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NCT01610895: BP
A Randomized Prospective Trial Comparing Split Dose Polyethylene Glycol-Based Lavage With Clear Fluids Versus Split Dose Polyethylene Glycol-Based Lavage With a Low-Residue Diet in Preparation of Patients for Colonoscopy.
NA trial testing Split-dose PEG Based Lavage (2L + 2L) with Low-Fibre Lunch Dietary instructions in Colorectal Cancer in 345 participants. Status unknown.
1 August 2012
Quick facts
| Lead sponsor | University of Calgary |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Enrollment | 345 |
| Start date | 1 December 2011 |
| Primary completion | 1 August 2012 |
| Estimated completion | 1 October 2012 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Split-dose PEG Based Lavage (2L + 2L) with Low-Fibre Lunch Dietary instructions
- Split-dose PEG Based Lavage (2L + 2L) with Standard Dietary Instructions
Conditions studied
- Colorectal Cancer — all drugs for Colorectal Cancer →
Sponsor
University of Calgary
Who can join
Adults 18 to 74, any sex, with Colorectal Cancer. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Quality of Bowel Cleanliness
Time frame: Procedure is completed (1 hour time). Questionnaires are manually entered by an assistant into the study database on the same day of collection.
Ottawa bowel prep scale will be done by the Doctor to assess the quality of bowel cleanliness. The right, mid and rectosigmoid colon are each rated on a 5-point scale (0-4). Also a complete 3 point rating for overall colonic fluid is assessed giving an overall score range of 0-14. An excellent preperation should score 0-1, a good preparation 2-4, while scores \>4 would indicate progressively worse
Sponsor's own description
The objective of the study is to examine the effect of adding a strict low-residue lunch on the day before colonoscopy has on clinical efficacy and patient tolerability of bowel preparation, with patients receiving split-dose Polyethylene Glycol Based Lavage. The primary outcomes will be 1) quality of preparation in cleansing the colon and 2) patient satisfaction
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01610895
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01610895 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Calgary
- Last refreshed: 1 June 2012
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01610895.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing