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.

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.

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.

Factors affecting patient adherence to publicly funded colorectal cancer screening programmes: a systematic review.

OBJECTIVES: Colorectal cancer (CRC) is the third most common cancer. Many countries in Europe have already implemented systematic screening programmes as per the recommendations by the European Union. The impact of screening is highly dependent on participation rates. The aim of the study was to identify barriers, facilitators and modifiers to participation in systematised, stool sample-based, publicly financed CRC screening programmes. STUDY DESIGN: Systematic review. METHODS: A systematic search in PubMed, Embase, MEDLINE, CINAHL, Cochrane CENTRAL, Google Scholar and PsycINFO was undertaken. We included both qualitative and quantitative studies reporting on barriers and facilitators (excluding sociodemographic variables) to participation in stool sample-based CRC screening. Barriers and facilitators to participation were summarised and analysed. RESULTS: The inclusion criteria were met in 21 studies. Reported barriers and facilitators were categorised into the following seven themes (examples): psychology (fear of cancer), religion (believing cancer is the will of God), logistics (not knowing how to conduct the test), health-related factors (mental health), knowledge and awareness (lack of knowledge about the test), role of the general practitioner (being supported in taking the test by the general practitioner), and environmental factors (knowing someone who has participated in a screening programme). Six studies reported that non-participation was not due to a negative attitude towards screening for CRC. CONCLUSION: Many barriers to screening were found. It is important to work with peoples' fear of screening. Moreover, this review suggests that it might be possible to increase participation rates, if the population-wide awareness and knowledge of potential health benefits of CRC screening are increased and proper logistical support is provided.

Differential recurrence after laparoscopic incisional hernia repair: importance of a nationwide registry-based mesh surveillance.

BACKGROUND: Identification of suboptimal mesh products is essential to improve the outcome after hernia surgery. This study investigated whether a national clinical database combined with administrative registries may serve as a tool for postmarketing evaluation of mesh products for hernia surgery. METHODS: This was a propensity score-matched case-control cohort study comparing outcomes in patients undergoing laparoscopic incisional hernia repair with either one particular mesh or any other synthetic mesh. Data on patients registered in the Danish Ventral Hernia Database between 2010 and 2016 were combined with administrative data from the Danish National Patient Registry. The primary outcome was operation for recurrence. Secondary outcomes were 30-day readmission, 30-day reoperation for complications (excluding hernia recurrence), and mortality after 30 and 90 days. RESULTS: In total, 740 patients who underwent repair with one particular mesh were matched with 1479 patients who received any other synthetic mesh. The rate of repair for hernia recurrence was significantly higher in the particular mesh group than in the reference group: 12·8 versus 6·3 per cent respectively (hazard ratio 2·09, 95 per cent c.i. 1·57 to 2·79; P < 0·001). Use of the particular mesh increased the risk of readmission (odds ratio (OR) 1·53, 1·16 to 2·01; P = 0·002) and reoperation for a complication (OR 1·60, 1·03 to 2·47, P = 0·030). No difference in mortality was found. CONCLUSION: Clinical registries with prospectively collected data can provide long-term surveillance of commercial mesh. Laparoscopic incisional hernia repair with one particular mesh was associated with an increased rate of short-term complications and double the risk of repair for recurrence.

