Seal-G MIST (Minimally Invasive Sealant/Spray Technology) System Safety Study [SEALAR Study]
Ontology highlight
ABSTRACT:
DISEASE(S): Diverticulitis Colon,Diverticulitis, Colonic,Diverticulitis,Colorectal Cancer
PROVIDER: 2267076 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:Right colectomy (hemicolectomy) involves the removal of the cecum, the ascending colon, the hepatic flexure, the first one-third of the transverse colon, part of the terminal ileum, and the associated regional fat and lymph nodes, and is the accepted treatment for malignant neoplasms of the right colon.
A minimally invasive approach is commonly used for right colectomy, with studies reporting reduced complications, less blood loss, and hospital stay when compared to an open approach.
However, there remains controversy regarding whether robotic assistance is advantageous for this technique and whether an intracorporeal (ICA) or extracorporeal anastomosis (ECA) is best.
MIRCAST is a prospective, observational, international, multi-center, 4-parallel-cohorts study. Sites or surgeons will select a cohort of the study for which they are qualified. Four cohorts will be the subject of study:
1. Robotic Right Colectomy with ICA
2. Robotic Right Colectomy with ECA
3. Laparoscopic Right Colectomy with ICA
4. Laparoscopic Right Colectomy with ECA
All patient assessments will be done according to the sites standard of care. Parameters routinely recorded during right colectomy surgery will be collected prospectively. Enrolled subjects will undergo assessments at the following intervals: pre-operative, operative, discharge, 30 days, 3 months, 1 year and 2 years post-surgery.
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Project description:Our aim is to review the benefits as well as techniques, surgical outcomes, and complications of minimally invasive inguinal lymph node dissection (ILND) for penile cancer. The PubMed, Wiley Online Library, and Science Direct databases were reviewed in March 2020 for relevant studies limited to those published in English and within 2000-2020. Thirty-one articles describing minimally invasive ILND were identified for review. ILND has an important role in both staging and treatment of penile cancer. Minimally invasive technologies have been utilized to perform ILND in penile cancer patients with non-palpable inguinal lymph nodes and intermediate to high-risk primary tumors or patients with unilateral palpable non-fixed inguinal lymph nodes measuring less than 4 cm, including videoscopic endoscopic inguinal lymphadenectomy (VEIL) and robotic videoscopic endoscopic inguinal lymphadenectomy (RVEIL). Current data suggest that VEIL and RVEIL are feasible and safe with minimal intra-operative complications. Perhaps the strongest appeal for the use of minimally-invasive approaches is their faster post-operative recovery and less post-operative complications. As a result, patients can tolerate this procedure better and surgeons can offer surgery to patients who otherwise would not be a candidate or personally willing to undergo surgery. When compared to open technique, VEIL and RVEIL have similar dissected nodal count, a surrogate metric for oncological adequacy, and a none-inferior inguinal recurrence rate. Larger randomized studies are encouraged to investigate long-term outcome and survival rates using these minimally-invasive techniques for ILND.
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Project description:Cardiac tissue slices preserve the heterogeneous structure and multicellularity of the myocardium and allow its functional characterization. However, access to human ventricular samples is scarce. We aim to demonstrate that slices from small transmural core biopsies collected from living donors during routine cardiac surgery preserve structural and functional properties of larger myocardial specimens, allowing accurate electrophysiological characterization. In pigs, we compared left ventricular transmural core biopsies with transmural tissue blocks from the same ventricular region. In humans, we analyzed transmural biopsies and papillary muscles from living donors. All tissues were vibratome-sliced. By histological analysis of the transmural biopsies, we showed that tissue architecture and cellular organization were preserved. Enzymatic and vital staining methods verified viability. Optically mapped transmembrane potentials confirmed that action potential duration and morphology were similar in pig biopsies and tissue blocks. Action potential morphology and duration in human biopsies and papillary muscles agreed with published ranges. In both pigs and humans, responses to increasing pacing frequencies and ?-adrenergic stimulation were similar in transmural biopsies and larger tissues. We show that it is possible to successfully collect and characterize tissue slices from human myocardial biopsies routinely extracted from living donors, whose behavior mimics that of larger myocardial preparations both structurally and electrophysiologically.
