Determining the value of the abdominal core health quality collaborative to support regulatory decisions.

PURPOSE: The study objective is to document value created by real-world evidence from the Abdominal Core Health Quality Collaborative (ACHQC) for regulatory decisions. The ACHQC is a national effort that generates data on hernia repair techniques and devices. METHODS: Two retrospective cohort evaluations compared cost and time of ACHQC analyses to traditional postmarket studies. The first analysis was based on 25 reports submitted to the European Medicines Agency of 20 mesh products for post-market surveillance. A second analysis supported label expansion submitted to the Food and Drug Administration, Center for Devices and Radiological Health for a robotic-assisted surgery device to include ventral hernia repair. Estimated costs of counterfactual studies, defined as studies that might have been done if the registry had not been available, were derived from a model described in the literature. Return on investment, percentage of cost savings, and time savings were calculated. RESULTS: 45,010 patients contributed to the two analyses. The cost and time differences between individual 25 ACHQC analyses (41,112 patients) and traditional studies ranged from $1.3 to $2.2 million and from 3 to 4.8 years, both favoring use of the ACHQC. In the second label expansion analysis (3,898 patients), the estimated return on investment ranged from 11 to 461% with time savings of 5.1 years favoring use of the ACHQC. CONCLUSIONS: Compared to traditional postmarket studies, use of ACHQC data can result in cost and time savings when used for appropriate regulatory decisions in light of key assumptions.

Treatment of patients with screen-detected colorectal cancer is less strenuous: a nationwide cohort study with long-term follow-up.

OBJECTIVE: During the last two decades, organised colorectal cancer (CRC) screening has been widely implemented. It remains to be established if screen-detected CRC (SD-CRC) is associated with reduced long-term requirements for treatment as compared with patients with non-screen-detected CRC (NSD-CRC). STUDY DESIGN AND METHODS: This nationwide cohort study evaluated differences in treatment and healthcare contacts from the date of diagnosis to two years after comparing patients with SD-CRC and NSD-CRC. Data were collected from national healthcare registers, including patients aged 50-75 years and diagnosed with CRC between January 1st 2014 and March 31st 2018. Analyses were stratified into UICC stages and adjusted for sex, 5-year age groups, type of cancer (colonic/rectal), and Charlson comorbidity index score to address healthy user bias. RESULTS: In total, 12,040 patients were included, 4708 with SD-CRC and 7332 with NSD-CRC. In patients with SD-CRC, the duration of hospitalisation and rate of emergency surgery were reduced by 38 % (relative risk [RR] = 0.62) and 66 % (RR = 0.34), respectively. Moreover, this group was characterised by a 75 % reduction in oncological outpatient visits (RR = 0.35) and a reduced number of treatments with chemotherapy (RR = 0.57) and radiotherapy (RR = 0.50). There were no significant differences between the two populations in the rates of metastasectomy and the number of contacts with primary healthcare providers. CONCLUSION: Compared to patients with NSD-CRC, patients with SD-CRC experience less hospitalisation and treatment within the first two years after diagnosis.

Five-Year Follow-Up of a Slowly Resorbable Biosynthetic P4HB Mesh (Phasix) in VHWG Grade 3 Incisional Hernia Repair.

Objective: To assess the 5-year recurrence rate of incisional hernia repair in Ventral Hernia Working Group (VHWG) 3 hernia with a slowly resorbable mesh. Summary Background Data: Incisional hernia recurs frequently after initial repair. In potentially contaminated hernia, recurrences rise to 40%. Recently, the biosynthetic Phasix mesh has been developed that is resorbed in 12-18 months. Resorbable meshes might be a solution for incisional hernia repair to decrease short- and long-term (mesh) complications. However, long-term outcomes after resorption are scarce. Methods: Patients with VHWG grade 3 incisional midline hernia, who participated in the Phasix trial (Clinilcaltrials.gov: NCT02720042) were included by means of physical examination and computed tomography (CT). Primary outcome was hernia recurrence; secondary outcomes comprised of long-term mesh complications, reoperations, and abdominal wall pain [visual analogue score (VAS): 0-10]. Results: In total, 61/84 (72.6%) patients were seen. Median follow-up time was 60.0 [interquartile range (IQR): 55-64] months. CT scan was made in 39 patients (68.4%). A recurrence rate of 15.9% (95% confidence interval: 6.9-24.8) was calculated after 5 years. Four new recurrences (6.6%) were found between 2 and 5 years. Two were asymptomatic. In total, 13/84 recurrences were found. No long-term mesh complications and/or interventions occurred. VAS scores were 0 (IQR: 0-2). Conclusions: Hernia repair with Phasix mesh in high-risk patients (VHWG 3, body mass index >28) demonstrated a recurrence rate of 15.9%, low pain scores, no mesh-related complications or reoperations for chronic pain between the 2- and 5-year follow-up. Four new recurrences occurred, 2 were asymptomatic. The poly-4-hydroxybutyrate mesh is a safe mesh for hernia repair in VHWG 3 patients, which avoids long-term mesh complications like pain and mesh infection.

