Prospective Randomized Multicenter Study Research Articles

Endoscopic full-thickness resection versus endoscopic submucosal dissection for challenging colorectal lesions: a randomized trial

The optimal endoscopic resection method of challenging colorectal lesions, (i.e. adenomatous recurrences, laterally spreading non-granular tumors (LST-NG), lesions without lifting sign <30mm), is still under debate. Aim of our study was to directly compare Endoscopic Submucosal Dissection (ESD) and Endoscopic Full Thickness Resection (EFTR) for the resection of challenging colorectal lesions in a randomized trial. We underwent a multicenter prospective randomized study in four Italian referral centers. Consecutive patients referred for endoscopic resection of challenging lesions were randomly assigned to receive EFTR or ESD. Primary outcomes were R0 resection and en-bloc resection of lesions. We also compared technical success, procedure time, procedure speed, area of the resected specimen, complication rate and local recurrence rate at 6 months. Overall, 90 patients were included in the study, equally representing the three challenging lesion types. Age and sex were comparable in the two groups. En-bloc resection was obtained in 95.5% in EFTR group and in 93.3% in ESD group. R0 resection rate was comparable in the two groups (EFTR vs ESD: 42 [93.3%] vs 36 [80%], p=0.06. EFTR group showed a significantly shorter total procedure time (25.6 [10.6] vs 76.7 [26.4] minutes, p=<0.01) as well as overall procedure speed (16.8 [11.8] vs 11.9 [9.2] mm2/min, p=0.0.3). EFTR group showed a significantly smaller mean lesion size (21.6 mm [8.3] vs 28.7 mm [7.7], p=<0.01. Complications were reported less frequently in patients in the EFTR group (4.44 vs. 15.5 %, p=0.04). EFTR is comparable to ESD in the treatment of challenging colorectal lesions in terms of safety and efficacy. EFTR is considerably faster than ESD in the treatment of non-lifting lesions and adenoma recurrences.

Effects of the baseline prognostic factors on efficacy of the p62/SQSTM1-encoding plasmid combined with gemcitabine in patients with recurrent platinum-resistant ovarian cancer.

e17540 Background: We recently reported on the efficacy of the p62/SQTM1-encoding plasmid in patients with advanced, recurrent platinum-resistant ovarian cancer (PROC) receiving gemcitabine chemotherapy. Here we analyze the effects of baseline prognostic factors on efficacy. Methods: A prospective multicenter randomized study took place between 01/2020 and 08/2023. Cohort A (n=20) consisted of Gemcitabine 1000 mg/m2 days 1,8 every 3 weeks and Cohort B (n=20) consisted of Gemcitabine (Gem) 1000 mg/m2 days 1,8 every 3 weeks plus p62-plasmid 2.5 mg i.m. weekly. We stratified the patients into subgroups according to their baseline CA-125 level (normal vs high), number of lines of chemo (1 vs 2-3) received by a platinum-sensitive ovarian cancer (PSOC) patient before they became PROC, platinum-free interval (PFI) (up to 3 mo vs more than 3 mo), and presence or absence of peritoneal effusion. Cox proportional hazards regression analysis was utilized to determine effect of progression free survival (PFS). Results: The median follow-up was 13.8 months (mos). The median PFS was 2.8 mos in Gem (Arm A) and 7.2 mos in Gem + Plasmid (Arm B) respectively (p = 0.03). The overall response rate (ORR) by RESIST 1.1 was higher in the Gem +Plasmid arm: partial response (PR) - 5.0% and 20.0%, stable disease (SD) - 40.0% and 60.0%, and disease control rate 41.2 and 80% in Chemo and Plasmid arms respectively). In cohort A, all patients have progressed, whereas in Cohort B (Gem +Plasmid) 9 patients (45%) remained progression-free with the longest duration of response being 30 mo. Overall survival cannot be assessed yet. Analyzing prognostic factors with Cox Proportional Hazards Regression Analysis identified that the following factors increase p62 sensitivity: initial high CA-125 level PFS 2.5 and 6.5 (p = 0.01) in Arm A vs B, 1 line chemo vs 2 or 3 lines for PSOC, PFS 2.3 and 7.1 (p = 0.008) in Arm A vs B, and presence of peritoneal effusion PFS 2.4 and 7.6 (p = 0.008) in Arm A vs B (Table ). Conclusions: We observed maximal effect on PFS when combining the p62-encoding plasmid with Gem in the patients with the most dismal prognosis PROC: rapid progression (relapse as PROC after the first line of treatment and/or short PFI), in patients with an initial high level of CA-125, and/or pleural effusion. [Table: see text]

