Incisionless near-infrared fluorescent cholangiography (NIFC) is emerging as a promising tool to enhance the visualization of extrahepatic biliary structures during laparoscopic cholecystectomies.
We ...conducted a single-blind, randomized, 2-arm trial comparing the efficacy of NIFC (n = 321) versus white light (WL) alone (n = 318) during laparoscopic cholecystectomy. Using the KARL STORZ Image1 S imaging system with OPAL1 technology for NIR/ICG imaging, we evaluated the detection rate for 7 biliary structures-cystic duct (CD), right hepatic duct (RHD), common hepatic duct, common bile duct, cystic common bile duct junction, cystic gallbladder junction (CGJ), and accessory ducts -before and after surgical dissection. Secondary calculations included multivariable analysis for predictors of structure visualization and comparing intergroup biliary duct injury rates.
Predissection detection rates were significantly superior in the NIFC group for all 7 biliary structures, ranging from 9.1% versus 2.9% to 66.6% versus 36.6% for the RHD and CD, respectively, with odds ratios ranging from 2.3 (95% CI 1.6-3.2) for the CGJ to 3.6 (1.6-9.3) for the RHD. After dissection, similar intergroup differences were observed for all structures except CD and CGJ, for which no differences were observed. Significant odds ratios ranged from 2.4 (1.7-3.5) for the common hepatic duct to 3.3 (1.3-10.4) for accessory ducts. Increased body mass index was associated with reduced detection of most structures in both groups, especially before dissection. Only 2 patients, both in the WL group, sustained a biliary duct injury.
In a randomized controlled trial, NIFC was statistically superior to WL alone visualizing extrahepatic biliary structures during laparoscopic cholecystectomy.
NCT02702843.
Zusammenfassung
Die laparoskopische Chirurgie ist ein elementarer Bestandteil der gesamten Abdominalchirurgie. Dennoch hat sich bis heute nur die laparoskopische Cholezystektomie als
Goldstandard
...durchgesetzt und wird bei etwa 90 % der Patienten weltweit erfolgreich eingesetzt. Bei anderen abdominellen Operationen ist der Anteil an minimal-invasiver Chirurgie bedeutend geringer. Die laparoskopische kolorektale Chirurgie – v. a. bei onkologischer Indikation – hat sich seit ihrer Erstbeschreibung 1991 nur zögerlich verbreitet, wobei im internationalen Vergleich große regionale Unterschiede bestehen. Auch wenn ein Großteil der Patienten mit einem kolorektalen Karzinom (CRC) für eine laparoskopische Operation geeignet wäre, liegt die Verbreitung vielerorts noch unter 50 % der Eingriffe. Die allgemeinen Vorteile der laparoskopischen Chirurgie im früh-postoperativen Verlauf sind bekannt. Zahlreiche Studien haben auch zumindest die Gleichwertigkeit der laparoskopischen Operation beim Karzinom in Bezug auf die onkologischen Kriterien nachgewiesen. In den deutschen Leitlinien wird die laparoskopische Operation beim CRC bei entsprechender Expertise des Behandlungsteams seit 2013 als Alternative zur konventionellen Operation betrachtet. Für eine weitere Implementierung der laparoskopischen kolorektalen Chirurgie sind eine Standardisierung der Operationstechnik, eine profunde Ausbildung und Training des Chirurgen sowie eine adäquate technische Ausstattung die wichtigsten Faktoren, die von der Lehre bis zur einzelnen Klinik umgesetzt werden müssen.
To investigate the rate of laparoscopic colectomies for colon cancer using registries and population-based studies. To provide a position paper on mini-invasive (MIS) colon cancer surgery based on ...the opinion of experts leader in this field.
A systematic review of the literature was conducted using PRISMA guidelines for the rate of laparoscopy in colon cancer. Moreover, Delphi methodology was used to reach consensus among 35 international experts in four study rounds. Consensus was defined as an agreement ≥75.0%. Domains of interest included nosology, essential technical/oncological requirements, outcomes and MIS training.
