ABSTRACT
Aims Provide a report on all patients who underwent laparoscopic incisional hernia repair as part of the TACKoMesh RCT prior to unblinding of treatment arms. Methods Trial recruitment was for primary incisional hernia with a defect diameter of 3–10cm. 63 patients (target 74–136) were operated on prior to the outbreak of COVID-19. Post-operative pain is the primary trial outcome. Surgery was performed with spiral-tack mesh-fixation devices (Protack™ (permanent) or Reliatack™ (absorbable)), Symbotex™ IPOM mesh, and sutured fascial closure using extracorporeal knot ties. Data was collected on trial forms and lifestyle questionnaires (SF-36 and CCS). All data were explored and described in RStudio v1.4.1106. Results Patients were aged 36–80 and 57.1% male. Mean preoperative BMI was 30.91. Mean operating time was 81minutes. In 20.6% patients multiple hernia defects were identified. A good degree of fascial closure was achieved in all patients using a median 3 knots. Median mesh-fixation time was 286seconds and a mean of 25 tacks/patient were used. Median length of hospital stay was 3.5days. Patients were asked “Please indicate on this scale [VAS 0–10] the pain that you currently experience from your incisional hernia during activity?”. Median responses for Day0/pre-op, Day1, Day6, Day30 and Day365 were 4.5, 8.0, 6.0, 3.0 and 1.5 respectively. At one year, 11% patients had experienced hernia recurrence and 52% a post-operative seroma. Conclusions Target recruitment was not possible owing to COVID-19. This technique has comparable recurrence rates. Reported pain increases post-operatively but is reduced at post-operative day30 and day365.
ABSTRACT
Aim Provide a report on all patients who underwent laparoscopic incisional hernia repair as part of the TACKoMesh RCT prior to unblinding of treatment arms. Material and Methods Trial recruitment was for primary incisional hernia with a defect diameter of 3–10cm. 63 patients (target 74-136) were operated on prior to the outbreak of COVID-19. Post-operative pain is the primary trial outcome. Surgery was performed with either spiral-tack mesh-fixation device (Protack (permanent) or Reliatack (absorbable)), Symbotex IPOM mesh, and fascial closure with no 1 Maxon suture(s) using extracorporeal knot ties – the Manchester Technique. Data was collected on trial forms and lifestyle questionnaires (SF-36 and CCS). All data were explored and described in RStudio v1.4.1106. Results Patients were aged 36-80 and 36(57.1%) patients were male. Mean preoperative BMI was 30.91(sd5.11,range21.15–43.93). Mean operating time was 80.81(37.34,20-240)minutes. In 13(20.6%) patients multiple hernia defects were identified. A good degree of fascial closure was achieved in all patients using a median of 3(IQR 2.0-3.5)knots. Median mesh-fixation time was 286(159.5-428.0)seconds and a mean 25.24(5.49,14-41)tacks/patient were used. Median length of hospital stay was 3.5(2.0–6.0)days. Patients were asked “Please indicate on this scale [VAS 0–10] the pain that you currently experience from your incisional hernia during activity?”. Median responses for Day0/pre-op, Day1, Day6, Day30 and Day365 were 4.5, 8.0, 6.0, 3.0 and 1.5 respectively. At one year, 7(11%) patients had experienced hernia recurrence and 33(52%) post-operative seroma. Conclusions Target recruitment was not possible owing to COVID-19. The Manchester Technique has comparable recurrence rates. Reported pain increases post-operatively but is reduced at post-operative day30 and day365.
ABSTRACT
New treatments and increased experience are changing the management of hospitalized coronavirus disease 2019 patients but the impact on ICU management is unclear. OBJECTIVES: To examine characteristics, ventilatory management, and outcomes of critically ill patients in two distinct waves of the pandemic. DESIGN SETTING AND PARTICIPANTS: Observational cohort study in an ICU in a single-center university-affiliated U.K. hospital. Two-hundred ten adults with coronavirus disease 2019 admitted to ICU between March 17, 2020, to May 31, 2020, and September 1, 2020, to December 10, 2020, with hourly data and 100% follow-up to ICU discharge. MAIN OUTCOMES AND MEASURES: Data were extracted from the electronic medical record for patient characteristics and clinical data. Patients were classified into distinct waves of the pandemic and assessed for differences between the two waves. RESULTS: The duration of noninvasive ventilation/nasal high flow increased in wave 2 versus wave 1, both in self-ventilating patients (107 vs 72 hr; p = 0.02), and in those ultimately requiring invasive mechanical ventilation (34 vs 10 hr; p = 0.02). The proportion of survivors treated without invasive mechanical ventilation increased in wave 2 (59% vs 39%; p = 0.01). In both waves, longer duration of noninvasive ventilation/nasal high flow prior to intubation was associated with higher ICU mortality (survivors 10 hr [4-21 hr] vs nonsurvivors 50 hr [23-124 hr]; p < 0.01). Proned invasive mechanical ventilation was common (54.7%) and prolonged. In wave 2, invasive mechanical ventilation patients were generally more hypoxic with proning initiated at lower Pao2/Fio2 ratios (81 vs 116 mm Hg; p = 0.02) and yielding smaller improvements in Fio2 requirements. Continued proning episodes despite poor responses were commonplace and typically futile. Length of stay for patients requiring tracheostomy increased markedly in wave 2 (51.3 vs 33.7 d; p = 0.03). Overall survival remained similar in wave 2 (68.0% vs 60.9%; p = 0.31). CONCLUSIONS AND RELEVANCE: Our data suggest that management of critically ill coronavirus disease 2019 patients is changing with more survivors avoiding invasive mechanical ventilation. Duration of noninvasive ventilation/nasal high flow use is increasing, which may be associated with worsening outcomes for individuals who require invasive mechanical ventilation. Among invasively ventilated patients, changes in the use of and response to prone positioning and increased length of stay following tracheostomy may imply that the care of these patients is becoming more challenging.