Introduction

Bowel preparation is essential for colonoscopy. Patients often experience bowel preparation as the most deterrent factor for undergoing colonoscopy. To alleviate burden for patients, intermediate (2L) and low-volume (1L) bowel preparation solutions have been developed. Little is known on the effect of low-volume bowel preparation on patient reported outcomes.

Aims & Methods

We aimed to assess the impact of bowel preparation on quality of life and productivity loss. We performed an open-label, non-inferiority, randomized trial in 4 centers in the Netherlands. Patients scheduled for screening, surveillance, or diagnostic colonoscopy were invited to participate and 1:1 randomized between a split-dose 2L Poly Ethylene Glycol with ascorbate (2LPEG+Asc, intermediate volume) laxative or a split-dose 1L PEG+Asc laxative with added sodium sulfate (low-volume). Before and after bowel preparation, patients filled out the following validated questionnaires: Institute for Medical Technology Assessment Productivity Costs Questionnaire (iPCQ), Mayo Florida bowel preparation tolerability questionnaire (MBTQ), Short form 36 (SF-36), and Euroqol group 5 Dimensions 5 Levels (EQ-5D-5L). Colonoscopy data included Boston bowel preparation score (BBPS) and surveillance interval as provided by the endoscopist. Primary outcome was non-inferiority of low-volume to intermediate volume bowel preparation, defined as the rate of adequately prepared colonoscopies with a non-inferiority margin of 5%. Secondary outcomes included change in SF-36 and EQ-5D-5L scores after bowel preparation, tolerability, and impact on working productivity.

Results

We included 467 patients (intermediate-volume, n=229 and low-volume, n=238). Questionnaire response rates were 86.3% and 88.7%, respectively (p=0.378). Low-volume bowel preparation was non-inferior to intermediate volume bowel preparation, with adequate cleaning rates of 96.8% (95% confidence interval [CI] 93.5-98.6) and 96.1% (95%CI 92.6-98.0), respectively (p=0.801). Low-volume bowel preparation had a higher high-quality cleaning rate (i.e., BBPS 3-3-3) with 72.7% vs 63.4% in the intermediate-volume group (P=0.032). No clinically significant changes were found on the EQ-5D-5L and SF-36 questionnaire. Patients in the low-volume group were more willing to repeat the bowel preparation with 60.1% vs 47.8% in the intermediate volume group (p=0.034), but nausea/vomiting and a bad taste were more frequent in the low-volume group (p=0.007 and p=0.006, respectively). Absenteeism and impaired working productivity were present in 15.1% and 23.0% of patients, respectively, but did not differ significantly between groups or before and after bowel preparation.

Conclusion

Low-volume bowel preparation is non-inferior to intermediate volume bowel preparation but has a higher willingness to repeat compared to intermediate volume bowel preparation, at the expense of more non-serious side-effects. This data can help patients to select their preferred bowel preparation.

Disclosure

Funding: This investigator initiated trial was financially supported by Norgine, Amsterdam. The funder had no role in protocol design, study procedures, data acquisition, analysis, and decision to submit for publication.
Competing interests: Author P.S. receives unrestricted grants from Pentax (Japan), Norgine (UK), Motus GI (USA), MicroTech (China) and The eNose Company (Netherlands) and is in the advisory board of Motus GI (USA) and Boston Scientific (USA). Authors F.I, K.H., R.M.S., L.W., A.T. and M.R. declare no competing interests.

Introduction

Colonoscopy is used in people with chronic kidney disease receiving hemodialysis for renal replacement therapy and forms part of routine pre-transplant assessment. Concerns exist about use of oral bowel-cleansing agents for colonoscopy in people receiving haemodialysis, despite guidelines recommendations. It is plausible that intravascular depletion and consequent hypotension may cause thrombosis of the vascular access use for hemodialyisis. We evaluated the comparative efficacy, safety and tolerability a low-volume versus a high-volume polyethylene glycol based bowel preparation for colonoscopy in people on hemodialysis.

Aims & Methods

This was a multicentre, PROBE design, parallel-arm, centrally randomized, non-inferiority phase IV trial. Eligible subjects were allocated 1:1 to either low-volume (2 liters) or high-volume (4 liters) bowel preparation. The primary outcome was the proportion of participants with adequate bowel cleansing, evaluated using the Boston Bowel Preparation Scale (BBPS). Secondary outcomes were adenoma detection rate (ADR), caecal intubation rate, patient tolerability/compliance, and adverse events (both related to colonoscopy and to dialysis/renal function). Differences were tested via t-test or Mann–Whitney U test for continuous normal variables or through chi-square or Fisher exact test for categorical ones.