Towards optimal use of antithrombotic therapy of people with cancer at the end of life: A research protocol for the development and implementation of the SERENITY shared decision support tool.

BACKGROUND: Even though antithrombotic therapy has probably little or even negative effects on the well-being of people with cancer during their last year of life, deprescribing antithrombotic therapy at the end of life is rare in practice. It is often continued until death, possibly resulting in excess bleeding, an increased disease burden and higher healthcare costs. METHODS: The SERENITY consortium comprises researchers and clinicians from eight European countries with specialties in different clinical fields, epidemiology and psychology. SERENITY will use a comprehensive approach combining a realist review, flash mob research, epidemiological studies, and qualitative interviews. The results of these studies will be used in a Delphi process to reach a consensus on the optimal design of the shared decision support tool. Next, the shared decision support tool will be tested in a randomised controlled trial. A targeted implementation and dissemination plan will be developed to enable the use of the SERENITY tool across Europe, as well as its incorporation in clinical guidelines and policies. The entire project is funded by Horizon Europe. RESULTS: SERENITY will develop an information-driven shared decision support tool that will facilitate treatment decisions regarding the appropriate use of antithrombotic therapy in people with cancer at the end of life. CONCLUSIONS: We aim to develop an intervention that guides the appropriate use of antithrombotic therapy, prevents bleeding complications, and saves healthcare costs. Hopefully, usage of the tool leads to enhanced empowerment and improved quality of life and treatment satisfaction of people with advanced cancer and their care givers.

Appetite stimulation with cannabis-based medicine and methods for assessment of glomerular filtration in older patients with medical illness: A study protocol.

BACKGROUND AND AIM: Malnutrition in older patients is linked to poor appetite. Cannabis-based medicine may have orexigenic properties in older patients, but this has to our knowledge never been investigated. In older patients, uncertainty applies to the accuracy of estimated glomerular filtration rate (eGFR) based on creatinine, which is crucial for medication prescribing. In older patients with poor appetite, the study aims (1) to assess the efficacy of Sativex® (8.1-mg delta-9-tetrahydrocannabinol [THC] and 7.5-mg cannabidiol [CBD]) to stimulate appetite and (2) to compare the performance of various GFR-estimates and measured-GFR (mGFR) for determining gentamicin clearance utilizing population pharmacokinetic (popPK) modelling methods. METHODS AND OBJECTIVES: This study is composed of two substudies. Substudy 1 is an investigator-initiated single-center, double-blinded, randomized, placebo-controlled, superiority, cross-over study. Substudy 1 will recruit 17 older patients with poor appetite, who will also be invited to substudy 2. Substudy 2 is a single-dose pharmacokinetics study and will recruit 55 patients. Participants will receive Sativex® and placebo in substudy 1 and gentamicin with simultaneous measurements of GFR in substudy 2. The primary endpoints are as follows: Substudy 1-the difference in energy intake between Sativex® and placebo conditions; substudy 2- the accuracy of different eGFR equations compared to mGFR. The secondary endpoints include safety parameters, changes in the appetite hormones, total ghrelin and GLP-1 and subjective appetite sensations, and the creation of popPK models of THC, CBD, and gentamicin.

Scandcleft randomized trials of primary surgery for unilateral cleft lip and palate: Speech proficiency at 10 years of age.

