'French LARS score': validation of the French version of the low anterior resection syndrome (LARS) score for measuring bowel dysfunction after sphincter-preserving surgery among rectal cancer patients: a study protocol.

INTRODUCTION: Many bowel problems following low anterior resection (LAR) for rectal cancer considerably impair the quality of life (QoL) of patients. The LAR syndrome (LARS) scale is a self-report questionnaire to identify and assess bowel dysfunction after rectal cancer surgery. It has been translated and validated in several languages but not in French (metropolitan French). The primary objective is to adapt the LARS scale to the French language (called French-LARS score) and to assess its psychometric properties. Secondary objectives are to assess both the prevalence and severity of LARS and to measure their impact on QoL. METHODS AND ANALYSIS: A French multicentre observational cohort study has been designed. The validation study will include translation of the LARS scale following the current international recommendations, assessment of its reliability, convergent and discriminant validities, sensitivity, internal consistency, internal validity and confirmatory analyses. One thousand patients will be enrolled for the analyses. The questionnaire will be initially administered to the first 100 patients to verify the adequacy and degree of comprehension of the questions. Then reproducibility will be investigated by a test-retest procedure in the following 400 patients.An analysis will be conducted to determine the correlation between the LARS score and the Quality of Life Questionnaire (QLQ; European Organization for Treatment and Research of Cancer's QLQ-C30, QLQ-CR29). Risk factors linked to QoL deterioration will be identified and their impact will be measured. This study will meet the need for a validated tool to improve patient care and QoL. ETHICS AND DISSEMINATION: The institutional review board of the University Hospital of Caen and the ethics committee (CPP Nord Ouest I, 25 January 2019) approved the study. TRIAL REGISTRATION NUMBER: NCT03569488.

Maggot therapy for wound debridement: a randomized multicenter trial.

OBJECTIVE: To study the efficacy of bagged larvae on wound debridement compared with conventional treatment. DESIGN: Randomized, multicenter, controlled, prospective phase 3 trial with blinded assessment of outcome measures by a single observer. SETTING: Two hospital referral centers in Caen and Lyon, France. PATIENTS: Random sampling of 119 patients with a nonhealing, sloughy wound 40 cm(2) or smaller, less than 2 cm deep, and an ankle brachial index of 0.8 or higher. INTERVENTION: During a 2-week hospital stay, patients received either maggot debridement therapy (MDT) or conventional treatment. At discharge, conventional dressings were applied and a follow-up visit occurred at day 30. MAIN OUTCOME MEASURE: Percentage of slough in wounds at day 15. RESULTS: There was a significant difference between groups at day 8 (54.5% in the MDT group and 66.5% in the control group) (P = .04). The mean percentage of slough at day 15 was 55.4% in the MDT group and 53.8% in the control group (P = .78). CONCLUSIONS: Although MDT shows no significant benefit at day 15 compared with conventional treatment, debridement by MDT is significantly faster and occurs during the first week of treatment. Because there is no benefit in continuing the treatment after 1 week, another type of dressing should be used after 2 or 3 applications of MDT. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01211236.

Radio-opaque ethylcellulose-ethanol is a safe and efficient sclerosing agent for venous malformations.

OBJECTIVE: To evaluate the efficacy and safety of gelified ethanol, a newly developed sclerosing agent for slow-flow vascular malformations. METHODS: Seventy-nine sclerotherapy procedures were performed on 44 patients with 37 venous malformations, 2 glomuvenous malformations, 2 lymphatic malformations, 2 lymphatico-venous malformations, and 1 Klippel-Trenaunay syndrome. The median injected volume was 1.00 mL/site of injection. Effects of sclerotherapy on pain, functional and cosmetic disturbance were statistically evaluated with a final result score. Local and systemic complications were recorded. RESULTS: The mean Visual Analogue Scores were 5.20 ± 2.81 before and 1.52 ± 1.25 after treatment (p < 0.001). Functional and aesthetic improvement was achieved in 31/35 patients (89%) and in 33/41 (80%), respectively. Minor local side effects included necrosis with or without issue of ethylcellulose, palpable residue, and hematoma. No systemic side-effects occurred. CONCLUSION: Per mL used, radio-opaque gelified ethanol is at least as effective as absolute ethanol. No systemic complication was observed, as only a low dose of ethanol was injected. Indications for sclerotherapy can be widened to areas with higher risk for local side effects (hands and periocular region), as ethanol is trapped in the lesion. Careful injection procedure is though necessary, because only a limited amount of ethylcellulose can be used per puncture. Key Points • Development of a new sclerosing agent for venous malformations. • Interesting novel way to deliver alcohol to slow-flow vascular malformations. • Alcohol-based with less local and systemic side-effects.