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1.
Cochrane Database Syst Rev ; 8: CD010168, 2021 08 17.
Article in English | MEDLINE | ID: covidwho-1813437

ABSTRACT

BACKGROUND: This is the second update of a Cochrane Review first published in 2015 and last updated in 2018. Appendectomy, the surgical removal of the appendix, is performed primarily for acute appendicitis. Patients who undergo appendectomy for complicated appendicitis, defined as gangrenous or perforated appendicitis, are more likely to suffer postoperative complications. The routine use of abdominal drainage to reduce postoperative complications after appendectomy for complicated appendicitis is controversial. OBJECTIVES: To assess the safety and efficacy of abdominal drainage to prevent intraperitoneal abscess after appendectomy (irrespective of open or laparoscopic) for complicated appendicitis; to compare the effects of different types of surgical drains; and to evaluate the optimal time for drain removal. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Ovid Embase, Web of Science, the World Health Organization International Trials Registry Platform, ClinicalTrials.gov, Chinese Biomedical Literature Database, and three trials registers on 24 February 2020, together with reference checking, citation searching, and contact with study authors to identify additional studies. SELECTION CRITERIA: We included all randomised controlled trials (RCTs) that compared abdominal drainage versus no drainage in people undergoing emergency open or laparoscopic appendectomy for complicated appendicitis. We also included RCTs that compared different types of drains and different schedules for drain removal in people undergoing appendectomy for complicated appendicitis. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Two review authors independently identified the trials for inclusion, collected the data, and assessed the risk of bias. We used the GRADE approach to assess evidence certainty. We included intraperitoneal abscess as the primary outcome. Secondary outcomes were wound infection, morbidity, mortality, hospital stay, hospital costs, pain, and quality of life. MAIN RESULTS: Use of drain versus no drain We included six RCTs (521 participants) comparing abdominal drainage and no drainage in participants undergoing emergency open appendectomy for complicated appendicitis. The studies were conducted in North America, Asia, and Africa. The majority of participants had perforated appendicitis with local or general peritonitis. All participants received antibiotic regimens after open appendectomy. None of the trials was assessed as at low risk of bias. The evidence is very uncertain regarding the effects of abdominal drainage versus no drainage on intraperitoneal abscess at 30 days (risk ratio (RR) 1.23, 95% confidence interval (CI) 0.47 to 3.21; 5 RCTs; 453 participants; very low-certainty evidence) or wound infection at 30 days (RR 2.01, 95% CI 0.88 to 4.56; 5 RCTs; 478 participants; very low-certainty evidence). There were seven deaths in the drainage group (N = 183) compared to one in the no-drainage group (N = 180), equating to an increase in the risk of 30-day mortality from 0.6% to 2.7% (Peto odds ratio 4.88, 95% CI 1.18 to 20.09; 4 RCTs; 363 participants; low-certainty evidence). Abdominal drainage may increase 30-day overall complication rate (morbidity; RR 6.67, 95% CI 2.13 to 20.87; 1 RCT; 90 participants; low-certainty evidence) and hospital stay by 2.17 days (95% CI 1.76 to 2.58; 3 RCTs; 298 participants; low-certainty evidence) compared to no drainage. The outcomes hospital costs, pain, and quality of life were not reported in any of the included studies. There were no RCTs comparing the use of drain versus no drain in participants undergoing emergency laparoscopic appendectomy for complicated appendicitis. Open drain versus closed drain There were no RCTs comparing open drain versus closed drain for complicated appendicitis. Early versus late drain removal There were no RCTs comparing early versus late drain removal for complicated appendicitis. AUTHORS' CONCLUSIONS: The certainty of the currently available evidence is low to very low. The effect of abdominal drainage on the prevention of intraperitoneal abscess or wound infection after open appendectomy is uncertain for patients with complicated appendicitis. The increased rates for overall complication rate and hospital stay for the drainage group compared to the no-drainage group are based on low-certainty evidence. Consequently, there is no evidence for any clinical improvement with the use of abdominal drainage in patients undergoing open appendectomy for complicated appendicitis. The increased risk of mortality with drainage comes from eight deaths observed in just under 400 recruited participants. Larger studies are needed to more reliably determine the effects of drainage on morbidity and mortality outcomes.