BACKGROUND & AIM: To assess consonant proficiency and velopharyngeal function in 10-year-old children born with unilateral cleft lip and palate (UCLP) within the Scandcleft project. METHODS & PROCEDURES: Three parallel group, randomized, clinical trials were undertaken as an international multicentre study by nine cleft teams in five countries. Three different surgical protocols for primary palate repair (Arm B-Lip and soft palate closure at 3-4 months, hard palate closure at 36 months, Arm C-Lip closure at 3-4 months, hard and soft palate closure at 12 months, and Arm D-Lip closure at 3-4 months combined with a single-layer closure of the hard palate using a vomer flap, soft palate closure at 12 months) were tested against a common procedure (Arm A-Lip and soft palate closure at 3-4 months followed by hard palate closure at 12 months) in the total cohort of 431 children born with a non-syndromic UCLP. Speech audio and video recordings of 399 children were available and perceptually analysed. Percentage of consonants correct (PCC) from a naming test, an overall rating of velopharyngeal competence (VPC) (VPC-Rate), and a composite measure (VPC-Sum) were reported. OUTCOMES & RESULTS: The mean levels of consonant proficiency (PCC score) in the trial arms were 86-92% and between 58% and 83% of the children had VPC (VPC-Sum). Only 50-73% of the participants had a consonant proficiency level with their peers. Girls performed better throughout. Long delay of the hard palate repair (Arm B) indicated lower PCC and simultaneous hard and soft palate closure higher (Arm C). However, the proportion of participants with primary VPC (not including velopharyngeal surgeries) was highest in Arm B (68%) and lowest in Arm C (47%). CONCLUSIONS & IMPLICATIONS: The speech outcome in terms of PCC and VPC was low across the trials. The different protocols had their pros and cons and there is no obvious evidence to recommend any of the protocols as superior. Aspects other than primary surgical method, such as time after velopharyngeal surgery, surgical experience, hearing level, language difficulties and speech therapy, need to be thoroughly reviewed for a better understanding of what has affected speech outcome at 10 years. WHAT THIS PAPER ADDS: What is already known on the subject Speech outcomes at 10 years of age in children treated for UCLP are sparse and contradictory. Previous studies have examined speech outcomes and the relationship with surgical intervention in 5-year-olds. What this study adds to the existing knowledge Speech outcomes based on standardized assessment in a large group of 10-year-old children born with UCLP and surgically treated according to different protocols are presented. While speech therapy had been provided, a large proportion of the children across treatment protocols still needed further speech therapy. What are the potential or actual clinical implications of this work? Aspects other than surgery and speech function might add to the understanding of what affects speech outcome. Effective speech therapy should be available for children in addition to primary surgical repair of the cleft and secondary surgeries if needed.

Reducing Shoulder Complaints in Employees with High Occupational Shoulder Exposures: A Cluster-Randomised Controlled Study (The Shoulder-Café Study).

PURPOSE: To evaluate if a group-based Shoulder-Café intervention could reduce shoulder complaints more effectively than an individual-based control intervention in employees with shoulder complaints and high occupational shoulder exposures. METHODS: A cluster-randomised controlled study of 109 participants from 60 companies in Central Denmark Region. Companies were randomised and allocated to either Shoulder-Café or control intervention. Participants in both interventions received a pamphlet on home-based shoulder exercises and a pamphlet with general information on reducing occupational shoulder exposures. They also had their occupational shoulder exposures assessed. Shoulder-Café participants additionally received three café-meetings with casual discussion, clinical shoulder evaluation, education about shoulder anatomy and occupational shoulder exposures, supervised exercises, workplace-oriented counselling, and an optional workplace visit. The primary outcome measure was the Oxford Shoulder Score (OSS) at 6-month follow-up. Secondary outcome measures were the OSS at 12 months, Fear-Avoidance Beliefs Questionnaire - Physical Activity at 6 and 12 months, and Patients' Global Impression of Change at 6 months. The study also included seven supplementary outcome measures. RESULTS: Both groups improved from baseline to 6 months with respect to the primary outcome (P < 0.01). No group differences were found for the primary outcome (mean difference (MD) [95% confidence interval]: 0.3 [- 1.6; 2.2]) or secondary outcomes. The supplementary outcomes "felt informed about handling shoulder complaints" and "felt informed about reducing occupational exposures" at 6 months, and "Patients' Global Impression of Change" and "overall satisfaction" at 12 months favoured the Shoulder-Café intervention. CONCLUSION: The Shoulder-Café intervention did not reduce shoulder complaints more effectively than the control intervention. TRIAL REGISTRATION: The trial was registered at Clinicaltrials.gov on 19 May 2017 (ID: NCT03159910).

Morphological alterations of the abdominal wall after open incisional hernia repair with endoscopic anterior and open posterior component separation.

PURPOSE: Effects of component separation (CS) on abdominal wall morphology have only been investigated in smaller case series or cadavers. This study aimed to compare abdominal wall alterations following endoscopic anterior CS (EACS) or open transverse abdominis release (TAR). METHODS: Computed tomography scans were evaluated in patients who had undergone open incisional hernia repair with EACS or TAR. Abdominal wall circumference, lateral abdominal wall muscle thickness, and displacement were compared with (1) preoperative images after bilateral CS and (2) the undivided side postoperatively after unilateral CS. RESULTS: In total, 105 patients were included. Fifty-five (52%) and 15 (14%) underwent bilateral and unilateral EACS, respectively. Five (5%) and 14 (13%) underwent bilateral and unilateral TAR, respectively. Sixteen (15%) underwent unilateral EACS and contralateral TAR. The external oblique and transverse abdominis muscles were significantly laterally displaced with a mean of 2.74 cm (95% CI 2.29-3.19 cm, P < 0.001) and 0.82 cm (0.07-1.57 cm, P = 0.032) after EACS and TAR, respectively. The combined thickness of the lateral muscles was significantly decreased after EACS (mean decrease 10.5% (5.8-15.6%, P < 0.001)) and insignificantly decreased after TAR (mean decrease 2.6% (- 4.8 to 9.5%, P = 0.50)). The abdominal wall circumference was unchanged after bilateral (mean reduction 0.90 cm (- 0.77 to 2.58 cm), P = 0.29) and unilateral CS (mean increase 0.03 cm (- 1.01 to 1.08 cm), P = 0.95). CONCLUSION: Postoperative changes in the lateral abdominal wall musculature were different following EACS and open TAR. Either technique seems not to compromise the overall integrity of the lateral abdominal wall.

Even minor alteration of plasma creatinine after open abdominal surgery is associated with 30-day mortality: A single-centre cohort study.

PURPOSE: Postoperative acute kidney injury is common and associated with increased length of hospital stay, costs and mortality. The impact from postoperative subclinical changes in plasma concentration of creatinine (p-creatinine) on postoperative mortality has received less attention. In this study, the association between the postoperative change of p-creatinine and all-cause mortality was investigated. METHODS: A single-centre register-based, retrospective study was conducted including patients ≥60 years undergoing open abdominal surgery from 2000 to 2013. Postoperative p-creatinine change was analysed for association with 30-day mortality following adjustment for age, gender, surgical setting and surgical procedure. Main findings A total of 3,460 patients were included in the study of whom 67.6% underwent emergency surgery. The 30-day mortality rate was 18.3%, and a given 10µmol/L daily postoperative increase in p-creatinine was associated with an increased mortality risk with an odds ratio (OR) of 2.67 (95% CI; 2.28-3.14, P<0.001). In patients undergoing emergency surgery, a daily 10µmol/L increase in p-creatinine increased the risk for a fatal outcome a 2.39 OR (CI 95%; 2.05-2.78), P<0.001). In patients undergoing elective surgery, a similar increase in p-creatinine increased risk of postoperative death with a 28.85 OR (CI 95%; 10.25-81.19). CONCLUSION: Even a minor postoperative p-creatinine increase following open abdominal surgery below the criteria for acute kidney injury was associated with increased 30-day mortality in patients aged 60 years or above.

Impact of early inoculation of probiotics to suckling piglets on postweaning diarrhoea - A challenge study with Enterotoxigenic E. Coli F18.

