Bile duct clearance and cholecystectomy for choledocholithiasis: Definitive single-stage laparoscopic cholecystectomy with intraoperative endoscopic retrograde cholangiopancreatography versus staged procedures. Bass GA, Pourlotfi A, Donnelly M, Ahl R, McIntyre C, Flod S, Cao Y, McNamara D, Sarani B, Gillis AE, Mohseni S. J Trauma Acute Care Surg. 2021 Feb 1;90(2):240-248.
Summary: There is equipoise in the optimal sequence in the definitive management of choledocholithiasis. This study seeks to compare interval biliary ductal clearance and cholecystectomy to simultaneous “laparoendoscopic” management in one theater visit. The authors perform a retrospective, nonrandomized, observational study of two large, publicly funded European tertiary-referral university hospitals with emergency surgery coverage, one in Sweden and one in Ireland. It should be noted that both countries provide universal health care for all its citizens. Simultaneous therapy was provided in Sweden while in Ireland patients underwent index admission ERCP and then were readmitted for interval ‘day-surgery’ laparoscopic cholecystectomy. Simultaneous therapy was defined by an initial dissection identifying the cystic duct, subsequent intraoperative cholangiography, and when a stone is identified, endoscopy performed employing a “rendezvous” technique while supine. This is followed by clearance of the stone and then sphincterotomy. 357 Patients were enrolled during the study period (222 simultaneous, 135 two stage). The primary outcome studied was the incidence of major 30-day postoperative complications, with the only statistically significant finding of urinary retention rates higher in the simultaneous group. There was no significant difference between the two strategies in terms of Clavien-Dindo Grade 3 or 4 complications. As expected, the single stage cohort experience a shorter mean post-procedure LOS and total LOS in spite of the fact that the single stage cohort has a significantly higher age-adjusted Charlson Comorbidity Index.
Take away: The authors conclude current data “suggests” that there may be benefits for patients in the application of simultaneous management (single-stage approach of index-admission laparoscopic cholecystectomy with intraoperative ERCP) once a protocol is established and the institution is “adequately resourced.” There is the suggested possibility of then improving patient flow, cost savings, bed occupancy rates through shortened length of stay, and fewer need for readmissions, but more needs to be studied before making these kinds of definitive conclusions.
Trauma and nontrauma damage-control laparotomy: The difference is delirium (data from the Eastern Association for the Surgery of Trauma SLEEP-TIME multicenter trial). McArthur K, Krause C, Kwon E, Luo-Owen X, Cochran-Yu M, Swentek L, Burruss S, Turay D, Krasnoff C, Grigorian A, Nahmias J, Butt A, Gutierrez A, LaRiccia A, Kincaid M, Fiorentino MN, Glass N, Toscano S, Ley E, Lombardo SR, Guillamondegui OD, Bardes JM, DeLa'O C, Wydo SM, Leneweaver K, Duletzke NT, Nunez J, Moradian S, Posluszny J, Naar L, Kaafarani H, Kemmer H, Lieser MJ, Dorricott A, Chang G, Nemeth Z, Mukherjee K. J Trauma Acute Care Surg. 2021 Jul 1;91(1):100-107.
Summary: The utilization of damage control laparotomy (DCL) in emergency general surgery patients is increasing. What is not well described is how patient demographics and outcomes differ between trauma (T) and non-trauma (NT) patients relating to the use of DCL. The authors reviewed retrospective data from 15 centers for a 2-year period as part of the EAST MCT entitled “Sedation Level after Emergency Exlap with Packing-TIME to Primary Fascial Closure (SLEEP-TIME),” which focuses on the endpoints of mortality and delirium. They hypothesized that mortality and delirium would both be elevated in the NT cohort due to inherent differences in age and baseline comorbidities. Analysis identified that mortality and discharge disposition were similar between NT and T cohorts and the NT cohort had significantly higher incidence of postoperative abdominal sepsis and need for dialysis. The authors used a surrogate marker of freedom-from-delirium calculated in a manner that avoids bias from the heterogeneity in ICU length of stay employing the Richmond Agitation Sedation Score and the CAM-ICU. Employing this strategy, they identify that there was a higher incidence of delirium in the T cohort, despite the T cohort being younger and the mortality and ICU utilization being similar to the NT cohort. ANOVA suggests though that in particularly severe traumatic brain injury cases, the injury may play a role.
Take away: In spite older age and more comorbidities, T and NT cohorts in DCL had similar mortality rates and discharge dispositions. NT cohort had an appreciated higher incidence of post-operative abdominal sepsis and need for dialysis. The incidence of delirium was identified to be higher in the T cohort possibly influenced by traumatic brain injury. Confounding this is the fact that several centers did not record CAM-ICU scores that altered sample size when examining delirium. The heterogeneity in critical care management practices was also acknowledged to limit the impact of the finding.
Frail geriatric patients with acute calculous cholecystitis: Operative versus nonoperative management?
Asmar S, Bible L, Obaid O, et al. J Trauma Acute Care Surg. 2021;91(1):219-225.
Dr. Asmar and colleagues publish their work on assessing outcomes after operative and nonoperative management of elderly cholecystitis patients. The key factor here is that all the geriatric patients included in the study are frail - and therefore would likely be considered poor or prohibitive operative risk.
A retrospective cohort analysis was performed of elderly patients (age ≥65) who were assessed to be frail using the modified Frailty Index, and were admitted with a primary diagnosis of acute cholecystitis (i.e. these are not patients already admitted for other medical conditions who develop cholecystitis during the course of their management) using the Nationwide Readmissions Database (NRD). Patients were subsequently stratified as those who underwent operative management or those who did not (i.e. antibiotics alone, or antibiotics in combination with percutaneous cholecystostomy). The primary outcomes were procedure-related complications in the operative group (which included technical complications as well as episodes of physiologic decompensations such as procedure-related cardiovascular or cerebrovascular complications) and 6-month failure in the nonoperative group. Secondary outcomes were mortality and overall hospital length of stay.
Of over 27,000 patients, 61.6% of patients underwent a cholecystectomy while 38.4% underwent non-operative management. Although the level of frailty was comparable between the two groups, the operative group had an increased number of patients in the 65- to 74-year age group (i.e. younger) and more patients suffering hypertension and diabetes mellitus (as compared to other comorbidities such as chronic liver or kidney disease) compared to patients managed nonoperatively. The group's findings were that the rate of 6-month failure of non-operative management was 18.9% and the median time to said failure was 36 days. In addition, 6-month mortality was higher in the non-operative group (5.2% vs. 3.2%) and with a longer hospital length of stay (8 vs. 5).
The authors conclude that despite accounting for frailty, illness severity, and comorbidities - classically reasons to consider patients to be unfit for surgery - patients did better when they underwent an operation. The findings of this paper corroborate other studies on the topic including the CHOCOLATE randomized trial. This reproducibility of outcomes is important in the context of interpreting the results of this retrospective study. Since no randomization occurred, some confounding bias must be assumed. Similarly, the exact cause of death for these patients is unknown and only a correlation, not causation, may be noted between these deaths and nonoperative management. In conclusion, Dr. Asmar’s group provides a high-fidelity retrospective study that updates our knowledge on the care of patients with cholecystitis who may generally be considered of high or prohibitive surgical risk.
A Randomized Clinical Trial Evaluating the Efficacy and Quality of Life of Antibiotic-only Treatment of Acute Uncomplicated Appendicitis - Results of the COMMA Trial. O'Leary DP, Walsh SM, Bolger J, et al. Ann Surg. 2021;274(2):240-247.
Dr. O’Leary and colleagues recently published the COMMA randomized trial examining the efficacy of as well as the quality of life associated with non-operative management of uncomplicated appendicitis. Their study is a single-center trial conducted at an acute hospital in Dublin, Ireland. They included patients aged 16 or above who presented with clinical signs of acute appendicitis that was then confirmed with radiographic imaging (Ultrasound with or without MRI, or CT imaging). Patients with complicated appendicitis (which included patients with a fecalith, abscess, and/or perforation) were excluded. Patients were randomized to undergo laparoscopic appendectomy (no open procedures) or antibiotics-only therapy. The latter entailed inpatient IV antibiotics until clinical improvement followed by five days of oral therapy. Their primary endpoint in the nonoperative management arm was recurrence rate of appendicitis at 1-year. Secondary endpoints were quality of life, cost, and length of stay. This trial adds more data to an area where data is lacking and of poor quality as demonstrated by the EAST PMG on the topic unable to make a recommendation for or against antibiotics-first in the management of acute uncomplicated appendicitis.
Ultimately, the authors note that the success rate of nonoperative management at one year was only 74.7% (which excluded recurrences which occurred after a year) compared to a 100% success rate in the operative arm. Quality of life was evaluated using telephone surveys at 1 week, 1 month, 3 months, and 12 months. After the 1 week and 1 month assessments, surgery patients had consistently superior quality of life scores with a higher number of patients claiming to be at full health at the 12 month mark. As has been demonstrated in other trials, the cost associated with antibiotics-only treatment is lower as long as patients with recurrences are excluded though, as expected, the management of failures of nonoperative management is more expensive than those who undergo surgery upfront.
This new RCT adds to the relevant literature on the management of acute uncomplicated appendicitis. Unlike similar studies, all the patients in the surgical arm underwent only laparoscopic appendectomy (a superior procedure from a quality of life perspective to open appendectomy) as well as a thorough evaluation of patients’ quality of life characteristics in both arms. In summary, this RCT shows that patients with uncomplicated appendicitis managed nonoperatively have a higher than acceptable recurrence rate (over one in four within a year) and an inferior quality of life.