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A randomized controlled trial of pre-procedure simethicone and N-acetylcysteine to improve mucosal visibility during gastroscopy - NICEVIS.

ABSTRACT: Background and study aims: Mucosal views can be impaired by residual bubbles and mucus during gastroscopy. This study aimed to determine whether a pre-gastroscopy drink containing simethicone and N-acetylcysteine improves mucosal visualisation. Patients and methods: We conducted a randomized controlled trial recruiting 126 subjects undergoing routine gastroscopy. Subjects were randomized 1:1:1 to receive: A-pre-procedure drink of water, simethicone and N-acetylcysteine (NAC); B-water alone; or C-no preparation. Study endoscopists were blinded to group allocation. Digital images were taken at 4 locations (lower esophagus/upper gastric body/antrum/fundus), and rated for mucosal visibility (MV) using a 4-point scale (1?=?best, 4?=?worst) by 4 separate experienced endoscopists. The primary outcome measure was mean mucosal visibility score (MVS). Secondary outcome measures were procedure duration and volume of fluid flush required to achieve adequate mucosal views. Results: Mean MVS for Group A was significantly better than for Group B (1.35 vs 2.11, P?

SUBMITTER: Basford PJ

PROVIDER: S-EPMC5110361 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature

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A randomized controlled trial of pre-procedure simethicone and N-acetylcysteine to improve mucosal visibility during gastroscopy - NICEVIS.

Basford Peter John PJ Brown James J Gadeke Lisa L Fogg Carole C Haysom-Newport Ben B Ogollah Reuben R Bhattacharyya Rupam R Longcroft-Wheaton Gaius G Thursby-Pelham Fergus F Neale James R JR Bhandari Pradeep P

Endoscopy international open 20161028 11

<b>Background and study aims:</b> Mucosal views can be impaired by residual bubbles and mucus during gastroscopy. This study aimed to determine whether a pre-gastroscopy drink containing simethicone and N-acetylcysteine improves mucosal visualisation. <b>Patients and methods:</b> We conducted a randomized controlled trial recruiting 126 subjects undergoing routine gastroscopy. Subjects were randomized 1:1:1 to receive: A-pre-procedure drink of water, simethicone and N-acetylcysteine (NAC); B-wat ...[more]

PMID: 27853746

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Project description:Few randomized controlled trials (RCTs) report interventions targeting improvement of frailty status as an outcome.This RCT enrolled 117 older adults (65-79?years of age) in Toufen, Taiwan who scored 3-6 on The Chinese Canadian Study of Health and Aging Clinical Frailty Scale Telephone Version and then score ?1 on the Cardiovascular Health Study Phenotypic Classification of Frailty (CHS_PCF). With a two by two factorial design, subjects were randomly assigned to interventions (Exercise and nutrition, EN, n?=?55 or problem solving therapy, PST, n?=?57) or controls (non-EN, n?=?62 or non-PST, n?=?60). Educational booklets were provided to all. EN group subjects received nutrition consultation and a thrice-weekly exercise-training program while PST group subjects received 6 sessions in 3?month. Subjects were followed at 3, 6, and 12?months. Primary outcome was improvement of the CHS_PCF by at least one category (from pre-frail to robust, or from frail to pre-frail or robust) from baseline assessments. One hundred and one completed final assessments. Intention-to-treat analysis with the generalized estimating equation model was applied with adjustment for time and treatment-by-time interactions.Mean age was 71.4?±?3.7?years, with 59% females. Baseline characteristic were generally comparable between groups. EN group subjects had a higher improvement rate on the primary outcome than non-EN group subjects (45% vs 27%, adjusted p?=?0.008) at 3?months, but not 6 or 12?months. They also had more increase of serum 25(OH) vitamin D level (4.9?±?7.7 vs 1.2?±?5.4, p?=?0.006) and lower percentage of osteopenia (74% vs 89% p?=?0.042) at 12?months. PST group subjects had better improvement (2.7?±?6.1 vs 0.2?±?6.7, p?=?0.035, 6-month) and less deterioration (-3.5?±?9.7 vs -7.1?±?8.7, p?=?0.036, 12-month) of dominant leg extension power than non-PST subjects. Some secondary outcomes were also improved in control groups (non-EN or non-PST). No adverse effects were reported.The three-month EN intervention resulted in short-term (3-month) frailty status improvement and long-term effect on bone mineral density and serum vitamin D (12-month) among Taiwanese community-dwelling elders. The effect of PST was less pronounced.ClinicalTrials.gov: EC0970301

Dataset Information

A randomized controlled trial of pre-procedure simethicone and N-acetylcysteine to improve mucosal visibility during gastroscopy - NICEVIS.

Publications

A randomized controlled trial of pre-procedure simethicone and N-acetylcysteine to improve mucosal visibility during gastroscopy - NICEVIS.

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