Pulmonary vein isolation and additional selective ablation of low voltage areas and atrial late potentials for persistent atrial fibrillation (SOLVE-AF-Study)

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Abbott Introduction Novel catheter ablation technologies (e.g. RF with contiguous lesions) for pulmonary vein isolation (PVI) achieve high (80-85%) arrhythmia freedom rates at 12 months in both paroxysmal and persistent AF. However, success rates are importantly reduced (45-50%) in persistent AF patients presenting atrial cardiomyopathy with additional low voltage areas in the left atrial body. Aim SOLVE-AF study is a prospective randomized multicenter study, in which the standard approach "circumferential PVI" is compared to "additional ablation of low voltage areas and ablation of slow conducting "atrial late potentials (ALPs)" during sinus rhythm (SR)". Methods 320 patients with persistent AF will be included. Patients undergo left atrial high definition voltage mapping in SR. 160 patients with low voltage areas (&amp;lt;0.5mV at &amp;gt;5cm2) within the LA body will be randomized to "circumferential-PVI" vs. "additional low-voltage-guided ablation". The remaining 160 without low voltage substrate (registry group) will undergo "circumferential-PVI". Arrhythmia recurrences (defined as AF/AT &amp;gt;30 sec) will be assessed at 6 and 12 months (7-day-Holter and event-recorder) following ablation therapy (top panel). Results Currently, 120 patients have been included into the registry group and 120 patients with low voltage substrate have been randomized. Results of the SOLVE-AF-pilot study including a total of 210 patients (110 registry patients without LA-LVS and 100 patients with LA-LVS who were assigned to PVI-only versus additional substrate-based ablation) at the University-Heart-Center-FR-BK favor "PVI plus substrate-based ablation" in those patients who do present significant low voltage areas (see KM-curve bottom panel). Conclusions Results from the pilot trial suggests improved arrhythmia freedom rate with PVI plus additional substrate-based ablation during sinus rhythm. Final results of the prospective randomized multi-center trial SOLVE-AF are expected in June 2024.

O067 Vessel prep trials – real life or alternative reality?

Abstract Introduction During the last ten years there have been two notable studies within vessel preparation for peripheral vascular disease; the DEFINITIVE AR prospective multi-centre randomised study (evaluating the use of atherectomy prior to drug-eluting balloon catheters (DCB)) and the DISRUPT PAD III randomized control trial (evaluating the use of intravascular lithotripsy (IVL)). This study aimed to analyse a true cohort of vascular patients who underwent vessel prep and whether this reflects those included in the studies. Methods Data were collected on patients with SFA disease in 14 countries across 17 centres. We applied the inclusion criteria for the DEFINITIVE AR and DISRUPT PAD III studies to our cohort. Results Data were collected on n=974 patients who received at least one form of vessel prep. Of these patients, 202 (20.7%) underwent atherectomy and 22 (2.26%) underwent lithotripsy. 50.1% (n=103) of those who underwent atherectomy would have been eligible to participate in the DEFINITVE AR study. 18% (n=4) of patients who underwent lithotripsy would have been eligible to participate in the DISRUPT PAD III trial. Conclusion Both the DEFINITIVE AR and DISRUPT PAD III trials have shown promising results however in this large multicentre study we have shown that the study participants reflect only a small percentage of the patients seen within a real vascular ward. We would advise caution when interpreting the results from these studies considering the disparity we have shown between the study cohorts and the real life vascular population.

SPinal coRd stimulatiOn coMpared with lumbar InStrumEntation for low back pain after previous lumbar decompression (PROMISE): a prospective multicentre RCT

IntroductionPersistent spine pain syndrome type 2 (PSPS2) represents a significant burden to the individual and society. Treatment options include revision surgery, stabilisation surgery of the spine, neuromodulation, analgesics and cognitive...

SAFESTEREO: phase II randomized trial to compare stereotactic radiosurgery with fractionated stereotactic radiosurgery for brain metastases

BackgroundStereotactic radiosurgery (SRS) is a frequently chosen treatment for patients with brain metastases and the number of long-term survivors is increasing. Brain necrosis (e.g. radionecrosis) is the most important long-term side effect of the treatment. Retrospective studies show a lower risk of radionecrosis and local tumor recurrence after fractionated stereotactic radiosurgery (fSRS, e.g. five fractions) compared with stereotactic radiosurgery in one or three fractions. This is especially true for patients with large brain metastases. As such, the 2022 ASTRO guideline of radiotherapy for brain metastases recommends more research to fSRS to reduce the risk of radionecrosis. This multicenter prospective randomized study aims to determine whether the incidence of adverse local events (either local failure or radionecrosis) can be reduced using fSRS versus SRS in one or three fractions in patients with brain metastases.MethodsPatients are eligible with one or more brain metastases from a solid primary tumor, age of 18 years or older, and a Karnofsky Performance Status ≥ 70. Exclusion criteria include patients with small cell lung cancer, germinoma or lymphoma, leptomeningeal metastases, a contraindication for MRI, prior inclusion in this study, prior surgery for brain metastases, prior radiotherapy for the same brain metastases (in-field re-irradiation). Participants will be randomized between SRS with a dose of 15–24 Gy in 1 or 3 fractions (standard arm) or fSRS 35 Gy in five fractions (experimental arm). The primary endpoint is the incidence of a local adverse event (local tumor failure or radionecrosis identified on MRI scans) at two years after treatment. Secondary endpoints are salvage treatment and the use of corticosteroids, bevacizumab, or antiepileptic drugs, survival, distant brain recurrences, toxicity, and quality of life.DiscussionCurrently, limiting the risk of adverse events such as radionecrosis is a major challenge in the treatment of brain metastases. fSRS potentially reduces this risk of radionecrosis and local tumor failure.Trial registrationClincalTrials.gov, trial registration number: NCT05346367, trial registration date: 26 April 2022.

Abstract OT1-06-01: Preservation of axillary lymph nodes in breast cancer patients undergoing mastectomy with 1-2 metastatic sentinel lymph nodes: The current status and future perspectives of the multicenter randomized clinical trial SINODAR-ONE

Abstract Introduction: Axillary lymph node dissection (ALND) has always been part of breast cancer (BC) treatment. However, during the past 25 years, the surgical management of the axilla has shifted towards a more conservative approach. Until now, ALND has remained the standard surgical technique when the sentinel lymph node (SLN) is macrometastatic. However, ALND may now be considered overtreatment for early-stage BC. The SINODAR-ONE trial is a prospective non-inferiority multicenter randomized study aimed at assessing the role of ALND in patients undergoing either breast-conserving surgery (BCS) or mastectomy for T1-2 BC presenting 1-2 macrometastatic SLNs. Objectives: The primary endpoint was to evaluate whether sentinel lymph node biopsy (SLNB) only was associated with clinically relevant worsening of the prognosis compared with ALND in terms of overall survival (OS). The secondary endpoint was to evaluate whether there was increased regional (lymph node recurrence) or distant recurrence in terms of recurrence-free survival (RFS) in patients with macrometastatic SLN who did not undergo ALND. Methods: Patients were randomly assigned (1:1 ratio) to either removal of ≥10 axillary level I/II non-SLNs followed by adjuvant therapy (standard arm) or no further axillary treatment (experimental arm). Results: The trial started in April 2015 and ceased in April 2020, involving 889 patients. The majority of the patients (75.2%) underwent BCS; 328 of 439 patients (74.7%) in the standard treatment arm, and 333 of 440 patients (75.7%) in the experimental treatment arm. 218 patients (24.8%) underwent mastectomy. SLN status at randomization was comparable between the two groups of treatment, with a median number of two SLNs removed and a median number of one positive SLN in both arms. The median number of non-SLNs identified at definitive histopathological evaluation was 16 (interquartile range [IQR] 12–21) in the ALND group. Overall, 193 of 439 patients (44.0%) in the standard treatment arm had additional macrometastases in the removed axillary lymph nodes. However, the median number of positive non SLNs was 0 (IQR 0–1) in the ALND group. Median follow-up was 34.0 months. There were eight deaths (ALND, 4; SNLB only, 4), with a 5-year cumulative mortality of 5.8% and 2.1% in the standard and experimental arm, respectively (p = 0.984). There were 26 recurrences (ALND 11; SNLB only, 15), with a 5-year cumulative incidence of recurrence of 6.9% and 3.3% in the standard and experimental arm, respectively (p = 0.444). Only one axillary lymph node recurrence was observed in each arm. The 5-year OS rates were 98.9% and 98.8%, in the ALND and SNLB only arm, respectively (p = 0.936). Conclusion: The 3-year survival and relapse rates of T1-2 BC patients with 1-2 macrometastatic SLNs treated with SLNB only, and adjuvant therapy, were not inferior to those of patients treated with ALND. These results do not support the use of routine ALND in patients undergoing BCS. However, given the low number of patients treated with mastectomy, there is no certainty that ALND omission can be extended also to this sub-group. In order to collect further evidence regarding the safety of the experimental treatment in patients candidates for mastectomy, the reopening of the enrollment of these patients as part of a single-arm experimental study started in June 2022. Citation Format: Damiano Gentile, Wolfgang Gatzemeier, Andrea Sagona, Erika Barbieri, Alberto Testori, Valentina Errico, Alberto Bottini, Simone Di Maria Grimaldi, Giulia Caraceni, Luca Boni, Paolo Bruzzi, Bethania Fernandes, Davide Franceschini, Ruggero Spoto, Rosalba Torrisi, Marta Scorsetti, Armando Santoro, Giuseppe Canavese, Corrado Tinterri. Preservation of axillary lymph nodes in breast cancer patients undergoing mastectomy with 1-2 metastatic sentinel lymph nodes: The current status and future perspectives of the multicenter randomized clinical trial SINODAR-ONE [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT1-06-01.

Effect of single dose prophylactic antibiotics versus phytotherapy in altering the microbial colonization related to indwelling double-J stent A prospective randomized controlled multicenter study

Effect of single dose prophylactic antibiotics versus phytotherapy in altering the microbial colonization related to indwelling double-J stent A prospective randomized controlled multicenter study

Initial experience with superpulsed thulium laser in prostate enucleation: Prospective randomized multicenter comparative study between HoLEP and ThuLEP in terms of efficacy and safety

Initial experience with superpulsed thulium laser in prostate enucleation: Prospective randomized multicenter comparative study between HoLEP and ThuLEP in terms of efficacy and safety

A PROSPECTIVE MULTICENTRE RANDOMIZED COMPARATIVE STUDY ASSESSING A NEW MORPHOMETRIC-DESIGNED STEM FOR TOTAL HIP ARTHROPLASTY: BENCHMARKING AGAINST AN ESTABLISHED COMPARATOR

Clinical success of prostheses in joint arthroplasty is ultimately determined by survivorship and patient satisfaction. The purpose of this study was to compare (non-inferiority) a new morphometric designed stem for total hip arthroplasty (THA) against an established comparator.A prospective randomised multi-centre study of 144 primary cementless THA performed by nine experienced orthopaedic surgeons was completed (70 received a fully coated collarless tapered stem and 74 received a morphometric designed proximally coated tapered stem). PROMs and blood serum markers were assessed preoperatively and at intervals up to 2-years postoperatively. In addition, measures of femoral stem fit, fill and subsidence at 2-years post-operatively were measured from radiographs by three observers, with an intra-class correlation coefficient of 0.918. A mixed effects model was employed to compare the two prosthesis over the study period. A p-value &lt;0.05 was considered statistically significant.Demographics, Dorr types and blood serum markers were similar between groups. Both stems demonstrated a significant improvement in PROMs between the pre- and post-operative measurements, with no difference at any timepoint (p &gt; 0.05). The fully coated tapered collarless femoral stem had a non-significantly higher intra-operative femoral fracture rate (5.8% vs 1.4%, p = 0.24), with all patients treated with cable fixation and partial weight bearing. The mean subsidence at 2-years was 2.5mm +/− 2.3mm for the morphometric stem and 2.4mm +/− 1.8mm for the fully coated tapered collarless femoral stem (p = 0.879). There was one outlier in each group with increased subsidence (fully coated tapered collarless femoral stem 6.9mm, morphometric wedge stem 7.4mm), with both patients reporting thigh pain at 2 years.When compared with an established stem, the newer designed morphometric wedge stem performed well with comparable radiological and PROM outcomes at 2 year follow up. Continued follow-up is required for long term benchmarking.

