Adenoma detection by Endocuff-assisted versus standard colonoscopy in routine practice: a cluster-randomised crossover trial.

OBJECTIVE: Endocuff Vision (ECV) is the second generation of a device designed to improve polyp detection. The aim of this study was to evaluate its impact on adenoma detection rate (ADR) in routine colonoscopy. DESIGN: This cluster-randomised crossover trial compared Endocuff-assisted (ECV+) with standard (ECV-) colonoscopy. Two teams of 11 endoscopists each with prior ECV experience, balanced in terms of basal ADR, gender and case volume were compared. In randomised fashion, the teams started with ECV+ or ECV- and switched group after inclusion of half of the cases. The main outcome criterion was ADR difference between ECV+ and ECV-. Subgroup analysis was done for physicians with low and high ADR (< or ≥ 25%). RESULTS: During two periods of 20 and 21 weeks, respectively, the 22 endoscopists included 2058 patients (1032 ECV- vs 1026 ECV+, both groups being comparable). Overall ADR for both groups taken together was higher with ECV (39.2%) than without (29.4%; p<0.001) irrespective of the sequence of use (ECV+ or ECV- first), but mostly in adenomas <1 cm. In the physician subgroup analysis, only high detectors showed a significant ADR increase (from 31% to 41%, p<0.001), while the increase in the low detectors was not significant (from 24% to 30%, p=0.11). ECV had a positive impact in all colonic locations, except for the rectum. No ECV- related complication was reported. CONCLUSION: We observed a significant ADR difference of approximately 10% by the use of ECV. By subgroup analysis, this increase was significant only in physicians classified as high detectors. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT03344055).

Radiological factors affecting functional outcome after the implantation of BDYN™ dynamic stabilization system for low-grade lumbar degenerative spondylolisthesis.

BACKGROUND: The objectives of this study are to identify radiological factors associated with good functional outcomes after the implantation of BDYN™ dynamic stabilization system in the setting of painful low-grade degenerative lumbar spondylolisthesis (DLS). MATERIAL AND METHODS: In this monocentric, retrospective study, we followed 50 patients, a 5-years period, with chronic lower back pain, radiculopathy and/or neurogenic claudication evolving for at least one year that failed conservative treatment. All patients presented low-grade DLS and underwent lumbar dynamic stabilization. Radiological and clinical outcomes were assessed preoperatively and 24months after surgery. Functional evaluation was based on the Oswestry Disability Index (ODI), the Numerical Rating Scale (NRS), and the Walking Distance (WD). Radiological analysis was based on lumbar X-rays and MRI parameters. Patients were divided into two groups according to the reduction in the postoperative ODI score (more or less than 15 points), and statistical analysis was performed between both groups to find predictive radiological factors for a satisfying functional outcome. RESULTS: Clinically, 80% (40 patients) had a satisfying functional result, and 20% (10 patients) were considered having a poor outcome according to the ODI score. Radiologically, the loss in segmental lordosis was statistically associated with bad functional outcomes (18° for ODI decrease>15 versus 11° for ODI decrease<15). There is also a tendency showing that a higher Pfirmann disc signal grade (grade IV) and a severe canal stenosis according to Schizas classification (grade C & D) are predictive of a poor clinical result, but that must be confirmed in future studies. CONCLUSIONS: BDYN™ appears safe and well-tolerated. This new device should be effective for the treatment of patients with low-grade DLS. It provides significant improvement in terms of daily life activity and pain. Moreover, we have been able to deduce that a kyphotic disc is associated with a bad functional outcome after BDYN™ device implantation. It may represent a contraindication for the implantation of such DS device. Moreover, it seems that it is better to implant BDYN™ in DLS with mild or moderate disc degeneration and canal stenosis.