Automating Endoscope Motion in Robotic Surgery: A Usability Study on da Vinci-Assisted Ex Vivo Neobladder Reconstruction

Robots for minimally invasive surgery introduce many advantages, but still require the surgeon to alternatively control the surgical instruments and the endoscope. This work aims at providing autonomous navigation of the endoscope during a surgical procedure. The autonomous endoscope motion was based on kinematic tracking of the surgical instruments and integrated with the da Vinci Research Kit. A preclinical usability study was conducted by 10 urologists. They carried out an ex vivo orthotopic neobladder reconstruction twice, using both traditional and autonomous endoscope control. The usability of the system was tested by asking participants to fill standard system usability scales. Moreover, the effectiveness of the method was assessed by analyzing the total procedure time and the time spent with the instruments out of the field of view. The average system usability score overcame the threshold usually identified as the limit to assess good usability (average score = 73.25 > 68). The average total procedure time with the autonomous endoscope navigation was comparable with the classic control (p = 0.85 > 0.05), yet it significantly reduced the time out of the field of view (p = 0.022 < 0.05). Based on our findings, the autonomous endoscope improves the usability of the surgical system, and it has the potential to be an additional and customizable tool for the surgeon that can always take control of the endoscope or leave it to move autonomously.

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A Decade of Marketing Authorization Applications of Anticancer Drugs in the European Union: An Analysis of Procedural Timelines

Therapeutic Innovation & Regulatory Science ◽

10.1007/s43441-021-00260-5 ◽

2021 ◽

Author(s):

Marjolein Garsen ◽

Maaike Steenhof ◽

Alex Zwiers

Keyword(s):

Anticancer Drugs ◽

Marketing Authorization ◽

European Medicines Agency ◽

Company Size ◽

Scientific Advice ◽

The European Union ◽

Small Companies ◽

Procedure Time ◽

Total Procedure Time ◽

Total Procedure

Abstract Background Cancer is a serious global health problem and a major cause of death. The European Medicines Agency (EMA) has established several regulatory initiatives to expedite the development and authorization of drugs to ensure timely access of patients. In this study, we analyzed the procedural timelines of marketing authorization applications for anticancer drugs in the EU, with a specific focus to special regulatory programs, scientific advice and company size. Methods Anticancer drugs that received an opinion from the EMA between January 2010 and December 2019 were included in the study. Public assessment reports were used to obtain publicly available information of the drugs. Results We identified 96 applications for new anticancer drugs. 34 applications were granted access to at least one expedited program offered by the EMA. Total procedure time was reduced from average 370 to 200–215 days when accelerated assessment was granted. Granting of a conditional marketing authorization or an orphan designation, as well as having scientific advice, only mildly affected total procedure time. Average total procedure time of small companies was much longer compared with medium-sized and large companies (483 versus 356 days), which was caused by an increased clock stop time. Conclusion Total procedure time for anticancer is mainly affected by the granting of accelerated assessment, which reduced the total procedure time, and company size, where total procedure time is much longer for small companies. Small companies are advised to have, and especially adhere to scientific advice to reduce procedure time and increase the chance of success.

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Ex vivo porcine model study on the treatment outcomes of scissor-type knife versus needle-type knife in endoscopic submucosal dissection performed by trainees

BMC Surgery ◽

10.1186/s12893-020-00955-w ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Ryoji Ichijima ◽

Mitsuru Esaki ◽

Shun Yamakawa ◽

Yosuke Minoda ◽

Sho Suzuki ◽

...

