Clinical Trial: A Comparison of Air Insufflation, Water Immersion and Water Exchange Colonoscopy in Diagnostic Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Controlled Trial Comparing Air Insufflation, Water Immersion and Water Exchange During on Demand Sedation Colonoscopy in Diagnostic Patients

Brief Summary: Water-aided method for colonoscopy can be broadly subdivided into two major categories. Water Immersion (WI), characterized by suction removal of the infused water predominantly during the withdrawal phase of colonoscopy, and Water Exchange (WE), characterized by suction removal of infused water predominantly during the insertion phase of colonoscopy. Several studies showed that WE significantly reduces pain compared to WI and colonoscopy with traditional air insufflation (AI), increases the number of unsedated procedures and adenoma detection rate (ADR), in particular proximal ADR. This randomized controlled trial will be a direct comparison of Air Insufflation, Water Immersion and Water Exchange to test the hypothesis that WAC (particularly WE) would significantly decrease pain score during colonoscopy in diagnostic patients. Several other secondary outcomes will also be analyzed.

Detailed Summary:

Introduction Water-aided methods for colonoscopy can be broadly subdivided into two major categories.

Water Immersion (WI) is characterized by suction removal of the infused water predominantly during the withdrawal phase of colonoscopy and Water Exchange (WE) is characterized by suction removal of infused water predominantly during the insertion phase of colonoscopy.

Several studies showed that WE significantly reduces pain compared to WI and colonoscopy with traditional air insufflation (AI), increases the number of unsedated procedures and adenoma detection rate (ADR), in particular proximal ADR. This randomized controlled trial will be a direct comparison of Air Insufflation, Water Immersion and Water Exchange to test the hypothesis that WAC (particularly WE) would significantly decrease pain score during colonoscopy in diagnostic patients. Several other secondary outcomes will also be analyzed.

Method

Examinations will be allocated to Water Exchange, Water Immersion or Air Insufflation during the insertion phase of colonoscopy based on a computer generated random list. Procedures will be started by 6 board-certified endoscopists, three with experience in 8,000-10,000 and three with experience in 2,000-5,000 colonoscopies with AI, 285 with WI and 890 with WE overall.

High-resolution wide-angle variable-stiffness adult video colonoscopes (Olympus HD 180 series; Olympus Corp, Hamburg, Germany) will be used. Need to change to a smaller caliber colonoscope will be considered ITT failure.

Patients will have a low volume split dose bowel preparation with 2L of polyethylene glycol (PEG) solution or Sodium Picosulfate. Investigato
Sponsor: Presidio Ospedaliero Santa Barbara

Current Primary Outcome: Maximum pain score recorded during colonoscopy. [ Time Frame: 1 hour ]

Pain will be 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. The patient will be informed that the request for pain information is not to remind the patient that the examination should be uncomfortable, but to let the colonoscopist be alerted to the need to use maneuvers to minimize discomfort (e.g. loop reduction, removal of colonic content, abdominal compression and/or change in patient position). At regular intervals during colonoscopy (e.g. every 2-3 minutes) patients will be asked about discomfort or pain. The responses will be recorded, and the maximum pain score noted.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Need for sedation/analgesia and its dosage. [ Time Frame: 1 hour ]
    Sedation and analgesia will be available on demand. Medication will be offered when VAS score reaches ≥2 (discomfort). Patients can accept or decline the medication. If patients agree to accept the medication, it will be given. Midazolam, no more than 5 mg per patient, will be used. When pain is reported, sedation will be started with midazolam with a single intravenous dose of 2 mg, plus incremental doses of 1 mg if the patient still continues to complain about pain. To avoid bias by the colonoscopist, sedation medication will be administered based on the patients' confirmation that the pain is no longer tolerable, and not at the discretion of the colonoscopist. No other analgesic or sedative medications will be administered. The colon segment in which patients requests sedation will be recorded.
  • 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 were present. Patients will be asked to quantify the degree of pain experienced and to place a mark over the VAS accordingly.
  • 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. This will be analyzed on an intention- to-treat basis according to group allocation.
  • 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.
  • Total procedure time. [ Time Frame: 1 hour ]
    Total procedure time (including time required for polyp resection or biopsy).
  • Adenoma detection rate. [ Time Frame: 6 months ]
    Proportion of subjects with at least one adenoma of any size.
  • Adenoma resection rate. [ Time Frame: 6 months ]
    Total number of adenomas resected per subject.
  • Advanced adenoma. [ Time Frame: 6 months ]
    Total number of advanced adenomas: diameter ≥10mm, or high grade dysplasia, or with ≥20% villous components.


Original Secondary Outcome: Same as current

Information By: Presidio Ospedaliero Santa Barbara

Dates:
Date Received: January 29, 2013
Date Started: March 2013
Date Completion:
Last Updated: January 14, 2014
Last Verified: January 2014