Subject(s)
Abscess/prevention & control , Appendectomy/adverse effects , Appendicitis/surgery , Drainage/methods , Peritonitis/prevention & control , Postoperative Complications/prevention & control , Humans
3.
Transplantation ; 105(7): 1405-1422, 2021 07 01.
Article in English | MEDLINE | ID: covidwho-1706459

ABSTRACT

The emergence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus responsible for the coronavirus disease 2019 (COVID-19) pandemic has raised concerns for programs overseeing donation and transplantation of cells, tissues, and organs (CTO) that this virus might be transmissible by transfusion or transplantation. Transplant recipients are considered particularly vulnerable to pathogens because of immunosuppression, and SARS-CoV-2 is likely to generate complications if contracted. Several signs and symptoms observed in COVID-19 positive patients reflect damage to multiple organs and tissues, raising the possibility of extrapulmonary SARS-CoV-2 infections and risk of transmission. At the beginning of the pandemic, a consensus has emerged not to consider COVID-19 positive patients as potential living or deceased donors, resulting in a global decrease in transplantation procedures. Medical decision-making at the time of organ allocation must consider safely alongside the survival advantages offered by transplantation. To address the risk of transmission by transplantation, this review summarizes the published cases of transplantation of cells or organs from donors infected with SARS-CoV-2 until January 2021 and assesses the current state of knowledge for the detection of this virus in different biologic specimens, cells, tissues, and organs. Evidence collected to date raises the possibility of SARS-CoV-2 infection and replication in some CTO, which makes it impossible to exclude transmission through transplantation. However, most studies focused on evaluating transmission under laboratory conditions with inconsistent findings, rendering the comparison of results difficult. Improved standardization of donors and CTO screening practices, along with a systematic follow-up of transplant recipients could facilitate the assessment of SARS-CoV-2 transmission risk by transplantation.


Subject(s)
COVID-19/transmission , Donor Selection/methods , Hematopoietic Stem Cell Transplantation/adverse effects , Organ Transplantation/adverse effects , Postoperative Complications/etiology , SARS-CoV-2/isolation & purification , COVID-19/diagnosis , COVID-19/prevention & control , COVID-19/virology , Humans , Postoperative Complications/diagnosis , Postoperative Complications/prevention & control , Risk
6.
J Clin Endocrinol Metab ; 107(2): 549-562, 2022 01 18.
Article in English | MEDLINE | ID: covidwho-1633480

ABSTRACT

CONTEXT: Though posttransplant diabetes mellitus (PTDM, occurring > 45 days after transplantation) and its complications are well described, early post-renal transplant hyperglycemia (EPTH) (< 45 days) similarly puts kidney transplant recipients at risk of infections, rehospitalizations, and graft failure and is not emphasized much in the literature. Proactive screening and management of EPTH is required given these consequences. OBJECTIVE: The aim of this article is to promote recognition of early post-renal transplant hyperglycemia, and to summarize available information on its pathophysiology, adverse effects, and management. METHODS: A PubMed search was conducted for "early post-renal transplant hyperglycemia," "immediate posttransplant hyperglycemia," "post-renal transplant diabetes," "renal transplant," "diabetes," and combinations of these terms. EPTH is associated with significant complications including acute graft failure, rehospitalizations, cardiovascular events, PTDM, and infections. CONCLUSION: Patients with diabetes experience better glycemic control in end-stage renal disease (ESRD), with resurgence of hyperglycemia after kidney transplant. Patients with and without known diabetes are at risk of EPTH. Risk factors include elevated pretransplant fasting glucose, diabetes, glucocorticoids, chronic infections, and posttransplant infections. We find that EPTH increases risk of re-hospitalizations from infections (cytomegalovirus, possibly COVID-19), acute graft rejections, cardiovascular events, and PTDM. It is essential, therefore, to provide diabetes education to patients before discharge. Insulin remains the standard of care while inpatient. Close follow-up after discharge is recommended for insulin adjustment. Some agents like dipeptidyl peptidase-4 inhibitors and glucagon-like peptide-1 receptor agonists have shown promise. The tenuous kidney function in the early posttransplant period and lack of data limit the use of sodium-glucose cotransporter 2 inhibitors. There is a need for studies assessing noninsulin agents for EPTH to decrease risk of hypoglycemia associated with insulin and long-term complications of EPTH.


