Trial record 3 of 255 for:    Open Studies | colonoscopy

Randomized Controlled Trial Comparing Water vs. Air Method for Performing Colonoscopy in Adult Female Subjects

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of California, Davis
Sponsor:
Information provided by (Responsible Party):
Surinder Mann, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT01790425
First received: January 17, 2013
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Screening for Colon Cancer
Procedure: to infuse water into colon to open the lumen for water infusion colonoscopy
Procedure: Air colonoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Water vs. Air Method for Performing Colonoscopy in Adult Female Subjects

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Cecal intubation [ Time Frame: Three years ] [ Designated as safety issue: No ]
    Examination of the cecum by endoscopy


Secondary Outcome Measures:
  • Amount of opiate and benzodiazepines used for sedation. [ Time Frame: Three years ] [ Designated as safety issue: No ]
    The total amount of opiate (either demerol of fentanyl) used for sedation.


Other Outcome Measures:
  • Patient discomfort Patient pain rating during and after procedure [ Time Frame: Three years ] [ Designated as safety issue: No ]
    Patient's pain score (on a 1-10 scale) during and after the procedure.


Estimated Enrollment: 100
Study Start Date: August 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: water colonoscopy
The water (study) method: Warm water (body temperature) will be infused into colon to open the lumen for water infusion colonoscopy. Higher rate of complete colonoscopy will be achieved.
Procedure: to infuse water into colon to open the lumen for water infusion colonoscopy
N/A
Other Name: Water colonoscopy
Active Comparator: Air Colonoscopy
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
Procedure: Air colonoscopy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-All female patients between the ages of 18 to 80 years scheduled for colonoscopy at UC Davis GI Lab.

Exclusion Criteria:

  • Patients who refuse to be randomized to the air or water colonoscopy method.
  • Patients who are unable to respond to study questionnaires.
  • Patients with partial colon resection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01790425

Locations
United States, California
University of California, Davis Recruiting
Sacramento, California, United States, 95817
Contact: Surinder K Mann, M.D.    916-734-0779    surinder.mann@ucdmc.ucdavis.edu   
Contact: Joseph Leung, M.D.    916-734-0779    joseph.leung@ucdmc.ucdavis.edu   
Principal Investigator: Surinder K Mann, M.D.         
Sub-Investigator: Joseph W Leung, M.D.         
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Surinder Mann, M.D. UCD
  More Information

No publications provided

Responsible Party: Surinder Mann, MD, Clinical Professor of Medicine, University of California, Davis
ClinicalTrials.gov Identifier: NCT01790425     History of Changes
Other Study ID Numbers: UCD IRB # 319719
Study First Received: January 17, 2013
Last Updated: February 11, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 26, 2014