ANTECEDENTES: Es esencial identificar los productos subóptimos referidos a las mallas para mejorar los resultados en la cirugía de la hernia. Este estudio analizó si un registro clínico nacional combinado con registros de bases de datos administrativos puede servir como herramienta para la evaluación post-comercialización de productos de mallas para cirugía de la hernia. MÉTODOS: Se efectuó un estudio de emparejamiento por puntaje de propensión de una cohorte de casos y controles en el que se comparaban los resultados de la malla Physiomesh® frente a cualquier otra malla sintética en pacientes sometidos a una reparación laparoscópica de una eventración. Se combinaron los datos de los pacientes del registro danés de hernia entre 2010 y 2016 con los datos administrativos del registro nacional de pacientes de Dinamarca. La variable principal fue la reintervención por recidiva. Las variables secundarias fueron el reingreso a 30 días, la reoperación a 30 días por complicaciones (excluyendo la recidiva de la hernia) y la mortalidad a 30 y 90 días. RESULTADOS: Para la reparación herniaria se utilizó la malla Physiomesh® en 740 pacientes, que se emparejaron mediante el análisis por puntaje de propensión con 1.479 pacientes en los que se colocó otra malla sintética. La reintervención por recidiva herniaria fue significativamente mayor en el grupo Physiomesh® (12,8%) que en el grupo de referencia (6,3%); cociente de riesgos instantáneos (hazard ratio, HR): 2,09 (i.c. del 95%: 1,57-2,79), P < 0,001. El riesgo de reingreso (razón de oportunidades, odds ratio, OR: 1,53, 1,16-2,01, P = 0,002)) y de reoperación por una complicación (OR: 1,60, 1,03-2,47, P = 0,030) fueron superiores en el grupo Physiomesh®. No hubo diferencia en la mortalidad. CONCLUSIÓN: Los grandes registros clínicos con datos recogidos de forma prospectiva pueden ser útiles para efectuar el seguimiento a largo plazo de una malla comercializada para garantizar la seguridad del producto y su calidad quirúrgica. La reparación laparoscópica de una eventración con la malla Physiomesh® se asociaba con un riesgo doble de recidiva y un aumento de la tasa de complicaciones a corto plazo.

International classification of abdominal wall planes (ICAP) to describe mesh insertion for ventral hernia repair.

BACKGROUND: Nomenclature for mesh insertion during ventral hernia repair is inconsistent and confusing. Several terms, including 'inlay', 'sublay' and 'underlay', can refer to the same anatomical planes in the indexed literature. This frustrates comparisons of surgical practice and may invalidate meta-analyses comparing surgical outcomes. The aim of this study was to establish an international classification of abdominal wall planes. METHODS: A Delphi study was conducted involving 20 internationally recognized abdominal wall surgeons. Different terms describing anterior abdominal wall planes were identified via literature review and expert consensus. The initial list comprised 59 possible terms. Panellists completed a questionnaire that suggested a list of options for individual abdominal wall planes. Consensus on a term was predefined as occurring if selected by at least 80 per cent of panellists. Terms scoring less than 20 per cent were removed. RESULTS: Voting started August 2018 and was completed by January 2019. In round 1, 43 terms (73 per cent) were selected by less than 20 per cent of panellists and 37 new terms were suggested, leaving 53 terms for round 2. Four planes reached consensus in round 2, with the terms 'onlay', 'inlay', 'preperitoneal' and 'intraperitoneal'. Thirty-five terms (66 per cent) were selected by less than 20 per cent of panellists and were removed. After round 3, consensus was achieved for 'anterectus', 'interoblique', 'retro-oblique' and 'retromuscular'. Default consensus was achieved for the 'retrorectus' and 'transversalis fascial' planes. CONCLUSION: Consensus concerning abdominal wall planes was agreed by 20 internationally recognized surgeons. Adoption should improve communication and comparison among surgeons and research studies.