Subject(s)
Hyperglycemia/etiology , Hyperglycemia/therapy , Kidney Transplantation/adverse effects , COVID-19/complications , Glycemic Control , Humans , Male , Middle Aged , Postoperative Complications/prevention & control , Postoperative Complications/therapy , Transplant Recipients
8.
Ann Surg ; 275(1): 31-36, 2022 01 01.
Article in English | MEDLINE | ID: covidwho-1583930

ABSTRACT

OBJECTIVE: The purpose of this study was to determine the effect of COVID-19 vaccination on postoperative mortality, pulmonary and thrombotic complications, readmissions and hospital lengths of stay among patients undergoing surgery in the United States. BACKGROUND: While vaccination prevents COVID-19, little is known about its impact on postoperative complications. METHODS: This is a nationwide observational cohort study of all 1,255 Veterans Affairs facilities nationwide. We compared patients undergoing surgery at least 2 weeks after their second dose of the Pfizer BioNTech or Moderna vaccines, to contemporary propensity score matched controls. Primary endpoints were 30-day mortality and postoperative COVID-19 infection. Secondary endpoints were pulmonary or thrombotic complications, readmissions, and hospital lengths of stay. RESULTS: 30,681 patients met inclusion criteria. After matching, there were 3,104 in the vaccination group (1,903 received the Pfizer BioNTech, and 1,201 received the Moderna vaccine) and 7,438 controls. Full COVID-19 vaccination was associated with lower rates of postoperative 30-day COVID-19 infection (Incidence Rate Ratio and 95% confidence intervals, 0.09 [0.01,0.44]), pulmonary complications (0.54 [0.39, 0.72]), thrombotic complications (0.68 [0.46, 0.99]) and decreased hospital lengths of stay (0.78 [0.69, 0.89]). Complications were also low in vaccinated patients who tested COVID-19 positive before surgery but events were too few to detect a significant difference compared to controls. CONCLUSION: COVID-19 vaccination is associated with lower rates of postoperative morbidity. The benefit is most pronounced among individuals who have never had a COVID-19 infection before surgery.


Subject(s)
COVID-19 Vaccines , COVID-19/prevention & control , Postoperative Complications/prevention & control , Adult , Aged , Aged, 80 and over , COVID-19/epidemiology , Female , Humans , Length of Stay/statistics & numerical data , Male , Matched-Pair Analysis , Middle Aged , Patient Readmission/statistics & numerical data , Poisson Distribution , Postoperative Complications/epidemiology , Propensity Score , Regression Analysis , Retrospective Studies , Treatment Outcome
9.
J Cardiothorac Surg ; 16(1): 340, 2021 Nov 24.
Article in English | MEDLINE | ID: covidwho-1533269

ABSTRACT

INTRODUCTION: Post-operative atrial fibrillation (POAF) is associated with poorer outcomes, increased resource utilisation, morbidity and mortality. Its pathogenesis is initiated by systemic inflammation and oxidative stress. It is hypothesised that a potent antioxidant and anti-inflammatory agent such as tocotrienol, an isomer of Vitamin E, could reduce or prevent POAF. AIMS: The aim of this study is to determine whether a potent antioxidative and anti-inflammatory agent, Tocovid, a tocotrienol-rich capsule, could reduce the incidence of POAF and affect the mortality and morbidity as well as the duration of ICU, HDU and hospital stay. METHODS: This study was planned as a prospective, randomised, controlled trial with parallel groups. The control group received placebo containing palm superolein while the treatment group received Tocovid capsules. We investigated the incidence of POAF, the length of hospital stay after surgery and the health-related quality of life. RESULTS: Recruitment commenced in January 2019 but the preliminary results were unblinded as the study is still ongoing. Two-hundred and two patients have been recruited out of a target sample size of 250 as of January 2021. About 75% have completed the study and 6.4% were either lost during follow-up or withdrew; 4% of participants died. The mean age group was 61.44 ± 7.30 years with no statistical difference between the groups, with males having a preponderance for AF. The incidence of POAF was 24.36% and the mean time for developing POAF was 55.38 ± 29.9 h post-CABG. Obesity was not a predictive factor. No statistically significant difference was observed when comparing left atrial size, NYHA class, ejection fraction and the premorbid history. The mean cross-clamp time was 71 ± 34 min and the mean bypass time was 95 ± 46 min, with no difference between groups. There was a threefold increase in death among patients with POAF (p = 0.008) and an increase in the duration of ICU stay (p = 0.01), the total duration of hospital stay (p = 0.04) and reintubation (p = 0.045). CONCLUSION: A relatively low incidence rate of POAF was noted although the study is still ongoing. It remains to be seen if our prophylactic intervention using Tocovid would effectively reduce the incidence of POAF. Clinical Registration Number: US National Library of Medicine. Clinical Trials - NCT03807037. Registered on 16th January 2019. Link: https://clinicaltrials.gov/ct2/show/NCT03807037.


