Multidisciplinary Approach Versus Conventional Approach in Colonic Preparation of Hospitalized Patients

Bowel Preparation for Colonoscopy Clinical Trial

Official title:

Multidisciplinary Approach Versus Conventional Approach in Colonic Preparation of Hospitalized Patients. A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01853709
• Other study ID #: CSPT-END-DIG-2012
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 29, 2013
• Last updated: May 9, 2013
• Start date: May 2013
• Est. completion date: December 2013

Study information

• Verified date: May 2013
• Source: Corporacion Parc Tauli
• Contact: Félix Junquera, PhD
• Phone: 34937458320
• Email: fjunquera[@]tauli.cat
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

Colonoscopy is the gold standard diagnostic procedure for colonic disease. Excellent bowel cleansing is critical for this procedure. However, an inadequate bowel cleansing is a common problem that occurs up to 20% of procedures. This fact has a deep clinical and economical impact. In fact, inadequate bowel preparation is associated to misdiagnosis in 30% of lesions. Moreover several clinical conditions such as cirrhosis, antidepressant drugs, and hospitalized patients are predictive factors of inadequate colonic preparations. These circumstances have promoted multiple clinical trials, however there is no consensus about the optimal strategy for colonic cleansing. Education in colonic preparation has obtained conflicting results. Polyethylene glycol (PEG) and sodium phosphate solutions have been the commonest preparations used with a similar efficacy. However, the large volume to ingest (4 litters) makes PEG compliance difficult. Likewise, sodium phosphate also contains high levels in sodium and phosphate which contraindicate its use in elderly patients and / or with comorbidity. The use of adjuvants such as olive oil and bisacodyl allows reducing the volume of polyethylene glycol thereby improving the tolerance and right colon preparation.

The aim of this study is to compare the efficacy of a multidisciplinary approach (education, fiber free diet, polyethylene glycol (PEG) 2L, and adjuvant bisacodyl + olive oil) vs. a conventional approach (fiber free diet+ PEG 4L in split doses ) in cleaning the colon of hospitalized patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 162
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hospitalized patients who undergo a non urgent colonoscopy

• Patients who give informed consent to participate in the study

• Patients older than 18 years

• Patients who undergo total colonoscopy

Exclusion Criteria:

• Non compliance with the 48 hours diet prescribed

• The endoscopy planned is a rectosigmoidoscopy

• Previous colonic surgery

• Mental/cognitive impairment preventing the study assessments

• Severe renal failure

• Electrolytic disbalance(hyponatremia, hypokaliemia, Hyperphosphatemia, hypocalcemia and hypomagnesemia)

• Intestinal obstruction, perforation or toxic megacolon

• Pregnant or nursing women

• Allergy/intolerance to PEG, bisacodyl or adjuvants

• No informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bowel Preparation for Colonoscopy

Intervention

Behavioral:
• Education

Other:
• Fiber free diet

Dietary Supplement:
• Adjuvants

Drug:
• Polyethylene glycol (PEG)

• Bisacodyl

Locations

Country	Name	City	State
Spain	Hospital de Sabadell	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of patients with adequate bowel preparation	Adequate bowel preparation is defined as a preparation which allows exploring the whole colonic mucose and detecting flat lesions (Rating as good or excellent in the Boston Bowel preparation scale)	at the time of performing the colonoscopy	No
Secondary	Percentage of patients with adequate bowel preparation by bowel segments	The boston scale will be assessed by the investigators during the procedure.	At the time of performing the colonoscopy	No
Secondary	Tolerance to the colonoscopy	Tolerance to the colonoscopy will be measured by VAS during the colonoscopy, 30 minutes after colonoscopy and 24 hours after colonoscopy	from colonoscopy up to 24 hours after colonoscopy	Yes
Secondary	Percentage of complete/incomplete colonoscopies and reprogramming	Evaluation of incomplete or inadequate bowel preparation will be assessed after performing the colonoscopy	After the colonoscopy	No
Secondary	Complications during and after the procedure		up to 24 hours after colonoscopy	Yes
Secondary	Doses of sedation needed during the colonoscopy	Final dose will be calculated at the end of the procedure	During the colonoscopy process	No
Secondary	Tolerance to the preparation		up to 48 hours	Yes
Secondary	Endoscopic findings		during the colonoscopy	No