A PROSPECTIVE, MULTICENTRE RANDOMIZED COMPARATIVE STUDY ASSESSING A NEW MORPHOMETRIC-DESIGNED STEM FOR TOTAL HIP ARTHROPLASTY: BENCHMARKING AGAINST AN ESTABLISHED COMPARATOR

Clinical success of prostheses in joint arthroplasty is ultimately determined by survivorship and patient satisfaction. The purpose of this study was to compare (non-inferiority) a new morphometric designed stem for total hip arthroplasty (THA) against an established comparator.A prospective randomised multi-centre study of 144 primary cementless THA performed by nine experienced orthopaedic surgeons was completed (70 received a fully coated collarless tapered stem and 70 received a morphometric designed proximally coated tapered stem). PROMs and blood serum markers were assessed preoperatively and at intervals up to 2-years postoperatively. In addition, measures of femoral stem fit, fill and subsidence at 2-years post-operatively were measured from radiographs by three observers, with an intra-class correlation coefficient of 0.918. A mixed effects model was employed to compare the two prostheses over the study period. A p-value &lt;0.05 was considered statistically significant.Demographics and Dorr types were similar between groups. Both stems demonstrated a significant improvement in PROMs between the pre- and post-operative measurements, with no difference at any timepoint (p &gt; 0.05). The fully coated tapered collarless femoral stem had a non-significantly higher intra-operative femoral fracture rate (5.8% vs 1.4%, p = 0.24), with all patients treated with cable fixation and partial weight bearing. The mean subsidence at 2-years was 2.5mm +/- 2.3mm for the morphometric stem and 2.4mm +/- 1.8mm for the fully coated tapered collarless femoral stem (p = 0.879). There was one outlier in each group with increased subsidence (fully coated tapered collarless femoral stem 6.9mm, morphometric wedge stem 7.4mm), with both patients reporting thigh pain at 2 years.When compared with an established stem, the newer designed morphometric wedge stem performed well with comparable radiological and PROM outcomes at 2 year follow up. Continued follow-up is required for long term benchmarking.

Management and effects of residual limbus inversion following closed reduction in developmental hip dysplasia: Protocol for a multicenter randomized controlled trial.

Closed reduction is a common treatment method for developmental dysplasia of the hip (DDH) in children aged 6-18 months. Residual acetabular dysplasia (RAD) is the most common complication associated with closed reduction. Residual limbus inversion (RLI) is a common condition following DDH closed reduction. Previously, we confirmed that when limbus inversion exceeds 32.2% of the acetabular depth after closed reduction, RLI persists and leads to RAD; however, this was based on a small cohort with a short-term follow-up period. The long-term fate of RLI and the correlation between RLI and RAD have yet to be verified. Therefore, this multicenter clinical study protocol was designed in three parts to investigate the effect of RLI on acetabular development after closed reduction of DDH (a multicenter retrospective cohort study), effect of RLI clearance on acetabular development (a multicenter retrospective and prospective randomized controlled study), and influence of inverted limbus clearance on acetabular development during DDH reduction (a multicenter prospective cohort study). Statistical analysis was performed by assessing the basic measures of acetabular development including the acetabular index and central-edge angle using frontal pelvic radiographs; the magnitude of limbus inversion, cartilaginous acetabular index, and T1ρ mapping values were measured using magnetic resonance imaging. The multicenter retrospective cohort studies required 5 years of follow-up period at minimum, and the prospective randomized controlled studies required reviews of frontal pelvic radiographs every 6 months as well as data pooling every 2 years to compare the short- and mid-term outcomes of hip joint morphological development between the two groups of pediatric patients. This research program is expected to verify that RLI following closed reduction of DDH can affect acetabular development and that limbus excision during DDH reduction can improve postoperative RAD. Therefore, the indication and timing of surgical intervention for RLI after closed reduction of DDH provide a basis for revising the acceptable criteria for utilizing closed reduction of DDH to reduce the incidence of osteoarthritis caused by RAD following DDH treatment. Clinical Trial: http://www.chictr.org.cn/showproj.aspx?proj=35045 (ChiCTR1900020996).

