracy of 0.952 on slides with cancerous areas and 0.996 on slides with benign samples. N+ disease (metastases, micrometastases, or tumor deposits) was present in 103 of the 1517 sections. The algorithm highlighted cancerous areas in 102 of these sections, with a sensitivity of 0.990. Assisted by the algorithm, the median time needed for evaluation was significantly shortened for both pathologists (median time for pathologist 1, 26 vs 14 seconds; P &lt; .001; 95% CI, 11.0-12.0; median time for pathologist 2, 25 vs 23 seconds; P &lt; .001; 95% CI, 2.0-4.0). Our DNN showed high accuracy for detecting metastatic CRC in digitized histologic sections of lymph nodes. This decision support tool has the potential to improve the diagnostic workflow by shortening the time needed for the evaluation of lymph nodes in CRC specimens without impairing diagnostic accuracy.</p