Article 1
Laparoscopic cholecystectomy versus percutaneous catheter drainage for acute cholecystitis in high risk patients (CHOCOLATE): multicentre randomised clinical trial. Loozen, C.S., H.C. van Santvoort, P. van Duijvendijk, M.G. Besselink, D.J. Gouma, G.A. Nieuwenhuijzen, J.C. Kelder, S.C. Donkervoort, A.A. van Geloven, P.M. Kruyt, D. Roos, K. Kortram, V.N. Kornmann, A. Pronk, D.L. van der Peet, R.M. Crolla, B. van Ramshorst, T.L. Bollen, and D. Boerma. BMJ. 2018 Oct 8;363:k3965
Although the majority of cases of acute cholecystitis are now best managed by early laparoscopic cholecystectomy (LC), there remains a subset of patients who may be better temporized (or even definitively managed) with drainage of the gallbladder via percutaneous cholecystostomy (PC). This is most commonly utilized in the patient who is felt to be at high risk for surgical intervention, typically due to advanced age, severe baseline medical comorbidities, or acute disease burden (such as myocardial infarction) that is a relative contraindication to surgery. However, there are no well-validated criteria or scoring systems to help the surgeon in selecting between LC versus PC in these scenarios, and prior to this study there had been no Level 1 evidence comparing early surgery versus PC.
The authors performed a very well-designed and executed prospective randomized trial at 11 hospitals in the Netherlands over a 5-year period. 142 “high risk” patients with calculous cholecystitis were randomized to either early LC versus PC within 24 hours and then followed for one-year. The primary endpoints were mortality or reinterventions within one year, and infectious or cardiopulmonary complications within one month. LC was performed in 97% of patients assigned to that arm, with a 17% incidence of conversion to open cholecystectomy. PC was performed in all patients assigned to that arm, with one patient requiring emergent open cholecystectomy due to gallbladder perforation. The endpoint analysis was firmly in favor of the LC arm; with major complications of 12% with LC versus 65% for PC, reintervention rates of 12% for LC versus 66% for PC, recurrent biliary disease of 5% versus 53%, and no different in infectious and cardiopulmonary complications. LC was also associated with a significantly shorter hospital stay, reduced ER visits, reduced readmission rates, and lower average medical costs.
This study is the first randomized trial comparing PC to LC in a high-risk patient population, and significantly challenges the dogma that PC is a safe and effective temporizing or definitive treatment modality in this cohort. The PC group had statistically and clinically significant elevated rates of adverse outcomes and need for reinterventions and rehospitalizations, again challenging the dogma that proceeding to early LC in these higher risk patients results in unacceptably high rates of adverse outcomes. In addition, although there was no statistically significant mortality difference, the mortality was three-fold higher in the PC arm (9% vs 3% for LC) and two of the PC deaths were as a result of uncontrolled sepsis due to cholecystitis. However, this study should not be interpreted as an open license to proceed immediately to surgery on all high-risk patients. The study protocol actually excluded the highest risk patients: those with APACHE scores >/= 1, symptoms > 7 days, and those admitted to an ICU at the time of cholecystitis diagnosis. It does provide compelling evidence that many of the patients that are being called “high risk” and managed with PC are probably better off proceeding to early LC, but that PC still has a role in those who are severely ill or comorbid.
Article 2
Two-year results of the randomized clinical trial DILALA comparing laparoscopic lavage with resection as treatment for perforated diverticulitis. Kohl, A., J. Rosenberg, D. Bock, T. Bisgaard, S. Skullman, A. Thornell, J. Gehrman, E. Angenete, and E. Haglind. Br J Surg. 2018 Aug;105(9):1128-1134.
The management of acute diverticulitis has become increasingly complicated over the past decade as the number of treatment options have expanded and new data and guidelines have been developed. For “perforated” diverticulitis, characterized as Hinchey grade III or IV for this discussion, the acute care surgeon is now faced with a number of surgical options including the traditional Hartmann’s procedure, open or laparoscopic resection and anastomosis with or without diverting loop ileostomy, or the more recently touted option of laparoscopic lavage (LL). Early retrospective series reported a high success rate with this procedure, which avoided an emergent resection (and need for a stoma) and facilitates delaying surgical resection to the elective setting. However, the DILALA trial is one of three major randomized studies of LL that have reported conflicting results in terms of efficacy and outcomes and fueled ongoing debate about when, how, or even if we should be using this procedure.
