ABSTRACT
BACKGROUND: Endoscopic resection of adenomas prevents colorectal cancer, but the optimal technique for larger lesions is controversial. Piecemeal endoscopic mucosal resection (EMR) has a low adverse event (AE) rate but a variable recurrence rate necessitating early follow-up. Endoscopic submucosal dissection (ESD) can reduce recurrence but may increase AEs. OBJECTIVE: To compare ESD and EMR for large colonic adenomas. DESIGN: Participant-masked, parallel-group, superiority, randomized controlled trial. (ClinicalTrials.gov: NCT03962868). SETTING: Multicenter study involving 6 French referral centers from November 2019 to February 2021. PARTICIPANTS: Patients with large (≥25 mm) benign colonic lesions referred for resection. INTERVENTION: The patients were randomly assigned by computer 1:1 (stratification by lesion location and center) to ESD or EMR. MEASUREMENTS: The primary end point was 6-month local recurrence (neoplastic tissue on endoscopic assessment and scar biopsy). The secondary end points were technical failure, en bloc R0 resection, and cumulative AEs. RESULTS: In total, 360 patients were randomly assigned to ESD (n = 178) or EMR (n = 182). In the primary analysis set (n = 318 lesions in 318 patients), recurrence occurred after 1 of 161 ESDs (0.6%) and 8 of 157 EMRs (5.1%) (relative risk, 0.12 [95% CI, 0.01 to 0.96]). No recurrence occurred in R0-resected cases (90%) after ESD. The AEs occurred more often after ESD than EMR (35.6% vs. 24.5%, respectively; relative risk, 1.4 [CI, 1.0 to 2.0]). LIMITATION: Procedures were performed under general anesthesia during hospitalization in accordance with the French health system. CONCLUSION: Compared with EMR, ESD reduces the 6-month recurrence rate, obviating the need for systematic early follow-up colonoscopy at the cost of more AEs. PRIMARY FUNDING SOURCE: French Ministry of Health.
Subject(s)
Adenoma , Colonic Neoplasms , Colorectal Neoplasms , Humans , Colonic Neoplasms/surgery , Colonic Neoplasms/pathology , Colonoscopy/adverse effects , Colonoscopy/methods , Biopsy , Adenoma/surgery , Adenoma/pathology , Treatment Outcome , Colorectal Neoplasms/surgery , Colorectal Neoplasms/pathology , Neoplasm Recurrence, Local , Intestinal Mucosa/pathology , Intestinal Mucosa/surgery , Retrospective StudiesABSTRACT
OBJECTIVE: To evaluate the effect of trigeminal nerve block (TNB) on patients' quality of life (QOL) 15 days after the procedure in patients with refractory TN. METHODS: This retrospective observational cohort study involved patients receiving TNB (levobupivacaine, clonidine, corticosteroid) between 2014 and 2018 at a postoperative pain clinic in France. Change in QOL from Day 0 (before block) to Day 15 was assessed according to SF-12. RESULTS: 21 patients (62 ± 14 y) were included in the study. Most patients (71%) were referred following surgery or dentistry. Of the 9 patients (43%) who exhibited >10% increase in SF-12 scores and so were deemed responders, SF12-physical and SF12-mental were increased by mean differences of 17 and 9 points, respectively. The mean duration of block lasted 15 ± 59 days (range 1 to 90 days) and no severe adverse effects were observed. CONCLUSION: Improved QOL was observed in approximately 50% of patients with trigeminal neuralgia (TN) two weeks after specific nerve block. The technique was easy to administer and well accepted by the patients.
