Laparoscopic Cholecystectomy Versus Percutaneous Catheter Drainage for Acute Cholecystitis in High Risk Patients (CHOCOLATE): Multicentre Randomised Clinical Trial

Loozen CS, et al. Laparoscopic cholecystectomy versus percutaneous catheter drainage for acute cholecystitis in high risk patients (CHOCOLATE): multicentre randomised clinical trial. BMJ. 2018 Oct 8; 363:k3965.

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what this study adds

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Dor versus Toupet fundoplication after laparoscopic Heller myotomy

Torres-Villalobos G, et al. Dor Vs Toupet Fundoplication After Laparoscopic Heller Myotomy: Long-Term Randomized Controlled Trial Evaluated by High-Resolution Manometry. J Gastrointest Surg. 2018 Jan;22(1):13-22.

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Surgical data table

Results: Seventy-three patients were randomized, 38 underwent Dor and 35 Toupet. Baseline characteristics were similar between groups. Postoperative HRM showed that the integrated relaxation pressure (IRP) and basal lower esophageal sphincter (LES) pressure were similar at 6 and 24 months. The number of patients with abnormal acid exposure was significantly lower for Dor (6.9%) than that of Toupet (34.0%) at 6 months, but it was not different at 12 or 24 months. No differences were found in postoperative symptom scores at 1, 6, or 24 months.

Conclusion: There were no differences in symptom scores or HRM between fundoplications in the long term. A higher percentage of abnormal 24-h pH test were found for the Toupet group, with no difference in the long term.


More PubMed results on Dor vs.Toupet fundoplication after Heller myotomy.

What is the impact of abdominal binder on seroma formation?

One discussion this week included the impact of abdominal binder on seroma formation.


Reference: Christoffersen MW, Olsen BH, Rosenberg J, Bisgaard T. Randomized clinical trial on the postoperative use of an abdominal binder after laparoscopic umbilical and epigastric hernia repair. Hernia. 2015 Feb;19(1):147-153. doi:10.1007/s10029-014-1289-6

Summary: Application of an abdominal binder is often part of a standard postoperative regimen after ventral hernia repair to reduce pain and seroma formation. However, there is lack of evidence of the clinical effects.

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Intraoperative cardiac arrest: Resuscitation and Management

One discussion this week included intraoperative cardiac arrest.


Reference: Moitra VK, et al. Cardiac arrest in the operating room: resuscitation and management for the anesthesiologist: part 1. Anesthesia & Analgesia. 2018 Mar;126(3):876-888. doi: 10.1213/ANE.0000000000002596.

Summary: Cardiac arrest in the operating room and procedural areas has a different spectrum of causes (ie, hypovolemia, gas embolism, and hyperkalemia), and rapid and appropriate evaluation and management of these causes require modification of traditional cardiac arrest algorithms. There is a small but growing body of literature describing the incidence, causes, treatments, and outcomes of circulatory crisis and perioperative cardiac arrest. These events are almost always witnessed, frequently known, and involve rescuer providers with knowledge of the patient and their procedure.

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Meta-analysis, systematic review of carbonic anhydrase inhibitors in respiratory failure and metabolic alkalosis

One discussion this week involved carbonic anhydrase inhibitors (CAIs) in the setting of respiratory failure and metabolic alkalosisa.

Reference: Tanios BY, et al. Carbonic anhydrase inhibitors in patients with respiratory failure and metabolic alkalosis: a systematic review and meta-analysis of randomized controlled trials. Critical Care. 2018 Oct 29;22(1):275.  doi: 10.1186/s13054-018-2207-6

Summary: Metabolic alkalosis is common in patients with respiratory failure and may delay weaning in mechanically ventilated patientsCarbonic anhydrase inhibitors (such as acetazolamide, methazolamide, and dichlorphenamide) block renal bicarbonate reabsorption, and thus reverse metabolic alkalosis. However, uncertainty remains about
their effects in the setting of respiratory failure with concurrent metabolic alkalosis on duration of hospitalization, mechanical ventilation (MV), or noninvasive positive pressure ventilation (NIPPV), and mortality.

The objective of this systematic review is to assess the benefits and harms of carbonic anhydrase inhibitor therapy in patients with respiratory failure and metabolic alkalosis.

Randomized clinical trials were included if they assessed at least one of the following outcomes: mortality, duration of hospital stay, duration of mechanical ventilation, adverse events, and blood gas parameters. Six eligible studies were identified with a total of 564 patients.

