Water Method in Low-body Mass Index (BMI) Female Patients With Unsedated Colonoscopy

NCT01546259 | Withdrawn DMC

• 1 other identifier: 20120216-7
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Water method with water exchange has been shown to reduce medication requirement and pain experienced during colonoscopy. It increases the success rate of cecal intubation in sedated and unsedated patients undergoing screening colonoscopy. Exchange of water during scope insertion minimizes distension of the colonic lumen and decreases loop formation. Exclusion of air from the colon during insertion by omission of air insufflations and suction removal of residual air prevent elongation of the colon. These maneuvers facilitate colonoscopy insertion in average patients and may enhance the success of difficult colonoscopy. Female gender and low-body mass index (BMI) is independently associated with incomplete colonoscopy, respectively. The investigators postulate that low-BMI female patients may benefit from using the water method for colonoscopy. In this proposal the investigators test the hypothesis that compared with conventional air insufflations the water method with water exchange significantly enhances the success rate of cecal intubation in low-BMI female patients. The aim of the study is to compare the outcome of colonoscopy using the water method versus the conventional air method in low-BMI female patients. The primary outcome is cecal intubation success rate. The secondary outcomes include cecal intubation time, maximum pain score during colonoscopy, overall pain score after colonoscopy and adenoma detection rate.

Conditions

Adenoma; Pain

Keywords

colonoscopy; water; female; BMI; unsedated; low BMI female patients; Intubation

Outcome Measures

Primary Outcomes (1)

• Cecal intubation success rate

  Insertion of a colonoscope to the cecum

  up to two years

Secondary Outcomes (3)

• Adenoma detection rate

  up to two years

• Pain Scores on the Visual Analog Scale

  up to two years

• Cecum intubation time

  up to two years

Study Arms (2)

Air colonoscopy

NO INTERVENTION

Colonoscopy will be performed without medications and with judicious air insufflation during colonoscope insertion.

Water colonoscopy

OTHER

Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope.

Other: Water colonoscopy

Interventions

Water colonoscopy OTHER

Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope. The water infusion involves putting warm sterile water into the colon to open up the colon for advancement of the colonoscope until the end of the colon (cecum) is reached. The water is delivered through scope irrigation channel by an infusion pump equipped with a foot switch which will be controlled by the endoscopist. Infused water used to cleanse residual fecal matter will be suctioned as needed to clear the colonic lumen.

Also known as: Water, colonoscopy

Water 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:

• Female patients with BMI \< 20

You may not qualify if:

• History of colorectal surgery
• Severe colonic stricture or obstructing tumor
• Patients who cannot give informed consent and those who are hemodynamically unstable

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Adenoma; Pain

Interventions

Water; Colonoscopy

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Yanglin Pan, MD

  Air Force Military Medical University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: March 7, 2012
• Study Start: November 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 25, 2016

Record last verified: 2016-03

Locations

CN (1)