This study reports the DILALA Trial results with the inclusion of longer-term (2-year) follow-up data, which had been a noted weakness in the literature to date on this topic. 139 patients from nine centers in Sweden and Denmark underwent exploratory laparoscopy with 83 randomized to either LL or open Hartmann’s procedure (HP) upon confirmation of Hinchey III diverticulitis. The primary and main secondary outcome measures were the need for secondary operations, number and types of secondary operations, readmissions, mortality, and presence of a stoma at 24 months. Patients randomized to LL had a 45% risk reduction for secondary operations and required fewer total reoperations. There were no differences in readmissions or mortality, but only 7% in the LL group had a stoma at 24 months versus 23% in the HP group. The authors conclude that LL can be a safe and definitive option for treatment of Hinchey III diverticulitis, and that the reduced risks of secondary operations or stoma formation are a major benefit with this approach.
Parsing the current literature on LL for diverticulitis can be exceedingly difficult as there are three randomized trials (DILALA, Ladies/LOLA, and SCANDIV) which have reported somewhat conflicting results, largely due to differences in the categorization of outcome measures and how they are grouped or weighted. For example, percutaneous abscess drainage is coded as a complication in one study but as a reoperation in another. In addition, there are now at least 7 meta-analyses on this topic, which also have come to conflicting conclusions even when analyzing the same group of studies. The main arguments against LL have resulted from findings of higher reintervention rates, but again these are highly dependent on what qualifies as a “reintervention”, whether reoperation for stoma closures is included in the analysis, and the duration of follow-up. In the Ladies/LOLA initial report there was a higher reintervention rate for LL at 30 days, but the subsequent 1-year data showed no difference. It should also be understood that a much more minimal procedure like LL will have a naturally higher failure or reintervention rate versus a formal sigmoid resection. This is not a reason to abandon the procedure and advocate routine resectional surgery, particularly if it avoids emergent colectomy and a stoma in a large percentage of patients. Thus, LL should continue to have a role in the armamentarium of the acute care surgeon for select patients with Hinchey III diverticulitis, particularly in comparison to the Hartmann’s procedure with its attendant morbidity and adverse impact on quality of life. Remaining questions include whether LL would have the same benefits if compared to surgery with an aggressive approach to primary anastomosis without the use of colostomy or diverting loop ileostomy, and identifying the most effective technical approach to LL to better standardize this procedure.
Article 3
Are we doing too many non-therapeutic laparotomies in trauma? An analysis of the National Trauma Data Bank. Shamim AA, Zeineddin S, Zeineddin A, Olufajo OA, Mathelier GO, Cornwell Iii EE, Fullum T, Tran D. Surg Endosc. 2020 Sep;34(9):4072-4078.
Negative laparotomies (NL) for trauma have morbidity characteristics of therapeutic laparotomies, including but not limited to surgical site infections (SSI), incisional hernias, pneumonia, and lengthy hospitalizations. Diagnostic laparoscopy (DL) is an established alternative to open explorations, and numerous studies have documented an improved morbidity profile and diagnostic efficacy compared to laparotomy. The data supporting laparoscopy, however, is limited primarily to single-institution studies that lack generalizable application. The authors of this study address this critical deficit by using the national trauma data bank (NTDB) to evaluate and compare outcomes between patients with negative laparotomies to patients evaluated with diagnostic laparoscopy for suspected intra-abdominal injuries.
A total of 118,117 patients who underwent abdominal surgery for trauma comprised the initial study group, spanning 2010-2015. The final comparison groups were 3197 for NL and 1323 for DL. Inclusion criteria involved patients with an AIS of zero in the abdomen and pelvis, an AIS <3 in other body regions with an ISS of <16. Exclusion criteria were patients with hemodynamic instability, conversion from DL to laparotomy, and any non-abdominal procedures.
Patients were older in the DL group (mean age: 35 vs. 31, P < 0.001), and mechanisms were different (86 penetrating in DL vs. 77% in NL, P < 0.001). Concomitant injuries showed differences between spine and extremity injuries being higher in the NL group (7.4% vs. 3.2% and 37% vs. 29%, respectively, P < 0.001). Thoracic injury was higher in the DL group (49 vs. 37%, P < 0.001). Insurance status was similar between the groups, and care given in a level I trauma center was (71% NL vs. 74 DL, P=0.158).