Postweaning diarrhoea caused by Enterotoxigenic Escherichia coli (ETEC) is a threat to the pig industry. With an intensified focus on finding alternatives to the use of medical zinc oxide and antibiotics in newly weaned pigs, the objective of this study was to investigate the effect of early inoculation of probiotics to suckling piglets on subsequently ETEC faecal shedding and immune parameters in ETEC F18-challenged weaned piglets. Sixty pigs weaned on day 28 of age were assigned to three treatment groups: (i) Negative Control (non-challenged), (ii) Positive Control (challenged) and (iii) Probiotic (challenged and inoculated with a multi-species probiotic product during suckling). On days 1 and 2 postweaning, pigs in the Positive Control and Probiotic groups were challenged with 5 × 108 colony-forming unit ETEC F18/pig/day, whereas pigs in the Negative Control group were provided with NaCl. Growth and diarrhoea incidence were not significantly affected by ETEC challenge or probiotic administration. ETEC F18 shedding and C-reactive protein concentration in plasma were significantly lower in the Negative Control group, confirming a successful challenge model. Pigs in the Probiotic group had a significantly reduced number of pigs shedding ETEC F18 and STb toxin in faeces compared with the Positive Control group. Probiotic application did not significantly impact the concentration of C-reactive protein, haptoglobin and cytokines in plasma nor haematology numbers. In conclusion, weaned pigs administered with a multi-species probiotic product early in life had a more rapid response towards the pathogen challenge and a faster clearance of ETEC compared with the Positive Control group. Administration of a multi-species probiotic to newborn piglets may thus promote resilience in the newly weaned pig. However, further studies with pigs subjected to a more severe pathogen challenge are needed to confirm these results and to investigate the mechanism of action of the probiotic intervention.

The European Hernia Society Prehabilitation Project: A Systematic Review of Intra-Operative Prevention Strategies for Surgical Site Occurrences in Ventral Hernia Surgery.

Background: Ventral hernia repair is one of the most commonly performed surgical procedures worldwide. To reduce the risk of complications, pre- and intra-operative strategies have received increasing focus in recent years. To assess possible preventive surgical strategies, this European Hernia Society endorsed project was launched. The aim of this review was to evaluate the current literature focusing on pre- and intra-operative strategies for surgical site occurrences (SSO) and specifically surgical site infection (SSI) in ventral hernia repair. Methods: A systematic review was conducted and reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Databases used were Pubmed and Web of Science. Original retrospective or prospective human adult studies describing at least one intra-operative intervention to reduce SSO after ventral hernia repair were considered eligible. Results: From a total of 4775 results, a total of 18 papers were considered suitable after full text reading. Prehospital chlorhexidine gluconate (CHG) scrub appears to increase the risk of SSO in patients undergoing ventral hernia repair, while there is no association between any type of surgical hat worn and the incidence of postoperative wound events. Intraoperative measures as prophylactic negative pressure therapy, surgical drain placement and the use of quilt sutures seem beneficial for decreasing the incidence of SSO and/or SSI. No positive effect has been shown for antibiotic soaking of a synthetic mesh, nor for the use of fibrin sealants. Conclusion: This review identified a limited amount of literature describing specific preventive measures and techniques during ventral hernia repair. An advantage of prophylactic negative pressure therapy in prevention of SSI was observed, but different tools to decrease SSIs and SSOs continuously further need our full attention to improve patient outcomes and to lower overall costs.

The European Hernia Society Prehabilitation Project: a systematic review of patient prehabilitation prior to ventral hernia surgery.

BACKGROUND: Ventral hernia repair is one of the most commonly performed surgical procedures worldwide. To reduce the risk of complications, patient prehabilitation has received increasing focus in recent years. To assess prehabilitation measures, this European Hernia Society endorsed project was launched. The aim of this systematic review was to evaluate the current literature on patient prehabilitation prior to ventral hernia repair. METHODS: The strategies examined were optimization of renal disease, obesity, nutrition, physical exercise, COPD, diabetes and smoking cessation. For each topic, a separate literature search was conducted, allowing for seven different sub-reviews. RESULTS: A limited amount of well-conducted research studies evaluating prehabilitation prior to ventral hernia surgery was found. The primary findings showed that smoking cessation and weight loss for obese patients led to reduced risks of complications after abdominal wall reconstruction. CONCLUSION: Prehabilitation prior to ventral hernia repair may be widely used; however, the literature supporting its use is limited. Future studies evaluating the impact of prehabilitation before ventral hernia surgery are warranted.

Fit for Surgery-feasibility of short-course multimodal individualized prehabilitation in high-risk frail colon cancer patients prior to surgery.

