4-L Split-dose Polyethylene Glycol and Bisacodyl and Docusate Sodium Regimen Versus 2-L Split-dose Polyethylene Glycol Plus Oral Simethicone Regimen for Bowel Preparation Before Colonoscopy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTanta University

About this trial

The goal of this randomized controlled trial is to compare the safety, compliance, and efficacy of different bowel preparation methods prior to colonoscopy. Researchers will compare 4-L split-dose polyethylene glycol and the bisacodyl + docusate sodium regimen versus 2-L split-dose polyethylene glycol plus oral simethicone regimen versus the conventional method for bowel preparation before colonoscopy. Participants will undergo history-taking, clinical examination, laboratory investigations, and colonoscopy. Patients will be randomly assigned to receive 4-L split-dose polyethylene glycol and bisacodyl + docusate sodium, a 2-L split-dose polyethylene glycol regimen plus oral simethicone, or 2-L split-dose polyethylene glycol alone as a control. Colonoscopy will be done 24 hrs after the start of medication. Researchers will assess the quality of the bowel preparation using the Aronchick bowel preparation scale. Researchers will also assess the number of adverse events and ask the patients about the ease of bowel preparation administration, tolerability of preparation regimen, and willingness to take the same agent again for a repeat colonoscopy in the future.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing colonoscopy as a day-care procedure for various indications (lower GI bleeding, colorectal cancer screening, altered bowel habits, etc.)

Patients of either sex aged >18 years and <70 years.

Patients willing to give written informed consent.

Disqualifiers

Presence of Renal failure, cirrhosis, ascites, CCF, bleeding disorders, seizure disorder, gastrointestinal obstruction, or perforation.

History of serious adverse events to other electrolyte-based colonic lavages.

Female patients who are pregnant or lactating or considering pregnancy.

Allergy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 4-L split-dose polyethylene glycol and Bisacodyl + Docusate sodium.

    Drug

    Patients who were randomized to receive PEG were instructed to mix four sachets of PEG (Moviprep) in 4 liters of water and drink it over a period of 8 hours starting at 09:00 a.m. and Biscodyl 10 mg + Docusate sodium 100 mg (Minalax) 8 tablets.

  • 2-L split-dose polyethylene glycol plus Oral Simethicone regimen .

    Drug

    Patients who are randomized to receive PEG with simethicone are instructed to mix two sachets of PEG (Moviprep) in 2 liters of water and drink it over a period of 4 hours starting at 09:00 a.m. with simethicone (Flatidyl) 4 tablets.

  • 2-L split-dose polyethylene glycol regimen

    Drug

    Patients who are randomized to receive PEG with simethicone instructed to mix two sachet of PEG (moviprep) in 2 liters of water and drink it over a period of 4 hours starting at 09:00 a.m.

Treatment groups

450 Participants
are divided into 3 treatment groups
Group A: 4-L split-dose polyethylene glycol and Bisacodyl + docusate sodium.Experimental treatment 1 intervention
Group B: 2-L split-dose polyethylene glycol plus oral simethicone regimen .Active comparator 1 intervention
Group C: 2-L split-dose polyethylene glycol regimen (control).Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Performing a complete and successful full colonoscopy.

Bowel preparation administration, whether completed or not, and the reason for it will be recorded. Assessment of the quality of the bowel preparation using the Aronchick bowel preparation scale.

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

Bowel preparation side effects

Any adverse events (like nausea, vomiting, dizziness, pain abdomen, bloating and anal irritation) will be recorded.

Time frame
through study completion, an average of 1 year
2

Ease of bowel preparation administration

Patients were asked to rate the ease of administration and taste as easy/tolerable/difficult/intolerable.

Time frame
through study completion, an average of 1 year
3

Tolerability assessment

the tolerability is assessed based on whether the patient would take the preparation again in case repeat colonoscopy is required and rate the product as excellent/good/satisfactory/bad.

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

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