Background Perioperative hypothermia during laparoscopy for bowel resection is a risk factor for postoperative medical complications and surgical wound infections. Despite various warming methods used during surgery, a significant number of patients experience perioperative hypothermia. Use of dry, unwarmed insufflation carbon dioxide (CO2) during laparoscopic procedures may contribute to this problem. Evidence exists that the HumiGard device, which humidifies and heats CO2 for insufflation, can reduce the risk of perioperative hypothermia. Objective The aim is to determine if insufflation with warmed, humidified CO2 using the HumiGard device, alongside standard perioperative warming techniques, can improve patient recovery, including pain, surgical site infections, complications, and the use of analgesia compared with standard care alone. Methods The study is a multicenter, randomized, blinded (patient, surgeon, and assessor), sham device-controlled, parallel group-controlled trial of 232 patients. The study aims to recruit patients undergoing elective laparoscopic, segmental, or total colectomy. Patients will be randomized to receive HumiGard plus standard care or standard care alone (1:1 ratio). The primary outcome is patient-reported quality of recovery, measured by the validated QoR-40 (quality of recovery) questionnaire, from baseline to postoperative day 1. Secondary outcomes include postoperative pain, the incidence of hypothermia, and the rate of postoperative complications. Results The information gathered during a small-scale service evaluation at a single hospital was used to inform this study protocol. Before applying for a grant for this full randomized controlled trial, the authors will conduct a feasibility study of 40 patients to ensure that the protocol is feasible and to inform our sample size calculation. Conclusions The randomized controlled trial is designed to provide high-quality evidence on the effectiveness of the HumiGard device in potentially reducing the risk of perioperative hypothermia in patients scheduled for laparoscopic colectomy. The results will be used to improve the maintenance of adequate patient body temperature during surgery. International Registered Report Identifier (IRRID) PRR1-10.2196/14533
Background Previously, routine antenatal anti‐D prophylaxis (RAADP) was administered to all RhD‐negative mothers to reduce the risk of sensitisation in the UK's National Health Service (NHS). If the baby is RhD‐negative, RAADP is not required. In 2016, the UK National Institute for Health and Care Excellence (NICE) recommended non‐invasive prenatal testing (NIPT) for fetal RHD genotype as a cost‐effective option to guide RAADP. Objectives To evaluate the implementation of high‐throughput NIPT for fetal RHD genotype in maternity units in England by addressing research recommendations from the NICE. These were to reduce uncertainty around the resource use and cost of staff training, management of samples and results and record‐keeping, as well as resultant changes to antenatal or post‐partum care and performance of NIPT. Methods A cross‐sectional survey was developed and sent to clinicians at 39 English NHS Trusts in May 2018. Qualitative interviews with seven individuals were conducted to explore missing or contraindicatory data. Qualitative findings were supplemented with NIPT test results (April 2017 to February 2019) from English hospitals. Results Staff reported that training took up to 30 minutes. There were no extra costs associated with sample management or additional appointments. Extra time required for record‐keeping and management of test results was balanced later in the patient pathway. The antenatal pathway was not changed in the Trusts surveyed. The survey revealed that four post‐partum scenarios were being used within English NHS Trusts. The frequency of inconclusive NIPT results was 4.3%. Conclusion NIPT for fetal RHD genotype can be implemented without consuming substantial extra resources through incorporation into an existing patient pathway.
Background Tauroselcholic [75selenium] acid (SeHCAT™) (GE Healthcare, Chicago, IL, USA) is a radiopharmaceutical that may be useful in diagnosing bile acid diarrhoea. Objectives To assess the clinical effectiveness and cost-effectiveness of SeHCAT for the investigation of adults with chronic unexplained diarrhoea, diarrhoea-predominant irritable bowel syndrome or functional diarrhoea (suspected primary bile acid diarrhoea), and adults with chronic diarrhoea and Crohn’s disease who have not undergone ileal resection (suspected secondary bile acid diarrhoea). Methods Sixteen databases were searched to November 2020. The review process included measures to minimise error and bias. Results were summarised by primary or secondary bile acid diarrhoea and study quality was considered. The cost-effectiveness analysis combined a short-term (6-month) decision-analytic model (diagnosis and initial treatment response) and a lifetime Markov model comprising three health states (diarrhoea, no diarrhoea and death), with transitions determined by probabilities of response to treatment. Analyses were conducted from an NHS and Personal Social Services perspective. Results Twenty-four studies were included in this review. Of these, 21 were observational studies, reporting some outcome data for patients treated with bile acid sequestrants, and in which only patients with a positive SeHCAT test were offered bile acid sequestrants. The median rate of response to bile acid sequestrants, among patients with a 7-day SeHCAT retention value of ≤ 15%, was 68% (range 38–86%) (eight studies). The estimated sensitivity of SeHCAT (≤ 15% threshold) to predict positive response to colestyramine was 100% (95% confidence interval 54.1% to 100%) and the specificity estimate was 91.2% (95% confidence interval 76.3% to 98.1%) (one study). The median proportion of treated patients who were intolerant/discontinued bile acid sequestrants was 15% (range 4–27%) (eight studies). There was insufficient information to determine whether or not intolerance varied between colestyramine, colestipol and colesevelam. For both populations, the SeHCAT 15% (i.e. a SeHCAT retention value of ≤ 15%) strategy dominated other strategies or resulted in incremental cost-effectiveness ratios of < £20,000–30,000 per quality-adjusted life-year gained. For the suspected primary bile acid diarrhoea population, SeHCAT 15% was the strategy most likely to be cost-effective: 67% and 73% probability at threshold incremental cost-effectiveness ratios of £20,000 and £30,000 per quality-adjusted life-year gained, respectively. For the Crohn’s disease population, these probabilities were 89% and 92% at £20,000 and £30,000 per quality-adjusted life-year gained, respectively. Cost-effectiveness was mostly led by treatment response. SeHCAT 15% was the strategy with the highest response rate in the majority of scenarios explored. Limitations and conclusions There is a lack of evidence linking the use of SeHCAT testing to patient-relevant outcomes. The optimal SeHCAT threshold, to define bile acid diarrhoea and select patients for treatment with bile acid sequestrants, is uncertain. It is unclear whether or not patients with ‘borderline’ or ‘equivocal’ 7-day SeHCAT retention values (e.g. between 10% and 15%) and patients with values of > 15% could benefit from treatment with bile acid sequestrants. Although the results of the economic evaluation conducted for both populations indicated that the SeHCAT 15% strategy dominated the other two strategies or resulted in incremental cost-effectiveness ratios that were lower than the common thresholds of £20,000 or £30,000 per quality-adjusted life-year gained, the paucity and poor quality of evidence mean that uncertainty is high. Future work The optimum study design would be a multiarm randomised controlled trial, in which participants meeting the inclusion criteria are randomised to receive colestyramine, colestipol, colesevelam or placebo, and all participants receive SeHCAT testing. Study registration This study is registered as PROSPERO CRD42020223877. Funding This project was funded by the National Institute for Health and Care Research (IHR) Evidence Synthesis programme and will be published in full in Health Technology Assessment; Vol. 26, No. 45. See the NIHR Journals Library website for further project information.