Results

Sixty-nine patients were randomized in four centres, 35 to low volume and 34 to high volume groups. Mean age was 62.5±10.7 years; 54 were men and 15 were women. A total of 33 in the low-volume and 27 in high-volume completed colonoscopy; the main reasons for exclusion was stopping to take preparation (n=5). 15.No difference in caecal intubation rate was observed (100% vs 96.6%, p=1). Adequate bowel preparation was achieved in 69.7% and 63.0% of low and high-volume groups, respectively (p=0.58). Mean BBPS was similar in the two groups (5.6±2.4 vs 5.4±2.4, p=0.51). When sub-analyzing according to each bowel segment, we did not observe any difference for right, transverse nor left colon.
The ADR was 35.0% in low-volume and 37.0% in high volume (p=0.10). Median number of polyps per patient was 1.5 in low and 2 in high-volume group (p=0.45).
Mild abdominal swelling was the most common adverse event (27.3% vs 25.9% for high and low volume respectively, p=0.29), followed by mild nauseas (27.3% vs18.5%, p=0.29). A similar rate of willingness to repeat the same preparation was observed (87.9% vs 85.2%, p=0.76). No emergency dialysis sessions were required and no deaths were recorded. Levels of serum creatinine remained stable before and after preparation in both groups.

Conclusion

This small scale study based on an opportunistic sample confirms the difficulties in adequate preparation for colonoscopy in people on hemodialysis. It shows that both a low and a high-volume preparation were equally effective and safe. We did not observe a better tolerability for low-volume preparations, which may be a key findings but also due to suboptimal small sample size. Further large scale studies may be required to confirm our findings.

Introduction

Colonoscopy techniques is an independent factor of adenoma detection rate. However, the colonoscope insertion methods and cecal intubation time is often ignored compared with relevant technology or colonoscopy performance indicator in withdrawal stage. The effect of water exchange (WE) method characterized by water infusion with water removal primarily during insertion stage on colonoscopy has remained controversial. We aimed to carry out a meta-analysis to systematically evaluate the relationship between WE and quality of colonoscopy compared with the conventional methods include air insufflation and carbon dioxide insufflation.

Aims & Methods

Aims: To evaluate the effect of water exchange method versus conventional methods including air insufflation and carbon dioxide insufflation method for the quality of colonoscopy.
Methods: ​We searched randomized controlled trials published up to October 2022 from PubMed, Web of Science, the Cochrane Library, CNKI, Wanfang, SinoMed databases. Two reviewers independently searched the literatures based on standards to extract the data and evaluate the quality. The primary outcomes were cecal intubation time and adenoma detection rate. The secondary outcomes included cecal intubation rate, quality of bowel preparation, pain score, number of abdominal compression, number of position change. Meta-analysis was conducted by RevMan5.4.1.The study protocol was registered in PROSPERO (CD42022327954).

Results

A total of 23 studies involving 10654 patients were included. Although cecal intubation time was prolonged in WE (MD=1.81, 95%CI: 1.28, 2.35; P < 0.001), WE had higher adenoma detection rate (OR=1.40，95%CI：1.26, 1.55；P<0.001), cecal intubation rate (OR=1.62；95%CI：1.24,2.10；P<0.001) and quality of bowel preparation (MD=0.61；95%CI：0.42, 0.79；P<0.001) compared with conventional colonoscopy. In addition, WE had significantly lower pain sores (MD=-1.07；95%CI：-1.39,-0.76；P<0.001), number of abdominal compression (OR=0.42；95%CI：0.29,0.60；P<0.001) and number of position change (OR=0.59；95%CI：0.42,0.82；P=0.002) than conventional colonoscopy.

Conclusion

Despite WE colonoscopy prolonged cecal intubation time, it could significantly increase adenoma detection rate, cecal intubation rate and quality of bowel preparation. And beyond that, WE reduced patient pain, the proportion of abdominal compression and position change. WE is a better choice for high-quality colonoscopy.

Introduction

Bowel preparation is recognized as the most burdensome aspect of the whole colonoscopy procedure, sometimes even worse that the examination itself, and represents a major barrier to screening colonoscopy. Mannitol could significantly improve patient acceptability as it is rapid, requires a single dose, a low volume and has a pleasant taste. The SATISFACTION study compared oral mannitol 100g/750ml with standard split-dose 2L PEG-ASC (MoviPrep®).

Aims & Methods

The SATISFACTION Phase III study was an international, multicentre, randomized (1:1), parallel-group, endoscopist-blinded non inferiority trial. Primary endpoint was the proportion of patients with adequate bowel cleansing. Secondary endpoints concerned efficacy (adenoma detection rate, caecal intubation rate, time of evacuation), safety (intestinal gases concentration, haematobiological parameters, adverse events) and patient satisfaction. The study included 703 patients (352 treated with mannitol and 351 with PEG-ASC) undergoing elective colonoscopy.

Results

Mannitol was not inferior to PEG-ASC for proportion of patients with adequate cleansing (91.1% and 95.5% respectively; p value for the non-inferiority =0.0095). There was no significant difference for secondary efficacy endpoints. The profile of acceptability was significantly better in mannitol group for easy to use, taste, willingness to use (p<0.0001 for all parameters). The concentration of intestinal gases (H₂, CH₄) was similar in the two groups and well below those potentially critical.