Keyword(s):

Endoscopic Submucosal Dissection ◽

Treatment Outcomes ◽

Subgroup Analysis ◽

Porcine Model ◽

Ex Vivo ◽

Procedure Time ◽

Needle Type ◽

Submucosal Dissection ◽

Muscular Injury ◽

Total Procedure

Abstract Background Endoscopic submucosal dissection (ESD) for gastrointestinal neoplasms can be technically difficult for trainee endoscopists. Presently, there is no consensus for trainees to select the endo-knife type in ESD. Therefore, we conducted a comparison study of treatment outcomes between scissors-type and needle-type knives in ESD performed by trainees in an ex vivo porcine model. Methods This study was conducted on trainee endoscopists who participated in ESD hands-on seminars held in August 2018 and September 2019. A total of 22 trainees from 13 institutions were divided into two groups according to their endoscopic experience. Under expert supervision, each trainee performed two ESDs in porcine models, namely, scissor-type knife (ESD-S) and needle-type knife (ESD-N). The efficacy and safety, including the procedure time and rates of self-completion, en bloc resection, and complications, were compared between ESD-S and ESD-N. In subgroup analysis, we also investigated the predictors associated with the difficulty of ESD for trainees using multivariate logistic regression analysis. Results Eight trainees had an experience of over 1000 endoscopies (senior trainee: S-Trainee), whereas the others had an experience of less than 1000 endoscopies (junior trainee: J-Trainee). Among the S-Trainees, no significant differences were observed in any treatment outcome between ESD-S and ESD-N. Among the J-Trainees, the total procedure and mucosal incision times were significantly shorter in ESD-S than in ESD-N [total procedure time: 16.5 min (range 10.0–31.0) vs. 22.3 min (range 10.0–38.0), P = 0.018; circumferential incision time: 10.0 min (range 6–16) vs. 17.0 min (range 5.0–31.5); P = 0.019]. Regarding complications, muscular injury occurred in two patients during ESD-N performed by J-Trainees; however, no muscular injury occurred during ESD-S. In subgroup analysis, ESD-N was an independent predictive factor of difficult ESD (odds ratio 5.28, 95% confidence interval 1.25–22.30; P = 0.024). Conclusions This study revealed that trainees, particularly those who have experienced less than 1000 endoscopies, should opt for the scissor-type knife to perform ESD.

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P338 The road to zero-fluoroscopy catheter ablation in recurrent paroxysmal atrial fibrillation using ICE: training, learning, getting closer

European Heart Journal - Cardiovascular Imaging ◽

10.1093/ehjci/jez319.191 ◽

2020 ◽

Vol 21 (Supplement_1) ◽

Author(s):

I A Minciuna ◽

M Puiu ◽

G Cismaru ◽

S Istratoaie ◽

G Simu ◽

...

Keyword(s):

Catheter Ablation ◽

Radiation Exposure ◽

Radiofrequency Catheter Ablation ◽

Procedure Time ◽

Total Procedure Time ◽

The Mean ◽

Group 2 ◽

Total Procedure ◽

Zero Fluoroscopy ◽

Group 1

Abstract INTRODUCTION Catheter ablation is the treatment of choice for patients with recurrent paroxysmal atrial fibrillation (AF) in which antiarrhythmic drug therapy has failed to maintain sinus rhythm. Since its first introduction, intracardiac echocardiography (ICE) has proved to increase the efficacy and reduce complications in AF catheter ablation. One of the main advantages of ICE in the electrophysiology laboratory is the reduction of radiation exposure, for both the patient and the physician. Multiple recent studies have shown the feasibility and safety of zero or near-zero fluoroscopy AF ablation, including transseptal puncture, and outlined the importance of using ICE under the support of 3D mapping systems in reducing radiation exposure. PURPOSE The aim of this study was to show whether the use of ICE reduced the radiation exposure and total procedure time in recurrent paroxysmal AF patients undergoing radiofrequency catheter ablation. METHODS Forty patients that undergone radiofrequency catheter ablation for recurrent paroxysmal AF between January 2018 and May 2019 were included. They were divided in two groups: Group 1 – 20 patients in which ICE was performed and Group 2 – 20 patients in which ablation was performed without ICE guidance. We compared the total ablation time and fluoroscopy dose and time between the two groups. The total ablation time was defined as the time from the groin puncture until the withdrawal of all catheters. RESULTS Among the 40 patients included, 28 were men (70%) and the mean age was 57 years old. The mean procedure time was similar between the two groups (175 ± 52.0 for group 1 and 193 ± 49.9 for group 2, p = 0.33). The difference between the two groups was observed in fluoroscopy dose (9914.13 ± 5018.14 vs. 14561.43 ± 7446.1, p = 0.02) and time (26.04 ± 12.5 vs. 40.52 ± 12.6, p = 0.001). We found that in both groups higher fluoroscopy dose was correlated with higher fluoroscopy time (R = 0.74, p = 0.0001 vs. R = 0.57, p = 0.008) and higher total procedure time (R = 0.63, p = 0.002 vs. R = 0.46, p = 0.03). Furthermore, there was also a correlation between higher fluoroscopy dose and time (R = 0.59, p = 0.005 vs. R = 0.58, p = 0.006). No severe procedure-related complications were recorded. CONCLUSIONS This study shows that the use of ICE for recurrent paroxysmal AF catheter ablation reduces radiation exposure by lowering the fluoroscopy dose and the time of exposure. As a result, by increasing the training and learning curve in low-experienced centers it may finally get us closer to the ideal zero or near-zero fluoroscopy ablation. Abstract P338 Figure. ICE-guided transseptal puncture

