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CompletedNCT01596686Updated Dec 24, 2013

Comparison of Preparation Regimens for Colonoscopy

An interventional study of one of two possible colon preparation regimens in Colonoscopy Preparation, sponsored by Clinical Hospital Colentina. Completed at 2 sites in Romania. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-12-24.

Sponsored by Clinical Hospital Colentina · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
184
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The investigators intend to study the impact of two different preparation regimens for colonoscopy (PEG vs sodium picosulphate) on the quality of the endoscopy as well as patient tolerability.

02

Conditions studied

  • Colonoscopy Preparation
03

In context

Lead sponsor

Clinical Hospital Colentina is the lead sponsor of 14 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • all patients undergoing colonoscopy

Exclusion criteria

Exclusion Criteria:

  • patient refusal to sign informed consent
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
184 participants (actual)

Study arms

  • Active comparator
    sodium picosulphate and magnesium citrate (Picoprep)

    Drug: one of two possible colon preparation regimens

  • Active comparator
    polyethylene glycol (Fortrans)

    Drug: one of two possible colon preparation regimens

Interventions

  • Drugone of two possible colon preparation regimens

    Patients are randomized to receive one of the two different preparation regimens for colonoscopy usually employed in our unit, polyethylene glycol or sodium picosulphate and magnesium citrate

    Also known as: Fortrans, Picoprep

06

What researchers measure

Primary outcomes

  1. colon preparation

    the impact of colon preparation as assessed by the endoscopist (scale from 1 to 4, 1 representing the worst and 4 the best prepared colon) on the quality of the endoscopic examination

    Time frame: 24 h

07

Study locations

2 sites
  • Colentina Clinical Hospital
    Bucharest, Romania
  • Spitalul clinic judetean
    Timisoara, 300783, Romania
08

References and documents

Publications

  • Manno M, Pigo F, Manta R, Barbera C, Bertani H, Mirante VG, Dabizzi E, Caruso A, Olivetti G, Hassan C, Zullo A, Conigliaro R. Bowel preparation with polyethylene glycol electrolyte solution: optimizing the splitting regimen. Dig Liver Dis. 2012 Jul;44(7):576-9. doi: 10.1016/j.dld.2012.02.012. Epub 2012 Mar 26. PubMed 22456624 ↗
  • Voiosu T, Ratiu I, Voiosu A, Iordache T, Schipor A, Baicus C, Sporea I, Voiosu R. Time for individualized colonoscopy bowel-prep regimens? A randomized controlled trial comparing sodium picosulphate and magnesium citrate versus 4-liter split-dose polyethylene glycol. J Gastrointestin Liver Dis. 2013 Jun;22(2):129-34. PubMed 23799210 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01596686
Lead sponsor
Clinical Hospital Colentina
Responsible party
dr. Theodor Alexandru Voiosu (gastroenterology resident, Clinical Hospital Colentina) — Principal investigator
First posted
May 11, 2012
Start date
May 2012
Primary completion
Dec 2012
Completion
Feb 2013
Last update
Dec 24, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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