February 2021 - Minimally Invasive Surgery

February 2021
EAST Monthly Literature Review


"Keeping You Up-to-Date with Current Literature"
Brought to you by the EAST Manuscript and Literature Review Committee

This issue was prepared by EAST Career Development Committee Member Prerna Ladha, MBBS and Heath Walden, MD, FACS of the EAST Minimally Invasive Surgery and Emerging Technologies Committee.

Thank you to Haemonetics for supporting the EAST Monthly Literature Review.


In This Issue: Minimally Invasive Surgery and Emerging Technologies

Scroll down to see summaries of these articles

Article 1 reviewed by Prerna Ladha, MBBS
Diaphragm pacing decreases hospital charges for patients with acute cervical spine injury. Kerwin AJ, Diaz Zuniga Y, Yorkgitis BK, Mull J, Hsu AT, Madbak FG, Ebler DJ, Skarupa DJ, Shiber J, Crandall ML. Trauma Surg Acute Care Open. 2020 Dec 21;5(1):e000528.

Article 2 reviewed by Prerna Ladha, MBBS
Laparoscopy Compared with Laparotomy for the Management of Pediatric Blunt Abdominal Trauma. Butler EK, Mills BM, Arbabi S, Groner JI, Vavilala MS, Rivara FP. J Surg Res. 2020 Jul;251:303-310.

Article 3 reviewed by Heath Walden, MD
Patient-Reported Outcomes of Robotic vs Laparoscopic Ventral Hernia Repair With Intraperitoneal Mesh. The PROVE-IT Randomized Clinical Trial. Petro C, Zolin S, Krpata D, Alkhatib H, Tu C, Rosen M, Prabhu A. JAMA Surg. 2021;156(1):22-29.

Article 4 reviewed by Heath Walden, MD
Comparing Laparoscopic Elective Sigmoid Resection With Conservative Treatment in Improving Quality of Life of Patients With Diverticulitis The Laparoscopic Elective Sigmoid Resection Following Diverticulitis (LASER) Randomized Clinical Trial. Santos A, Mentula P, Pinta T, Ismail S, Rautio T, Juusela R, Lähdesmäki A, Scheinin T, Sallinen V. JAMA Surg. 2020 Nov 18; e205151.

Article 1
Diaphragm pacing decreases hospital charges for patients with acute cervical spine injury. Kerwin AJ, Diaz Zuniga Y, Yorkgitis BK, Mull J, Hsu AT, Madbak FG, Ebler DJ, Skarupa DJ, Shiber J, Crandall ML. Trauma Surg Acute Care Open. 2020 Dec 21;5(1):e000528.

Summary: Diaphragm pacing is a treatment where electrodes are imbedded in the diaphragm to help it contract, thus facilitating spontaneous breathing in patients with cervical spinal cord injuries (CSCI). While this procedure has been utilized for approximately two decades with several studies demonstrating its role in liberating patients from the ventilator, one of the biggest roadblocks to its widespread use is its cost. This paper hypothesized that early implantation of diaphragm pacing system (DPS) would decrease hospital costs.
 
This is a single-institution retrospective cohort study which includes patients with spinal cord injuries from 2005-2017. The institution began using laparoscopic DPS implantation in 2011, after which all patients admitted with acute CSCI were evaluated for DPS implantation. Variables studied included age, gender, year of injury, Injury Severity Scale, level of spinal cord injury and Glasgow Coma Scale. Outcome measures were ventilator liberation before discharge, days to liberation, tidal volume change before discharge, and mortality. Costs were normalized to 2016 and the primary outcome of adjusted hospital charges was determined while controlling for confounders.
 
The study reported 40 DPS patients and used propensity scoring to match them to 61 DPS patients who had not received DPS. The level of injury was classified as high (C1-4) or low (C5-7), and two-thirds of patients in each group had a low CSCI. Eighty percent of patients had complete CSCI. The authors found that after DPS implantation, patients had an 88 mL increase in spontaneous Vt compared with decrease of 13 mL Vt in NO DPS group. (p= 0.008). Patients in the DPS group liberated from the ventilator in a mean of 10.1 days compared to NO DPS group, where the mean was 29.2 days. (p<0.001). Average hospital charges in DPS group were $639,093 compared to the average charges in NO DPS group, $784,536. (p=0.003). All these findings were statistically significant.
 
This study is not without limitations. There are a small number of patients included, and the costs studied are total hospital charges, and do not include professional charges for the surgery or inpatient care. The long study period of the study, 2005-2017 may have seen changes in critical care delivery, which could have also factored into outcomes. However, it is the largest single center study of DPS utilization and makes a significant contribution to this body of literature.
 
Take Away:  Diaphragm pacing has been shown to have a positive impact on patients with CSCI by hastening their liberation from the ventilator. A negative consideration when using this treatment modality has been hospital cost. This study showed that there was a cost saving benefit to early implementation of DPS, in addition to its clinical benefits. While there is need for large, multi-center studies to evaluate this modality further, it is important to consider DPS in the comprehensive critical care management of patients with CSCI.

Article 2
Laparoscopy Compared with Laparotomy for the Management of Pediatric Blunt Abdominal Trauma. Butler EK, Mills BM, Arbabi S, Groner JI, Vavilala MS, Rivara FP. J Surg Res. 2020 Jul;251:303-310.

Summary: The role of laparoscopy in trauma surgery is unclear, and there is ongoing controversy regarding its role in the injured patient. This paper hypothesized that laparoscopy in pediatric trauma patients may be associated with shorter hospital stays and fewer perioperative complications compared with laparotomy.

Using the National Trauma Data Bank patients aged <18 years who underwent an abdominal operation for blunt trauma within 48 hours of presentation were included. To ensure that the groups were comparable, patients with hypotension, ISS >25 or a GCS <13 were excluded. Patients were grouped into ‘laparoscopy’, ‘laparotomy’ and ‘laparoscopy converted to laparotomy’. Outcomes measured were hospital length of stay (LOS), ICU LOS, ventilator days, number of abdominal operations, in-hospital mortality, and common complications. Of the 720 patients included, 504 underwent laparotomy and 216 underwent laparoscopy. 21% of the laparotomy group and 28.2% of the laparoscopy group did not receive any therapeutic intervention. In the laparoscopy group, 38.4% were subsequently converted to laparotomy. Not surprisingly, the study found that the laparotomy group was more severely injured with an ISS of 10 compared to 6 in the laparoscopy group and had a higher rate of intubation. Patients in the laparoscopy group were more frequently cared for at pediatric only level I/II centers, likely due to greater comfort levels among the surgeons. The most common injuries found were bowel injury, followed by splenic injury.  Mean hospital LOS was 2.1 days shorter, and ICU LOS was 1.1 days shorter in the laparoscopy group compared to laparotomy group. No differences in postoperative complications were noted, other than 2% lower mean probability of surgical site infection.
 
By excluding severely injured patients and including only stable patients with blunt trauma mechanism, the study compared similar groups and eliminated many confounders. Of the laparoscopic procedures 28.4% were non-therapeutic, which translates to the number of negative laparotomies avoided. While the small number of patients limits the power of the study, the number of missed injuries was comparable in both groups, contrary to popular belief.
 
Take Away: Utilization of laparoscopy in trauma in the pediatric population has similar benefits and considerations as the adult population. This paper described a group of hemodynamically stable patients who were suspected to have intraabdominal injuries. In appropriately chosen patients, there is significant benefit of decreased LOS, decreased postoperative complications, and improved recovery. While there is a role for laparoscopy in trauma, that role still requires better characterization. The Minimally Invasive Surgery and Emerging Technologies task force is presently working on an EAST practice management guideline that aims to better describe the role of laparoscopy in trauma.

Article 3
Patient-Reported Outcomes of Robotic vs Laparoscopic Ventral Hernia Repair With Intraperitoneal Mesh. The PROVE-IT Randomized Clinical Trial. Petro C, Zolin S, Krpata D, Alkhatib H, Tu C, Rosen M, Prabhu A. JAMA Surg. 2021;156(1):22-29.

Summary: Robotic-assisted surgery has been rapidly adopted with little high-level evidence to support its use in general surgery. There is retrospective data demonstrating decreased LOS and postoperative morbidity compared to laparoscopic repair; however prospective data is scarce. The authors hypothesized that a robotic approach to ventral hernia repair would improve early postoperative pain compared to laparoscopic. This study is a prospective, single-blinded RCT, performed at a single center by two fellowship trained minimally invasive surgeons. After enrollment, the patients were randomly assigned to receive either a laparoscopic or robotic repair. The differences in technique were that in the robotic arm, the fascial defect was closed with a permanent running locking suture, and the mesh was secured with an absorbable running suture. In contrast, in the laparoscopic arm, the fascial defect was closed with interrupted figure-of-eight and the mesh secured with four permanent trans-fascial sutures and permanent tacks. The primary outcome was pain measured preoperatively, in the PACU, and then on POD#1, 7, 30, and 365. Secondary outcomes were: quality of life, operating room time, PACU opioid consumption, rates of same day discharge, hospital LOS, SSI, surgical site occurrence, surgical site occurrence requiring intervention, ventral hernia recurrence, and cost. 216 patients were screened and 81 patients enrolled. There were no differences in demographics and hernia characteristics except BMI, with the higher being in the robotic arm. Two patients crossed over from the robotic arm to the laparoscopic due to a broken bed and an intraperitoneal space concern. Three patients in both arms were converted to an open procedure. The intraoperative complication rates and long term follow up was similar between groups. The results showed no statistically or clinically significant difference for pain outcomes between the two groups. The authors then adjusted for the statistically significant difference in baseline BMI and there was still no difference in pain scores.
 
