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