There were no definitive results for the effects of CAI therapy on clinically important outcomes such as mortality and duration of hospital stay in patients with respiratory failure and metabolic alkalosis. The results suggest that CAI therapy may decrease the duration of mechanical ventilation. There was a trend towards increased incidence of adverse events in the CAI group; however, most of these adverse events were mild.

On the other hand, the results suggest that CAI therapy has favorable effects on arterial blood gas parameters (PaCO2, PaO2, bicarbonate and pH), with decreased PaCO2, increased PaO2, and, as expected, decreased bicarbonate and pH levels.

Conclusion

In patients with respiratory failure and metabolic alkalosiscarbonic anhydrase inhibitor therapy may have favorable effects on blood gas parameters. The authors note that this analysis did not provide conclusive results for clinically important outcomes.

In mechanically ventilated patientscarbonic anhydrase inhibitor therapy may decrease the duration of mechanical ventilation. A major limitation was that only two trials assessed this clinically important outcome.

HAP vs VAP treatment: a flowchart

One discussion this week involved treatment for hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP).

Reference: Kenny JES. IDSA Guidelines 2016: HAP, VAP & It’s the End of HCAP as We Know It (And I Feel Fine) [website]. 2016 Jul 30. Retrieved from https://pulmccm.org/infectious-disease-sepsis-review/idsa-guidelines-2016-hap-vap-end-hcap-know-feel-fine/

Summary: “While the current [IDSA 2016] guidelines discuss a number of issues germane to HAP and VAP including: microbiological evaluation, ventilator-associated tracheobronchitis, the use of biomarkers and clinical prediction scores, inhaled antibiotics, etc. this post will focus on standard, empiric therapy as this is a common clinical quandary [see figure 1]” (Kenny 2016).

hap vap

“The current guidelines recommend 7 days of antimicrobial therapy for both HAP and VAP.  The authors conducted their own meta-analysis and found no difference in mortality or recurrence between long and short-courses of therapy.  This is incongruent with an often referenced trial in 2003 which noted a higher pneumonia recurrence rate if non-fermenting gram negative bacilli [e.g. pseudomonas] were isolated and patients were treated with 8 days versus 15 days of anti-microbials” (Kenny 2016).

Will there be positive neurological outcomes after ECMO resuscitation?

One discussion this week involved neurological outcomes following ECMO resuscitation.


Reference: Ryu JA, et al. Predictors of neurological outcomes after successful extracorporeal cardiopulmonary resuscitation. BMC Anesthesiology. 2015 Mar 8;15:26. doi: 10.1186/s12871-015-0002-3

Summary: Extracorporeal membrane oxygenation (ECMO) is a useful intervention for refractory cardiogenic shock and respiratory failure. Because ECMO implementation can rapidly normalize circulation in patients under cardiac arrest, it has been used to assist cardiopulmonary resuscitation (CPR). Using traditional chest compression is less effective than using ECMO with CPR (known as extracorporeal CPR or ECPR). ECPR can achieve more effective recovery of spontaneous circulation (ROSC) than conventional CPR.

Since the brain is the organ most vulnerable to hypoxia and inadequate perfusion, ECPR can result in severe neurologic deficits if ECMO is not performed promptly. In addition to delay, several factors may lead to poor neurological outcomes after ECPR. Achieving good neurological outcomes and successful resuscitation are important, so the authors investigated predictors of favorable neurological outcomes rather than survival after ECPR.

The study’s primary endpoint was neurological outcome at hospital discharge, assessed with the Glasgow-Pittsburgh Cerebral Performance Categories (CPC) scale (1 to 5, as shown in Table 1). CPC 1 and 2 were classified as good neurological outcomes. CPC 3, 4, and 5 were considered poor neurological outcomes.

Of 115 patients, 68 (59%) had good neurological outcomes but 47 (41%) did not (Figure 2). Therapeutic hypothermia was performed in 10 patients (5%). Mean duration of ECMO support was 47.5 (range 18.5–101) hours. Total length of stay in intensive care unit (ICU) was 11 (range 7–22.5) days and 24 patients died from brain death.

Univariate analysis showed no differences between the good and poor neurological outcome groups for age, comorbidities, bystander CPR, therapeutic hypothermia, total bilirubin, creatinine, 24-hour lactic acid clearance, ROSC before ECMO, or ROSC time (Table 2).

Multivariate analysis revealed neurological outcomes were affected by hemoglobin level, serum lactic acid before ECMO insertion, and interval from cardiac arrest to ECMO (Figure 3). However, age, gender, cardiac arrest out of the hospital, hemoglobin level after ECMO, acute coronary syndrome, initial shockable rhythm, and CPR duration were not independent predictors of neurological outcomes (Table 3).

Risk factors for aspiration in community-acquired pneumonia

One discussion this week involved the risk factors for aspiration in community-acquired pneumonia (CAP).

References: Komiya K, et al. Prognostic implications of aspiration pneumonia in patients with community acquired pneumonia: A systematic review with meta analysis. Scientific Reports. 2016 Dec7;6:38097. doi: 10.1038/srep38097

Taylor JK et al. Risk factors for aspiration in community-acquired pneumonia: analysis of a hospitalized UK cohort. American Journal of Medicine. 2013 Nov;126(11):995-1001. doi:10.1016/j.amjmed.2013.07.012.

Summary: Aspiration pneumonia can be defined as pneumonia in patients who have aspiration risk. Komiya et al (2016) list the following as risk factors for aspiration:

  • impaired consciousness
  • chronic neurological disease
  • weakness
  • swallowing difficulties
  • esophageal dysfunction or mechanical obstruction
  • aspiration witnessed during eating or vomiting
  • sedation

Overt aspiration is generally not witnessed, and aspiration alone cannot fully explain the development of pneumonia. Most healthy subjects passively aspirate oropharyngeal secretions during night, but their cough reflex, mucociliary clearance, and immune system usually prevents the development of pneumonia (Komiya et al, 2016).

In their observational study of 1348 patients with CAP, Taylor et al (2013), while also listing the factors above, noted these additional risk factors:

  • older (above 60-84, median of 74 years)
  • comorbidities of chronic liver disease, congestive heart failure, and stroke

Komiya et al’s (2016) systematic review findings suggest that aspiration risk is associated with greater in-hospital and 30-day mortality in subjects with CAP except, perhaps, in the ICU setting. Although there are insufficient data to perform a meta-analysis on long-term mortality, recurrent pneumonia, and hospital readmission, the few reported studies suggest that aspiration pneumonia is also associated with these outcomes.

 

Laparoscopic sleeve gastrectomy vs laparoscopic Roux-en-Y gastric bypass on weight loss: Two RCTs

A discussion in December included gastric bypass versus sleeve gastrectomy.

References: Peterli R, et al. Effect of laparoscopic sleeve gastrectomy vs laparoscopic Roux-en-Y gastric bypass on weight loss patients with morbid obesity: the SM-BOSS randomized clinical trial. JAMA. 2018 Jan 16;319(3):255-265. doi:10.1001/jama.2017.20897

Salminen P, et al. Effect of laparoscopic sleeve gastrectomy vs laparoscopic Roux-en-Y gastric bypass on weight loss at 5 years among patients with morbid obesity: the SLEEVEPASS randomized clinical trial. JAMA. 2018 Jan 16;319(3):241-254. doi:10.1001/jama.2017.20313

Summary: Published in the same issue of JAMA, these two trials – one in Switzerland, one in Finland – provide thorough insight into comparing the sleeve and gastric bypass for weight loss in morbidly obese patients. To be consice, the study designs, results, and conclusions are quoted below.

SM-BOSS trial – clinicaltrials.gov Identifier: NCT00356213

DESIGN, SETTING, AND PARTICIPANTS: The Swiss Multicenter Bypass or Sleeve Study (SM-BOSS), a 2-group randomized trial, was conducted from January 2007 until November 2011 (last follow-up in March 2017). Of 3971 morbidly obese patients evaluated for bariatric surgery at 4 Swiss bariatric centers, 217 patients were enrolled and randomly assigned to sleeve gastrectomy or Roux-en-Y gastric bypass with a 5-year follow-up period.

RESULTS: Among the 217 patients (mean age, 45.5 years; 72% women; mean BMI, 43.9) 205 (94.5%) completed the trial. Excess BMI loss was not significantly different at 5 years: for sleeve gastrectomy, 61.1%, vs Roux-en-Y gastric bypass, 68.3% (absolute difference, −7.18%; 95% CI, −14.30% to −0.06%; P = .22 after adjustment for multiple comparisons). Gastric reflux remission was observed more frequently after Roux-en-Y gastric bypass (60.4%) than after sleeve gastrectomy (25.0%). Gastric reflux worsened (more symptoms or increase in therapy) more often after sleeve gastrectomy (31.8%) than after Roux-en-Y gastric bypass (6.3%). The number of patients with reoperations or interventions was 16/101 (15.8%) after sleeve gastrectomy and 23/104 (22.1%) after Roux-en-Y gastric bypass.