Subject(s)
Atrial Fibrillation , Tocotrienols , Aged , Atrial Fibrillation/epidemiology , Atrial Fibrillation/etiology , Atrial Fibrillation/prevention & control , Humans , Male , Middle Aged , Postoperative Complications/prevention & control , Prospective Studies , Quality of Life , Risk Factors
10.
Transplant Proc ; 53(4): 1126-1131, 2021 May.
Article in English | MEDLINE | ID: covidwho-1525970

ABSTRACT

Coronavirus disease 2019 drastically impacted solid organ transplantation. Lacking scientific evidence, a very stringent but safer policy was imposed on liver transplantation (LT) early in the pandemic. Restrictive transplant guidelines must be reevaluated and adjusted as data become available. Before LT, the prevailing policy requires a negative severe acute respiratory syndrome coronavirus 2 real-time polymerase chain reaction (RT-PCR) of donors and recipients. Unfortunately, prolonged viral RNA shedding frequently hinders transplantation. Recent data reveal that positive test results for viral genome are frequently due to noninfectious and prolonged convalescent shedding of viral genome. Moreover, studies demonstrated that the cycle threshold of quantitative RT-PCR could be leveraged to inform clinical transplant decision-making. We present an evidence-adjusted and significantly less restrictive policy for LT, where risk tolerance is tiered to recipient acuity. In addition, we delineate the pretransplant clinical decision-making, intra- and postoperative management, and early outcome of 2 recipients of a liver graft performed while their RT-PCR of airway swabs remained positive. Convalescent positive RT-PCR results are common in the transplant arena, and the proposed policy permits reasonably safe LT in many circumstances.


Subject(s)
COVID-19 Nucleic Acid Testing/standards , COVID-19/diagnosis , Health Policy , Liver Transplantation/legislation & jurisprudence , SARS-CoV-2/genetics , COVID-19/prevention & control , COVID-19 Nucleic Acid Testing/methods , Female , Humans , Infection Control/legislation & jurisprudence , Infection Control/methods , Liver Transplantation/adverse effects , Male , Middle Aged , Postoperative Complications/prevention & control , Postoperative Complications/virology , Preoperative Care/legislation & jurisprudence , Preoperative Care/methods , Reference Values , Tissue Donors , Virus Shedding
12.
BMJ Open ; 11(11): e045526, 2021 11 02.
Article in English | MEDLINE | ID: covidwho-1501709

ABSTRACT

INTRODUCTION: The enhanced recovery after surgery (ERAS) protocol provides optimised care guidelines for patients undergoing elective colorectal surgery. To ensure high compliance with active ERAS elements, patients must be educated to actively participate in the perioperative care pathway. Mobile health is a rapidly expanding area of the digital health sector that is effective in educating and engaging patients during follow-up. iColon is a mobile application designed by the Operative Unit of General Surgery of IRCCS Sacro Cuore Don Calabria Hospital of Negrar of Valpolicella, which is specifically targeted at patients undergoing elective colorectal surgery. iColon is organised into ERAS phases, and it provides real-time feedback to surgeons about a patient's adherence to perioperative active ERAS elements. METHODS AND ANALYSIS: We hypothesise that by providing a patient-focused mobile application, compliance with active ERAS elements could be improved.The first coprimary objective is to build patient confidence in using the mobile application, iColon, during perioperative care. The second coprimary objective is to establish patient compliance with active ERAS elements.Secondary objectives include examining: length of stay, 30-day readmission rate, postoperative complications and patient satisfaction of received care.This study is a prospective observational real-world study of patients undergoing elective colorectal surgery who are following the ERAS protocol and using iColon during perioperative periods between September 2020 and December 2022.By educating and engaging patients in the ERAS protocol, the mobile application, iColon, should stimulate patients to be more proactive in managing their healthcare by complying more closely with active ERAS elements. ETHICS AND DISSEMINATION: This study has been approved by the local Ethics Committee with the protocol number 29219 of 25 May 2020. The results will be actively disseminated through peer-reviewed journals, conference presentations and various community engagement activities.