Оценка эффективности сукросомальной формы железа при лечении пациенток с железодефицитной анемией 1–2-й степени тяжести на фоне обильных менструальных кровотечений

Aim: to evaluate the clinical efficacy of Sucrosomial® iron (SiderAL® Forte) in the treatment of stage 1–2 iron deficiency anemia (IDA) in patients with menorrhagia in the setting of ovulation disorders. Patients and Methods: a prospective randomized multicenter clinical case study of 110 patients with stage 1–2 IDA developed in the setting of menorrhagia as a result of ovulation disorders was conducted. Female patients of the main group (n=74) received Sucrosomial® iron 30 mg 2 times a day for 60 days. In the control group (n=36), a liposomal iron preparation of 30 mg 2 times a day was also prescribed for 60 days. Results: during Sucrosomial® iron ferrotherapy, an increase in Hb levels by more than 20 g/L was observed after 30 days of administration in 65 (87%) female patients, after 60 days in 73 (98.6%) female patients, which demonstrated higher therapeutic efficacy versus liposomal iron preparation (69.4 and 88.8%, respectively, p=0.0001). There was also a greater adherence to therapy (98.6%) during Sucrosomial® iron intake versus liposomal iron intake (86.1%, p=0.0001), due to fewer (1.4%) adverse events compared with the control group (5.5%, p=0.0002). Conclusion: oral ferrotherapy with Sucrosomial® iron is a reasonable option for the IDA treatment in patients with menorrhagia due to its higher efficacy versus the liposomal iron. The effect occurs after 30 days of drug intake with a minimum number of adverse events, due to the unique structural, physico-chemical and pharmacokinetic characteristics of the sucrosomial iron, thanks to which it is protected from the gastric juice action, does not contact with the gastrointestinal mucosa and is absorbed through special intestinal M-cells with further iron release in liver cells. KEYWORDS: iron deficiency anemia, menorrhagia, ovulation disorders, Sucrosomial® iron, women, therapy. FOR CITATION: Kononova I.N., Dobrokhotova Yu.E., Kareva E.N., Shmakova N.A., Graban I.V., Ogurtsova T.A. Evaluation of the sucrosomial iron efficacy in the patient treatment with stage 1–2 iron deficiency anemia during heavy menstrual bleeding. Russian Journal of Woman and Child Health. 2023;6(4):332–339 (in Russ.). DOI: 10.32364/2618-8430-2023-6-4-2.

Проградиентное форсированное наращивание объема энтерального питания у глубоконедоношенных детей: результаты мультицентрового проспективного рандомизированного исследования

Проградиентное форсированное наращивание объема энтерального питания у глубоконедоношенных детей: результаты мультицентрового проспективного рандомизированного исследования

Artificial intelligence empowers the second-observer strategy for colonoscopy: a randomized clinical trial.

In colonoscopy screening for colorectal cancer, human vision limitations may lead to higher miss rate of lesions; artificial intelligence (AI) assistance has been demonstrated to improve polyp detection. However, there still lacks direct evidence to demonstrate whether AI is superior to trainees or experienced nurses as a second observer to increase adenoma detection during colonoscopy. In this study, we aimed to compare the effectiveness of assistance from AI and human observer during colonoscopy. A prospective multicenter randomized study was conducted from 2 September 2019 to 29 May 2020 at four endoscopy centers in China. Eligible patients were randomized to either computer-aided detection (CADe)-assisted group or observer-assisted group. The primary outcome was adenoma per colonoscopy (APC). Secondary outcomes included polyp per colonoscopy (PPC), adenoma detection rate (ADR), and polyp detection rate (PDR). We compared continuous variables and categorical variables by using R studio (version 3.4.4). A total of 1,261 (636 in the CADe-assisted group and 625 in the observer-assisted group) eligible patients were analysed. APC (0.42 vs 0.35, P = 0.034), PPC (1.13 vs 0.81, P < 0.001), PDR (47.5% vs 37.4%, P < 0.001), ADR (25.8% vs 24.0%, P = 0.464), the number of detected sessile polyps (683 vs 464, P < 0.001), and sessile adenomas (244 vs 182, P = 0.005) were significantly higher in the CADe-assisted group than in the observer-assisted group. False detections of the CADe system were lower than those of the human observer (122 vs 191, P < 0.001). Compared with the human observer, the CADe system may improve the clinical outcome of colonoscopy and reduce disturbance to routine practice (Chictr.org.cn No.: ChiCTR1900025235).

