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NCT Number: NCT01954862

Comparison of Methods to Distend the Colon During Insertion: CO2, Air Insufflation, Water-aided Colonoscopy

Insufflation of the colon, usually with room air, is necessary to distend the lumen for exploration. Carbon dioxide (CO2) insufflation instead of room air insufflation (AI) has been shown to decrease symptoms of abdominal pain or discomfort during the procedure and particularly during the following 24 hours. CO2 is is rapidly absorbed by the intestinal mucosa and exhaled through respiration. AI colonoscopy has usually been the reference standard to compare colonoscopy using CO2 insufflation. In two recent articles AI was compared to either CO2 insufflation and Water-aided colonoscopy (WAC), which entails infusion of water to facilitate insertion to the cecum.

WAC can be categorized broadly in Water Immersion (WI) and Water Exchange (WE). In WI water is infused during the insertion phase of colonoscopy, with removal of infused water predominantly during withdrawal. Occasional use of insufflation may be allowed. WE entails complete exclusion of insufflation, removal of residual colonic air pockets and feces, and suction of infused water predominantly during insertion to minimize distention. During the withdrawal phase insufflation is used to distend the colonic lumen.

In the WAC arms of the two mentioned articles the insertion method used was WI, with infusion of water at room temperature or at 37°C. During withdrawal, air insufflation or either air or CO2 insufflation were employed.

Compared to AI, CO2 insufflation and WI (using room air insufflation or CO2 insufflation during withdrawal) were effective in both studies in decreasing sedation requirement, pain and tolerance scores, with patients' higher willingness to repeat the procedure.

Until now no direct comparison has been made within a single study about pain score during colonoscopy using AI, CO2 insufflation, WI/CO2, WE/CO2, WI/AI and WE/AI.

In this study we test the hypothesis that, compared to AI, CO2 insufflation and WAC/CO2-AI methods will decrease pain score during colonoscopy, with reduction of sedation requirement, and that WE will achieve the best result. This comparative study has also the aim to test the respective peculiarities of each method.

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Key information

Conditions

Pain Colonic Diseases Colorectal Adenomas Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vìtkovice Hospital, Ostrava, Czechia

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About this study

Design: Prospective double blinded two-center randomized controlled trial. Methods: Colonoscopy with air insufflation, CO2, Water Immersion/CO2, Water Exchange/CO2, Water Immersion/AI and Water Exchange/AI to aid insertion of colonoscope; split dose bowel preparation; on demand-sedation.

Control method: Air insufflation colonoscopy. Study methods: CO2 colonoscopy, Water Immersion/CO2 colonoscopy, Water Exchange/CO2 colonoscopy, Water Immersion/AI colonoscopy, Water Exchange/AI colonoscopy.

Population: Consecutive 18 to 85 year-old diagnostic in-patients and outpatients. After informed consent, assignment to control or study arms based on computer generated randomization list with block allocation and stratification.

Primary outcome: Maximum pain score recorded during colonoscopy. Secondary outcomes: Cecal intubation rate and time, total procedure time (including biopsy and/or polypectomy), need for sedation and its dosage, overall pain score at discharge. In addition, Adenoma Detection Rate, Mean Adenomas per Procedure, position changes, amount of infused and suctioned water during insertion and withdrawal will be recorded. Bloating after examination and at discharge and patient willingness to repeat the examination will be evaluated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consecutive 18 to 85 year-old diagnostic in-patients and outpatients agreeing to start procedure without premedication.

Exclusion criteria

  • Patient unwillingness to start the procedure without sedation/analgesia
  • previous colorectal surgery
  • proctosigmoidoscopy or bidirectional endoscopy
  • patient refusal or inability to provide informed consent
  • inadequate assumption of bowel preparation
  • moderate or severe chronic obstructive pulmonary disease requiring oxygen
  • medical history of CO2 retention

Treatment and study plan

Air Insufflation method.

Other

Air Insufflation method.

CO2 insufflation

Other

CO2 insufflation.

Water Immersion/CO2

Other

Water Immersion during insertion, CO2 insufflation during withdrawal.

Water Exchange/CO2

Other

Water Exchange during insertion, CO2 insufflation during withdrawal.

Water Immersion/AI

Other

Water Immersion during insertion, AI insufflation during withdrawal.

Water Exchange/AI

Other

Water Exchange during insertion, AI insufflation during withdrawal.

Primary outcomes

  1. Maximum pain score recorded during colonoscopy.

    Time frame: 1 hour

    Pain assessed using a visual analogue scale (VAS) with a score 0=absence of pain, 2=simply "discomfort", 10=the worst possible pain. Before the procedure, an endoscopic nurse will explain the VAS scoring system to the patients. Every 60 seconds during colonoscopy patients will be asked about discomfort or pain. The responses will be recorded, and the maximum pain score noted.

Secondary outcomes

  1. Overall pain after the procedure.

    Time frame: 1 hour.

    After the procedure and at discharge from the Endoscopy Unit, an assistant nurse blinded to the procedure will ask patients about overall pain using the same VAS when neither the endoscopist nor the assistant nurse who performed the colonoscopy will be present. Patients will be asked to quantify the degree of pain experienced and to place a mark over the VAS accordingly.

  2. Cecal intubation rate.

    Time frame: 1 hour

    Cecal intubation will be defined as passage of the tip of the colonoscope beyond the ileocecal valve so that the medial wall of the cecum proximal to the ileocecal valve will be observed.

  3. Cecal intubation time.

    Time frame: 1 hour.

    Cecal intubation time will be defined as the time for passage of the colonoscope from the rectum to the cecum.

  4. Total procedure time.

    Time frame: 1 hour.

    Total procedure time (including time required for polyp resection or biopsy).

  5. Adenoma detection rate.

    Time frame: 15 months.

    Proportion of subjects with at least one adenoma of any size.

  6. Mean adenomas per procedure.

    Time frame: 15 months.

    Total number of adenomas resected per subject.

  7. Advanced adenomas.

    Time frame: 15 months.

    Total number of advanced adenomas: diameter ≥10mm, or high grade dysplasia, or with ≥20% villous components.

Other outcomes

  1. Position changes.

    Time frame: 1 hour.

    Change in patient position as needed if advancement of the colonoscope fails.

  2. Loop reduction maneuvers.

    Time frame: 1 hour.

    Applied as needed if advancement of the colonoscope fails.

  3. Amount of water used during the procedure.

    Time frame: 1 hour.

    Amount of water infused and aspirated during insertion and withdrawal.

  4. Bloating at completion of examination.

    Time frame: 1 hour.

    Bloating felt by patients at completion of examination on a 10 point visual analogue scale.

  5. Bloating at discharge.

    Time frame: 1 hour.

    Bloating felt by patients at discharge measured on a ten point visual analogue scale.

  6. Patients willingness to repeat the examination.

    Time frame: 1 hour.

    Patients willingness to repeat the examination based on overall satisfaction about procedure. Measured at discharge on a yes/no question.

  7. Oxygen desaturation.

    Time frame: 1 hour.

    Significant oxygen desaturation will be recorded when values less than 85% will be maintained for more than 15 seconds.

  8. Vagal reaction.

    Time frame: 1 hour.

    Vagal reaction is defined as heart rate <60 beats per minute accompanied by excessive sweating, nausea and/or vomiting.

  9. Abdominal Compression.

    Time frame: 1 hour.

    Compression of abdomen if advancement of the colonoscope fails.

Sponsors and collaborators

Lead sponsor

Presidio Ospedaliero Santa Barbara

Other

Registry information

Official study title

Comparison of Methods for Luminal Distention for on Demand Sedation Colonoscopy: Air Insufflation, Carbon Dioxide and Water-aided Colonoscopy. A Randomized Controlled Trial.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 7, 2013
Registry last updated
Jul 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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