Take Away: In this single center study, there was no difference in pain and quality of life markers comparing robotic to laparoscopic ventral hernia repair. The only statistically significant difference was the operative time, which directly led to an increased cost for robotic repairs. The authors theorize that a decrease in operative time would offset the cost difference but could not postulate if this was possible. In all, there was no statistically significant difference in pain when comparing robotic to laparoscopic ventral hernia repair. They conclude that a justification for robotic ventral hernia repair is to improve the efficiency of the surgeon allowing them to become more comfortable with the robotic platform working towards more complex surgeries.                                                                                                 
 
Article 4
Comparing Laparoscopic Elective Sigmoid Resection With Conservative Treatment in Improving Quality of Life of Patients With Diverticulitis The Laparoscopic Elective Sigmoid Resection Following Diverticulitis (LASER) Randomized Clinical Trial. Santos A, Mentula P, Pinta T, Ismail S, Rautio T, Juusela R, Lähdesmäki A, Scheinin T, Sallinen V. JAMA Surg. 2020 Nov 18; e205151.

Summary: Treatment strategies for managing acute diverticulitis have been changing. Treatment recommendations have shifted to a more conservative and tailored approach that considers the patients' symptoms vs. the risks of elective resections. There has only been one randomized clinical trial comparing conservative treatment with elective sigmoid resection in patients with recurrent diverticulitis or persistent complaints. To compensate for the lack of prospective high-level evidence, the authors hypothesized that elective sigmoid resection would improve patients' quality of life with recurrent, complicated, or persistent diverticulitis. This is a multicenter, prospective parallel open-label randomized control trial in a mix of five academic and community hospitals in Finland. Inclusion criteria were patients who fell into one of three categories: 3 or more episodes of left colon diverticulitis within a two year period, 1 or more episodes of complicated diverticulitis or prolonged pain or disturbance in bowel habits more than three months after an episode of diverticulitis. The authors defined complicated diverticulitis as having fistula, stricture, abscess, or free air verified by CT.  Conservative management was education and increased fiber for at least six months. Those randomized to surgery would be scheduled within three months, had a distal transection line in the upper rectum, and a tension free anastomosis created with a circular stapler. The primary outcome was the Gastrointestinal Quality of Life Index (GIQLI) difference at the time of randomization and 6 months. Secondary outcomes were GIQLI score at 12, 24, 48, and 96 months, 36-Item Short Form Health Survey scores at 6, 12, 24, 48, and 96 months and then various other postoperative complications. For both scoring systems, a higher score correlated to a better quality of life. 128 patients were assessed for eligibility. After exclusions and removal of patients who did not fill out the questionnaires, 72 patients were analyzed; there were no differences between the groups after randomization. The initial aim was to show a change of at least 12 points on the GIQLI between the groups, and the authors calculated they would need a sample size of 133 to show a difference with 90% power. A pre-specified interim analysis was planned when the primary outcome could be assessed in 66 patients. At the time of the interim analysis, an additional 24 patients had been enrolled due to the lag and were included in the final analysis. After the interim analysis, the trial was stopped due to a significant difference in GIQLI score from baseline to 6 months in the surgical group vs. the conservative group (11.96 vs -0.2). Additionally, the raw GIQLI score at 6 months was significantly higher in the surgical group compared to the conservative management group.
 
Take Away: This multicenter prospective study confirms the results of a previous study done in 2016 (DIRECT Trial) showing that quality of life was significantly improved after laparoscopic surgery compared to conservative treatment in the management of recurrent, complicated, or persistent painful diverticulitis. The limitations were that the trial was ended early, with a low number of patients over a long enrollment period, and the inclusion criteria were strict. Additionally, there was no sham surgery in the conservative arm, so possible placebo effect in the QOL results cannot be ruled out.

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 This Literature Review is being brought to you by the EAST Manuscript and Literature Review Committee. Have a suggestion for a review or an additional comment on articles reviewed? Please email litreview@east.orgPrevious issues available on the EAST website.