ANTECEDENTES: La nomenclatura de la inserción de una malla para la reparación de una hernia incisional ventral (ventral hernia, VH) es inconsistente y confusa. En la literatura indexada se usan varios términos, tales como 'inlay', 'sublay', y 'underlay' que pueden referirse a los mismos planos anatómicos. Este hecho frustra las comparaciones de técnicas quirúrgicas e invalida los metaanálisis que comparan resultados quirúrgicos en función del plano de inserción de la malla. En consecuencia, el objetivo de este estudio fue establecer una clasificación internacional de los planos de la pared abdominal (International Classification of Abdominal Wall Planes, ICAP). MÉTODOS: Se realizó un estudio Delphi, en el que participaron 20 cirujanos de pared abdominal reconocidos internacionalmente. Se identificaron diferentes términos que describían los planos de la pared abdominal anterior mediante la revisión de la literatura y el consenso de expertos. La lista inicial incluía 59 términos posibles. Los panelistas completaron un cuestionario que sugería una lista de opciones para los planos individuales de la pared abdominal. El consenso sobre un término fue predefinido cuando dicho término había sido seleccionado por ≥ 80% de panelistas. Se eliminaron los términos con una puntuación < 20%. RESULTADOS: La votación comenzó en agosto de 2018 y se completó en enero de 2019. Durante la Ronda 1, 43 (73%) términos fueron seleccionados por < 20% de los panelistas y se sugirieron 37 términos nuevos, dejando 53 términos para la Ronda 2. Cuatro planos alcanzaron un consenso en la Ronda 2 con los términos 'onlay', 'inlay', 'pre-peritoneal' e 'intra-peritoneal'. Treinta y cinco (66%) términos fueron seleccionados por < 20% de los panelistas y fueron eliminados. Después de la Ronda 3, se logró un consenso para 'anterectus' (ante-recto), 'interoblique' (inter-oblicuo), 'retrooblique' (retro-oblicuo) y 'retromuscular'. Se alcanzó un consenso por defecto para los planos 'retrorectus' (retro-recto) y 'transversalis fascial' (fascial transverso). CONCLUSIÓN: La ICAP ha sido desarrollada por el consenso de 20 cirujanos reconocidos internacionalmente. Su implementación debería mejorar la comunicación y la comparación entre cirujanos y estudios de investigación.

Update of Guidelines for laparoscopic treatment of ventral and incisional abdominal wall hernias (International Endohernia Society (IEHS)): Part B.

In 2014 the International Endohernia Society (IEHS) published the first international "Guidelines for laparoscopic treatment of ventral and incisional abdominal wall hernias". Guidelines reflect the currently best available evidence in diagnostics and therapy and give recommendations to help surgeons to standardize their techniques and to improve their results. However, science is a dynamic field which is continuously developing. Therefore, guidelines require regular updates to keep pace with the evolving literature. METHODS: For the development of the original guidelines all relevant literature published up to year 2012 was analyzed using the ranking of the Oxford Centre for Evidence-Based-Medicine. For the present update all of the previous authors were asked to evaluate the literature published during the recent years from 2012 to 2017 and revise their statements and recommendations given in the initial guidelines accordingly. In two Consensus Conferences (October 2017 Beijing, March 2018 Cologne) the updates were presented, discussed, and confirmed. To avoid redundancy, only new statements or recommendations are included in this paper. Therefore, for full understanding both of the guidelines, the original and the current, must be read. In addition, the new developments in repair of abdominal wall hernias like surgical techniques within the abdominal wall, release operations (transversus muscle release, component separation), Botox application, and robot-assisted repair methods were included. RESULTS: Due to an increase of the number of patients and further development of surgical techniques, repair of primary and secondary abdominal wall hernias attracts increasing interests of many surgeons. Whereas up to three decades ago hernia-related publications did not exceed 20 per year, currently this number is about 10-fold higher. Recent years are characterized by the advent of new techniques-minimal invasive techniques using robotics and laparoscopy, totally extraperitoneal repairs, novel myofascial release techniques for optimal closure of large defects, and Botox for relaxing the abdominal wall. Furthermore, a concomitant rectus diastasis was recognized as a significant risk factor for recurrence. Despite still insufficient evidence with respect to these new techniques it seemed to us necessary to include them in the update to stimulate surgeons to do research in these fields. CONCLUSION: Guidelines are recommendations based on best available evidence intended to help the surgeon to improve the quality of his daily work. However, science is a continuously evolving process, and as such guidelines should be updated about every 3 years. For a comprehensive reference, however, it is suggested to read both the initially guidelines published in 2014 together with the update. Moreover, the presented update includes also techniques which were not known 3 years before.

Correction to: Update of Guidelines for laparoscopic treatment of ventral and incisional abdominal wall hernias (International Endohernia Society (IEHS))-Part A.

This article was updated to include the middle initial of author L. N. Jorgensen's name.

Update of Guidelines for laparoscopic treatment of ventral and incisional abdominal wall hernias (International Endohernia Society (IEHS))-Part A.