Subject(s)
Trigeminal Neuralgia , Humans , Trigeminal Neuralgia/surgery , Quality of Life , Retrospective Studies , Levobupivacaine , Clonidine , Treatment Outcome , Trigeminal Nerve , Observational Studies as TopicABSTRACT
BACKGROUND: Stroke is the leading cause of acquired disability in France. While 90% of patients recover the ability to walk, it is often limited with a steady speed of approximately 0.7 m/s. This limitation of walking activity is partly related to a decrease in strength associated with more or less significant spasticity. In particular, it seems that the strength of the dorsiflexor muscles is directly related to walking speed. We hypothesise that a protocol based on gestural repetition targeted at the ankle during the subacute phase potentiates the recovery of motor control, improving walking activity, and participates in recovering better social participation. METHODS: An estimated total of 60 patients with subacute stroke will be recruited to participate in this multicentre, interventional, prospective, randomised controlled trial. All participants will benefit from conventional rehabilitation. In addition, the experimental group will take part in an ankle isokinetic rehabilitation programme for 6 weeks (at least 25 sessions). The control group will receive the same duration of conventional rehabilitation. The primary outcome measure will be a 10-m walking speed at post-intervention. Secondary outcomes will include social participation, walking spatio-temporal parameters, and dorsiflexor strength. Outcome measurements will be taken at baseline, immediately after treatment (6 weeks), then at 6 months and 1 year of follow-up. DISCUSSION: This study aims to provide scientific evidence that a protocol based on an early over-solicitation of the ankle dorsiflexor muscles to promote their "awakening" can serve to achieve a more effective walking activity, which in turn encourages social participation following discharge from the hospital. This protocol should also help optimise physical medicine and rehabilitation practices: the more systematic use of the isokinetic dynamometer as a technique associated with, and integrated into the conventional rehabilitation protocol would allow an objective evaluation of the rehabilitation benefits and should increase the rehabilitation gain in central nervous system disorders. TRIAL REGISTRATION: Limoges University Hospital is the sponsor of this research (Unique Protocol ID: 87RI18_0010) This research is supported by the French Ministry of Health (PHRC 2020-A03328-31) and is conducted with the support of DGOS (PHRC interregional - GIRCI SOHO). The study protocol was approved by the French Human Subjects Protection Review Board (Comité de Protection des Personnes Nord-Ouest III) on February 23, 2021. The trial was registered in the ClinicalTrials.gov registry ( NCT04800601 ) on March 16, 2021.
Subject(s)
Stroke Rehabilitation , Stroke , Ankle , Clinical Protocols , Exercise Therapy/methods , Hemiplegia , Humans , Prospective Studies , Recovery of Function/physiology , Stroke/diagnosis , Treatment Outcome , Walking/physiologyABSTRACT
Background: Tonsil surgery causes significant and challenging postoperative pain. The Analgesia Nociception Index (ANI) and videopupillometry are two techniques of interest to monitor nociception in adults and may predict postoperative morphine requirements. We hypothesised that these techniques could predict the need for morphine after tonsillectomy in children. The main objective was to assess the prognostic significance of ANI and videopupillometry, measured at the end of surgery, on morphine consumption determined by a Face, Legs, Activity, Cry, Consolability (FLACC) scale score >3 in the Post Anesthesia Care Unit (PACU). Methods: A single-centre, prospective, interventional study evaluating children between 2 and 7 yr old undergoing tonsil surgery was performed. ANI and videopupillometry with tetanic stimulation were measured under general anaesthesia 4 min after the end of the surgical procedure. Each child was evaluated every 10 min by a nurse using the FLACC scale in the PACU and blinded to the measurements performed in the operating theatre. Results: Eighty-nine children were analysed and 39 (44%) received morphine in the PACU. Neither ANI values nor videopupillometry values were predictive of postoperative morphine consumption (areas under the receiver operating characteristic curve 0.54, 95% confidence interval [CI; 0.42-0.65], and P=0.57; and 0.52, 95% CI [0.41-0.63], and P=0.69, respectively). Neither ANI values nor videopupillometry values were correlated to the maximum FLACC scale score in the PACU with ρ=0.04 (P=0.71) and ρ=0.06 (P=0.57), respectively. Conclusions: Neither ANI nor videopupillometry performed at the end of surgery can predict morphine consumption in the PACU in children undergoing tonsillectomy.