Split-dose Versus Single-dose Polyethylene Glycol Regimen for Capsule Endoscopy
1 other identifier
interventional
50
1 country
1
Brief Summary
To compare the small bowel cleanliness for wireless capsule endoscopy using two different Polyethylene Glycol administration schedules (before the wireless capsule endoscopy ingestion versus in a split-dose fashion).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2015
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedFirst Posted
Study publicly available on registry
March 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMarch 24, 2015
March 1, 2015
2 months
February 18, 2015
March 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Small-bowel cleanliness
The cleansing quality of the small-bowel will be evaluated according to the system validated by Brotz et al., using the quantitative index (QI), because this score is less susceptible to the subjective element. The used cut-off value accepted for an adequate small-bowel cleansing was ≥ 8 points.
at the end of capsule endoscopy exploration
Secondary Outcomes (3)
The number of all the observed lesions
at the end of capsule endoscopy exploration
The clinical tolerance questionnaire
at the end of capsule endoscopy exploration
The transit time
at the end of capsule endoscopy exploration
Study Arms (2)
Single-dose Polyethylene Glycol regimen
ACTIVE COMPARATORDrug: Polyethylene Glycol Intervention: 2 liters of Polyethylene Glycol will be given in the day before Capsule Endoscopy ingestion.
Split-dose Polyethylene Glycol regimen
EXPERIMENTALDrug: Polyethylene Glycol Intervention: 1 liter of Polyethylene Glycol will be given in the day before Capsule Endoscopy ingestion and another 1 liter Polyethylene Glycol will be given in the same day of Capsule Endoscopy ingestion.
Interventions
Endoscopic device
Bowel purgative
Eligibility Criteria
You may qualify if:
- All adult patients referred to our institution for CE during the study period
You may not qualify if:
- inpatients, bedridden, patients with clinical evidence of active bleeding, past history of abdominal surgery, abdominal or pelvic radiation therapy, occlusion, bowel perforation (suspected or confirmed), use of oral iron replacement therapy, severe cardiopulmonary, renal or hepatic disease, pregnancy, hypersensitivity to any components of the preparation, patients that didn't complete the preparation protocol, patients with incomplete enteroscopies (a complete enteroscopy is defined by the visualization of the mucosa from the duodenal bulb to the cecum), patients enrolled in other clinical studies and patients who didn't signed informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gastroenterology Department, Hospital Egas Moniz
Lisbon, Lisbon District, 1349-019 Lisboa, Portugal
Related Publications (5)
Rokkas T, Papaxoinis K, Triantafyllou K, Pistiolas D, Ladas SD. Does purgative preparation influence the diagnostic yield of small bowel video capsule endoscopy?: A meta-analysis. Am J Gastroenterol. 2009 Jan;104(1):219-27. doi: 10.1038/ajg.2008.63.
PMID: 19098872BACKGROUNDLadas SD, Triantafyllou K, Spada C, Riccioni ME, Rey JF, Niv Y, Delvaux M, de Franchis R, Costamagna G; ESGE Clinical Guidelines Committee. European Society of Gastrointestinal Endoscopy (ESGE): recommendations (2009) on clinical use of video capsule endoscopy to investigate small-bowel, esophageal and colonic diseases. Endoscopy. 2010 Mar;42(3):220-7. doi: 10.1055/s-0029-1243968. Epub 2010 Mar 1.
PMID: 20195992BACKGROUNDBrotz C, Nandi N, Conn M, Daskalakis C, DiMarino M, Infantolino A, Katz LC, Schroeder T, Kastenberg D. A validation study of 3 grading systems to evaluate small-bowel cleansing for wireless capsule endoscopy: a quantitative index, a qualitative evaluation, and an overall adequacy assessment. Gastrointest Endosc. 2009 Feb;69(2):262-70, 270.e1. doi: 10.1016/j.gie.2008.04.016. Epub 2008 Oct 11.
PMID: 18851851BACKGROUNDHassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18.
PMID: 23335011BACKGROUNDMagalhaes-Costa P, Carmo J, Bispo M, Santos S, Chagas C. Superiority of the Split-dose PEG Regimen for Small-Bowel Capsule Endoscopy: A Randomized Controlled Trial. J Clin Gastroenterol. 2016 Aug;50(7):e65-70. doi: 10.1097/MCG.0000000000000460.
PMID: 26646803DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Cristina Chagas, MD
Gastroenterology Department, Hospital Egas Moniz, Centro Hospitalar Lisboa Ocidental
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
February 18, 2015
First Posted
March 24, 2015
Study Start
March 1, 2015
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
March 24, 2015
Record last verified: 2015-03