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P182 Bowel Preparation in inflammatory bowel diseases (IBD): preliminary results from a randomised trial evaluating efficacy, tolerability and safety of cleansing solutions in IBD patients

J.L. Rueda Garcia, C. Suárez Ferrer, E. Martín-Arranz, J. Poza, M. Sánchez-Azofra, L. García-Ramirez, B. Poladura, T. Verges, J. Noci, M.D. Martín-Arranz

Hospital Universitario La Paz, Gastroenterology, Madrid, Spain

Background

Colonoscopy is the first-line procedure for the diagnosis and management of inflammatory bowel disease (IBD). Data regarding bowel preparation in patients with IBD are scarce. Our aim was to evaluate efficacy, safety and tolerability of the main available colon cleansing formulations in IBD patients: sodium picosulfate with magnesium citrate (SM+MC), 2L polyethylene glycol-ascorbate (2L-PEG-a) and 1L polyethylene glycol-ascorbate (1L-PEG-a).

Methods

Study design: Phase 4, randomised, single-centre, prescriber and colonoscopist-blinded study. EudraCT Number 2018-001402-28. Patients: IBD patients aged over 18 requiring colonoscopy. Exclusion criteria: pregnant women, past history of bowel resection, severe acute IBD flare or low-quality cleansing score in a colonoscopy performed 12 months prior to enrolment. Patients were randomized 1:1:1 to receive 1L PEG-a, 2L PEG-a or SP+MC; all preparations were administered in a split-dose regimen. Colonoscopies are performed by trained IBD specialists. Endpoints: Primary endpoint: Bowel cleansing using Boston Bowel Preparation Score (BBPS). We considered high-quality cleansing (HQC) a BBPS ≥5. Secondary endpoints: tolerability and patient satisfaction, evaluated via questionnaires filled before and after undergoing colonoscopy. Questionnaires contained items to be ranged on a scale from 1 to 10. Safety was monitored via adverse event reporting, laboratory evaluation at colonoscopy and telephonic follow-up. Statistical analysis: We used Student’s T/ANOVA and χ² tests for comparison between quantitative and qualitative variables, respectively. Software was Stata for Mac OS. We considered statistical significance a p-value < 0.05.

Results

Seventy-seven patients have been enrolled and subsequently randomised: 31 SP+MC vs. 24 2L-PEG-a vs. 22 1L-PEG-a. Colon cleansing was similar between solutions (% of HQC: SP+MC 100% vs. 2L-PEG-a 91% vs. 1L-PEG-a 95’4%, p = 0.28). Tolerability among the different formulations was also comparable (p = 0.68). Looking at patient satisfaction, instructions for SM+MC were rated higher (p = 0.05). No serious adverse events were reported. Data can be seen in Table 1.

SP+MC2L-PEG-a1L-PEG-ap-value
Pre-colonoscopy symptoms:0.68
None181311
Abdominal pain442
Nausea/vomiting557
Both421
Others001
% of HQC100%91%95.4%0.28
Tolerability (% of complete intake)96.7%86.9%86.3%0.4
Instructions (% of highest rating)87%69.5%50%0.05
Post-colonoscopy symptoms0.33
None271820
Abdominal pain021
Nausea/vomiting010
Diarrhoea411
Others010

Conclusion

No differences were observed between bowel preparations in patients with IBD concerning cleansing and tolerability. Instructions for SP+MC were easier from patient’s point of view than the others. Recruiting is still active so definitive conclusions are yet to be reported.