Tesis

Perbandingan Bersihan Kolon Antara Polyethylene Glycol dan Sodium Phosphate Pada Persiapan Kolonoskopi : Uji Klinis Acak Tersamar Tunggal = Bowel Preparation for Colonoscopy with Polyethylene Glycol versus Sodium Phosphate Based Lavage : A Single Blind Randomized Clinical Trial

Latar belakang. Bersihan kolon yang adekuat berkaitan dengan persiapan
kolonoskopi yang baik namun hingga saat ini belum ada penelitian mengenai dua
preparat bersihan kolon yang paling umum digunakan di Indonesia yaitu
polyethylene glycol (PEG) dan sodium phosphate (SP).
Tujuan. Mengetahui perbandingan bersihan kolon antara PEG dan SP pada
pasien yang akan dilakukan kolonoskopi di Indonesia.
Metode. Uji klinis acak tersamar tunggal, satu sentral penelitian di pusat
endoskopi saluran cerna (PESC) RS. Cipto Mangunkusumo (RSCM) pada pasien
usia lebih dari 18 tahun yang menjalani kolonoskopi periode Maret – September
2014. Randomisasi manual, teknik sampling konsekutif dilakukan untuk
mengalokasikan preparat PEG dan SP, kemudian penilaian bersihan kolon secara
tersamar tunggal dilakukan oleh dua orang dengan Boston Bowel Preparation
Scale (BBPS). Nilai adekuat bila skor ≥ 5. Analisis dilakukan dengan intention to
treat.
Hasil. Dari 135 subyek yang dirandomisasi, dieksklusi 14 subyek sehingga yang
dianalisis 121 subyek (PEG n=62; SP n=59). Semua subyek menjalani penelitian
hingga selesai. Bersihan adekuat pada PEG 88,7% dengan rerata skor BPPS 5,89,
sedangkan pada SP 89,8% dengan rerata skor BPPS 6,34 (nilai p=0,84).
Didapatkan nilai Control Event Rate (CER) 11,3%, Experiment Event Rate (EER)
10,17%, Absolute Risk Reduction (ARR) 1,13%, Relative Risk Reduction (RRR)
9,92%, dan Number Needed to Treat (NNT) untuk SP sebesar 90 subyek. Efek
samping pada PEG adalah mual (19,4%), rasa tidak enak (3,2%), muntah (1,6%)
sedangkan pada SP hanya rasa tidak enak (5,1%). Kedua kelompok tidak
mengalami alergi.
Kesimpulan. Tidak ada perbedaan bermakna secara statistik dan klinis antara
PEG dan SP dalam bersihan kolon yang adekuat menggunakan skor BPPS.
Kata kunci : Bersihan Kolon; Kolonoskopi; Polyethylene Glycol; Sodium Phosphate.


Background. Adequate clearance of the colon is associated with a good
preparation for colonoscopy. Up until now research on colon adequate clearance
by using two of the most commonly used preparations in Indonesia, namely
polyethylene glycol and sodium phosphate has not been done.
Aims. To compare the effectivity of PEG and SP in colon clearance for patients
undergoing colonoscopy in Indonesia.
Design and Methods. A single blind randomized clinical trial in one centre at
gastrointestinal endoscopy centre RSCM, was conducted on patients aged over 18
years old that had colonoscopy in the period from March to September 2014.
Consecutive manual randomization was performed to allocate the PEG and SP
lavage and assessment of adequate colon clearance will be evaluated by two
investigators using the Boston Bowel Preparation Scale (BBPS). Adequate score
if > 5. Analysis was done by intention to treat.
Results. From the 135 randomized subjects, 14 was excluded, and 121 subjects
obtained (PEG n=62; SP n=59). All subjects completed the research. Adequate
clearance in PEG was 88.7% with BPPS mean score 5.89. While, SP had adequate
clearance of 89.8% with BPPS mean score 6.34 (p value=0.84). Analysis resulted
in CER 11.3%, EER 10.17%, ARR 1.13%, RRR 9.92%, and NNT for SP was 90
subjects. Side effects in PEG participants were nausea (19.4%), unpleasant taste
(3.2%), vomit (1.6%) while in SP participants only experienced unpleasant taste
(5.1%). Both groups did not experience allergic reaction.
Conclusion. There was no significant difference in terms of adequate colon
clearance preparation between PEG and SP using BPPS score.
Keywords:Colon clearance; Colonoscopy; Polyethylene Glycol; Sodium Phosphate.