Comparing Water Immersion and Water Exchange Methods During Minimally Sedated Colonoscopy

Study Overview
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Brief Summary
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In minimally sedated Asian patients in a community setting the investigators showed that a limited volume of water infusion instead of air insufflation in either the rectal sigmoid colon or the whole colon significantly reduced pain score during colonoscopy. Cecal intubation rate was not compromised. The reduction of pain score ranges from 25% to 32 % in our previous studies.1, 2 In contrast, several US reports described the successful use larger volumes of water infused throughout the entire colon in patients undergoing colonoscopy which result in a greater reduction of the pain score, averaging about 56%.3-5 A recent review suggested that the cause of the difference might lies in the timing of water removal.6 Specifically, the investigators group removed the infused water predominantly during withdrawal phase (water immersion) and the U.S. group removed water during insertion phase (water exchange). This prospective, randomized controlled trial compared water exchange or water immersion with traditional air insufflation in patients undergoing minimally sedated colonoscopy. The investigators test the hypothesis that water exchange can reduce more pain than water immersion in the investigators clinical setting.

Detailed Description
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All procedures will be recorded and stored as digital files.

Official Title
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Comparing Air Insufflation, Water Immersion and Water Exchange Methods During Minimal Sedated Colonoscopy, a Randomized, Controlled Trial

Conditions
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Pain, Colon Neoplasm

Intervention / Treatment
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* Procedure: air insufflation
* Procedure: water immersion
* Procedure: water exchange


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing minimally sedated colonoscopy Exclusion Criteria: Obstructive lesions of the colon, inadequate bowel preparation, allergy to meperidine, massive ascites, past history of partial colectomy, or refusal to provide written informed consent.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: air insufflation<br>Use air insufflation during colonoscopy | Procedure: air insufflation<br>* insufflate air during the insertion of colonoscopy<br>|
| Active Comparator: water immersion<br>infuse water during insertion, remove water during withdrawal of colonoscopy | Procedure: water immersion<br>* infuse water during insertion, aspirate water during withdrawal<br>|
| Active Comparator: water exchange<br>infuse and remove water during insertion phase of colonoscopy | Procedure: water exchange<br>* infuse and remove water during insertion phase of colonoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients Without Pain | proportion of patients without insertion pain during colonoscopy | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Pain Score | The maximal pain score during insertion phase of colonoscopy was assessed with 0 to 10 scale VAS score (0: no pain; 10: maximal pain) | 9 to 12 months | 
| Patient Satisfaction Score | satisfaction score obtained after colonoscopy 0 = no satisfied; 10 = most satisfied | 9 to 12 months | 
| Number of Participants With at Least One Adenoma | the number of participants with at least one adenoma in each of the study groups. | 9 to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy