Evidence map›Paper›PMID 30083580›Full record

ArticleEndoscopy international open2018

Efficacy and safety of a new low-volume PEG with citrate and simethicone bowel preparation for colonoscopy (Clensia): a multicenter randomized observer-blind clinical trial vs. a low-volume PEG with ascorbic acid (PEG-ASC).

Patrizia Kump, Cesare Hassan, Cristiano Spada, Eva Brownstone, Christian Datz, Michael Haefner, Friedrich Renner, Rainer Schoefl, Florian Schreiber

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Endoscopy international open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04709770 (Comparison of Low-volume Versus High-volume Polyethylene Glycol Based Bowel Preparation for Colonoscopy in People Receiving Hemodialysis), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.8field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04709770 phase4unknown statusnot on this mapstarted 2021, after this paper: background citation

Comparison of Low-volume Versus High-volume Polyethylene Glycol Based Bowel Preparation for Colonoscopy in People Receiving Hemodialysis: a Randomized Non-inferiority Trial

TypeinterventionalSponsorAlfredo Di LeoRan2021 to 2022Enrolled264ConditionsChronic Kidney Diseases, Colon Polyp, Dialysis, ComplicationsArms2-liters polyethylene glycol with citrate and simethicone, 4-liters polyethylene glycol with simethicone, Low-residue diet
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 21 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 7 institutions in 2 countries.

Patrizia KumpDepartment of Internal Medicine, Division of Gastroenterology and Hepatology, Medical University Graz, Graz, Austria.
Cesare HassanGastroenterology Department, Nuovo Regina Margherita Hospital, Rome, Italy.
Cristiano SpadaDigestive Endoscopy Unit, Catholic University, Rome, Italy.
Eva BrownstoneInternal Medicine IV, KH Rudolfstiftung, Vienna, Austria.
Christian DatzDepartment of Internal Medicine, Oberndorf Hospital, Teaching Hospital of the Paracelsus Medical University, Salzburg, Austria.
Michael HaefnerDepartment of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria.
Friedrich RennerInterne Abteilung, Krankenhaus der Barmherzigen Schwestern Ried, Ried, Austria.
Rainer SchoeflInternal Medicine IV, KH der Elisabethinen, Linz, Austria.
Florian SchreiberDepartment of Internal Medicine, Division of Gastroenterology and Hepatology, Medical University Graz, Graz, Austria.
Medical University of Graz · ATFondazione Poliambulanza Istituto Ospedaliero · ITKrankenhaus der Elisabethinen · ATMedical University of Vienna · ATOrdensklinikum Linz Barmherzige Schwestern · ATOspedale Regina Margherita · ITParacelsus Medical University · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND STUDY

aimsQuality of inspection during colonoscopy is strictly related to the level of cleansing. High-volume (PEG-based) solutions are highly effective and safe, but their high volume affects tolerability and compliance. The aim of this study was to compare a new low-volume PEG with citrate and simethicone solution (PMF 104,Clensia) with a low-volume PEG with ascorbic acid solution (PEG-ASC; Moviprep). PATIENTS AND

methodsThis was a multicenter, randomized, observer-blind, parallel-group, phase 3 clinical trial, where patients were randomized between PMF 104 and PEG-ASC. In both groups, patients were instructed to take a full-dose regimen the evening before if colonoscopy was scheduled before 11 am to 12 pm, or to take a split regimen if colonoscopy was scheduled after 11 am to 12 pm. The primary end-point was an equivalence between PMF104 and PEG-ASC in the rate of adequate level of cleansing (Ottawa scale ≤ 6), with safety, mucosal visibility, tolerability, acceptance and compliance being also assessed.

resultsOf the 403 enrolled, 367 patients (Mean age [SD]: 55.6 (14.4) years; male:166 [45.2 %]) were included in the per protocol (PP) analysis: 184 being randomized in the PMF 104 group and 183 in the PEG-ASC group. Successful bowel cleansing was 78.3 % and 74.3 % in PMF104 and in PEG-ASC, respectively (

conclusionThe new low-volume product Clensia is equivalent to the reference low-volume PEG-ASC in terms of bowel cleansing, safety and acceptance.

Identifiers

PMID30083580
PMCPMC6070370
OpenAlexW2890113419

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.