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Completed

NCT Number: NCT01584817

A Repeated Instruction by Telephone on the Day Before Colonoscopy to Patients Undergoing Colonoscopy

Cell phone retell the instruction of bowel preparation on the day before colonoscopy would help patient to prepare for colonoscopy and improve the quality of the bowel preparation.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

About this study

Colonoscopy is the gold standard in the diagnosis of colorectal disease. The success of colonoscopy depends on high-quality bowel preparation by patients. Inadequate bowel cleansing reduces the speed, the cecal intubation rate, and the number of polyps detected. It also increases costs, mostly due to repeated procedures. The quality of bowel cleansing has remained suboptimal even though numerous different products and regimens have been tested and compared in no fewer than six meta-analyses. Therefore, a completely different approach to improve precolonoscopy bowel cleansing is welcome.

There are many factors effect the bowel preparation such as age, cirrhosis diabetes, drug compliance, cerebral infarction, dementia, history of major surgery. 20% of patients with poor bowel preparation were due to bad compliance. Studies found that addressing patient perceptions with an inexpensive and simple booklet based on the Health Belief Model improved preparation quality. We assume that doctor retelling the instruction of bowel preparation by cell phone on the day before colonoscopy would help patient to prepare for colonoscopy and improve the quality of the bowel preparation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients undergoing colonoscopy

Exclusion criteria

  • disturbance of water and electrolyte
  • history of colorectal surgery
  • severe colonic stricture or obstructing tumor
  • known or suspected bowel obstruction or perforation
  • toxic colitis or megacolon
  • dysphagia
  • compromised swallowing reflex or mental status
  • significant gastroparesis or gastric outlet obstruction or ileus
  • severe chronic renal failure (creatinine clearance <30 mL/minute)
  • severe congestive heart failure (New York Heart Association class III or IV)
  • uncontrolled hypertension (average systolic blood pressure >170 mm Hg, average diastolic blood pressure >100 mm Hg)
  • pregnant or lactating women
  • patients who cannot give informed consent

Treatment and study plan

telephone education

Other

A repeated instruction by telephone on the day before colonoscopy was conducted

Primary outcomes

  1. Adequate bowel preparation quality at the time of colonoscopy defined by Ottawa score<6

    Time frame: up to 3 months

    Ottawa score:A)cleanliness of each part of the colon: 0=excellent 1=good 2=fair 3=poor 4=inadequate B)fluid in whole colon: small=0 moderate=1 large=2

    The bowel preparation was considered inadequate if (1) inadequate visualization on colonoscopy defined by Ottawa score≥6; (2) the colonoscopy was cancelled because of poor bowel preparation or personal reasons; (3) incomplete colonoscopy.

Secondary outcomes

  1. Cecum intubation time

    Time frame: up to 3 months

    Total time of colonoscope intubation from anus to cecum

  2. Withdrawal time

    Time frame: up to 3 months

    Total time of colonoscope intubation from cecum to anus

  3. Polyp detection rate

    Time frame: up to 3 months

    The proportion of participants with at least one polyp in each group

  4. Compliance rate to instruction

    Time frame: up to 3 months

    The proportion of participants compliance to instruction of bowel preparation

  5. Willingness undergo a repeated bowel preparation

    Time frame: up to 3 months

    The number of patients have a willingness to undergo a repeated bowel preparation if needed

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

A Repeated Instruction by Telephone on the Day Before Colonoscopy Improves the Quality of Bowel Preparation and Colonoscopy Procedure : a Prospective Randomized, Controlled Trial

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 25, 2012
Registry last updated
Dec 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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