An interventional study of polyethylene glycol (Protocol I) in Colonoscopy, Colonoscopy Diagnostic Techniques and Procedures and Colonoscopy Preparation, sponsored by Eastern Mediterranean University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-26.
Sponsored by Eastern Mediterranean University · Not applicable, Interventional, and Health services research
The aim of this study was to investigate the effect of different bowel preparation protocols applied on the same day on patients' compliance, tolerance and bowel cleansing before colonoscopy.
Hypotheses of the Study : Same-day administration of bowel preparation before colonoscopy; H1.1: There is a significant difference between the bowel preparation protocol with polyethylene glycol (Protocol I) and the protocol with sodium phosphate (Protocol II) in bowel preparation score scores H1.2: There is a significant difference between the compliance levels of the patients who underwent a bowel preparation protocol containing polyethylene glycol (Protocol I) and a protocol containing sodium phosphate (Protocol II) H1.3: There is a significant difference between the tolerance of the patients who underwent a bowel preparation protocol containing polyethylene glycol (Protocol I) and a protocol containing sodium phosphate (Protocol II)
In patients in Protocol I and II groups, data will be collected one day before the procedure with the Descriptive Characteristics Form and the procedure will be explained face to face. After the procedure, bowel preparation score during colonoscopy and compliance and tolerance to the bowel preparation protocol will be evaluated from the patients in both groups.
The aim of this study was to investigate the effect of different bowel preparation protocols applied on the same day on patients' compliance, tolerance and bowel cleansing before colonoscopy.
This study will be conducted as a single centre prospective randomised controlled trial in accordance with the principles of the Declaration of Helsinki. The study will be conducted in a private clinic in Famagusta region in patients undergoing colonoscopy.
Patients undergoing colonoscopy will be given written material about bowel preparation the day before the procedure and the protocol will be explained verbally and in writing. The bowel preparation protocol is described below.
Protocol I 06.30 Breakfast 09.00 hours: Phospho-Soda 45 ml 10.00: Phospho-Soda 45 ml At least 3 litres of liguid fluid intake until 14.00 14.30- 15.00: Colonoscopy Protocol II 06.30 Breakfast 09.00 :Polyethylene Glycol (PEG) will be diluted with 4 litres of water and one glass (200ml) will be drunk every 10 minutes until it is finished (It will be finished in about 4 hours) Colonoscopy after 2 hours Inclusion criteria
A total of 118 patients were planned to be included in the study with an effect size of d=0.50, α =0.05 margin of error, 85% power, and 59 patients in each group. Considering the possibility of missing data, the sample number was increased by 10% and it was decided to take 128 patients by taking 64 patients in the groups in total.
The patients will be assigned to the experimental and control groups according to the list to be created using the randomisation program at a ratio of 1.1(https://www.random.org/). Randomisation and assignment to groups will be done by an independent researcher who is not involved in the implementation phase of the research. Thus, selection bias will be prevented in the randomization process.
In patients in Protocol I and II groups, data will be collected one day before the procedure with the Descriptive Characteristics Form and the procedure will be explained face to face. After the procedure, the bowel preparation score during colonoscopy and compliance and tolerance to the bowel preparation protocol will be evaluated from the patients in both groups.
5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
This study's planned enrollment of 128 is above the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Eastern Mediterranean University is the lead sponsor of 141 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
Intestinal preparation protocol with polyethylene glycol (Protocol I)
Other: polyethylene glycol (Protocol I)
Intestinal preparation protocol with with sodium phosphate content (protocol II)
Other: polyethylene glycol (Protocol I)
Intestinal preparation protocol with polyethylene glycol (Protocol I)
Compliance and Tolerance to the Bowel Preparation Protocol
The Bowel Preparation Protocol Compliance and Tolerance Assessment Form will assess this primary outcome. This form assesses tolerance to the bowel preparation protocol; abdominal pain, nausea, vomiting, Abdominal distension -gas,thirst , headache, weakness and fatigue and intolerance to the solution. The rate of patients experiencing variables including Compliance and Tolerance to the Bowel Preparation Protocol will be calculated.
Time frame: The patients were interviewed 30-60 dk minutes after the procedure was completed.
Bowel cleansing quality level
The effect of the bowel preparation protocol on bowel readiness will be assessed using the Boston Bowel Readiness Classification. Boston Classification of Bowel Preparation (BBPS) scores bowel cleanliness between 0 and 3 points. According to BBPS, 3 segments of the colon (left, transverse, right) are scored according to the degree of cleanliness. According to BBPS, a score of 0 indicates inadequate cleanliness and a score of 9 indicates perfect cleanliness. As the cleanliness score progresses from zero to nine, it is assessed that bowel cleanliness is approaching perfection.
Time frame: BBPS will be assessed by the surgeon during colonoscopy.
No study locations are listed for this record.
Start is estimated for Mar 2025; primary completion for Nov 2025, 8 months later.
Of 801 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 60. This study's planned 8 months is below that.
Counting every sponsor, half of 845 studies reached it within 32 months; a quarter within 14 and three quarters within 60.
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This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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