BACKGROUND: Prehabilitation is a promising modality for improving patient-related outcomes after major surgery; however, very little research has been done for those who may need it the most: the elderly and the frail. This study aimed to investigate the feasibility of a short course multimodal prehabilitation prior to primary surgery in high-risk, frail patients with colorectal cancer and WHO performance status I and II. METHODS: The study was conducted as a single-center, prospective one-arm feasibility study of eight patients with colon cancer between October 4, 2018, and January 14, 2019. The intervention consisted of a physical training program tailored to the patients with both high-intensity interval training and resistance training three times a week in sessions of approximately 1 h in length, for a duration of at least 4 weeks, nutritional support with protein and vitamins, a consultation with a dietician, and medical optimization prior to surgery. Feasibility was evaluated regarding recruitment, retention, compliance and adherence, acceptability, and safety. Retention was evaluated as the number of patients that completed the intervention, with a feasibility goal of 75% completing the intervention. Compliance with the high-intensity training was evaluated as the number of sessions in which the patient achieved a minimum of 4 min > 90% of their maximum heart rate and adherence as the attended out of the offered training sessions. RESULTS: During the study period, 64 patients were screened for eligibility, and out of nine eligible patients, eight patients were included and seven completed the intervention (mean age 80, range 66-88). Compliance to the high-intensity interval training using 90% of maximum heart rate as the monitor of intensity was difficult to measure in several patients; however, adherence to the training sessions was 87%. Compliance with nutritional support was 57%. Half the patients felt somewhat overwhelmed by the multiple appointments and six out of seven reported difficulties with the dosage of protein. CONCLUSIONS: This one-arm feasibility study indicates that multimodal prehabilitation including high-intensity interval training can be performed by patients with colorectal cancer and WHO performance status I and II. TRIAL REGISTRATION: Clinicaltrials.gov : the study current feasibility study was conducted prior to the initiation of a full ongoing randomized trial registered by NCT04167436; date of registration: November 18, 2019. Retrospectively registered. No separate prospectively registration of the feasibility trial was conducted but outlined by the approved study protocol (Danish Scientific Ethical Committee SJ-607).

Visceral obesity is a predictor of surgical site occurrence and hernia recurrence after open abdominal wall reconstruction.

PURPOSE: High body mass index (BMI) increases the risk of postoperative complications and hernia recurrence after abdominal wall reconstruction (AWR). However, BMI does not provide specific information on the mass and distribution of adipose tissue. We hypothesized that visceral fat volume (VFV) was a better predictor than BMI for recurrence after AWR. METHODS: We included all patients undergoing AWR at our institution from November 2010 to December 2016. Data were collected from a prospective database and all patients were summoned for follow-up. VFV was calculated from preoperative CT. The primary and secondary outcomes were hernia recurrence and 30-day postoperative surgical site occurrences (SSO), respectively. RESULTS: We included a total of 154 patients. At follow-up, 42 (27.3%) patients had developed recurrence. The recurrence rate was significantly higher in patients with a VFV higher than the mean compared to a VFV lower than the mean, P = 0.004. After multivariable Cox-regression, VFV remained significantly predictive of recurrence (HR 1.09 per 0.5 L increase of VFV, P = 0.018). In contrary, BMI was not associated with hernia recurrence. There was no significant difference in the rate of SSO between patients with a VFV above and below the mean. A multivariable logistic regression model showed that VFV was significantly associated with development of SSO (OR 1.12 per 0.5 L increase, P = 0.009). CONCLUSION: VFV was significantly associated with recurrence and SSOs after AWR. This study suggests VFV as a risk assessment tool for patients undergoing AWR.

Slowly resorbable biosynthetic mesh: 2-year results in VHWG grade 3 hernia repair.

INTRODUCTION: Information on the long-term performance of biosynthetic meshes is scarce. This study analyses the performance of biosynthetic mesh (Phasix™) over 24 months. METHODS: A prospective, international European multi-center trial is described. Adult patients with a Ventral Hernia Working Group (VHWG) grade 3 incisional hernia larger than 10 cm2, scheduled for elective repair, were included. Biosynthetic mesh was placed in sublay position. Short-term outcomes included 3-month surgical site occurrences (SSO), and long-term outcomes comprised hernia recurrence, reoperation, and quality of life assessments until 24 months. RESULTS: Eighty-four patients were treated with biosynthetic mesh. Twenty-two patients (26.2%) developed 34 SSOs, of which 32 occurred within 3 months (primary endpoint). Eight patients (11.0%) developed a hernia recurrence. In 13 patients (15.5%), 14 reoperations took place, of which 6 were performed for hernia recurrence (42.9%), 3 for mesh infection (21.4%), and in 7 of which the mesh was explanted (50%). Compared to baseline, quality of life outcomes showed no significant difference after 24 months. Despite theoretical resorption, 10.7% of patients reported presence of mesh sensation in daily life 24 months after surgery. CONCLUSION: After 2 years of follow-up, hernia repair with biosynthetic mesh shows manageable SSO rates and favorable recurrence rates in VHWG grade 3 patients. No statistically significant improvement in quality of life or reduction of pain was observed. Few patients report lasting presence of mesh sensation. Results of biosynthetic mesh after longer periods of follow-up on recurrences and remodeling will provide further valuable information to make clear recommendations. TRIAL REGISTRATION: Registered on clinicaltrials.gov (NCT02720042), March 25, 2016.