The Welsh Health Specialised Services Committee (WHSSC) is responsible for planning, commissioning and funding specialised healthcare in Wales. Investment in new technologies or services is based on clinical and economic evidence, using a consistent and transparent process. This is accomplished in three stages. The first stage is the preparation of a rapid evidence review. This then informs the development or update of the relevant Commissioning Policy. The final stage is to prioritise the Commissioning Policy recommendations against all other new services and interventions, to inform WHSSC's annual commissioning intentions. In 2017, a review was conducted of the WHSSC Commissioning Policy for transcatheter aortic valve implantation for severe aortic stenosis. Prior to this only high-risk patients were eligible for transcatheter aortic valve implantation. The rapid evidence review identified three randomised controlled trials and two economic analyses relevant to the decision problem. Transcatheter aortic valve implantation was generally found to be more expensive and more effective than medical management or surgical aortic valve replacement, with incremental cost-effectiveness ratios around £10,500-£36,000 for inoperable groups and £17,000-£24,000 in high-risk groups. The rapid evidence review, expert advice and stakeholder feedback informed the revision process of the Commissioning Policy for transcatheter aortic valve implantation. This recommended the addition of patients unsuitable for surgical aortic valve replacement and the removal of explicit risk scoring. This recommendation was subject to the prioritisation process (carried out annually). The updated transcatheter aortic valve implantation recommendation was ranked second out of 23 technologies and services competing for additional WHSSC funding. The WHSSC Integrated Commissioning Plan for specialised services in Wales (2019) therefore included funding to support the new criteria for transcatheter aortic valve implantation treatment. Plain Language SummaryIn Wales, specialised health services are selected and funded at a national level by the Welsh Health Specialised Services Committee. Specialised services are provided for small numbers of patients, requiring highly specialised professionals or technologies. When the aortic heart valve becomes narrowed with disease it can be replaced with an artificial valve. This normally requires open surgery, which is risky for some patients, particularly those who are frail. Since 2012, the Welsh Health Specialised Services Committee have funded a less invasive procedure called TAVI (transcatheter aortic valve implantation) for patients who could have open surgery but at a high risk. In 2017, this policy needed updating, thus a new evidence review was conducted. This showed that patients at high risk from open surgery were more likely to survive if they
BACKGROUND Perioperative hypothermia during laparoscopy for bowel resection is a risk factor for postoperative medical complications and surgical wound infections. Despite various warming methods used during surgery, a significant number of patients experience perioperative hypothermia. Use of dry, unwarmed insufflation carbon dioxide (CO<sub>2</sub>) during laparoscopic procedures may contribute to this problem. Evidence exists that the HumiGard device, which humidifies and heats CO<sub>2</sub> for insufflation, can reduce the risk of perioperative hypothermia. OBJECTIVE The aim is to determine if insufflation with warmed, humidified CO<sub>2</sub> using the HumiGard device, alongside standard perioperative warming techniques, can improve patient recovery, including pain, surgical site infections, complications, and the use of analgesia compared with standard care alone. METHODS The study is a multicenter, randomized, blinded (patient, surgeon, and assessor), sham device-controlled, parallel group-controlled trial of 232 patients. The study aims to recruit patients undergoing elective laparoscopic, segmental, or total colectomy. Patients will be randomized to receive HumiGard plus standard care or standard care alone (1:1 ratio). The primary outcome is patient-reported quality of recovery, measured by the validated QoR-40 (quality of recovery) questionnaire, from baseline to postoperative day 1. Secondary outcomes include postoperative pain, the incidence of hypothermia, and the rate of postoperative complications. RESULTS The information gathered during a small-scale service evaluation at a single hospital was used to inform this study protocol. Before applying for a grant for this full randomized controlled trial, the authors will conduct a feasibility study of 40 patients to ensure that the protocol is feasible and to inform our sample size calculation. CONCLUSIONS The randomized controlled trial is designed to provide high-quality evidence on the effectiveness of the HumiGard device in potentially reducing the risk of perioperative hypothermia in patients scheduled for laparoscopic colectomy. The results will be used to improve the maintenance of adequate patient body temperature during surgery.
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