Penn Evidence-Based Literature Review (PEBLR)

Summarized highlights from contemporary literature in surgical and allied disciplines for general surgery residents.

Colorectal Surgery

Quality-of-Life and Recurrence Outcomes Following Laparoscopic Elective Sigmoid Resection vs Conservative Treatment Following Diverticulitis: Prespecified 2-Year Analysis of the LASER Randomized Clinical Trial
Santos A, Mentula P, Pinta T, Ismail S, Rautio T, et al. and JAMA Surg. 2023 Apr 19 (PubMed)
Contributor: Ricky Straker

Brief Synopsis

This multicenter open-label randomized clinical trial in patients with recurrent, complicated, or persistent painful diverticulitis found that elective sigmoid resection resulted in improved quality of life compared to conservative treatment within 2 years.

Summary: Acute diverticulitis is one of the most common gastrointestinal problems requiring medical treatment. Although both complicated and uncomplicated acute episodes can be treated non-operatively, it has the tendency to recur or cause persistent pain. Elective sigmoidectomy, often able to be performed laparoscopically, can be used to reduce the risk of recurrence and to treat persistently painful diverticulitis. However, limited data is available comparing long-term quality of life outcomes between patients who undergo surgery versus those who continue non-operative management. The Laparoscopic Elective Sigmoid Resection vs Conservative Treatment Following Diverticulitis trial aimed to address this question, with one- and two-year follow-up data now available. 

Eighty-five patients were randomized, of which 75 and 70 had available QOL outcomes at one year and two years, respectively, and 79 and 78 had available recurrence outcomes at 1 year and 2 years, respectively. At one year, the mean QOL score was 9.5 points higher in the surgery group as compared to the non-operative management group (p=0.03). At 2 years, the QOL score was 7.5 points higher in the surgery group, although the statistical significance of this difference was lost (p=0.07). At 2 years, 25 patients (61%) who underwent non-operative management had recurrent diverticulitis, as compared to only 4 patients (11%) in the surgery group. At 2 years, patients in the surgery group were more satisfied and reported significantly less frequent and less intense pain. 

Although overall quality of life at 2 years did not remain significantly better for those who underwent surgery as compared to those who were treated non-operatively, recurrent diverticulitis was significantly less frequent, and pain was significantly improved in the surgery group. These results can be used to provide additional information regarding surgery versus conservative management for patients considering their treatment options for recurrent or complicated diverticulitis.

Cardiothoracic Surgery

Total arch replacement using a frozen elephant trunk device: Results of a 1-year US multicenter trial
Coselli JS, Roselli EE, Preventza O, Malaisrie SC, Stewart A, et al. and J Thorac Cardiovasc Surg. 2022 Sep 6 (PubMed)
Contributor: Matthew Brown, Mallory Hunt

Brief Synopsis

Use of the Thoraflex Hybrid device (Termuo Aortic) to treat complex aortic arch disease was associated with similar or better rates major adverse events (death, stroke, spinal cord ischemia) at one year as compared to the traditional elephant trunk technique. 

Summary: Over the last two decades, total arch replacement with the classic frozen elephant trunk technique has become the treatment of choice for complex aortic arch disease. This technique involves open replacement of the ascending/arch in the typical open fashion while also deploying a self-expandable stent graft into the descending thoracic aorta. The stent graft component serves to protect from aneurysmal changes at the distal suture line while also providing a reliable landing zone for future thoracic endovascular grafts. Until recently, frozen elephant trunks were fashioned on the back table using readily available components because there was not an FDA approved device available in the United States. The Thoraflex Hybrid is a recently FDA-approved manufactured device designed specifically to function as a single-stage frozen elephant trunk. The purpose of this trial was to evaluate the safety and 1-year clinical outcomes as measured by rate of permanent stroke, permanent paraplegia/paralysis, unanticipated aortic reoperation, and all-cause mortality associated with the Thoraflex Hybrid. 

Seventy-four patients across 12 U.S. medical centers were enrolled in the trial. Patients were categorized as being in the primary study group if they had aortic acute or chronic dissection or aneurysm. Patients with aortic rupture or high risk of imminent rupture and were analyzed separately. In the primary study group 27 patients had aneurysm only and 37 had chronic dissection. 

In the primary study group, 7 (11%) patients died, 3 (5%) patients suffered permanent stroke or paralysis respectively. In the rupture group 1 patient died (14%) and 2 (29%) patients had permanent stroke.   

While no direct comparisons were made to the classic frozen elephant technique in this study, the data reported is similar or better to the outcomes reported in numerous publications examining the classic frozen elephant trunk technique. Specifically, past trials have of the classic frozen elephant trunk technique has reported stroke rates ranging from 2-8% and early death from 7-17%. 

In summary, the Thoraflex Hybrid offers cardiac surgeons a safe, prefabricated single-staged option for the treatment of complex aortic arch disease. Early outcomes are encouraging but head-to-head trials are required to compare the long-term outcomes and durability with the classic frozen elephant trunk technique.

Pediatric Surgery

Association of Gangrenous, Suppurative, and Exudative Findings with Outcomes and Resource Utilization in Children with Nonperforated Appendicitis
Cramm SL, Lipskar AM, Graham DA, Kunisaki SM, Griggs CL, et al. and JAMA Surg. 2022 Aug 1;157(8):685-692 (PubMed)
Contributor: Valerie Luks

Brief Synopsis

This multi-center cohort study in children with non-perforated appendicitis found that findings of gangrene, suppuration, or exudate were associated with increased surgical site infection and resource utilization.

Summary: Disease severity of appendicitis, the most common indication for emergent surgery in children, ranges from mild inflammation to frank perforation and peritonitis. While management for more severe cases universally includes an inpatient stay and IV antibiotics, most surgical cases receive perioperative antibiotics and brief hospital observation prior to discharge. The Eastern Pediatric Surgery Network (EPSN) research consortium sought to evaluate whether the presence of gangrenous, suppurative, or exudative (GSE) findings in patients with nonperforated appendicitis is associated with increased risk of complications. 

The study was performed retrospectively, included patients with nonperforated appendicitis at 15 tertiary pediatric hospitals associated with EPSN, and used information obtained from the NSQIP-Pediatric database. Operative notes from each surgery were evaluated for mention of GSE by 2 independent blinded surgeon reviewers with overall 93.3% agreement on severity classification. 

Between 2015-2020, 6,133 children with nonperforated appendicitis were included in the study, of which 867 (14.1%) had findings of GSE. There was a 91% increased odds of surgical site infection and a 2.2-fold increased risk of organ space infection if GSE was present. Length of stay was significantly longer, 0.9 vs 1.6 days. Additionally, patients with GSE had a 70% increased risk of needing postoperative abdominal imaging, though there was no associated increased rate of return to ED. 

The importance of this study lies in the potential to standardize and optimize management of the ‘gray area’ of appendicitis – namely it is the first step toward identifying which patients might benefit from additional post operative antibiotics.  While some of the outcomes in this study may not be clinically significant (for instance a 0.9 vs 1.6-day length of stay which could equally be related to surgeon preference or to time of day of the operation), a 2.2-fold increased risk of organ space infection and need for additional intervention are substantial morbidities associated with a very common procedure. Similarly, while a 5% risk of needing additional post operative abdominal imaging seems low, given the incidence of cases, this translates into a significant increase in health care utilization and radiation exposure for children. 

Interestingly, the range of GSE findings between the 15 hospitals ranged from 4-30%. Given the limitations of a database study there is no provided explanation, whether due to use of templates for operative notes or other norms at specific institutions. Additionally, the 15 institutions were largely tertiary academic stand-alone children’s hospitals. These circumstances likely limit the generalizability of these findings. Regardless, these initial findings will hopefully guide prospective studies to stratify disease severity and determine the need for additional treatment in children with appendicitis.

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