In-house, mortality, the median length of stay, and major complications were lower in the DL group compared to NL, P<0.01, (mortality 0.6% vs. 4.5%, 3 days vs. 5 days, and 2% vs. 7.5%) respectively. Surgical site infections were similar between the groups (0.6% DL vs. 0.69% NL). Notable major complications of Pneumonia, VTE, and ARDS were higher in the NL group compared to DL, P<0.005, (2% vs. 0.8%, 1.3% vs. 0.38%, 1.38% vs. 0.3%) respectively.
This is the first study to evaluate diagnostic laparoscopy versus laparotomy for abdominal trauma using the NTDB. The limitations of this retrospective large data base study include not capturing subjective decisions of DL vs. laparotomy, potential variations in data reporting between facilities, and the lack of long-term outcome data. The data is compelling, however, in documenting favorable outcomes in stable patients managed with minimally invasive surgical exploration for suspected intra-abdominal injuries versus the traditional open laparotomy.
Article 4
Minimally invasive inguinal hernia repair is superior to open: a national database review. Pokala B, Armijo PR, Flores L, Hennings D, Oleynikov D. Hernia. 2019 Jun;23(3):593-599.
Inguinal hernia repairs are the most commonly performed operations for general surgery, and as minimally invasive technology has evolved, many surgeons continue to perform these procedures with open techniques. Although laparoscopic (LIHR) and robotic (RIHR) inguinal hernia repairs are supported in the literature to be safe and generally associated with less perioperative pain and morbidity compared to open procedures, these issues remain contested. Furthermore, there are limited multi-institutional or large database studies with much of the literature focusing on a single surgeon or single institutional data. This study uses a national database to evaluate differences in outcomes and cost metrics comparing LIHR, RIHR, and open inguinal hernia repair (OIHR).
The Vizient Clinical Data Base, comprised of greater than 230 community hospitals and 97% of academic centers, provided data for this study spanning October 2013 to June 2017. A validated severity of illness algorithm for comorbid conditions, demographics, and major diagnosis facilitated classification of disease severity into minor, moderate, and extreme groups. Patients with mild and moderate severity were only included in the final study group to limit variability. Complications, 30-day readmissions, LOS, hospital opiate utilization, and mortality were compared between the study groups. Cost metrics, namely direct cost, were also compared.
The majority of repairs were open (2413, 68%), 540 were LIHR (15.2%), and 594 were RIHR (16.7%). The study groups had demographics that were similar for age, gender, and race. Overall complications were highest in LIHR and lowest in RIHR, (4.4% LIHR, 3.85% OIHR, 0.67% RIHR, P<0.05). Post-operative infections were highest in the open group, and there were no documented infections in the RIHR group, (8.3% OHIR, 0.56% LIHR, 0.0% RIHR, P<0.05). 30-day readmission was similarly highest in the open group (3.61% OIHR, 2.2% LIHR, 0.84% RIHR, P<0.05). Median LOS was highest with open repairs (3.57 OIHR, 2.2 LIHR, 1.75 RIHR, P,0.05). Mortality was low and <1% in all groups. The median direct cost was highest in the robotic group and lowest in the laparoscopic group ($9431 RIHR, $8837 OIHR, $6502 LIHR, P,0.05). Opioid use was highest in the OIHR at 95.9% compared to 93% in LIHR (P=0.003) and 93.8% RIHR (P=0.022).
This study has limitations related to lack of knowledge of hernia characteristics, including technique, size, recurrence, mesh selection, and surgeon experience that may have influenced the chosen surgical approach. Different open techniques, as well as laparoscopic techniques (TEP vs. TAPP) were also not available for comparison. In addition, the cost analysis was not comprehensive of total institutional cost variables. Despite these limitations, this study demonstrated favorable short-term morbidity profiles for minimally invasive approaches to inguinal hernia repairs, including opioid use. Robotic repairs had the best morbidity profiles overall; however, the direct cost was the highest in this group. Further study is needed to elucidate hernia characteristics and the appropriate surgical approaches to optimize outcomes for inguinal hernia repairs as minimally invasive techniques evolve.