In 2014, the International Endohernia Society (IEHS) published the first international "Guidelines for laparoscopic treatment of ventral and incisional abdominal wall hernias." Guidelines reflect the currently best available evidence in diagnostics and therapy and give recommendations to help surgeons to standardize their techniques and to improve their results. However, science is a dynamic field which is continuously developing. Therefore, guidelines require regular updates to keep pace with the evolving literature. METHODS: For the development of the original guidelines, all relevant literature published up to year 2012 was analyzed using the ranking of the Oxford Centre for Evidence-Based Medicine. For the present update, all of the previous authors were asked to evaluate the literature published during the recent years from 2012 to 2017 and revise their statements and recommendations given in the initial guidelines accordingly. In two Consensus Conferences (October 2017 Beijing, March 2018 Cologne), the updates were presented, discussed, and confirmed. To avoid redundancy, only new statements or recommendations are included in this paper. Therefore, for full understanding both of the guidelines, the original and the current, must be read. In addition, the new developments in repair of abdominal wall hernias like surgical techniques within the abdominal wall, release operations (transversus muscle release, component separation), Botox application, and robot-assisted repair methods were included. RESULTS: Due to an increase of the number of patients and further development of surgical techniques, repair of primary and secondary abdominal wall hernias attracts increasing interests of many surgeons. Whereas up to three decades ago hernia-related publications did not exceed 20 per year, currently this number is about 10-fold higher. Recent years are characterized by the advent of new techniques-minimal invasive techniques using robotics and laparoscopy, totally extraperitoneal repairs, novel myofascial release techniques for optimal closure of large defects, and Botox for relaxing the abdominal wall. Furthermore, a concomitant rectus diastasis was recognized as a significant risk factor for recurrence. Despite insufficient evidence with respect to these new techniques, it seemed to us necessary to include them in the update to stimulate surgeons to do research in these fields. CONCLUSION: Guidelines are recommendations based on best available evidence intended to help the surgeon to improve the quality of his daily work. However, science is a continuously evolving process, and as such guidelines should be updated about every 3 years. For a comprehensive reference, however, it is suggested to read both the initial guidelines published in 2014 together with the update. Moreover, the presented update includes also techniques which were not known 3 years before.

Open ventral hernia repair with a composite ventral patch - final results of a multicenter prospective study.

BACKGROUND: This study assessed clinical outcomes, including safety and recurrence, from the two-year follow-up of patients who underwent open ventral primary hernia repair with the use of the Parietex™ Composite Ventral Patch (PCO-VP). METHODS: A prospective single-arm, multicenter study of 126 patients undergoing open ventral hernia repair for umbilical and epigastric hernias with the PCO-VP was performed. RESULTS: One hundred twenty-six subjects (110 with umbilical hernia and 16 with epigastric hernia) with a mean hernia diameter of 1.8 cm (0.4-4.0) were treated with PCO-VP. One hundred subjects completed the two-year study. Cumulative hernia recurrence was 3.0% (3/101; 95%CI: 0.0-6.3%) within 24 months. Median Numeric Rating Scale pain scores improved from 2 [0-10] at baseline to 0 [0-3] at 1 month (P < 0.001) and remained low at 24 months 0 [0-6] (P < 0.001). 99% (102/103) of the patients were satisfied with their repair at 24 months postoperative. CONCLUSIONS: The use of PCO-VP to repair primary umbilical and epigastric defects yielded a low recurrence rate, low postoperative and chronic pain, and high satisfaction ratings, confirming that PCO-VP is effective for small ventral hernia repair in the two-year term after implantation. TRIAL REGISTRATION: The study was registered publically at clinicaltrials.gov ( NCT01848184 registered May 7, 2013).

Genomic alterations accompanying tumour evolution in colorectal cancer: tracking the differences between primary tumours and synchronous liver metastases by whole-exome sequencing.

