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

NCT01790425 | Completed DMC

• 2 other identifiers: 319719UCD IRB # 319719
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Screening for Colon Cancer

Outcome Measures

Primary Outcomes (1)

• Cecal intubation

  Examination of the cecum by endoscopy

  Three years

Secondary Outcomes (1)

• Amount of opiate and benzodiazepines used for sedation.

  Three years

Other Outcomes (1)

• Patient discomfort Patient pain rating during and after procedure

  Three years

Study Arms (2)

water colonoscopy

EXPERIMENTAL

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

Air Colonoscopy

ACTIVE COMPARATOR

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

Interventions

to infuse water into colon to open the lumen for water infusion colonoscopy PROCEDURE

Also known as: Water colonoscopy

water colonoscopy

Air colonoscopy PROCEDURE

Air Colonoscopy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

Location

Study Officials

• Surinder Mann, M.D.

  UCD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2013
• First Posted: February 13, 2013
• Study Start: August 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: June 27, 2017

Record last verified: 2017-06

Locations

US (1)