Endoscopy 2018; 50(04): S75
DOI: 10.1055/s-0038-1637249
ESGE Days 2018 oral presentations
21.04.2018 – Stomach: Improving diagnosis
Georg Thieme Verlag KG Stuttgart · New York

EFFICACY OF SIMETHICONE AND N-ACETYLCYSTEINE COMBINATION PREMEDICATION PRIOR TO ESOPHAGOGASTRODUODENOSCOPY TO IMPROVE MUCOSAL VISIBILITY – A PROSPECTIVE DOUBLE BLINDED RANDOMIZED PLACEBO CONTROLLED TRIAL (CTRI/2017/09/009913)

K Veeraraghavan
1   Pondicherry Institute of Medical Sciences, Gastroenterology, Pondicherry, India
,
J Abel
1   Pondicherry Institute of Medical Sciences, Gastroenterology, Pondicherry, India
,
V Shreyas
1   Pondicherry Institute of Medical Sciences, Gastroenterology, Pondicherry, India
,
TT Malini
1   Pondicherry Institute of Medical Sciences, Gastroenterology, Pondicherry, India
,
D Vijayaraghavan
1   Pondicherry Institute of Medical Sciences, Gastroenterology, Pondicherry, India
,
AV Sangeetha
2   Pondicherry Institute of Medical Sciences, Microbiology, Pondicherry, India
,
G Kurien
1   Pondicherry Institute of Medical Sciences, Gastroenterology, Pondicherry, India
› Author Affiliations
Further Information

Publication History

Publication Date:
27 March 2018 (online)

Also available at
 
 

    Aims:

    To detect whether the combination of Simethicone with N-Acetyl Cystiene as premedication before Upper GI endoscopy improves mucosal visualization?

    Primary outcome: To find the effectiveness of Simethicone with N-AcetylCystiene combination for better mucosal visibility using Total Mucosal Visibility Score (TMVS)

    Secondary outcome:

    1. To estimate the total duration of the procedure time for each patient in various arms of the study groups

    2. To estimate the number of lesions detected in each study group

    Methods:

    A total of 768 consecutive patients were recruited. Informed consent was taken. The study was registered with Clinical Trials Registry of India (CTRI). The patients were randomized into four groups using sealed envelopes and the endoscopist was blinded for it. Group

    (A) N-Acetyl cysteine alone

    (B) Simethicone alone

    (C) Simethicone + N-Acetyl cysteine

    (D) Placebo.

    After randomization each patient was asked to drink 90 ml solution. Each 90 ml solution contain (15 ml Emulsion of Group A or B or C + 75 ml of water) and just plain water as placebo in group D. After 20 minutes of consuming the solution, Gastroscopy was done and multiple images were taken from esophagus, stomach and duodenum. Based on the various images obtained the TMVS, total duration of procedure and total number of lesions detected were calculated. SPSS software was used to analyze.

    Results:

    Tab. 1:

    Results of the study

    Objectives of the study

    Group – A (N-Acetyl cysteine alone)

    Group – B (Simethicone alone)

    Group – C (Simethicone + N-Acetyl cysteine)

    Group – D (Placebo)

    “p” value

    Total Mucosal Visibility Score

    1.71

    1.32

    1.2

    2.74

    0.03

    Total duration of the procedure (Mean)

    5 Min 45 s

    4 Min 50 s

    4 Min 15 s

    6 Min 15 s

    0.021

    Total number of lesions detected

    48

    56

    72

    32

    0.042

    Conclusions:

    Premedication with simethicone and N-acetylcysteine markedly improves the mucosal visibility, detects more lesions and reduces the time taken during gastroscopy. This low-cost and well tolerated intervention may improve the detection of early neoplastic lesions which are still missed.


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