Evidence map›Paper›PMID 36569131›Full record

ArticleFrontiers in medicine2022

A multicenter randomized phase 4 trial comparing sodium picosulphate plus magnesium citrate vs. polyethylene glycol plus ascorbic acid for bowel preparation before colonoscopy. The PRECOL trial.

Valentina D'Angelo, Maria Carmela Piccirillo, Massimo Di Maio, Ciro Gallo, Cristina Bucci, Corrado Civiletti, Elena Di Girolamo, Pietro Marone, Giovanni Battista Rossi, Alfonso Mario Tempesta and 12 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Frontiers in medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01649674 (PRECOL2011-1), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact, top 75% 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.

NCT01649674 phase4unknown statusnot on this map

PRECOL2011-1: Sodium Picophosphate and Magnesium Citrate Versus Polyethylene Glycol as Evacuating Treatment Prior to Colonoscopy: Phase IV Randomized Trial.

TypeinterventionalSponsorNational Cancer Institute, NaplesRan2011 to 2024Enrolled525ConditionsPatients Undergoing Elective ColonoscopyArmspolyethylene glycole (PEG) solution, sodium picosulphate and magnesium citrate solution
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 0 citations in OpenAlex.

  1. Trial
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

22 authors at 7 institutions in 1 country.

Valentina D'AngeloDivision of Gastroenterology and Digestive Endoscopy, Department of Abdominal Oncology, Istituto Nazionale Tumori-IRCCS-Fondazione G. Pascale, Napoli, Italy.
Maria Carmela PiccirilloClinical Trial Unit, Department of Translational Research, Istituto Nazionale Tumori-IRCCS-Fondazione G. Pascale, Napoli, Italy.
Massimo Di MaioDepartment of Oncology, Ospedale Mauriziano, University of Turin, Torino, Italy.
Ciro GalloMedical Statistics Unit, University of Campania Luigi Vanvitelli, Napoli, Italy.
Cristina BucciDivision of Gastroenterology and Digestive Endoscopy, Department of Abdominal Oncology, Istituto Nazionale Tumori-IRCCS-Fondazione G. Pascale, Napoli, Italy.
Corrado CivilettiDivision of Gastroenterology and Digestive Endoscopy, Department of Abdominal Oncology, Istituto Nazionale Tumori-IRCCS-Fondazione G. Pascale, Napoli, Italy.
Elena Di GirolamoDivision of Gastroenterology and Digestive Endoscopy, Department of Abdominal Oncology, Istituto Nazionale Tumori-IRCCS-Fondazione G. Pascale, Napoli, Italy.
Pietro MaroneDivision of Gastroenterology and Digestive Endoscopy, Department of Abdominal Oncology, Istituto Nazionale Tumori-IRCCS-Fondazione G. Pascale, Napoli, Italy.
Giovanni Battista RossiDivision of Gastroenterology and Digestive Endoscopy, Department of Abdominal Oncology, Istituto Nazionale Tumori-IRCCS-Fondazione G. Pascale, Napoli, Italy.
Alfonso Mario TempestaDivision of Gastroenterology and Digestive Endoscopy, Department of Abdominal Oncology, Istituto Nazionale Tumori-IRCCS-Fondazione G. Pascale, Napoli, Italy.
Maura C TraceyUnit for Rehabilitation Medicine, Department for the Support of Oncological Patients Pathways, Clinical Activities and Critical Area, Istituto Nazionale Tumori-IRCCS Fondazione G. Pascale, Napoli, Italy.
Marco RomanoDivision of Gastroenterology, University of Campania Luigi Vanvitelli, Napoli, Italy.
Agnese MirandaDivision of Gastroenterology, University of Campania Luigi Vanvitelli, Napoli, Italy.
Domenico TarantoDivision of Gastroenterology, Clinica Mediterranea, Napoli, Italy.
Gabriella SessaDivision of Gastroenterology, Clinica Mediterranea, Napoli, Italy.
Pasquale EspositoDivision of Gastroenterology, University of Campania Luigi Vanvitelli, Napoli, Italy.
Raffaele SalernoDivision of Gastroenterology, ASST Fatebenefratelli Sacco, Milano, Italy.
Rossella PumpoDigestive Endoscopy Unit, Ospedale S. Maria del Loreto Nuovo, Napoli, Italy.
Francesca Romana De FilippoDivision of Gastroenterology, Ospedale Riuniti San Giovanni di Dio e Ruggi D'Aragona, Salerno, Italy.
Elisabetta Della ValleDepartment of Public Health, University of Napoli Federico II, Napoli, Italy.
Mario de BellisDivision of Gastroenterology and Digestive Endoscopy, Department of Abdominal Oncology, Istituto Nazionale Tumori-IRCCS-Fondazione G. Pascale, Napoli, Italy.
Francesco PerroneClinical Trial Unit, Department of Translational Research, Istituto Nazionale Tumori-IRCCS-Fondazione G. Pascale, Napoli, Italy.
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" · ITUniversity of Campania "Luigi Vanvitelli" · ITClinica Mediterranea · ITA. O. Ordine Mauriziano di Torino · ITASST Fatebenefratelli Sacco · ITOspedale Santa Maria di Loreto Nuovo · ITOspedali Riuniti San Giovanni di Dio e Ruggi d'Aragona · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Adequate bowel preparation before colonoscopy is crucial. Unfortunately, 25% of colonoscopies have inadequate bowel cleansing. From a patient perspective, bowel preparation is the main obstacle to colonoscopy. Several low-volume bowel preparations have been formulated to provide more tolerable purgative solutions without loss of efficacy. Objectives: Investigate efficacy, safety, and tolerability of Sodium Picosulphate plus Magnesium Citrate (SPMC) vs. Polyethylene Glycol plus Ascorbic Acid (PEG-ASC) solutions in patients undergoing diagnostic colonoscopy. Materials and methods: In this phase 4, randomized, multicenter, two-arm trial, adult outpatients received either SPMC or PEG-ASC for bowel preparation before colonoscopy. The primary aims were quality of bowel cleansing (primary endpoint scored according to Boston Bowel Preparation Scale) and patient acceptance (measured with six visual analogue scales). The study was open for treatment assignment and blinded for primary endpoint assessment. This was done independently with videotaped colonoscopies reviewed by two endoscopists unaware of study arms. A sample size of 525 patients was calculated to recognize a difference of 10% in the proportion of successes between the arms with a two-sided alpha error of 0.05 and 90% statistical power. Results: Overall 550 subjects (279 assigned to PEG-ASC and 271 assigned to SPMC) represented the analysis population. There was no statistically significant difference in success rate according to BBPS: 94.4% with PEG-ASC and 95.7% with SPMC ( Conclusion: SPMC and PEG-ASC are not different in terms of efficacy, but SPMC is better tolerated than PEG-ASC. SPMC could be an alternative to low-volume PEG based purgative solutions for bowel preparation. Clinical trial registration: [ClinicalTrials.gov], Identifier [NCT01649674 and EudraCT 2011-000587-10].

Indexed as

bowel preparationcolonoscopypatients compliancepolyethylene glycol plus ascorbic acidrandomized controlled trialsodium picosulphate plus magnesium citrate

Identifiers

PMID36569131
PMCPMC9773881
OpenAlexW4311870368

What OpenQuestion holds

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LicenceCC BY
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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.