Residents perform better technically, have less stress and workload, and prefer robotic to laparoscopic technique during inanimate simulation.

INTRODUCTION: With the widespread adoption of minimally invasive surgery, there is a growing need for surgical residents to be trained by a procedure-specific curriculum. This study aimed to evaluate the technical performance and feedback of surgical residents undergoing the robotic and laparoscopic hepaticojejunostomy (HJ) and gastrojejunostomy (GJ) biotissue modules. METHODS: A total of 23 PGY-3 surgical residents participated in this study and performed the laparoscopic and robotic HJ and GJ drills, which were recorded and scored by two independent graders using the modified objective structured assessment of technical skills (OSATS). After completing each drill, all participants filled out the NASA Task Load Index (NASA-TLX), Borg Exertion Scale, and Edwards Arousal Rating Questionnaire. RESULTS: Twenty-two (95.7%) residents had already received fundamentals of laparoscopic surgery certification. Eighteen (78.3%) residents had robotic virtual simulation training and the median (range) number of robotic surgery console experience was 4 (0-30). In the HJ comparison of the six OSATS domains, the robotic system was superior in Gentleness (p = 0.031). In the GJ comparison, the robotic system was superior in Time and Motion (p < 0.001), Instrument Handling (p = 0.001), Flow of Operation (p = 0.002), Tissue Exposure (p = 0.013), and Summary (p < 0.001). Participants answered significantly higher demand scores for laparoscopy on all six facets of NASA-TLX for both HJ and GJ (p < 0.05). The Borg Level of Exertion was > 2 points higher for laparoscopic HJ and GJ (p < 0.001). Residents rated more Nervousness and Anxiety for laparoscopic compared to robotic (p < 0.05) HJ and GJ. Additionally, when asked to score preference for robotic and laparoscopic approach in terms of technique and ergonomics, residents scored robot as better (laparoscopy worse) for both HJ and GJ in both domains. CONCLUSIONS: The robotic surgical system provided a more favorable environment for trainees with less mental and physical burden for minimally invasive HJ and GJ curriculum.

Patient-reported outcomes and quality of life in dominant dystrophic epidermolysis bullosa: A global cross-sectional survey.

INTRODUCTION: Dystrophic epidermolysis bullosa is a debilitating skin condition, without curative treatment. Previous research has focused on the recessive variant, which is known to cause severe disease. Limited work focusing on the clinical manifestations and outcomes of dominant dystrophic epidermolysis bullosa is found (DDEB). METHODS: Analysis of an online survey of 42 DDEB patients. RESULTS: Self-reported severity of disease did not correlate with size of the wound or number of dressing changes, but did correlate with severity of pain reported in the last 12 months (3.4 mild vs 6.8 severe disease, P = 0.0002). Patients with severe DDEB also reported more severe internal disease symptoms, such as difficulty swallowing (62.5%, P = 0.01) and greater analgesic use during dressing changes (4.4% mild vs 81.3% severe, P = <0.001). DISCUSSION: Patient perception of disease severity in DDEB appears to be most impacted by pain, presence of chronic open wounds, difficulty swallowing, difficulty walking, and anal strictures. As research on DDEB increases, future studies focused on these symptoms might be the most impactful for DDEB patients. However, distinguishing DDEB from other subtypes remains a challenge.

Clinical characteristics associated with increased wound size in patients with recessive dystrophic epidermolysis bullosa.

As more therapeutic clinical trials focus on treatment of individual wounds in patients with recessive dystrophic epidermolysis bullosa, it has become crucial to understand the baseline clinical characteristics of these wounds. To investigate these features, we administered an RDEB-specific wound survey. Forty participants reported on location, size, pain, infection frequency, wound type, and duration of 189 wounds; a subset of 22 participants reported on pruritus in 63 wounds. Increased wound size was significantly associated with increased pain, increased pruritus, longer wound duration, increased infection frequency, and patients with mutations resulting in truncated type VII collagen.

Phase 2 trial of a neurokinin-1 receptor antagonist for the treatment of chronic itch in patients with epidermolysis bullosa: A randomized clinical trial.

BACKGROUND: Chronic pruritus causes major morbidity in epidermolysis bullosa (EB). The substance P-neurokinin 1 receptor (SP-NK1) pathway is a promising target for treating EB-related pruritus. OBJECTIVE: To evaluate the safety and efficacy of the oral NK1 receptor antagonist serlopitant in treating moderate-severe pruritus in EB. METHODS: The study randomized 14 patients to serlopitant or placebo for 8 weeks, followed by a 4-week washout and optional open-label extension. The primary end point was change in itch as measured by the Numeric Rating Scale. Secondary end points were change in itch during dressing changes and wound size. RESULTS: We observed greater itch reduction with serlopitant, equivalent to a 0.64-point comparative reduction on the 11-point Numeric Rating Scale by week 8, although this failed to meet statistical significance (P = .11). More serlopitant patients achieved ≥3-point reduction compared with placebo (43% vs 14%, P = .35). In post hoc analysis excluding 1 patient with a concurrent seborrheic dermatitis flare, serlopitant achieved significantly greater median itch reduction from baseline by week 4 (-2 points vs 0, P = .01). We observed no statistically significant differences in secondary end points. Serlopitant was well-tolerated. LIMITATIONS: Small sample size due to disease rarity. CONCLUSION: The potential itch reduction with serlopitant observed in this trial will be pursued by a larger powered trial (NCT03836001).

Phase 1/2a clinical trial of gene-corrected autologous cell therapy for recessive dystrophic epidermolysis bullosa.

BACKGROUNDRecessive dystrophic epidermolysis bullosa (RDEB) patients have mutations in the COL7A1 gene and thus lack functional type VII collagen (C7) protein; they have marked skin fragility and blistering. This single-center phase 1/2a open-label study evaluated the long-term efficacy, safety, and patient-reported outcomes in RDEB patients treated with gene-corrected autologous cell therapy.METHODSAutologous keratinocytes were isolated from participant skin biopsies. Epidermal sheets were prepared from cells transduced with a retrovirus carrying the full-length human COL7A1 gene. These gene-corrected autologous epidermal sheets measured 5 × 7 cm (35 cm2) and were transplanted onto 6 wound sites in each of 7 adult participants (n = 42 sites total) from 2013 to 2017. Participants were followed for 2 to 5 years.RESULTSNo participants experienced any serious related adverse events. Wound healing of 50% or greater by Investigator Global Assessment was present in 95% (36 of 38) of treated wounds versus 0% (0 of 6) of untreated control wounds at 6 months (P < 0.0001). At year 1, 68% (26 of 38) of treated wounds had 50% or greater healing compared with 17% (1 of 6) of control wounds (P = 0.025). At year 2, 71% (27 of 38) of treated wounds had 50% or greater healing compared with 17% (1 of 6) of control wounds (P = 0.019).CONCLUSIONC7 expression persisted up to 2 years after treatment in 2 participants. Treated wounds with 50% or greater healing demonstrated improvement in patient-reported pain, itch, and wound durability. This study provides additional data to support the clinically meaningful benefit of treating chronic RDEB wounds with ex vivo, C7 gene-corrected autologous cell therapy. This approach was safe and promoted wound healing that was associated with improved patient-reported outcomes.TRIAL REGISTRATIONClinicaltrials.gov identifier: NCT01263379.FUNDINGEpidermolysis Bullosa Research Partnership, Epidermolysis Bullosa Medical Research Foundation, NIH R01 AR055914, Office of Research and Development at the Palo Alto Veteran's Affairs Medical Center, and the Dermatology Foundation.