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Project description:With the increase in Natural Orifice Transluminal Endoscopic Surgery procedures, there is an increasing demand for surgical instruments with additional degrees of freedom, able to travel along tortuous pathways and guarantee dexterity and high accuracy without compromising the surrounding environment. The implementation of follow-the-leader motion in surgical instruments allows propagating the decided shape through its body and moving through curved paths avoiding sensitive areas. Due to the limited operational area and therefore the instrument size, the steerable shaft of these instruments is usually driven by cables that are externally actuated. However, a large number of degrees of freedom requires a great number of actuators, increasing the system complexity. Therefore, our goal was to design a new memory system able to impose a follow-the-leader motion to the steerable shaft of a medical instrument without using actuators. We present a memory mechanism to control and guide the cable displacements of a cable-driven shaft able to move along a multi-curved path. The memory mechanism is based on a programmable physical track with a mechanical interlocking system. The memory system, called MemoBox, was manufactured as a proof-of-concept demonstration model, measuring 70 mm × 64 mm × 6 mm with 11 programmable elements and featuring a minimum resolution of 1 mm. The prototype shows the ability to generate and shift complex 2D pathways in real-time controlled by the user.
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Project description:Benign prostatic hyperplasia (BPH) represents a spectrum of related lower urinary tract symptoms (LUTS). The cost of currently recommended medications and the discontinuation rate due to side effects are significant drawbacks limiting their long-term use in clinical practice. Interventional procedures, considered as the definitive treatment for BPH, carry a significant risk of treatment-related complications in frail patients. These issues have contributed to the emergence of new approaches as alternative options to standard therapies. This paper reviews the recent literature regarding the experimental treatments under investigation and presents the currently available experimental devices and techniques used under local anesthesia for the treatment of LUTS/BPH in the vast majority of cases. Devices for delivery of thermal treatment (microwaves, radiofrequency, high-intensity focused ultrasound, and the Rezum system), mechanical devices (prostatic stent and urethral lift), fractionation of prostatic tissue (histotripsy and aquablation), prostate artery embolization, and intraprostatic drugs are discussed. Evidence for the safety, tolerability, and efficacy of these "minimally invasive procedures" is analyzed.
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Project description:A modification of range of motion of the knee can significantly change a patient's quality of life. In general, range of motion of 0° to 125° is adequate for most activities of daily life. The rate of knee arthrofibrosis after ligament reconstruction is reported to be between 0% and 4%; after tibial fracture due to high-energy trauma, the rate is about 7%, with an undetermined incidence after limb lengthening. The purpose of this study was to describe a modification of the operative technique of Judet. We describe minimally invasive quadricepsplasty in 4 steps, aiming to obtain an end result with an arc of movement of at least 120° to 130°. We believe that our technique is a good option for the treatment of the stiff knee, having low morbidity and being an easy method to perform.
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Project description:BackgroundMinimally invasive oesophagectomy has been shown to reduce the risk of pulmonary complications compared with open oesophagectomy, but the effects on health-related quality of life (HRQoL) and oesophageal cancer survivorship remain unclear. The aim of this study was to assess the longitudinal effects of minimally invasive compared with open oesophagectomy for cancer on HRQoL.MethodsAll patients who had surgery for oesophageal cancer in Sweden from January 2013 to April 2018 were identified. The exposure was total or hybrid minimally invasive oesophagectomy, compared with open surgery. The study outcome was HRQoL, evaluated by means of the European Organisation for Research and Treatment of Cancer questionnaires QLQ-C30 and QLQ-OG25 at 1 and 2 years after surgery. Mean differences and 95 per cent confidence intervals were adjusted for confounders.ResultsOf the 246 patients recruited, 153 underwent minimally invasive oesophagectomy, of which 75 were hybrid minimally invasive and 78 were total minimally invasive procedures. After adjustment for age, sex, Charlson Co-morbidity Index score, pathological tumour stage and neoadjuvant therapy, there were no clinically and statistically significant differences in overall or disease-specific HRQoL after oesophagectomy between hybrid minimally invasive and total minimally invasive surgical technique versus open surgery.ConclusionIn this population-based nationwide Swedish study, longitudinal HRQoL after minimally invasive oesophagectomy was similar to that of the open surgical approach.
