Water Method in Low-body Mass Index (BMI) Female Patients With Unsedated Colonoscopy

Study Overview
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Brief Summary
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Water method with water exchange has been shown to reduce medication requirement and pain experienced during colonoscopy. It increases the success rate of cecal intubation in sedated and unsedated patients undergoing screening colonoscopy. Exchange of water during scope insertion minimizes distension of the colonic lumen and decreases loop formation. Exclusion of air from the colon during insertion by omission of air insufflations and suction removal of residual air prevent elongation of the colon. These maneuvers facilitate colonoscopy insertion in average patients and may enhance the success of difficult colonoscopy. Female gender and low-body mass index (BMI) is independently associated with incomplete colonoscopy, respectively. The investigators postulate that low-BMI female patients may benefit from using the water method for colonoscopy. In this proposal the investigators test the hypothesis that compared with conventional air insufflations the water method with water exchange significantly enhances the success rate of cecal intubation in low-BMI female patients. The aim of the study is to compare the outcome of colonoscopy using the water method versus the conventional air method in low-BMI female patients. The primary outcome is cecal intubation success rate. The secondary outcomes include cecal intubation time, maximum pain score during colonoscopy, overall pain score after colonoscopy and adenoma detection rate.

Official Title
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Water Method With Water Exchange Versus Air Insufflation in Low-BMI Female Patients Undergoing Unsedated Colonoscopy: a Prospective Randomized, Controlled Trial

Conditions
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Adenoma, Pain

Intervention / Treatment
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* Other: Water colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients with BMI < 20 Exclusion Criteria: History of colorectal surgery Severe colonic stricture or obstructing tumor Patients who cannot give informed consent and those who are hemodynamically unstable

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Air colonoscopy<br>Colonoscopy will be performed without medications and with judicious air insufflation during colonoscope insertion. | |
| Other: Water colonoscopy<br>Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope. | Other: Water colonoscopy<br>* Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope. The water infusion involves putting warm sterile water into the colon to open up the colon for advancement of the colonoscope until the end of the colon (cecum) is reached. The water is delivered through scope irrigation channel by an infusion pump equipped with a foot switch which will be controlled by the endoscopist. Infused water used to cleanse residual fecal matter will be suctioned as needed to clear the colonic lumen.<br>* Other names: colonoscopy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cecal intubation success rate | Insertion of a colonoscope to the cecum | up to two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate | The proportion of participants with at least one adenoma in each group | up to two years | 
| Pain Scores on the Visual Analog Scale | 0 = no pain, to 10 = most severe pain | up to two years | 
| Cecum intubation time | Total time of colonoscope intubation from anus to cecum | up to two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, water, female, BMI, unsedated, low BMI female patients, Intubation