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Two electrosurgical endo-knives for endoscopic submucosal dissection of colorectal superficial neoplasms: a prospective randomized study

Endoscopy International Open ◽

10.1055/s-0043-111792 ◽

2017 ◽

Vol 05 (08) ◽

pp. E729-E735 ◽

Cited By ~ 1

Author(s):

Yuusaku Sugihara ◽

Keita Harada ◽

Yoshiro Kawahara ◽

Daisuke Takei ◽

Shiho Takashima ◽

...

Keyword(s):

Endoscopic Submucosal Dissection ◽

Controlled Trial ◽

Randomized Study ◽

Procedure Time ◽

Related Factors ◽

Submucosal Dissection ◽

Total Procedure Time ◽

Mucosal Incision ◽

The Difference ◽

Total Procedure

Abstract Background and study aims Few studies have directly compared endo-knives for endoscopic submucosal dissection (ESD) in humans. We compared the performances of the Mucosectom2 and SB knife Jr. Patients and methods Two trainee endoscopists performed ESD of 36 lesions in this prospective, randomized controlled trial. Mucosal incision with a 1.5-mm Dual knife and submucosal dissection using the Mucosectom2 were performed in 1 group. Mucosal incision with a 1.5-mm Dual knife and submucosal dissection with a SB knife Jr. were performed in the other group. The primary outcome was the ESD procedure time. Secondary outcomes were total procedure time, self-completion rates, and adverse events. Results ESD time in Mucosectom2 patients was not significantly shorter than in SB knife Jr. patients (57 ± 32 min vs. 61 ± 44 min, respectively; P = 0.94). Total procedure time in Mucosectom2 patients was not significantly shorter than in SB knife Jr. patients (81 ± 42 min vs. 82 ± 51 min, respectively; P = 0.85). The trainee self-completion rate was slightly higher in SB knife Jr. patients than in Mucosectom2 patients, although the difference was not significant (94 % vs. 100 %, respectively; P = 0.959). Fewer hemostatic procedures using the Coagrasper were performed in Mucosectom2 patients than in SB knife Jr. patients, although the difference was not significant (0.62 vs. 0.7, respectively; P = 0.432). Conclusions Mucosectom2 and SB knife Jr. did not significantly differ in performance for colorectal ESD to safely and reliably enhance ESD. Knife selection is not as important for learning colorectal ESD as patient- and lesion-related factors.

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Whitacre Needle Reduces the Incidence of Intravascular Uptake in Lumbar Transforaminal Epidural Steroid Injections

January 2018 - Pain Physician ◽

10.36076/ppj.2015/18/325 ◽

2015 ◽

Vol 18;4 (4;18) ◽

pp. 325-331

Author(s):

JiHee Hong

Keyword(s):

Steroid Injection ◽

Leg Pain ◽

Digital Subtraction ◽

Procedure Time ◽

Intravascular Injection ◽

Total Procedure Time ◽

Transforaminal Epidural Steroid Injection ◽

Interventional Pain Management ◽

Epidural Steroid ◽

Total Procedure

Background: Transforaminal epidural steroid injection (TFESI) is a commonly used interventional pain management procedures to treat radicular leg pain. Although most reported complications of TFESI are minor, serious morbidity has also been demonstrated including spinal cord infarction, paraplegia, and quadriparesis. Suggested mechanisms include direct vascular injury or intravascular injection of particulate steroid. Objective: We compared 2 different needle types, Whitacre and Quincke type needles, with regard to intravascular injection rate with total procedure time and the amount of radiation during lumbar TFESI. Study Design: Prospective, randomized trial. Setting: An interventional pain management practice in South Korea. Methods: After Institutional Review Board approval, 149 patients undergoing lumbar TFESI for radicular leg pain were randomly assigned to one of 2 needle groups (Whitacre needle or Quincke type needle). After final confirmation of intravascular injection with digital subtraction angiography, total procedure time and amount of radiation exposure during TFESI were measured. Results: The overall incidence of intravascular injection was 10.4% (28/269). We analyzed the overall incidence of intravascular injection according to the 2 different needle types. The incidence of intravascular injection of the Whitacre needle was 5.4% (8/146), whereas the incidence of intravascular injection of the Quincke needle was 16.2% (20/123). Total procedure time and amount of radiation required to complete the TFESI in the Whitacre and Quincke needle groups was 168.4 ± 57.9 (seconds) and 33.4 ± 15.9 (cGy/cm2 ), 131.9 ± 46.0 (seconds) and 33.2 ± 15.8 (cGy/cm2 ), respectively. Limitations: The physician who performed the TFESI was not blinded to the type of needle for detecting intravascular injection. This study was focused on lumbar TFESI, however, most TFESIs are performed at the L4-5 or L5-S1 level. Conclusion: The Whitacre needle had the benefit of reducing the incidence of intravascular injection with minimal differences in technical difficulties and the amount of radiation exposure during lumbar TFESI. Key words: Transforaminal epidural steroid injection, complication, intravascular injection, Whitacre needle, Quincke needle, procedure time, radiation, digital subtraction angiography

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Comparison of Standard Technique, Ultrasonography, and Near-Infrared Light in Difficult Peripheral Vascular Access: A Randomized Controlled Trial

Prehospital and Disaster Medicine ◽

10.1017/s1049023x21001217 ◽

2021 ◽

pp. 1-6

Author(s):

Sercan Yalçınlı ◽

Funda Karbek Akarca ◽

Özge Can ◽

İlhan Uz ◽

Gülbin Konakçı

Keyword(s):

Vascular Access ◽

Near Infrared ◽

Standard Technique ◽

Infrared Light ◽

Controlled Study ◽

Procedure Time ◽

Near Infrared Light ◽

Randomized Controlled ◽

Total Procedure Time ◽

Total Procedure

Abstract Objectives: Successful placement of a peripheral intravenous catheter (PIVC) on the first attempt is an important outcome for difficult vascular access (DVA) patients. This study compared standard technique, ultrasonography (USG), and near-infrared light (NIR) in terms of success in the first attempt in patients with DVA. Methods: This was a prospective, randomized controlled study. The study was conducted in a tertiary care hospital. Emergency department patients who describe DVA history, have no visible or palpable veins, and were assessed by the nurse to have a difficult PIVC were included to study. The PIVC procedure was performed on patients by standard, USG, or NIR device techniques. For all approaches, the success of the first attempt was the primary aim. Total procedure time, the total number of attempts, and the need for rescue intervention were secondary aims. Results: This study evaluated 270 patients. The first attempt success rates for USG, standard, and NIR methods were 78.9%, 62.2%, and 58.9%, respectively. The rate of first attempt success was higher in patients who underwent USG (USG versus standard, P = .014; USG versus NIR, P = .004; standard versus NIR, P = .648). The total median (IQR) procedure time for USG, standard, and NIR methods was 107 (69-228), 72 (47-134), and 82 (61-163) seconds, respectively. The total procedure time was longer in patients undergoing USG (standard versus USG, P <.001; NIR versus USG, P = .035; standard versus NIR, P = .055). The total median (IQR) number of attempts of USG, standard, and NIR methods were 1 (1-1), 1 (1-2), and 1 (1-2), respectively. A difference was found among the groups regarding the total number of attempts (USG versus NIR, P = .015; USG versus standard P = .108; standard versus NIR, P = .307). No difference was found among groups in terms of the need for rescue methods. Conclusion: It was found that USG increases the success of the first attempt compared with the standard method and NIR in patients with DVA.

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Mifepristone and misoprostol compared to osmotic dilators for cervical preparation prior to surgical abortion at 15–18 weeks' gestation: a randomised controlled non-inferiority trial

BMJ Sexual & Reproductive Health ◽

10.1136/bmjsrh-2019-200367 ◽

2019 ◽

Vol 46 (1) ◽

pp. 67-72 ◽

Cited By ~ 1

Author(s):

Amy E Paris ◽

Olivera Vragovic ◽

Sarita Sonalkar ◽

Molly Finneseth ◽

Lynn Borgatta

Keyword(s):

Operative Time ◽

Effective Means ◽

Procedure Time ◽

Medication Group ◽

Total Procedure Time ◽

The Future ◽

Cervical Preparation ◽

Randomised Controlled ◽

Surgical Abortion ◽

Total Procedure

ObjectiveCervical preparation is recommended prior to second-trimester surgical abortion. Osmotic dilators are an effective means to prepare the cervix, but require an additional procedure and may cause discomfort. We compared cervical preparation with mifepristone and misoprostol to preparation with osmotic dilators.Study designA randomised, controlled, non-inferiority trial was performed to compare cervical preparation with mifepristone and misoprostol to preparation with osmotic dilators in women undergoing surgical abortion between 15 and 18 weeks gestation. The medication group (n=29) received mifepristone 200 mg orally 24 hours prior to uterine evacuation and misoprostol 400 μg buccally 2 hours before the procedure. The dilator group (n=20) underwent osmotic dilator insertion 24 hours prior to the procedure. The primary outcome was total procedure time, from insertion to removal of the speculum. Secondary outcomes included operative time (from intrauterine instrumentation to speculum removal), initial cervical dilation, nausea, pain, ease of procedure, and whether participants would choose the same modality in the future.ResultsFor mean total procedure time, medication preparation (14.0 min, 95% CI 12.0–16.1) was not inferior to dilators (14.3 min, 95% CI 11.7 to 16.8, p<0.001). Mean operative time and ease of procedure were also similar between groups. More women in the medication group than the dilator group would prefer to use the same method in the future (86% vs 30%, p=0.003).ConclusionPrior to surgical abortion at 15–18 weeks, use of mifepristone and misoprostol did not result in longer procedure times than overnight osmotic dilators.Trial registration numberNCT01462.

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Preoperative Localization of Breast MRI Lesions: MRI-guided Marker Placement With Radioactive Seed Localization as an Alternative to MRI-guided Wire Localization

Journal of Breast Imaging ◽

10.1093/jbi/wbaa012 ◽

2020 ◽

Vol 2 (3) ◽

pp. 250-258

Author(s):

Nicole Saphier ◽

Jessica Kondraciuk ◽

Elizabeth Morris ◽

Blanca Bernard-Davila ◽

Victoria Mango

Keyword(s):

