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

Sponsor
Maltepe University (Other)
Overall Status
Completed
CT.gov ID
NCT01057446
Collaborator
Marmara University (Other)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Prospective Randomized Comparison of Oral Sodium Phosphate and Sennoside A+B Calcium Lavage for Colonoscopy Preparation

    Outcome Measures

    Primary Outcome Measures

    1. Colonic cleansing was evaluated by using the amount and consistency of stool remained in the colonic segment []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Maltepe University
    • Marmara University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01057446
    Other Study ID Numbers:
    • mütf
    First Posted:
    Jan 27, 2010
    Last Update Posted:
    Feb 5, 2010
    Last Verified:
    Nov 1, 2009

    Study Results

    No Results Posted as of Feb 5, 2010