Self-assessed visual function outcome in cataract surgery: minimum important difference of the Catquest-9SF questionnaire.

The purpose of this study was to study the minimum important difference (MID) of the Catquest-9SF questionnaire in cataract surgery. A nationwide multi-center prospective randomized study was conducted using the Swedish National Cataract Register and the Catquest-9SF questionnaire. Randomized patients (n = 400) who had completed the Catquest-9SF before surgery and threemonths after surgery were sent an anchor question on self-assessed change in visual function after cataract surgery 14days after the postoperative Catquest-9SF. Rasch analysis was performed on the preoperative and postoperative Catquest-9SF questionnaires, and the patients were dichotomized with regard to their preoperative Rasch score. The MID range of the two groups was calculated based on the anchor question, and the anchor question based MID was then estimated in a scatter plot. The MID was also estimated based on distribution by calculating Cohen's effect size. The analyses included 231 patients who had completed the Catquest-9SF on both occasions as well as the questionnaire with the anchor question. The group with better preoperative visual function had an anchor question based MID of - 0.5 and a Cohen's effect size based MID of - 1.07. The group with worse preoperative visual function had an anchor question based MID of -1.80 and a Cohen's effect size based MID of - 1.46. This article contributes detailed knowledge of the MID of Catquest-9SF, enabling even more accurate high-quality evaluation of the outcome and benefit of cataract surgery worldwide.

Needle-free injection of basal insulin improves fasting glucose variability as assessed by continuous glucose monitoring in T2DM: a prospective randomized multicenter open-label crossover study

ABSTRACT Background Fasting glucose variability (FGV) extensively promotes the onset and development of diabetic complications. This study aimed to evaluate the FGV in type 2 diabetes mellitus (T2DM) patients administered basal insulin using a needle-free insulin injector (NFII). Research design and methods This was a prospective randomized multicenter open-label crossover study. We randomly assigned 48 T2DM patients to receive basal insulin by NFII or conventional insulin pen (CIP) for 7–14 days and were then crossed over after washout. We conducted continuous glucose monitoring to investigate the FGV, our primary outcome was a composite parameter of the FGV with a fasting blood glucose target between 4.4 and 6.1 mmol/L. Results The coefficient of variation for sensor glucose at 6 a.m. with CIP was 11.67 (8.70,14.81)% vs. 9.48 (6.48,12.24)% with NFII (p = 0.003), and the coefficient of variation for mean sensor glucose at 5–6 a.m. with CIP was 12.70 (9.17,16.56)% vs. 9.23 (7.01,11.98)% with NFII (p < 0.001). The overall basal insulin dosage with CIP injection was 18.00 (16.00, 20.00) IU vs. 16.00 (12.00, 19.00) IU during NFII (p < 0.003). Conclusion Compared with CIP, the use of the NFII to inject basal insulin improved FGV in T2DM. Clinical trial registration https://www.chictr.org.cn Identifier is ChiCTR2000034674.

Effect of Choline Alphoscerate on the Survival of Glioblastoma Patients: A Retrospective, Single-Center Study.