CONCLUSIONS AND RELEVANCE: Among patients with morbid obesity, there was no significant difference in excess BMI loss between laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass at 5 years of follow-up after surgery.

SLEEVEPASS trial – clinicaltrials.gov Identifier: NCT00793143

DESIGN, SETTING, AND PARTICIPANTS: The Sleeve vs Bypass (SLEEVEPASS) multicenter, multisurgeon, open-label, randomized clinical equivalence trial was conducted from March 2008 until June 2010 in Finland. The trial enrolled 240 morbidly obese patients aged 18 to 60 years, who were randomly assigned to sleeve gastrectomy or gastric bypass with a 5-year follow-up period (last follow-up, October 14, 2015).

RESULTS: Among 240 patients randomized (mean age, 48 [SD, 9] years; mean baseline body mass index, 45.9, [SD, 6.0]; 69.6% women), 80.4% completed the 5-year follow-up. At baseline, 42.1% had type 2 diabetes, 34.6% dyslipidemia, and 70.8% hypertension. The estimated mean percentage excess weight loss at 5 years was 49% (95% CI, 45%-52%) after sleeve gastrectomy and 57% (95% CI, 53%-61%) after gastric bypass (difference, 8.2 percentage units [95% CI, 3.2%-13.2%], higher in the gastric bypass group) and did not meet criteria for equivalence. Complete or partial remission of type 2 diabetes was seen in 37% (n = 15/41) after sleeve gastrectomy and in 45% (n = 18/40) after gastric bypass (P > .99). Medication for dyslipidemia was discontinued in 47% (n = 14/30) after sleeve gastrectomy and 60% (n = 24/40) after gastric bypass (P = .15) and for hypertension in 29% (n = 20/68) and 51% (n = 37/73) (P = .02), respectively. There was no statistically significant difference in QOL between groups (P = .85) and no treatment-related mortality. At 5 years the overall morbidity rate was 19% (n = 23) for sleeve gastrectomy and 26% (n = 31) for gastric bypass (P = .19).

CONCLUSIONS AND RELEVANCE: Among patients with morbid obesity, use of laparoscopic sleeve gastrectomy compared with use of laparoscopic Roux-en-Y gastric bypass did not meet criteria for equivalence in terms of percentage excess weight loss at 5 years. Although gastric bypass compared with sleeve gastrectomy was associated with greater percentage excess weight loss at 5 years, the difference was not statistically significant, based on the prespecified equivalence margins.

Early versus delayed cholecystectomy

A discussion in December compared early versus delayed cholecystectomy.

References: Ackerman J, et al. Beware of the interval cholecystectomy. The Journal of Trauma and Acute Care Surgery. 2017 Jul;83(10):55-60. doi: 10.1097/TA.0000000000001515.

Gurusamy KS, Davidson C, Gludd C, Davidson BR. Early versus delayed laparoscopic cholecystectomy for people with acute cholecystitis (Review). Cochrane Database of Systematic Reviews. 2013 Jun 30;(6):CD005440. doi:10.1002/14651858.CD005449.pub3.

Summary: Cochrane’s review on early vs delayed cholecystectomy included 6 trials and 488 individuals. Of those, 244 received laparoscopic cholecystectomy early (within 7 days of presentation), while the remaining 244 received it at least 6 weeks after index admission with acute cholecystitis. The primary conclusion is that “based on information from a varied number of participants as well as trials at high risk of bias, early laparoscopic cholecystectomy during acute cholecystitis appears safe and shortens the total hospital stay [by 4 days]” (p.2).

There was no significant difference in operating time. Only one of the trials measured time to return to work, nothing that patients in the early group returned to work an average of 11 days earlier than the delayed group. Four trials did not report any gallstone-related complications; one trial reported five, including two people with cholangitis. In five trials, one-sixth of people in the delayed group had either non-resolution or recurrence of symptoms before their planned operation and had to have emergency laparoscopic cholecystectomy (p.6).

Using the terms immediate and interval, Ackerman et al (2017) conducted a retrospective cohort analysis to quantify the morbidity and mortality associated with a delayed, or interval cholecystectomy (IC). Of all patients admitted to 7 hospitals within the same healthcare system, 337 had percutaneous cholecystostomy (PC), 177 (52.5%) of those also had an interval cholecystectomy (IC). The table below illustrates the outcomes:

ic outcomes

(Ackerman et al, 2017, p.57)