Forty-four studies from 42 articles were reviewed. Although it is still sub-optimal, the rate of MIS for colon cancer increased over the years and it is currently >50% in Korea, Netherlands, UK and Australia. The remaining European countries are un-investigated and presented lower rates with highest variations, ranging 7–35%. Using Delphi methodology, a laparoscopic colectomy was defined as a “colon resection performed using key-hole surgery independently from the type of anastomosis”. The panel defined also the oncological requirements recognized essential for the procedure and agreed that when performed by experienced surgeons, it should be marked as best practice in guidelines, given the principles of oncologic surgery be respected (R0 procedure, vessel ligation and mesocolon integrity).
The rate of MIS colectomies for cancer in Europe should be further investigated. A panel of leaders in this field defined laparoscopic colectomy as a best practice procedure when performed by an experienced surgeon respecting the standards of surgical oncology.
ObjectivesIntraoperative fluorescence imaging is currently used in a variety of surgical fields for four main purposes: assessing tissue perfusion; identifying/localizing cancer; mapping lymphatic ...systems; and visualizing anatomy. To establish evidence-based guidance for research and practice, understanding the state of research on fluorescence imaging in different surgical fields is needed. We evaluated the evidence on fluorescence imaging for perfusion assessments using the Idea, Development,Exploration, Assessment, Long Term Study (IDEAL) framework, which was designed for describing the stages of innovation in surgery and other interventional procedures.DesignNarrative literature review with analysis of IDEAL stage of each field of study.SettingAll publications on intraoperative fluorescence imaging for perfusion assessments reported in PubMed through 2019 were identified for six surgical procedures: coronary artery bypass grafting (CABG), upper gastrointestinal (GI) surgery, colorectal surgery, solid organ transplantation, reconstructive surgery, and cerebral aneurysm surgery.Main outcome measuresThe IDEAL stage of research evidence was determined for each specialty field using a previously described approach.Results196 articles (15 003 cases) were selected for analysis. Current status of research evidence was determined to be IDEAL Stage 2a for upper GI and transplantation surgery, IDEAL 2b for CABG, colorectal and cerebral aneurysm surgery, and IDEAL Stage 3 for reconstructive surgery. Using the technique resulted in a high (up to 50%) rate of revisions among surgical procedures, but its efficacy improving postoperative outcomes has not yet been demonstrated by randomized controlled trials in any discipline. Only one possible adverse reaction to intravenous indocyanine green was reported.ConclusionsUsing fluorescence imaging intraoperatively to assess perfusion is feasible and appears useful for surgical decision making across a range of disciplines. Identifying the IDEAL stage of current research knowledge aids in planning further studies to establish the potential for patient benefit.
Background
The use of 3D laparoscopic systems is expanding. The European Association of Endoscopic Surgery (EAES) initiated a consensus development conference with the aim of creating evidence-based ...statements and recommendations for the surgical community.
Methods
Systematic reviews of the PubMed and Embase libraries were performed to identify evidence on potential benefits of 3D on clinical practice and patient outcomes. Statements and recommendations were prepared and unanimously agreed by an international surgical and engineering expert panel which were presented and voted at the EAES annual congress, London, May 2018.
Results
9967 abstracts were screened with 138 articles included. 18 statements and two recommendations were generated and approved. 3D significantly shortened operative time (mean difference 11 min (8% 95% CI 20.29–1.72, I
2
96%)). A significant reduction in complications was observed when 3D systems were used (RR 0.75, 95 CI% 0.60–0.94, I
2
0%) particularly for cases involving laparoscopic suturing (RR 0.57 95% CI 0.35–0.90, I
2
0%). In 69 box trainer or simulator studies, 64% concluded trainees were significant faster and 62% performed fewer errors when using 3D.
Conclusion
We recommend the use of 3D vision in laparoscopy to reduce the operative time (grade of recommendation: low). Future robust clinical research is required to specifically investigate the potential benefit of 3D laparoscopy system on complication rates (grade of recommendation: high).
Background
Although bariatric surgery is the most effective treatment for severe obesity, a subgroup of patients shows insufficient postbariatric outcomes. Differences may at least in part result ...from heterogeneous patient profiles regarding reactive and regulative temperament, emotion dysregulation, and disinhibited eating. This study aims to subtype patients based on these aspects before and 2 years after bariatric surgery and tests the predictive value of identified subtypes for health-related outcomes 3 years after surgery.
Methods
Within a prospective multicenter patient registry,
N
= 229 bariatric patients were examined before bariatric surgery, 2 and 3 years postoperatively via clinical interviews and self-report questionnaires. Pre- and postbariatric subtypes were differentiated by temperament, emotion dysregulation, and disinhibited eating using latent profile analyses (LPA). The predictive value of pre- and postbariatric subtypes for surgery outcomes measured 3 years postoperatively was tested via linear regression analyses.
Results
LPA resulted in five prebariatric and three postbariatric subtypes which were significantly associated with different levels of general and eating disorder psychopathology. Post- versus prebariatric subtypes explained more variance regarding eating disorder psychopathology, depression, and quality of life assessed 3 years postoperatively, whereas neither pre- nor postbariatric subtypes predicted postbariatric weight loss. Patients with prebariatric deficits in self- and emotional control had an increased risk for showing these deficits postoperatively.
Conclusions
A re-evaluation of patients’ psychological status after bariatric surgery is recommended to detect patients with potential risk for adverse psychological surgery outcomes in the long term.
Background
Single-port laparoscopic surgery as an alternative to conventional laparoscopic cholecystectomy for benign disease has not yet been accepted as a standard procedure. The aim of the ...multi-port versus single-port cholecystectomy trial was to compare morbidity rates after single-access (SPC) and standard laparoscopy (MPC).
Methods
This non-inferiority phase 3 trial was conducted at 20 hospital surgical departments in six countries. At each centre, patients were randomly assigned to undergo either SPC or MPC. The primary outcome was overall morbidity within 60 days after surgery. Analysis was by intention to treat. The study was registered with ClinicalTrials.gov (NCT01104727).
Results
The study was conducted between April 2011 and May 2015. A total of 600 patients were randomly assigned to receive either SPC (
n
= 297) or MPC (
n
= 303) and were eligible for data analysis. Postsurgical complications within 60 days were recorded in 13 patients (4.7 %) in the SPC group and in 16 (6.1 %) in the MPC group (
P
= 0.468); however, single-access procedures took longer 70 min (range 25–265) vs. 55 min (range 22–185);
P
< 0.001. There were no significant differences in hospital length of stay or pain VAS scores between the two groups. An incisional hernia developed within 1 year in six patients in the SPC group and in three in the MPC group (
P
= 0.331). Patients were more satisfied with aesthetic results after SPC, whereas surgeons rated the aesthetic results higher after MPC. No difference in quality of life scores, as measured by the gastrointestinal quality of life index at 60 days after surgery, was observed between the two groups.
Conclusions
In selected patients undergoing cholecystectomy for benign gallbladder disease, SPC is non-inferior to MPC in terms of safety but it entails a longer operative time. Possible concerns about a higher risk of incisional hernia following SPC do not appear to be justified. Patient satisfaction with aesthetic results was greater after SPC than after MPC.
Background
COVID-19 pandemic presented an unexpected challenge for the surgical community in general and Minimally Invasive Surgery (MIS) specialists in particular. This document aims to summarize ...recent evidence and experts’ opinion and formulate recommendations to guide the surgical community on how to best organize the recovery plan for surgical activity across different sub-specialities after the COVID-19 pandemic.
Methods
Recommendations were developed through a Delphi process for establishment of expert consensus. Domain topics were formulated and subsequently subdivided into questions pertinent to different surgical specialities following the COVID-19 crisis. Sixty-five experts from 24 countries, representing the entire EAES board, were invited. Fifty clinicians and six engineers accepted the invitation and drafted statements based on specific key questions. Anonymous voting on the statements was performed until consensus was achieved, defined by at least 70% agreement.