Cognitive impairment often occurs in glioblastoma (GBM) patients due to the tumor itself and treatment side effects. Choline alphoscerate (L-alpha-glycerylphosphorylcholine, GPC) is frequently used to compensate for cognitive impairment in GBM patients. This study was conducted to determine whether GPC affects the overall survival (OS) and progression-free survival (PFS) of GBM patients. From 2011 to 2020, 187 isocitrate dehydrongenase (IDH)-wild-type GBM patients were analyzed. The patients were classified based on whether GPC was continuously used for at least 3 or 12 months (mos) after GBM diagnosis. Although GPC usage (≥3 mos) did not make significant differences in survival extension, median OS in the long-term GPC group (≥12 mos) was longer with statistical significance, compared to the control group (<12 mos) (38.3 vs. 24.0 mos, p = 0.004). In addition to younger age, supratentorial location, complete resection, and MGMT promoter methylation, long-term use of GPC (≥12 mos) was significantly associated with longer OS in multivariate analysis (p = 0.019, hazard ratio [HR] 0.532, 95% confidence interval [CI] 0.314–0.900). Despite the limitations of this study, long-term GPC use was possibly associated with prolonged survival in GBM patients. Multi-center prospective randomized studies with a large number of patients are needed to validate these findings.

Laser minimally invasive technologies for pilonidal disease

AIM: to estimate results of minimally invasive laser procedures for pilonidal disease.PATIENTS AND METHODS: the prospective randomized multicenter study included 154 patients with chronic and 76 patients with acute inflammation of pilonidal sinus. Patients were blindly divided into equal groups by simple randomization. Patients of group A underwent laser coagulation and curettage of the pilonidal sinus, in group B — sinus excision, in group C — laser coagulation through a wound, in group D — simple abscess opening. Laser radiation of a diode device with a wavelength of 1.56 microns with a power of 10–15 W was used.RESULTS: the recurrence rate 1 year after laser coagulation and curettage of the pilonidal sinus was 5.2%. Significant advantages (lower pain level, wound infection rate, treatment duration, time of wound healing) of the sinus excision were revealed (p &lt; 0.05 for all). Ultrasound control a year after procedure showed that the infiltrative changes of tissues in the postoperative area were significantly less common, as well as scar deformities of the intergluteal area (p &lt; 0.0001; p = 0.006).No significant differences in wound healing time were revealed between groups C and D (p = 0.8). In group D, a secondary fistula was detected in 10.5% after a month of follow-up and required a sinus excision later. The disease remission rate was lowest in group C after 1 year of follow-up (p = 0.01). Morphometry and ultrasound after a year showed infiltration without fluid structures and inflammation in surgical site in group C in 7.9% of patients, in group D — in 23.7%.СONCLUSION: the laser coagulation with curettage and laser coagulation through a wound has a number of advantages over the traditional procedures. These methods can become alternative options for chronic and acute pilonidal disease in regimen of “one-day surgery”.

Management of normal long head of the biceps tendon in isolated grade-1 supraspinatus tear: Research protocol for a multicenter prospective single-blind randomized study

BackgroundThe long head of the biceps (LHB) tendon is a common locus of pain in rotator cuff tear and of residual pain after tendon repair. Therefore, systematic LHB tenotomy, with or without tenodesis, is usually recommended. However, the recent literature suggests that long-term functional results of supraspinatus tendon repair are comparable between conservation of a normal biceps and tenotomy. The study objective is to compare functional results between sectioning and sparing a normal LHB in treating isolated grade-1 supraspinatus tendon tear. The study hypothesis is that sparing the normal LHB is clinically preferable to sectioning in the particular case of distal supraspinatus tear. Methods and analysisA French nationwide prospective single-blind randomized clinical study will include 194 patients undergoing arthroscopic repair of grade-1 supraspinatus tear with normal LHB. They will be randomized to 2 parallel groups: LHB sparing and sectioning. The main endpoint is Constant-Murley score, and secondary endpoints comprise ASES and SSV scores, clinical assessment of the biceps, pain on VAS, ultrasound assessment of cuff repair healing and conserved LHBs, impact on return to work and sport, pathologic assessment of sectioned LHBs, and analysis of risk factors for cuff repair failure. Ethical approval and publicationThe protocol has been approved by the data protection committee (art.L.1122-1) and meets the criteria of the Declaration of Helsinki and of the SPIRIT statement defining standard protocol items for clinical trials. Results will be published in a peer-reviewed journal. Level of evidencenot applicable.