BACKGROUND: Colorectal cancer (CRC) patients with metastatic disease can become cured if neoadjuvant treatment can enable a resection. The search for predictive biomarkers is often performed on primary tumours tissue. In order to assess the effectiveness of tailored treatment in regard to the primary tumour the differences in the genomic profile needs to be clarified. METHODS: Fresh-frozen tissue from primary tumours, synchronous liver metastases and adjacent normal liver was collected from 21 patients and analysed by whole-exome sequencing on the Illumina HiSeq 2500 platform. Gene variants designated as 'damaging' or 'potentially damaging' by Ingenuity software were used for the subsequent comparative analysis. BAM files were used as the input for the analysis of CNAs using NEXUS software. RESULTS: Shared mutations between the primary tumours and the synchronous liver metastases varied from 50 to 96%. Mutations in APC, KRAS, NRAS, TP53 or BRAF were concordant between the primary tumours and the metastases. Among the private mutations were well-known driver genes such as PIK3CA and SMAD4. The number of mutations was significantly higher in patients with right- compared to left-sided tumours (102 vs. 66, p = 0.004). Furthermore, right- compared to left-sided tumours had a significantly higher frequency of private mutations (p = 0.023). Similarly, CNAs differed between the primary tumours and the metastases. The difference was mostly comprised of numerical and segmental aberrations. However, novel CNAs were rarely observed in specific CRC-relevant genes. CONCLUSION: The examined primary colorectal tumours and synchronous liver metastases had multiple private mutations, indicating a high degree of inter-tumour heterogeneity in the individual patient. Moreover, the acquirement of novel CNAs from primary tumours to metastases substantiates the need for genomic profiling of metastases in order to tailor metastatic CRC therapies. As for the mutational status of the KRAS, NRAS and BRAF genes, no discordance was observed between the primary tumours and the metastases.

Continuous vital sign monitoring after major abdominal surgery-Quantification of micro events.

INTRODUCTION: Millions of patients undergo major abdominal surgery worldwide each year, and the post-operative phase carries a high risk of respiratory and circulatory complications. Standard ward observation of patients includes vital sign registration at regular intervals. Patients may deteriorate between measurements, and this may be detected by continuous monitoring. The aim of this study was to compare the number of micro events detected by continuous monitoring to those documented by the widely used standardized Early Warning Score (EWS). METHODS: Fifty patients were continuously monitored with peripheral arterial oxygen saturation (SpO2 ), heart rate (HR), and respiratory rate (RR) the first 4 days after major abdominal cancer surgery. EWS was monitored as routine practice. Number and duration of events were analyzed using Fisher's exact test and Wilcoxon rank sum test. RESULTS: Continuous monitoring detected a SpO2 <92% in 98% of patients vs 16% of patients detected by EWS (P < .0001). Micro events of SpO2 <92% lasting longer than 60 minutes were found in 58% of patients by continuous monitoring vs 16% by the EWS (P < .0001). Fifty-two percent of patients had micro events of SpO2 <85% lasting longer than 10 minutes. Continuous monitoring found tachycardia in 60% of patients vs 6% by the EWS. Frequency of events for bradycardia, tachypnea, and bradypnea showed similar patterns. CONCLUSION: Very low SpO2 and tachycardia in post-operative patients are common and under-diagnosed by the EWS. Continuous monitoring can discover these micro events and potentially contribute to earlier detection and, potentially, result in prevention of clinical complications.

A post-market, prospective, multi-center, single-arm clinical investigation of Phasix™ mesh for VHWG grade 3 midline incisional hernia repair: a research protocol.