Conclusion

Mannitol was not inferior to PEG-ASC for proportion of patients with adequate cleansing (91.1% and 95.5% respectively; p value for the non-inferiority =0.0095). There was no significant difference for secondary efficacy endpoints. The profile of acceptability was significantly better in mannitol group for easy to use, taste, willingness to use (p<0.0001 for all parameters). The concentration of intestinal gases (H₂, CH₄) was similar in the two groups and well below those potentially critical.

Disclosure

Prof. Gian Eugenio Tontini and Prof. Maurizio Vecchi received a consultant fee from NTC Pharma. Anna Orsatti is a current NTC Pharma employee

Introduction

Up to 30% of the under 18 years age group suffer from functional constipation with significant impact on health-related quality of life. In addition to lifestyle and dietary modifications, the currently available medication (e.g. polyethylene glycol, lactulose, stimulant laxatives) have low response rates, frequent side-effects, and non-sustained effects. Lubiprostone is an oral chloride channel-2 activator that stimulates gastrointestinal fluid secretion, softens stools, and facilitates bowel movements. It is approved in the United States for the treatment of chronic idiopathic constipation in adults. The evidence about the effectiveness and safety of lubiprostone in pediatric age group is still limited, representing a gap in clinical practice.

Aims & Methods

Aim: To evaluation of the effectiveness and safety of lubiprostone in children and adolescents with functional constipation.
Patients and Methods: In an open label, randomized, controlled trial, we included 277 patients in the age group 8-18 years diagnosed as functional constipation (FC). The diagnosis of FC was dependent on ROME IV criteria. After physical evaluation, patients were randomly (Simple randomization) assigned to one of 2 arms. First arm (n =137): patients received lubiprostone at doses of 24 mcg/day on divided doses or 24 mcg BID if weighing < 50 kg or ≥ 50 kg, respectively. Second arm (control, n = 140): patients received Bisacodyl, lactulose, or Sodium Picosulfate in appropriate doses. Treatment extended for 12 weeks followed by 4 weeks follow-up after treatment cessation (week 16). Evaluation during the study was done at baseline, weeks 2, 8, 12, and 16 of the study. The primary endpoint was spontaneous bowel movements (SBM) at week 12 and 16 compared to baseline. Improvement in the constipation was defined as increased SBM ≥ 1 SBM/week in frequency compared with baseline and maintaining ≥ 3 SBMs/week for at least 8 weeks (including the last 4 study weeks and the 4 weeks of follow-up). Safety assessment was done at clinic visits and by telephone as well as recording of patient-reported AEs.

Results

The two arms were matched as regards the mean ± SD of SBM at baseline (1.23 ± 0.37 motions/week for lubiprostone vs. 1.19 ± 0.28 motions/ week for control, P = 0.24). the primary endpoint was achieved in 128 (93.4%) patients of lubiprostone group, and in 48 (34.3%) patients of the control group (p < 0.001, ꭓ² = 105.42). In subgroup analysis, lubiprostone was superior to different laxatives in the control arm (p< 0.001, F = 95.6). At 12 weeks, the mean SMB in lubiprostone arm was (4.78 ± 0.99 motion/week) vs. (2.70 ± 1.04 /week) for control group (P <0.001). This difference was sustained for 4 weeks follow-up in lubiprostone group only. The overall side-effects occurred among 46% of lubiprostone group, and 48% in control group (p = 0.99). The most common adverse event in lubiprostone group were colicky abdominal pain (26%), and headache (14%), There was no life-threatening drug-related adverse events.

Conclusion

Lubiprostone is superior to conventional laxatives, and well tolerated treatment for functional constipation in pediatric and adolescent age groups.

References

van den Berg MM, Benninga MA, Di Lorenzo C. Epidemiology of childhood constipation: a systematic review. Am J Gastroentero 2006;101:2401–9.
Hyams, J. S., Di Lorenzo, C., Saps, M., Shulman, R. J., Staiano, A., & van Tilburg, M. Childhood Functional Gastrointestinal Disorders: Child/Adolescent. Gastroenterology 2016; 150(6), 1456–1468.e2.
Levy EI, Lemmens R, Vandenplas Y, Devreker T. Functional constipation in children: challenges and solutions. Pediatric Health Med Ther. 2017 Mar 9;8:19-27. doi: 10.2147/PHMT.S110940.
Benninga, M. A., Hussain, S. Z., Sood, M. R., Nurko, S., Hyman, P., Clifford, R. A., et al. Lubiprostone for Pediatric Functional Constipation: Randomized, Controlled, Double-Blind Study With Long-term Extension. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2022; 20(3), 602–610.e5.

Disclosure

Nothing to declare