Randomized Controlled Trial Comparing Water vs. Air Method for Performing Colonoscopy in Adult Female Subjects
Condition: Screening for Colon Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      This is a prospective , single center, investigator initiated, randomized controlled trial to
      compare two methods of performing colonoscopy by experienced colonoscopist. Potential female
      subjects presenting for colonoscopy at UCD GI Lab will be presented with the study option and
      will be enrolled if they sign the informed consent.

      In recent years, the water infusion method has been reported to have several beneficial
      effects when studied in veteran patients. These include: significant reduction in discomfort
      to permit a significantly higher percentage (98% vs. 76%) of veterans to complete scheduled
      unsedated colonoscopy, lower sedation medication requirement when they accepted the option of
      minimal pre-medication sedation, more patients completing without sedation (78% vs 54%) when
      they accepted the on demand sedation and an increase in the yield of adenomas (a type of
      cancer seen in the colon) in screening and surveillance colonoscopy. Reviewers of the method
      have repeatedly called for studies using the method in female patients to confirm or refute
      the findings as most of the veteran patients are male patients.
    

Detailed description: 
      Study Aim Our aim is to perform a randomized controlled trial comparing air insufflation
      colonoscopy (conventional method ) vs. water infusion colonoscopy ( study method ) in non
      veteran female subjects presenting for colonoscopy . Subjects will be randomized 1:1 like the
      flip of coin.

      Study Design This is a prospective, single center, investigator initiated, randomized
      controlled trial (RCT) to compare the study method (water infusion colonoscopy) with
      conventional method (air insufflation colonoscopy "pump air to dilate the colon to visualize
      the colon mucosa) in female patients by experienced colonoscopist. Patients will be
      classified ASA 1 (No organic, physiologic, biomedical or psychiatric disturbance) and ASA 2
      (Mild to moderate systemic diseases which are well controlled including hypertension,
      diabetes mellitus, asthma, age 70 and over) before colonoscopy procedure.

      Research Methods and Procedures The air (conventional) method: Air is pumped gently
      (insufflation) into the colon will be used to open the inside space of the colon and aid in
      colonoscope insertion The water (study) method: Warm water (body temperature) will be pumped
      into the colon in place of air to open the inside of space of the colon and aid in
      colonoscope insertion After insertion, both methods may use any of the following procedures
      to advance the colonoscope in to the colon: colonoscope shortening maneuver, abdominal
      compression, by the assistant, and change of patient position. In both methods air
      insufflation will be used to distend the colon for inspection, biopsy and polypectomy.
      Washing of the stool covered mucosa and inspection behind the folds will be performed
      systematically. After turn around in the rectum, residual air and water will be removed by
      suction.

      Data gathering instruments used in the VA studies will be employed (subject interview
      questions are attached). Statistical analyses similar to those used in the previous VA
      studies (Student's t tests, Fischer's exact test, Mann-Whitney U test, etc) will be used to
      analyze the data.

      Biopsy and polypectomy will be performed as usual and all tissues will be submitted for
      routine histological assessment and the pathology will be recorded.
    

Intervention name(s): to infuse water into colon to open the lumen for water infusion colonoscopy; Air colonoscopy
Intervention type(s): Procedure; Procedure
Other intervention name(s): Water colonoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment