NCT07669116

Brief Summary

Colonoscopy is a commonly used minimally invasive method for evaluating the lower gastrointestinal tract. The quality of colonoscopy is assessed by factors such as cecal intubation rate and adenoma detection rate, both of which are affected by bowel preparation. Adequate bowel cleansing is critical for an ideal colonoscopy. Inadequate bowel preparation can prolong the procedure time, miss pathological findings, and increase hospital costs due to repeated procedures. Studies have shown that nearly 25% of patients have inadequate bowel preparation. Several factors influence bowel cleansing, including diet, bowel preparation medication, and a history of gastrointestinal surgery. In a study, male gender, hospitalization, and spring season were reported as independent risk factors for inadequate bowel preparation. A retrospective US study associated age ≥66 with poor colonoscopy preparation, while two Asian studies associated age ≥60. Comorbidities such as diabetes, stroke, and dementia, as well as low socioeconomic status, have also been reported to negatively impact adequate bowel cleansing. The Aronchick scale, Ottawa Bowel Preparation Scale (OBPS), and Boston Bowel Preparation Scale (BBPS) are commonly used in bowel preparation scoring. The BBPS is rated from 0 to 9, with 9 considered excellent bowel preparation. It is applied after cleansing and aspiration of colon segments, which are divided into right, transverse, and left colon. Among the current scoring systems, the BBPS is the most useful and reliable scale. The positive effects of alkaline pH water on the gastrointestinal system are well known. Alkaline mineral water has positive effects on intestinal epithelial regeneration, inflammatory response, improved barrier function, and antioxidant mechanisms. In this study, researchers aimed to investigate the effect of the pH value of water consumed during bowel preparation before colonoscopy on bowel cleansing. Demographic, clinical, and intraoperative data of patients undergoing colonoscopy in investigators hospital's surgical endoscopy unit between July 2026 - July 2027 will be examined. Patients meeting the inclusion criteria will be included in the study. For pre-procedure information, all patients will be given a bowel preparation form by the surgical endoscopy unit, and patients who do not fully adhere to the diet will be excluded from the study. Informed consent will be obtained from the patients or their legal representatives. All procedures will be performed under sedation with the assistance of an anesthesiologist. Bowel cleansing will be assessed according to the Boston Bowel Preparation Scale (BBHS). The pH value and content of the drinking water will be noted when the bowel preparation form is given; no specific instructions will be given regarding this. However, patients will be asked to use the same water throughout the bowel preparation period. Data regarding drinking water will be confirmed on the day of the procedure for a second check. This study will be the first of its kind in this field.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Jul 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Jul 2026Jun 2027

First Submitted

Initial submission to the registry

June 21, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

July 25, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2027

Last Updated

July 7, 2026

Status Verified

June 1, 2026

Enrollment Period

11 months

First QC Date

June 21, 2026

Last Update Submit

July 4, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • The effect of pH value of water consumed during bowel preparation before colonoscopy on bowel cleansing according to the Boston Bowel Preparation Scale

    July 2026-July 2027

Study Arms (3)

Group 1 according to pH range

Group 1 according to pH range

Procedure: Colon preparation for colonoscopy

Group 2 according to pH range

Group 2 according to pH range

Procedure: Colon preparation for colonoscopy

Group 3 according to pH range

Group 3 according to pH range

Procedure: Colon preparation for colonoscopy

Interventions

The quality of colonoscopy is assessed by factors such as cecal intubation rate and adenoma detection rate, both of which are affected by bowel preparation. Adequate bowel cleansing is critical for an ideal colonoscopy, and many factors influencing this have been identified. However, there are no studies in the literature regarding the water content consumed during colonoscopy preparation. Our study will be the first of its kind in this field.

Group 1 according to pH rangeGroup 2 according to pH rangeGroup 3 according to pH range

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Demographic, clinical, and intraoperative data of patients undergoing colonoscopy in our hospital's surgical endoscopy unit between July 2026 - July 2027 will be examined. Patients meeting the inclusion criteria will be included in the study. For pre-procedure information, all patients will be given a bowel preparation form by the surgical endoscopy unit, and patients who do not fully adhere to the diet will be excluded from the study. Informed consent will be obtained from the patients or their legal representatives. All procedures will be performed under sedation with the assistance of an anesthesiologist. Bowel cleansing will be assessed according to the Boston Bowel Preparation Scale (BBHS). The pH value and content of the drinking water will be noted when the bowel preparation form is given; no specific instructions will be given regarding this. However, patients will be asked to use the same water throughout the bowel preparation period.

You may qualify if:

  • Age over 18
  • Fully adhering to the pre-procedure diet
  • Bowel preparation performed with the bowel preparation routinely used in our surgical endoscopy unit (Sennoside A+B, Monobasic sodium phosphate+ Dibasic sodium phosphate)
  • No history of gastrointestinal surgery
  • Patients not using prokinetic drugs

You may not qualify if:

  • Those not following the diet
  • Those using another bowel preparation
  • Those with a history of stomach, small intestine, large intestine surgery or any major abdominal surgery for any reason
  • Those diagnosed with a known bowel disease such as inflammatory bowel disease or irritable bowel syndrome
  • Those with gastrointestinal motility disorders or those using medications that may cause this side effect
  • Patients for whom the pH value/content of drinking water cannot be obtained

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

June 21, 2026

First Posted

June 25, 2026

Study Start

July 25, 2026

Primary Completion (Estimated)

June 25, 2027

Study Completion (Estimated)

June 25, 2027

Last Updated

July 7, 2026

Record last verified: 2026-06