Open versus laparoscopic umbilical and epigastric hernia repair: nationwide data on short- and long-term outcomes.

BACKGROUND: It is unclear whether an open or laparoscopic approach results in the best outcomes for repair of umbilical and epigastric hernias. The aim of the study was to evaluate the rates of 90-day readmission and reoperation for complication, together with rate of operation for recurrence after either open or laparoscopic mesh repair for primary umbilical or epigastric hernias with defect widths above 1 cm. METHODS: A merge of data between the Danish Hernia Database and the National Patient Registry provided data from 2007 to 2018 on perioperative information, 90-day readmission, 90-day reoperation for complication, and long-term operation for hernia recurrence. RESULTS: A total of 6855 patients were included, of whom 4106 (59.9%) and 2749 (40.1%) patients had an open or laparoscopic repair, respectively. There were significantly more patients readmitted with a superficial surgical site infection 2.5% (102/4106) after open repair compared with laparoscopic repair (0.5% (15/2749), P < 0.001. The 90-day reoperation rate for complications was significantly higher for open repairs 5.0% (205/4106) compared with laparoscopic repairs 2.7% (75/2749), P < 0.001. The incidence of a reoperation for a severe condition was significantly increased after laparoscopic repair 1.5% (41/2749) compared with open repair 0.8% (34/4106), P = 0.010. The 4-year cumulative incidence of operation for hernia recurrence was 3.5% after open and 4.2% after laparoscopic repairs, P = 0.302. CONCLUSIONS: Recurrence rates were comparable between open and laparoscopic repair of umbilical and epigastric hernias. Open repair was associated with a significantly higher rate of readmission and reoperation due to surgical site infection, whereas the rate of reoperation due to a severe complication was significantly higher after laparoscopic repair.

Changes in the abdominal wall after anterior, posterior, and combined component separation.

KEY MESSAGE: Knowledge of the changes that occur in the abdominal wall after component separation (CS) is essential for understanding the mechanisms of action of the various CS techniques, the changes observed on computed tomography images, and, perhaps most importantly, the anatomic and physiologic changes observed in patients who have undergone CS. Purpose Component separation (CS) techniques are essential adjuncts during most abdominal wall reconstructions. They allow the fulfillment of most modern abdominal wall reconstruction principles, especially primary closure of defects and linea alba restoration under physiologic tension. Knowledge of the post-CS abdominal wall changes is essential to understanding the mechanism of action of the various types of CS, the changes observed on computed tomographic images, and, perhaps most importantly, the anatomic and physiologic changes following CS techniques. Methods A systematic review of the literature was conducted using the PubMed database and other sources to identify articles describing abdominal wall changes after CS Results After excluding non-pertinent articles, 14 articles constituted the basis for this review.  Conclusions After reviewing the literature on post CS abdominal wall changes, we conclude the following: (1)The external oblique muscle is significantly displaced laterally after anterior CS, the transversus abdominis muscle shifts very little after posterior CS, and muscle trophism is generally maintained after both techniques. These findings are consistent for both open and minimally invasive CS. (2) The anatomy and physiology of abdominal wall muscles are preserved mainly by the muscles' overlapping function and their ability to undergo compensatory trophism after midline restoration (reloading). (3) Well-performed CS techniques have a low risk of producing bulging and semilunar line hernias. (4) Anterior and posterior CS techniques probably have different mechanisms of action. (5) Current studies on how the nutritional status and postoperative conditioning can alter abdominal wall changes after CS and the mechanisms of the actions involved in anterior and posterior CS are underway.

Histopathological risk factors for lymph node metastases in T1 colorectal cancer: meta-analysis.

BACKGROUND: National screening programmes increase the proportion of T1 colorectal cancers. Local excision may be possible, but the risk of lymph node metastases (LNMs) could jeopardize long-term outcomes. The aim of the present study was to review the association between histopathological findings and LNMs in T1 colorectal cancer. METHODS: A systematic literature search was conducted using PubMed,Embase, and Cochrane online databases. Studies investigating the association between one or more histopathological factors and LNMs in patients who underwent resection for T1 colorectal cancer were included. RESULTS: Sixteen observational studies were included in the meta-analysis, including a total of 10 181 patients, of whom 1 307 had LNMs. Lymphovascular invasion (odds ratio (OR) 7.42; P < 0.001), tumour budding (OR 4.00; P < 0.001), depth of submucosal invasion, whether measured as at least 1000 µm (OR 3.53; P < 0.001) or Sm2-3 (OR 2.12; P = 0.020), high tumour grade (OR 3.75; P < 0.001), polypoid growth pattern (OR 1.59; P = 0.040), and rectal location of tumour (OR 1.36; P = 0.003) were associated with LNMs. CONCLUSION: Distinct histopathological factors associated with nodal metastases in T1 colorectal cancer can aid selection of patients for local excision or major excisional surgery.

Reporting guideline for interventional trials of primary and incisional ventral hernia repair.

BACKGROUND: Primary and incisional ventral hernia trials collect unstandardized inconsistent data, limiting data interpretation and comparison. This study aimed to create two minimum data sets for primary and incisional ventral hernia interventional trials to standardize data collection and improve trial comparison. To support these data sets, standardized patient-reported outcome measures and trial methodology criteria were created. METHODS: To construct these data sets, nominal group technique methodology was employed, involving 15 internationally recognized abdominal wall surgeons and two patient representatives. Initially a maximum data set was created from previous systematic and panellist reviews. Thereafter, three stages of voting took place: stage 1, selection of the number of variables for data set inclusion; stage 2, selection of variables to be included; and stage 3, selection of variable definitions and detection methods. A steering committee interpreted and analysed the data. RESULTS: The maximum data set contained 245 variables. The three stages of voting commenced in October 2019 and had been completed by July 2020. The final primary ventral hernia data set included 32 variables, the incisional ventral hernia data set included 40 variables, the patient-reported outcome measures tool contained 25 questions, and 40 methodological criteria were chosen. The best known variable definitions were selected for accurate variable description. CT was selected as the optimal preoperative descriptor of hernia morphology. Standardized follow-up at 30 days, 1 year, and 5 years was selected. CONCLUSION: These minimum data sets, patient-reported outcome measures, and methodological criteria have allowed creation of a manual for investigators aiming to undertake primary ventral hernia or incisional ventral hernia interventional trials. Adopting these data sets will improve trial methods and comparisons.

Low back pain scores correlate with the cytokine mRNA level in lumbar disc biopsies: a study of inflammatory markers in patients undergoing lumbar spinal fusion.

PURPOSE: The molecular mechanism behind pain in degenerative disc disease (DDD) and chronic low back pain (LBP) patients is largely unknown. This present study examines the association of LBP and disability to mediators of the inflammatory cascade, as indexed by mRNA gene expression of pro-inflammatory cytokine markers in the intervertebral disc (IVD). METHODS: Biopsies of the annulus fibrosus (AF) and the nucleus pulposes (NP) from patients with DDD undergoing 1-2 level fusion surgery at L4/L5 or L5/S1 were obtained from total of 34 patients [9 M, 25 F] with average age of 53 [32-63]. The mRNA expression of TNF-α, IL-1ß, and IL-6 in the AF and NP was analyzed using quantitative real-time polymerase chain reaction (RT-qPCR), and the expression level of these markers was correlated to the visual analogue scale (VAS) and Oswestry Disability Index (ODI) scores (0-100) for pain and disability. RESULTS: We report a statistically significant positive correlation between pain intensity (VAS score) and the expression of TNF-α in both the AF (r = 0.54, p = 0.001) and NP (r = 0.40, p = 0.02), similarly with IL-1ß in AF (r = 0.37, p = 0.02) and IL-6 in NP (r = 0.40, p = 0.02). In addition, we found significant positive correlation observed between disability score (ODI) and expression of IL-6 in both AF (r = 0.36, p = 0.03) and NP (r = 0.41, p = 0.01). CONCLUSION: We conclude that the intensity of LBP and disability is associated with the level of inflammation in the disc.