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Project description:BackgroundSucrose allyl ether (SAE) containing hemostatic drugs and a photoinitiator was established to treat mild postpartum hemorrhage or long-term continuous abnormal uterine bleeding in minimally invasive surgery (MIS) using a photopolymerization method.Methods and resultsReal-time infrared spectroscopy and rheological experiments showed that the SAE monomer with shear-thinning characteristics could polymerize rapidly into a transparent membrane. Cytotoxicity experiments in vitro showed that this system could elicit a long-term hemostatic effect. Tissue adhesion was also evaluated. The photo-stability of four delivered antifibrinolytic drugs (6-aminocaproic acid, ethylenediaminediacetic acid, tranexamic acid and p-(aminomethyl) benzoic acid) was tested by ultraviolet-photolysis experiments and illustrated by time-dependent density functional theory. Sustained-release experiments revealed that the formed film could be used as a drug carrier. Molecular docking and molecular dynamics were done to investigate the binding mechanism between hemostatic drugs as ligands and the human plasminogen kringle-1 (1HPK) as a target.ConclusionIt has been suggested that SAE with tranexamic acid could be a drug-release system of microchannel transport used in MIS. This system could tackle the dilemma of fluidity and adhesion in MIS. The photo-stable tranexamic acid was the most suitable drug according to its satisfactory binding energy, good photo-stability, and sustained release.
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Project description:Minimally invasive esophagectomy is increasingly performed for the treatment of esophageal cancer, but it is unclear whether hybrid minimally invasive esophagectomy (HMIE) or totally minimally invasive esophagectomy (TMIE) should be preferred. The objective of this study was to perform a meta-analysis of studies comparing HMIE with TMIE. A systematic literature search was performed in MEDLINE, Embase, and the Cochrane Library. Articles comparing HMIE and TMIE were included. The Newcastle-Ottawa scale was used for critical appraisal of methodological quality. The primary outcome was pneumonia. Sensitivity analysis was performed by analyzing outcome for open chest hybrid MIE versus total TMIE and open abdomen MIE versus TMIE separately. Therefore, subgroup analysis was performed for laparoscopy-assisted HMIE versus TMIE, thoracoscopy-assisted HMIE versus TMIE, Ivor Lewis HMIE versus Ivor Lewis TMIE, and McKeown HMIE versus McKeown TMIE. There were no randomized controlled trials. Twenty-nine studies with a total of 3732 patients were included. Studies had a low to moderate risk of bias. In the main analysis, the pooled incidence of pneumonia was 19.0% after HMIE and 9.8% after TMIE which was not significantly different between the groups (RR: 1.46, 95% CI: 0.97-2.20). TMIE was associated with a lower incidence of wound infections (RR: 1.81, 95% CI: 1.13-2.90) and less blood loss (SMD: 0.78, 95% CI: 0.34-1.22) but with longer operative time (SMD:-0.33, 95% CI: -0.59--0.08). In subgroup analysis, laparoscopy-assisted HMIE was associated with a higher lymph node count than TMIE, and Ivor Lewis HMIE was associated with a lower anastomotic leakage rate than Ivor Lewis TMIE. In general, TMIE was associated with moderately lower morbidity compared to HMIE, but randomized controlled evidence is lacking. The higher leakage rate and lower lymph node count that was found after TMIE in sensitivity analysis indicate that TMIE can also have disadvantages. The findings of this meta-analysis should be considered carefully by surgeons when moving from HMIE to TMIE.
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