Investigation of Cecal Intubation Rates and Pain Levels Between Water Exchange and Air Insufflation Flexible Sigmoidoscopy

NCT03209349 | Completed DMC

• 1 other identifier: 2016-17-078-I
• Study Type: interventional
• Target: 90
• Locations: 2 countries
• Sites: 2

Brief Summary

This study evaluates how often patients without sedation that receive screening sigmoidoscopy are able to have their full colon examined without significant discomfort by comparing a new colonoscopy technique known as the water exchange technique to the traditional air insufflation technique. It compares the differences between complete colon exam rates for water exchange when compared to the traditional air technique. Patients will be randomised and blinded to the procedure type. Previous studies have shown that the water exchange method is associated with a significant reduction in discomfort and often allows patients to receive colonoscopy without sedation or with only minimal sedation. However, the potential for water exchange to be used in the screening setting has yet to be evaluated. As per standard practices in sigmoidoscopy screening, patients will not be sedated. However, unlike standard practices in sigmoidoscopy screening, while maintaining minimal levels of discomfort, the investigators will attempt to scope beyond the distal colon.

Conditions

Colorectal Cancer

Keywords

Sigmoidoscopy

Outcome Measures

Primary Outcomes (1)

• Full colon exam

  Ability for patient to receive full exam of the colon with minimal discomfort

  Immediately following the procedure

Secondary Outcomes (2)

• Recalled Discomfort

  Immediately following the procedure

• Adenoma detection rates

  Immediately following the procedure

Study Arms (2)

Water Exchange Sigmoidoscopy

EXPERIMENTAL

As per standard practices, the patient will be walked to the procedure room and positioned in the left lateral position on the procedure bed, without pre-operative anesthesia. The procedures will be completed within the ambulatory endoscopy clinic at Kelowna General Hospital. The study will use the same colonoscopes that are already being used at KGH for colonoscopy. These are the Olympus 190 series colonoscopes. They can and will be fitted to support both water and air exchange. For patients assigned the water exchange intervention arm, the insertion of the scope will be followed by infusion and suction of water to minimally distend the lumen. If the lumen does not open, the instrument will be retracted slightly and the infusion started again. As the scope is inserted and progressed through the intestinal lumen some of the infused water will be suctioned back constantly, exchanging clean for opaque water.

Procedure: Water Exchange Sigmoidoscopy

Air Insufflation Sigmoidoscopy

ACTIVE COMPARATOR

As per standard practices, the patient will be walked to the procedure room and positioned in the left lateral position on the procedure bed, without pre-operative anesthesia. The procedures will be completed within the ambulatory endoscopy clinic at Kelowna General Hospital. The study will use the same colonoscopes that are already being used at KGH for colonoscopy. These are the Olympus 190 series colonoscopes. They can and will be fitted to support both water and air exchange. For patients assigned to the air insufflation intervention arm, extended sigmoidoscopy will be performed with the minimum insufflation required to reach the cecum.

Procedure: Air Insufflation Sigmoidoscopy

Interventions

Water Exchange Sigmoidoscopy PROCEDURE

See arm description.

Water Exchange Sigmoidoscopy

Air Insufflation Sigmoidoscopy PROCEDURE

See arm description.

Air Insufflation Sigmoidoscopy

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Asymptomatic average risk (as per BC colon screening guidelines) individuals
• Ages 50-74 years of age

You may not qualify if:

• A sigmoidoscopy or colonoscopy within 10 years,
• A FIT within 2 years,
• Individuals classified with any high-risk screening criteria in accordance to the
• BC colon screening guidelines including:
• a personal history of adenoma,
• a first degree relative that was diagnosed with colorectal cancer or multiple adenomas under the age of 60,
• two or more first degree relatives with colorectal cancer at any age, longstanding inflammatory bowel diseases,
• a family history of familial adenomatous polyposis or hereditary nonpolyposis colorectal cancer, - Individuals presenting with rectal pain, rectal bleeding, abdominal pain, or unintentional weight loss at the time of the examination.

Sponsors & Collaborators

• Kelowna Gastroenterology Associates: lead
• Veteran Affairs Sepulveda Ambulatory Care Cente: collaborator

Study Sites (2)

Sepulveda Ambulatory Care Center

North Hills, California, 91343, United States

Location

Brent Parker

Kelowna, British Columbia, V1Y 9Z5, Canada

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Rafael Perini, MD

  Kelowna General Hospital, Department of Gastroenterology

  PRINCIPAL INVESTIGATOR

• Adrian Bak, MD

  Kelowna General Hospital, Department of Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The study interviewer and the patient will be blinded to the procedure type both during and following the procedure type both during and following the procedure by concealing the monitors and relevant equipment from their sight. The physician performing the procedure will be blinded to the procedure type until the patient is brought into the procedure room. They will open the allocation envelope once the patient has been placed and positioned on the procedure bed. Neither the patient, the RN, nor the research assistant, who will be conducting the follow-up interviews, will be informed of the study arm. Patient assignment will be managed by the study project manager and will be kept in a password protected file and will remain separate from other study data until the time of the final analysis.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: July 6, 2017
• Study Start: June 14, 2017
• Primary Completion: November 3, 2022
• Study Completion: November 3, 2022
• Last Updated: November 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CA (1)