BACKGROUND: Incisional heia is a frequent complication of midline laparotomy. The use of mesh in hernia repair has been reported to lead to fewer recurrences compared to primary repair. However, in Ventral Hernia Working Group (VHWG) Grade 3 hernia patients, whose hernia is potentially contaminated, synthetic mesh is prone to infection. There is a strong preference for resorbable biological mesh in contaminated fields, since it is more able to resist infection, and because it is fully resorbed, the chance of a foreign body reaction is reduced. However, when not crosslinked, biological resorbable mesh products tend to degrade too quickly to facilitate native cellular ingrowth. Phasix™ Mesh is a biosynthetic mesh with both the biocompatibility and resorbability of a biological mesh and the mechanical strength of a synthetic mesh. This multi-center single-arm study aims to collect data on safety and performance of Phasix™ Mesh in Grade 3 hernia patients. METHODS: A total of 85 VHWG Grade 3 hernia patients will be treated with Phasix™ Mesh in 15 sites across Europe. The primary outcome is Surgical Site Occurrence (SSO) including hematoma, seroma, infection, dehiscence and fistula formation (requiring intervention) through 3 months. Secondary outcomes include recurrence, infection and quality of life related outcomes after 24 months. Follow-up visits will be at drain removal (if drains were not placed, then on discharge or staple removal instead) and in the 1st, 3rd, 6th, 12th, 18th and 24th month after surgery. CONCLUSION: Based on evidence from this clinical study Depending on the results this clinical study will yield, Phasix™ Mesh may become a preferred treatment option in VHWG Grade 3 patients. TRIAL REGISTRATION: The trial was registered on March 25, 2016 on clinicaltrials.gov: NCT02720042 .

Randomized multicentre feasibility trial of intermediate care versus standard ward care after emergency abdominal surgery (InCare trial).

BACKGROUND: Emergency abdominal surgery carries a considerable risk of death and postoperative complications. Early detection and timely management of complications may reduce mortality. The aim was to evaluate the effect and feasibility of intermediate care compared with standard ward care in patients who had emergency abdominal surgery. METHODS: This was a randomized clinical trial carried out in seven Danish hospitals. Eligible for inclusion were patients with an Acute Physiology And Chronic Health Evaluation (APACHE) II score of at least 10 who were ready to be transferred to the surgical ward within 24 h of emergency abdominal surgery. Participants were randomized to either intermediate care or standard surgical ward care after surgery. The primary outcome was 30-day mortality. RESULTS: In total, 286 patients were included in the modified intention-to-treat analysis. The trial was terminated after the interim analysis owing to slow recruitment and a lower than expected mortality rate. Eleven (7·6 per cent) of 144 patients assigned to intermediate care and 12 (8·5 per cent) of 142 patients assigned to ward care died within 30 days of surgery (odds ratio 0·91, 95 per cent c.i. 0·38 to 2·16; P = 0·828). Thirty (20·8 per cent) of 144 patients assigned to intermediate care and 37 (26·1 per cent) of 142 assigned to ward care died within the total observation period (hazard ratio 0·78, 95 per cent c.i. 0·48 to 1·26; P = 0·310). CONCLUSION: Postoperative intermediate care had no statistically significant effect on 30-day mortality after emergency abdominal surgery, nor any effect on secondary outcomes. The trial was stopped prematurely owing to slow recruitment and a much lower than expected mortality rate among the enrolled patients. REGISTRATION NUMBER: NCT01209663 (http://www.clinicaltrials.gov).

A randomised controlled trial of bilateral dual transversus abdominis plane blockade for laparoscopic appendicectomy.

We investigated the effects of pre-operative ultrasound-guided bilateral dual transversus abdominis plane blocks on pain when sitting up and pain at rest after laparoscopic appendicectomy. We allocated 28 participants to injection with 60 ml ropivacaine 0.375% and 28 participants to 60 ml isotonic saline. The median (IQR [range]) cumulative pain scores during the first 12 postoperative hours were less after ropivacaine than saline (maximum 120): on sitting, 34 (19-46 [0-59]) vs 50 (30-59 [0-97]), respectively, p = 0.009; and at rest, 25 (10-33 [0-49]) vs 31 (24-43 [0-72]), respectively, p = 0.035. There were no differences in morphine consumption, nausea, vomiting, time in recovery or time to walk.

Randomized clinical trial of single- versus multi-incision laparoscopic cholecystectomy.