Clinical Indication ◽

Secondary Outcome ◽

Procedure Time ◽

Wire Localization ◽

Total Procedure Time ◽

Seed Localization ◽

Radioactive Seed Localization ◽

Radioactive Seed ◽

Mri Guided ◽

Total Procedure

Abstract Objective Preoperative MRI-guided wire localization (MWL) presents challenges to both the physician and patient. In this study, we examined the efficiency and outcome of MRI-guided marker placement followed by mammographic-guided radioactive seed localization (MMP/RSL) as an alternative localization method. The primary outcome parameter was pathology upon excision. The secondary outcome parameters were total procedure time and clinical indication for localization. Methods A retrospective review of a large tertiary cancer center’s breast imaging database was performed. Records of 21 patients with MMP/RSL (24 markers) from August 2013 to January 2019 were compared with 34 patients receiving MWL (48 wires) from January 2016 to January 2019. Multiple factors, including age, prelocalization pathology, postsurgical pathology, concordance, re-excision rates, and total procedure time required for each technique, were compared. Univariate and descriptive statistical analyses were performed. Results Mean patient age in years (MMP/RSL = 54.1 ± 13.1, MWL = 55.1 ± 10.8, P = 0.389), time in MR scanner in minutes (MMP/RSL = 31.7 ± 12.0, MWL = 35.8 ± 13.1, P = 0.678), and postsurgical pathology malignancy rates (MMP/RSL = 71.4%, MWL = 65.7%, P = 0.7715) were similar without statistically significant differences. As expected, the mean total procedure time was slightly longer without a statistically significant difference (47.3 ± 19.8 min versus 35.8 ± 13.1 min, P = 0.922) for the MMP/RSL group. All patients in both groups underwent successful localization with 100% radiologic-pathology concordance. Re-excision rates were lower for the MMP/RSL group (9.5%) versus the MWL group (16.7%); however, they were not found to be statistically significant (P = 0.7104). Conclusion MMP/RSL is a feasible alternative to MWL and may alleviate many challenges presented by MWL. Further studies are needed.

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Abstract 16068: Local Anesthesia Using the “Tumescent Technique” versus General Anesthesia for Subcutaneous-implantable Cardioverter Defibirllator Implantation: Description of a Novel Technique

Circulation ◽

10.1161/circ.142.suppl_3.16068 ◽

2020 ◽

Vol 142 (Suppl_3) ◽

Author(s):

Jorge Romero ◽

Juan Diaz ◽

Isabella Alviz ◽

David Briceno ◽

Chintan Trivedi ◽

...

Keyword(s):

General Anesthesia ◽

Local Anesthesia ◽

Pain Control ◽

Procedural Pain ◽

Procedure Time ◽

Icd Implantation ◽

Total Procedure Time ◽

Significant Difference ◽

Skin To Skin ◽

Total Procedure

Introduction: General anesthesia is routinely used during the implantation of S-ICD which dramatically prolongs total procedure time, patient recovery time and adds unnecessary potential complications. The tumescent local anesthesia (TLA) technique provides anesthesia of large areas of skin and subcutaneous tissue by means of the direct infiltration of large volumes of a dilute local anesthetic solution into subcutaneous fat. Hypothesis: TLA during S-ICD implantation is feasible and associated with a reduction in total procedure time. Methods: A retrospective analysis was conducted in two medical centers during 2019. Five patients underwent S-ICD with TLA due to baseline conditions that represented relative contraindications to general anesthesia (e.g, muscular dystrophy). A large volume of a local anesthesia solution (i.e., 1 liter of normal saline, 30 cc of 1% lidocaine, 30 cc of bupivacaine, 1 mg of epinephrine, 12.5 mEq of sodium bicarbonate) was used in each patient and injected 10 minutes prior to incisions. Five other patients who underwent S-ICD under general anesthesia served as controls. The skin-to-skin time, total length of procedure and post-procedural pain levels were compared between groups. Results: A total of 10 patients were included (male: 60%; mean age: 62 ± 16). All devices were implanted for primary prevention of sudden cardiac death. TLA was considered the best anesthetic approach in five patients who had medical conditions that represented a high risk of complications if general anesthesia was employed. In the group of TLA, an average of 260 ± 45 cc was administered. The skin-to-skin times were 44.8 ± 13.9 minutes in patients who underwent general anesthesia vs. 46.2 ± 14.3 minutes in TLA (p = 0.3). The total procedural time was 148 ± 28 min vs 64.2 ± 13.4 min (p <0.001) for general anesthesia and TLA, respectively. There was a significant difference between groups in pain scale following the procedure being better pain control with TLA. Conclusions: S-ICD implantation using TLA appears to be a feasible and safe option in patients with contraindications to general anesthesia. This technique significantly decreases total procedure time with better post-procedural pain control.

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