Dataset Information

A multicenter prospective adapttive trial (Non-comparative phase2 and non-inferiority phase3 study) of underwater endoscopic miucosal resection (UEMR) compared to endoscopic submucosal dissection (ESD) for early colorectal cancer.

ABSTRACT: Interventions: ESD or UEMR Primary outcome(s): Pathological complete resection rate [The tumor component in the resected specimen shall be negative for horizontal margin and negative for vertical margin (R0 resection).] Study Design: randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose

DISEASE(S): Early Colorectal Cancer

PROVIDER: 2612669 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Similar Datasets

Project description:ObjectiveTo assess whether percutaneous transforaminal endoscopic discectomy (PTED) is non-inferior to conventional open microdiscectomy in reduction of leg pain caused by lumbar disc herniation.DesignMulticentre randomised controlled trial with non-inferiority design.SettingFour hospitals in the Netherlands.Participants613 patients aged 18-70 years with at least six weeks of radiating leg pain caused by lumbar disc herniation. The trial included a predetermined set of 125 patients receiving PTED who were the learning curve cases performed by surgeons who did not do PTED before the trial.InterventionsPTED (n=179) compared with open microdiscectomy (n=309).Main outcome measuresThe primary outcome was self-reported leg pain measured by a 0-100 visual analogue scale at 12 months, assuming a non-inferiority margin of 5.0. Secondary outcomes included complications, reoperations, self-reported functional status as measured with the Oswestry Disability Index, visual analogue scale for back pain, health related quality of life, and self-perceived recovery. Outcomes were measured until one year after surgery and were longitudinally analysed according to the intention-to-treat principle. Patients belonging to the PTED learning curve were omitted from the primary analyses.ResultsAt 12 months, patients who were randomised to PTED had a statistically significantly lower visual analogue scale score for leg pain (median 7.0, interquartile range 1.0-30.0) compared with patients randomised to open microdiscectomy (16.0, 2.0-53.5) (between group difference of 7.1, 95% confidence interval 2.8 to 11.3). Blood loss was less, length of hospital admission was shorter, and timing of postoperative mobilisation was earlier in the PTED group than in the open microdiscectomy group. Secondary patient reported outcomes such as the Oswestry Disability Index, visual analogue scale for back pain, health related quality of life, and self-perceived recovery, were similarly in favour of PTED. Within one year, nine (5%) in the PTED group compared with 14 (6%) in the open microdiscectomy group had repeated surgery. Per protocol analysis and sensitivity analyses including the patients of the learning curve resulted in similar outcomes to the primary analysis.ConclusionsPTED was non-inferior to open microdiscectomy in reduction of leg pain. PTED resulted in more favourable results for self-reported leg pain, back pain, functional status, quality of life, and recovery. These differences, however, were small and may not reach clinical relevance. PTED can be considered as an effective alternative to open microdiscectomy in treating sciatica.Trial registrationNCT02602093ClinicalTrials.gov NCT02602093.

Dataset Information

A multicenter prospective adapttive trial (Non-comparative phase2 and non-inferiority phase3 study) of underwater endoscopic miucosal resection (UEMR) compared to endoscopic submucosal dissection (ESD) for early colorectal cancer.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets