Volume 10, Issue 2

Evidence-based medicine demands treatment options for patients to be based on the current best available evidence. Systematic reviews (SRs) with meta-analyses allow surgeons to make therapeutical decisions in accordance with the highest level of evidence. Also, high-quality SRs support physicians to challenge the colossal amount of new research data created daily. The systematic review working group of the Study Center of the German Society of Surgery (SDGC) has created specific methodological literature regarding surgical SRs, giving recommendations to assess critical risk of bias and to prevent the creation of SRs that do not provide any new insights to the field. SRs should only be considered if there is new clinically relevant data available that allows the SR to create novel evidence. To address the dilemma of new SRs generated without adding new evidence, living systematic reviews and evidence mapping represent an innovative approach, in which SRs are regularly updated with new research data.

Over the years, clinical registries and randomized controlled trials gained acceptance. With increasing experience, it was possible to obtain knowledge of benefits and limitations in both designs. During the last years, the research focus was placed on new study concepts such as register-based randomized controlled trials intending to merge the benefits of evidence obtained by RCTs and clinical registers. In this review, we aim to provide an overview of the evolution and the present stage of clinical trials. While doing so, we outline past experience and look ahead toward improving models for high-quality clinical trials.

Objectives The treatment of acute respiratory distress syndrome (ARDS) in burn patients remains a major challenge. Veno-venous extracorporeal membrane oxygenation (vv-ECMO) is a standard treatment for severe ARDS today. But reports on survival outcome in burn patients remain variable in the literature. The aim of this study is to identify factors that may influence survival and therapy outcomes in this distinct patient population. Methods A single-center retrospective study was conducted in the burn intensive care unit (BICU). Inclusion criteria were the use of vv-ECMO for ARDS after burn injuries. The data analyzed included general medical data and various parameters from the BICU. Results Between January 2012 and December 2022, 21 consecutive adult patients were identified who underwent vv-ECMO treatment. Five patients (24 %) survived the therapy and could be discharged, and 16 patients (76 %) succumbed to their disease. A higher TBSA affected, lower pH in arterial blood gas analysis after 24 and 36 h, multiorgan dysfunction syndrome (MODS), renal insufficiency, and renal replacement therapy were significantly associated with a lethal outcome. Conclusions The data from the present study showed an overall mortality rate of 76 %, which is unsatisfactory compared to the literature. This could be explained by complicating factors such as MODS, renal failure, and renal replacement therapy. However, the indication for vv-ECMO must be adapted to the individual situation of the respective patient. Due to the additional higher risk for complications, the utilization of ECMO therapy should be reserved for specialized burn centers with an interdisciplinary setting.

Objectives Breast sensation following autologous breast reconstruction impacts patients’ quality of life. Although spontaneous reinnervation in free flaps was documented by many authors, there are efforts to further improve restoration of breast sensation. Interestingly, animal studies indicated that trastuzumab has several beneficial effects on transected peripheral nerves. Our aim was to compare spontaneous sensory recovery after free TRAM flap breast reconstruction between patients who were and were not treated with trastuzumab. Methods The study included 14 subjects who underwent tactile sensation examination in 5-year period after noninnervated free muscle-sparing TRAM flap breast reconstruction at the University Hospital Centre Zagreb, Croatia. Small and large flap skin islands and contralateral healthy breasts were tested with Semmes-Weinstein type monofilaments. Three sensory scores were created to more accurately compare breast sensation. Results In subjects receiving trastuzumab, sensory recovery earlier extended to at least four of five large skin island regions and was always present in the central flap area in comparison with subjects who were not administered trastuzumab (p=0.0476). As indicated by total sensory scores, trastuzumab-treated subjects restored sensation better resembling healthy control breasts (54 vs. 39 % in large skin islands; 95 vs. 71 % in small skin islands). Conclusions To the authors’ knowledge, the current study for the first time demonstrated trastuzumab’s potential to improve sensory outcomes in human. Our results support the strategy that accelerated nerve regeneration is a key to more successful reinnervation. HER2 and EGFR inhibitors emerge as new candidates for pharmacological interventions in peripheral nerve injury treatment.

Objectives Due to the close topographical relationship of functional relevant anatomic structures, limited space and cosmetic aspects orbital surgery will remain a challenging discipline. Therefore, novel technical capabilities are necessary for further surgical progress. We here tested the integration of augmented reality and optical navigation in one workflow for interdisciplinary decision-making, feasibility and intraoperative guidance. Methods High-resolution contrast-enhanced MRI and CT scans were automated and manual-assisted segmented to achieve a detailed three-dimensional (3D) model of the individual patho-anatomical relationships. Augmented reality was used for interdisciplinary preoperative planning and intraoperative intuitive navigation. Mayfield clamp head holder in combination with optical surface matching registration assured navigation assisted microsurgery. Results Combinations of different MRI-sequences and CT-scans were necessary for detailed 3D-modeling. Modeling was time consuming and only viable in the hands of medical, surgical and anatomical trained staff. Augmented reality assured a quick, intuitive interdisciplinary orientation. Intraoperative surface matching registration enabled precise navigation in the orbital space. Conclusions Optical Navigation and microscope integration achieved a straightforward microsurgical workflow and should be implemented regularly. Augmented reality represented a useful tool for preoperative interdisciplinary planning and intraoperative intuitive orientation. It further stated an excellent educational tool.

Objectives Reconstructing the hypopharynx while preserving the larynx poses a complex surgical challenge due to the limited space and the high position of the hypopharynx in the neck. We present our experience with hypopharyngeal reconstruction and larynx preservation using an ileal free flap. Case presentation Six consecutive cases were reported (age range 17–75; 2 females). Indications for surgery were tumor excision, postexcision flap failure, postradiation stenosis, caustic ingestion injury, and cervical esophageal perforation. The larynx was preserved in four cases. Graft survival rate was 100 %. Videofluoroscopic swallowing studies conducted at postoperative day 20–80 were normal in three cases. Two cases presented with stenosis but responded well to endoscopic dilations. Unfortunately, the third case expired due to tumor recurrence. Conclusions The ileal free flap is a surgical alternative for the reconstruction of the hypopharynx, especially in cases where the larynx is preserved.