NCT01675739

Brief Summary

The purpose of this study is to evaluate the effectiveness of SMS (short message service of mobile phone) reminder to fix PC interval for bowel preparation in afternoon colonoscopy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2012

Completed
Last Updated

August 30, 2012

Status Verified

August 1, 2012

Enrollment Period

6 months

First QC Date

August 28, 2012

Last Update Submit

August 29, 2012

Conditions

Keywords

colonoscopybowel preparationshort message service

Outcome Measures

Primary Outcomes (1)

  • the Ottawa bowel preparation scale

    This scale assesses cleanliness and fluid volume respectively and presents the total score as sum of these two values. Cleanliness was assessed for the right colon (cecum, ascending colon), midcolon (transverse, descending colon), and the rectosigmoid colon; each colon section was individually rated from 0 to 4 (0 = no liquid, 1 = minimal liquid, no suction required, 2 = suction required to see mucosa, 3 = wash and suction required, 4 = solid stool, not washable). Fluid quantity was rated from 0 to 2 for the entire colon (0 = minimal, 1 = moderate, 2 = large). The Ottawa Scale scores range from 0 (perfect) to 14 (solid stool in each colon segment and large amount of fluid).

    at the end of time of the colonoscopic examination (about 30 minutes-1hour)

Study Arms (2)

No-SMS group

ACTIVE COMPARATOR

In No-SMS group took 1st 2L of PEG solution at 6-8 PM on the day before colonoscopy and started drinking the 2nd 2L PEG at about 6hours before the day of the colonoscopy without SMS.

Drug: polyethylene glycol (PEG)

SMS group

EXPERIMENTAL

Patients in SMS group took 1st 2L PEG as same manner of No-SMS group and then started drinking the 2nd 2L PEG at about 6hours before the day of the colonoscopy after receiving scheduled short message service(SMS)

Behavioral: Short message service of mobile phone (SMS)Drug: polyethylene glycol (PEG)

Interventions

In SMS group, patients took 1st dose polyethylene glycol (PEG) 2L at 6-8pm the day before colonoscopy and then start to take 2nd dose PEG 2L after receiving Short message service of mobile phone (SMS) 6hours before afternoon colonoscopy.

SMS group

No-SMS group took 1st 2L of PEG solution at 6-8 PM on the day before colonoscopy and started drinking the 2nd 2L PEG at about 6hours before the day of the colonoscopy. SMS group took 1st 2L PEG as same manner of No-SMS group and then started drinking the 2nd 2L PEG at about 6hours before the day of the colonoscopy after receiving scheduled SMS

Also known as: Colyte
No-SMS groupSMS group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • and 80 years who were scheduled for afternoon colonoscopy (screening or surveillance)

You may not qualify if:

  • unavailable mobile phone nor SMS
  • age younger than 18 years
  • pregnancy
  • breastfeeding
  • history of large-bowel resection
  • renal failure (serum creatinine ≥ 3.0 mg/dL \[normal 0.8-1.4\])
  • drug addiction or major psychiatric illness
  • allergy to PEG
  • refusal to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, Haeundae Paik Hospital, Inje University, College of Medicine

Busan, 612-030, South Korea

Location

MeSH Terms

Interventions

Polyethylene GlycolsGolytely

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Tae Oh Kim

    Department of Internal Medicine, Haeundae Paik Hospital, Inje University, College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 28, 2012

First Posted

August 30, 2012

Study Start

October 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

August 30, 2012

Record last verified: 2012-08

Locations