Results
A total of 92 consensus statements were formulated with regard to safe resumption of surgery across eight domains, addressing general surgery, upper GI, lower GI, bariatrics, endocrine, HPB, abdominal wall and technology/research. The statements addressed elective and emergency services across all subspecialties with specific attention to the role of MIS during the recovery plan. Eighty-four of the statements were approved during the first round of Delphi voting (91.3%) and another 8 during the following round after substantial modification, resulting in a 100% consensus.
Conclusion
The recommendations formulated by the EAES board establish a framework for resumption of surgery following COVID-19 pandemic with particular focus on the role of MIS across surgical specialities. The statements have the potential for wide application in the clinical setting, education activities and research work across different healthcare systems.
Background
During laparoscopic surgery, CO
2
insufflation gas could leak from the intra-abdominal cavity into the operating theater. Medical staff could therefore be exposed to hazardous substances ...present in leaked gas. Although previous studies have shown that leakage through trocars is a contributing factor, trocar performance over longer periods remains unclear. This study investigates the influence of prolonged instrument manipulation on gas leakage through trocars.
Methods
Twenty-five trocars with diameters ranging from 10 to 15 mm were included in the study. An experimental model was developed to facilitate instrument manipulation in a trocar under loading. The trocar was mounted to a custom airtight container insufflated with CO
2
to a pressure of 15 mmHg, similar to clinical practice. A linear stage was used for prolonged instrument manipulation. At the same time, a fixed load was applied radially to the trocar cannula to mimic the reaction force of the abdominal wall. Gas leakage was measured before, after, and during instrument manipulation.
Results
After instrument manipulation, leakage rates per trocar varied between 0.0 and 5.58 L/min. No large differences were found between leakage rates before and after prolonged manipulation in static and dynamic measurements. However, the prolonged instrument manipulation did cause visible damage to two trocars and revealed unintended leakage pathways in others that can be related to production flaws.
Conclusion
Prolonged instrument manipulation did not increase gas leakage rates through trocars, despite damage to some individual trocars. Nevertheless, gas leakage through trocars occurs and is caused by different trocar-specific mechanisms and design issues.
Background
Anastomotic leakage (AL) is one of the dreaded complications following surgery in the digestive tract. Near-infrared fluorescence (NIRF) imaging is a means to intraoperatively visualize ...anastomotic perfusion, facilitating fluorescence image-guided surgery (FIGS) with the purpose to reduce the incidence of AL. The aim of this study was to analyze the current practices and results of NIRF imaging of the anastomosis in digestive tract surgery through the EURO-FIGS registry.
Methods
Analysis of data prospectively collected by the registry members provided patient and procedural data along with the ICG dose, timing, and consequences of NIRF imaging. Among the included upper-GI, colorectal, and bariatric surgeries, subgroup analysis was performed to identify risk factors associated with complications.
Results
A total of 1240 patients were included in the study. The included patients, 74.8% of whom were operated on for cancer, originated from 8 European countries and 30 hospitals. A total of 54 surgeons performed the procedures. In 83.8% of cases, a pre-anastomotic ICG dose was administered, and in 60.1% of cases, a post-anastomotic ICG dose was administered. A significant difference (
p
< 0.001) was found in the ICG dose given in the four pathology groups registered (range: 0.013–0.89 mg/kg) and a significant (
p
< 0.001) negative correlation was found between the ICG dose and BMI. In 27.3% of the procedures, the choice of the anastomotic level was guided by means of NIRF imaging which means that in these cases NIRF imaging changed the level of anastomosis which was first decided based on visual findings in conventional white light imaging. In 98.7% of the procedures, the use of ICG partly or strongly provided a sense of confidence about the anastomosis. A total of 133 complications occurred, without any statistical significance in the incidence of complications in the anastomoses, whether they were ICG-guided or not.
Conclusion
The EURO-FIGS registry provides an insight into the current clinical practice across Europe with respect to NIRF imaging of anastomotic perfusion during digestive tract surgery.
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