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

This study has been completed.
Sponsor:
Collaborator:
Marmara University
Information provided by:
Maltepe University
ClinicalTrials.gov Identifier:
NCT01057446
First received: January 26, 2010
Last updated: February 4, 2010
Last verified: November 2009
  Purpose

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
Colonoscopy

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Maltepe University:

Primary Outcome Measures:
  • Colonic cleansing was evaluated by using the amount and consistency of stool remained in the colonic segment [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Sampling Method:   Probability Sample
Study Population

Ninety-nine patients requiring diagnostic outpatient colonoscopy were prospectively recruited for the study and randomized by internet based Easy sample random numbers software program to two arms of sodium phosphate versus Sennosid A+B calcium preparation.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Maltepe University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Manuk Manukyan MD, Maltepe University
ClinicalTrials.gov Identifier: NCT01057446     History of Changes
Other Study ID Numbers: mütf
Study First Received: January 26, 2010
Last Updated: February 4, 2010
Health Authority: Turkey: Ministry of Health

Keywords provided by Maltepe University:
Colonoscopy preparation
sennoside
sodium phosphate
the aim is to assess the bowel cleansing effects of two different agents

Additional relevant MeSH terms:
Senna Extract
Sennoside A&B
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014