Subject(s)
Colorectal Surgery , Digestive System Surgical Procedures , Mobile Applications , Humans , Length of Stay , Observational Studies as Topic , Perioperative Care , Postoperative Complications/epidemiology , Postoperative Complications/prevention & control
13.
Surg Today ; 52(2): 260-267, 2022 Feb.
Article in English | MEDLINE | ID: covidwho-1453757

ABSTRACT

PURPOSE: Postoperative pancreatic fistula (POPF) remains the most clinically relevant complication of laparoscopic distal pancreatectomy (LDP). The present study evaluated the efficacy of the "slow firing method" using a reinforced triple-row stapler (Covidien, Tokyo, Japan) during LDP. METHODS: This retrospective single-center study included 73 consecutive patients who underwent LDP using the slow firing method. A black cartridge was used in all patients. The primary endpoint was the rate of clinically relevant POPF (CR-POPF) after LDP. Secondary endpoints included perioperative outcomes and factors associated with CR-POPF as well as the correlation between the transection time and thickness of the pancreas. RESULTS: Four patients (5.5%) developed CR-POPF (grade B). Overall morbidity rates, defined as grade ≥ II and ≥ III according to the Clavien-Dindo classification, were 21 and 11%, respectively. The median postoperative hospital stay was 10 days. Preoperative diabetes (13.6 vs. 0.2%, P = 0.044) and thickness of the pancreas ≥ 15 mm (13.8% vs. 0%, P = 0.006) were identified as independent risk factors for CR-POPF. The median transection time was 16 (8-29) min. CONCLUSION: The slow firing method using a reinforced triple-row stapler for pancreatic transection is simple, safe, and effective for preventing CR-POPF after LDP.


Subject(s)
Laparoscopy/methods , Pancreatectomy/methods , Pancreatic Fistula/prevention & control , Postoperative Complications/prevention & control , Surgical Staplers , Surgical Stapling/methods , Adolescent , Adult , Aged , Aged, 80 and over , Female , Glycosides , Humans , Male , Middle Aged , Operative Time , Pregnanes , Risk Factors , Safety , Surgical Stapling/instrumentation , Treatment Outcome , Young Adult
14.
J Clin Endocrinol Metab ; 107(2): 549-562, 2022 01 18.
Article in English | MEDLINE | ID: covidwho-1438330

ABSTRACT

CONTEXT: Though posttransplant diabetes mellitus (PTDM, occurring > 45 days after transplantation) and its complications are well described, early post-renal transplant hyperglycemia (EPTH) (< 45 days) similarly puts kidney transplant recipients at risk of infections, rehospitalizations, and graft failure and is not emphasized much in the literature. Proactive screening and management of EPTH is required given these consequences. OBJECTIVE: The aim of this article is to promote recognition of early post-renal transplant hyperglycemia, and to summarize available information on its pathophysiology, adverse effects, and management. METHODS: A PubMed search was conducted for "early post-renal transplant hyperglycemia," "immediate posttransplant hyperglycemia," "post-renal transplant diabetes," "renal transplant," "diabetes," and combinations of these terms. EPTH is associated with significant complications including acute graft failure, rehospitalizations, cardiovascular events, PTDM, and infections. CONCLUSION: Patients with diabetes experience better glycemic control in end-stage renal disease (ESRD), with resurgence of hyperglycemia after kidney transplant. Patients with and without known diabetes are at risk of EPTH. Risk factors include elevated pretransplant fasting glucose, diabetes, glucocorticoids, chronic infections, and posttransplant infections. We find that EPTH increases risk of re-hospitalizations from infections (cytomegalovirus, possibly COVID-19), acute graft rejections, cardiovascular events, and PTDM. It is essential, therefore, to provide diabetes education to patients before discharge. Insulin remains the standard of care while inpatient. Close follow-up after discharge is recommended for insulin adjustment. Some agents like dipeptidyl peptidase-4 inhibitors and glucagon-like peptide-1 receptor agonists have shown promise. The tenuous kidney function in the early posttransplant period and lack of data limit the use of sodium-glucose cotransporter 2 inhibitors. There is a need for studies assessing noninsulin agents for EPTH to decrease risk of hypoglycemia associated with insulin and long-term complications of EPTH.


Subject(s)
Hyperglycemia/etiology , Hyperglycemia/therapy , Kidney Transplantation/adverse effects , COVID-19/complications , Glycemic Control , Humans , Male , Middle Aged , Postoperative Complications/prevention & control , Postoperative Complications/therapy , Transplant Recipients
15.
BMJ Open ; 11(9): e045541, 2021 09 03.
Article in English | MEDLINE | ID: covidwho-1394105

ABSTRACT

INTRODUCTION: Between 5% and 30% of abdominal incisions eventually result in incisional hernias (IHs) that can lead to severe complications and impaired quality of life. Unfortunately, IH repair is often unsuccessful; therefore, hernia prophylaxis is an important issue. The efficacy of mesh augmentation has been proven for hernia prophylaxis in high-risk patients, but no randomised clinical trial has evaluated prophylactic mesh placement in emergency/urgent gastrointestinal operations. METHODS AND ANALYSIS: A multicentre, prospective randomised, open and patient-assessor blinded endpoint design will be conducted. A total of 470 patients will be enrolled and randomly allocated to retrorectus mesh augmentation with lightweight polypropylene mesh or primary suture closure. The primary outcome is IH occurrence within 24 months of follow-up, while other clinical outcomes are secondary endpoints. A cost-effectiveness analysis will be conducted from the societal and provider perspectives. ETHICS AND DISSEMINATION: Ethics approval was obtained from Ramathibodi Hospital (MURA2020/1478) and Vajira Hospital (COA164/2563). The protocol is on the process of submission to the local ethics committee of the other study sites. Results will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: TCTR20200924002.


Subject(s)
Incisional Hernia , Gastrointestinal Tract , Humans , Incisional Hernia/prevention & control , Multicenter Studies as Topic , Postoperative Complications/prevention & control , Prospective Studies , Quality of Life , Randomized Controlled Trials as Topic , Surgical Mesh/adverse effects
16.
Nutrients ; 13(9)2021 Aug 24.
Article in English | MEDLINE | ID: covidwho-1376921

ABSTRACT

Bariatric surgery is the most efficacious treatment for obesity, though it is not free from complications. Preoperative conditioning has proved beneficial in various clinical contexts, but the evidence is scarce on the role of prehabilitation in bariatric surgery. We describe the protocol and pilot study of a randomized (ratio 1:1), parallel, controlled trial assessing the effect of a physical conditioning and respiratory muscle training programme, added to a standard 8-week group intervention based on therapeutical education and cognitive-behavioural therapy, in patients awaiting bariatric surgery. The primary outcome is preoperative weight-loss. Secondary outcomes include associated comorbidity, eating behaviour, physical activity, quality of life, and short-term postoperative complications. A pilot sample of 15 participants has been randomized to the intervention or control groups and their baseline features and results are described. Only 5 patients completed the group programme and returned for assessment. Measures to improve adherence will be implemented and once the COVID-19 pandemic allows, the clinical trial will start. This is the first randomized, clinical trial assessing the effect of physical and respiratory prehabilitation, added to standard group education and cognitive-behavioural intervention in obese patients on the waiting list for bariatric surgery. Clinical Trial Registration: NCT0404636.


Subject(s)
Bariatric Surgery/adverse effects , Postoperative Complications/epidemiology , Preoperative Care/methods , Preoperative Exercise , Adult , Breathing Exercises/methods , Cognitive Behavioral Therapy/methods , Female , Follow-Up Studies , Humans , Male , Middle Aged , Patient Education as Topic , Pilot Projects , Postoperative Complications/etiology , Postoperative Complications/prevention & control , Quality of Life , Randomized Controlled Trials as Topic , Treatment Outcome , Weight Loss
17.
PLoS One ; 16(8): e0254698, 2021.
Article in English | MEDLINE | ID: covidwho-1354757

ABSTRACT

BACKGROUND: Pneumonia is a common and severe complication of abdominal surgery, it is associated with increased length of hospital stay, healthcare costs, and mortality. Further, pulmonary complication rates have risen during the SARS-CoV-2 pandemic. This study explored the potential cost-effectiveness of administering preoperative chlorhexidine mouthwash versus no-mouthwash at reducing postoperative pneumonia among abdominal surgery patients. METHODS: A decision analytic model taking the South African healthcare provider perspective was constructed to compare costs and benefits of mouthwash versus no-mouthwash-surgery at 30 days after abdominal surgery. We assumed two scenarios: (i) the absence of COVID-19; (ii) the presence of COVID-19. Input parameters were collected from published literature including prospective cohort studies and expert opinion. Effectiveness was measured as proportion of pneumonia patients. Deterministic and probabilistic sensitivity analyses were performed to assess the impact of parameter uncertainties. The results of the probabilistic sensitivity analysis were presented using cost-effectiveness planes and cost-effectiveness acceptability curves. RESULTS: In the absence of COVID-19, mouthwash had lower average costs compared to no-mouthwash-surgery, $3,675 (R 63,770) versus $3,958 (R 68,683), and lower proportion of pneumonia patients, 0.029 versus 0.042 (dominance of mouthwash intervention). In the presence of COVID-19, the increase in pneumonia rate due to COVID-19, made mouthwash more dominant as it was more beneficial to reduce pneumonia patients through administering mouthwash. The cost-effectiveness acceptability curves shown that mouthwash surgery is likely to be cost-effective between $0 (R0) and $15,000 (R 260,220) willingness to pay thresholds. CONCLUSIONS: Both the absence and presence of SARS-CoV-2, mouthwash is likely to be cost saving intervention for reducing pneumonia after abdominal surgery. However, the available evidence for the effectiveness of mouthwash was extrapolated from cardiac surgery; there is now an urgent need for a robust clinical trial on the intervention on non-cardiac surgery.


Subject(s)
Abdomen/surgery , Chlorhexidine/therapeutic use , Models, Theoretical , Pneumonia/prevention & control , COVID-19 , Cost-Benefit Analysis , Humans , Mouthwashes , Pandemics , Postoperative Complications/prevention & control , Preoperative Care , Prospective Studies , South Africa
18.
N Engl J Med ; 385(7): 609-617, 2021 08 12.
Article in English | MEDLINE | ID: covidwho-1354155

ABSTRACT

BACKGROUND: The role of factor XI in the pathogenesis of postoperative venous thromboembolism is uncertain. Abelacimab is a monoclonal antibody that binds to factor XI and locks it in the zymogen (inactive precursor) conformation. METHODS: In this open-label, parallel-group trial, we randomly assigned 412 patients who were undergoing total knee arthroplasty to receive one of three regimens of abelacimab (30 mg, 75 mg, or 150 mg) administered postoperatively in a single intravenous dose or to receive 40 mg of enoxaparin administered subcutaneously once daily. The primary efficacy outcome was venous thromboembolism, detected by mandatory venography of the leg involved in the operation or objective confirmation of symptomatic events. The principal safety outcome was a composite of major or clinically relevant nonmajor bleeding up to 30 days after surgery. RESULTS: Venous thromboembolism occurred in 13 of 102 patients (13%) in the 30-mg abelacimab group, 5 of 99 patients (5%) in the 75-mg abelacimab group, and 4 of 98 patients (4%) in the 150-mg abelacimab group, as compared with 22 of 101 patients (22%) in the enoxaparin group. The 30-mg abelacimab regimen was noninferior to enoxaparin, and the 75-mg and 150-mg abelacimab regimens were superior to enoxaparin (P<0.001). Bleeding occurred in 2%, 2%, and none of the patients in the 30-mg, 75-mg, and 150-mg abelacimab groups, respectively, and in none of the patients in the enoxaparin group. CONCLUSIONS: This trial showed that factor XI is important for the development of postoperative venous thromboembolism. Factor XI inhibition with a single intravenous dose of abelacimab after total knee arthroplasty was effective for the prevention of venous thromboembolism and was associated with a low risk of bleeding. (Funded by Anthos Therapeutics; ANT-005 TKA EudraCT number, 2019-003756-37.).


Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , Anticoagulants/therapeutic use , Arthroplasty, Replacement, Knee , Enoxaparin/therapeutic use , Factor XI/antagonists & inhibitors , Postoperative Complications/prevention & control , Venous Thromboembolism/prevention & control , Adult , Aged , Aged, 80 and over , Antibodies, Monoclonal, Humanized/administration & dosage , Antibodies, Monoclonal, Humanized/adverse effects , Anticoagulants/administration & dosage , Anticoagulants/adverse effects , Dose-Response Relationship, Drug , Enoxaparin/adverse effects , Factor XI/metabolism , Female , Hemorrhage/chemically induced , Humans , Infusions, Intravenous , Injections, Subcutaneous , Male , Middle Aged , Partial Thromboplastin Time
19.
Eur J Med Res ; 26(1): 86, 2021 Aug 04.
Article in English | MEDLINE | ID: covidwho-1339151

ABSTRACT

As one of the leading causes of elderly patients' hospitalisation, proximal femur fractures (PFFs) will present an increasing socioeconomic problem in the near future. This is a result of the demographic change that is expressed by the increasing proportion of elderly people in society. Peri-operative management must be handled attentively to avoid complications and decrease mortality rates. To deal with the exceptional needs of the elderly, the development of orthogeriatric centres to support orthogeriatric co-management is mandatory. Adequate pain medication, balanced fluid management, delirium prevention and the operative treatment choice based on comorbidities, individual demands and biological rather than chronological age, all deserve particular attention to improve patients' outcomes. The operative management of intertrochanteric and subtrochanteric fractures favours intramedullary nailing. For femoral neck fractures, the Garden classification is used to differentiate between non-displaced and displaced fractures. Osteosynthesis is suitable for biologically young patients with non-dislocated fractures, whereas total hip arthroplasty and hemiarthroplasty are the main options for biologically old patients and displaced fractures. In bedridden patients, osteosynthesis might be an option to establish transferability from bed to chair and the restroom. Postoperatively, the patients benefit from early mobilisation and early geriatric care. During the COVID-19 pandemic, prolonged time until surgery and thus an increased rate of complications took a toll on frail patients with PFFs. This review aims to offer surgical guidelines for the treatment of PFFs in the elderly with a focus on pitfalls and challenges particularly relevant to frail patients.


Subject(s)
Femoral Fractures/surgery , Aged , COVID-19/epidemiology , Delirium/prevention & control , Femoral Neck Fractures/classification , Femoral Neck Fractures/surgery , Femur Neck/anatomy & histology , Hip Fractures/surgery , Humans , Postoperative Complications/prevention & control , SARS-CoV-2
20.
PLoS One ; 16(7): e0254958, 2021.
Article in English | MEDLINE | ID: covidwho-1331994

ABSTRACT

BACKGROUND: The COVID-19 pandemic forced a reconsideration of surgical patient management in the setting of scarce resources and risk of viral transmission. Herein we assess the impact of implementing a protocol of more rigorous patient education, recovery room assessment for non-ICU admission, earlier mobilization and post-discharge communication for patients undergoing brain tumor surgery. METHODS: A case-control retrospective review was undertaken at a community hospital with a dedicated neurosurgery and otolaryngology team using minimally invasive surgical techniques, total intravenous anesthesia (TIVA) and early post-operative imaging protocols. All patients undergoing craniotomy or endoscopic endonasal removal of a brain, skull base or pituitary tumor were included during two non-overlapping periods: March 2019-January 2020 (pre-pandemic epoch) versus March 2020-January 2021 (pandemic epoch with streamlined care protocol implemented). Data collection included demographics, preoperative American Society of Anesthesiologists (ASA) status, tumor pathology, and tumor resection and remission rates. Primary outcomes were ICU utilization and hospital length of stay (LOS). Secondary outcomes were complications, readmissions and reoperations. FINDINGS: Of 295 patients, 163 patients were treated pre-pandemic (58% women, mean age 53.2±16 years) and 132 were treated during the pandemic (52% women, mean age 52.3±17 years). From pre-pandemic to pandemic, ICU utilization decreased from 92(54%) to 43(29%) of operations (p<0.001) and hospital LOS≤1 day increased from 21(12.2%) to 60(41.4%), p<0.001, respectively. For craniotomy cohort, median LOS was 2 days for both epochs; median ICU LOS decreased from 1 to 0 days (p<0.001), ICU use decreased from 73(80%) to 29(33%),(p<0.001). For endonasal cohort, median LOS decreased from 2 to 1 days; median ICU LOS was 0 days for both epochs; (p<0.001). There were no differences pre-pandemic versus pandemic in ASA scores, resection/remission rates, readmissions or reoperations. CONCLUSION: This experience suggests the COVID-19 pandemic provided an opportunity for implementing a brain tumor care protocol to facilitate safely decreasing ICU utilization and accelerating discharge home without an increase in complications, readmission or reoperations. More rigorous patient education, recovery room assessment for non-ICU admission, earlier mobilization and post-discharge communication, layered upon a foundation of minimally invasive surgery, TIVA anesthesia and early post-operative imaging are possible contributors to these favorable trends.


Subject(s)
Brain Neoplasms/surgery , COVID-19/prevention & control , Pandemics/prevention & control , Case-Control Studies , Craniotomy/methods , Enhanced Recovery After Surgery , Female , Hospitalization , Humans , Length of Stay , Male , Middle Aged , Minimally Invasive Surgical Procedures/methods , Patient Discharge , Patient Readmission , Postoperative Complications/prevention & control , Postoperative Period , Reoperation/methods , Retrospective Studies
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