Comparison of Oral Sodium Phosphate and Sennoside A+B Calcium Lavage for Colonoscopy Preparation

Colonoscopy Clinical Trial

Official title:

Prospective Randomized Comparison of Oral Sodium Phosphate and Sennoside A+B Calcium Lavage for Colonoscopy Preparation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01057446
• Other study ID #: mütf
• Status: Completed
• Phase: N/A
• First received: January 26, 2010
• Last updated: February 4, 2010

Study information

• Verified date: November 2009
• Source: Maltepe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The aim of the investigators study is to assess the bowel cleansing effects of two different agents and to compare their safety of application, ease of usage and effects on serum electrolytes.

Description:

Colorectal cancer is a leading cause of death from cancer. Because colonic cancer begins as a small adenoma that , evolves into carcinoma over a decade or more pre-emptive colonoscopic polypectomy can prevent this malignancy. For a good colonoscopic examination ideally the colon should be cleansed of all fecal material because poor bowel preparation before colonoscopy often leads to inability to reach the cecum or poor visualization of the mucosa . Thus , pathology may be missed, repeat examinations may be scheduled at earlier intervals than planned and the procedure is more difficult and time consuming. In addition , poor bowel preparation can increase the risk of significant complications. Perforations resulting from maneuvers has greater consequences in the setting of inadequate bowel preparation.

In the past two decades , various bowel preparation methods have been proposed including castor oil, anthraquinones, phenolphtalein and magnesium citrate, in combination with low residue diet4-7. Along these agents , cleansing enemas formed the traditional bowel preparation. Oral sodium phosphate (Fleet Phospo-soda, C.B Fleet Co, Inc., Lynchburg, Va.)(NaP) a preparation containing dibasic and monobasic sodium phosphate was proven to be cost effective and has since been used worldwide8,9. NaP osmotically draws plasma water into the bowel lumen to promote bowel cleansing. NaP must be accompanied by significant oral fluid to prevent dehydration. Patients with compromised renal function, dehydration, hypercalcemia or hypertension with the use of angiotensin converting enzyme inhibitors have experienced phosphate nephropathy after use of oral NaP solutions.

Senna laxatives containing sennosides activated by colonic bacteria have a direct effect on intestinal mucosa increasing the rate of colonic motility , enhancing colonic transit, and inhibiting water and electrolyte secretion10. Sennosides may result in hypokalemia and atonic colon.

The aim of our study is to assess the bowel cleansing effects of two different agents and to compare their safety of application, ease of usage and effects on serum electrolytes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients requiring diagnostic outpatient colonoscopy.

• Over the age of 18 and giving informed consent by their will.

Exclusion Criteria:

• Patients unable to give informed consent

• Those younger than 18 years old

• Those with a known history of chronic renal failure

• Pregnant women and those with a known history of bowel resection were excluded

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colonoscopy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Maltepe University	Marmara University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colonic cleansing was evaluated by using the amount and consistency of stool remained in the colonic segment			Yes