BACKGROUND: There are no randomized studies that compare outcomes after single-incision (SLC) and conventional multi-incision (MLC) laparoscopic cholecystectomy under an optimized perioperative analgesic regimen. METHODS: This patient- and assessor-blinded randomized three-centre clinical trial compared SLC and MLC in women admitted electively with cholecystolithiasis. Outcomes were registered on the day of operation (day 0), on postoperative days 1, 2, 3 and 30, and 12 months after surgery. Blinding of the patients was maintained until day 3. The primary endpoint was pain on movement measured on a visual analogue scale, reported repeatedly by the patient until day 3. RESULTS: The intention-to-treat population comprised 59 patients in the SLC and 58 in the MLC group. There was no significant difference between the groups with regard to any of the pain-related outcomes, on-demand administration of opioids or general discomfort. Median duration of surgery was 32·5 min longer in the SLC group (P < 0·001). SLC was associated with a reduced incidence of vomiting on day 0 (7 versus 22 per cent; P = 0·019). The incidences of wound-related problems were comparable. One patient in the SLC group experienced a biliary leak requiring endoscopic retrograde cholangiopancreatography. The rates of incisional hernia at 12-month follow-up were 2 per cent in both groups. Cosmetic rating was significantly improved after SLC at 1 and 12 months (P < 0·001). CONCLUSION: SLC did not significantly diminish early pain in a setting with optimized perioperative analgesic patient care. SLC may reduce postoperative vomiting. REGISTRATION NUMBER: NCT01268748 (http://www.clinicaltrials.gov).

Risk of new or recurrent cancer after a high perioperative inspiratory oxygen fraction during abdominal surgery.

BACKGROUND: Administration of supplemental oxygen in the perioperative period is controversial, as it may increase long-term mortality. Our aim was to assess the association between 80% oxygen and occurrence of subsequent cancer in patients undergoing abdominal surgery in a post hoc analysis of the PROXI trial. METHODS: The 1386 patients in the PROXI trial underwent elective or emergency laparotomy between 2006 and 2008 with randomization to either 80% or 30% oxygen during and for 2 h after surgery. We retrieved follow-up status regarding vital status, new cancer diagnoses, and new histological cancer specimens. Data were analysed using the Cox proportional hazards model. RESULTS: Follow-up was complete in 1377 patients (99%) after a median of 3.9 yr. The primary outcome of new cancer diagnosis or new malignant histological specimen occurred in 140 of 678 patients (21%) in the 80% oxygen group vs 150 of 699 patients (21%) assigned to 30% oxygen; hazards ratio 1.06 [95% confidence interval (CI) 0.84, 1.34], P=0.62. Cancer-free survival was significantly shorter in the 80% oxygen group; hazards ratio 1.19 (95% CI 1.01, 1.42), P=0.04, as was the time between surgery and new cancer, median 335 vs. 434 days in the 30% oxygen group. In patients with localized disease, non-significant differences in cancer and cancer-free survival were found with hazard ratios of 1.31 and 1.29, respectively. CONCLUSIONS: Although new cancers occurred at similar rate, the cancer-free survival was significantly shorter in the 80% oxygen group, but this did not appear to explain the excess mortality in the 80% oxygen group. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NCT01723280).

Do we know how much we put on the plate? Assessment of the accuracy of self-estimated versus weighed vegetables and whole grain portions using an Intelligent Buffet at the FoodScape Lab.

The aim of this study was to assess the accuracy of self-estimated vegetable and whole grain serving sizes in a self-served buffet meal. The study took place in a laboratory setting where an Intelligent Buffet was used to register the exact weight of each food type that was self-served by each participant. The initial sample consisted of 58 participants recruited from Aalborg University in Copenhagen, of which 52 participants (59% male) provided complete estimates on the weight of whole grains and 49 participants (63% male) provided complete estimates on the weight of vegetable servings in their meal. The majority of the participants were students aged 20-29 years (85% for whole grain responses and 82% for vegetable responses). Significant differences between self-estimated and actual portion size estimates were observed for both vegetables and whole grains (P < 0.001). The mean self-estimated weight of a vegetable serving was 218(±134) g compared to the mean actual weight of 74(±44) g. The mean self-estimated and mean actual weights of a whole grain serving were 36(±34) g and 10(±9) g, respectively. There was no significant correlation between self-estimated and actual weights for each food group (P > 0.05). In conclusion, the participants' ability to accurately assess the serving size of vegetables and whole grains in a self-served meal did not correspond with the actual amount served. This may have implications for consumer interpretation of dietary recommendations used in nutrition interventions in Denmark.

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.