Factors Associated With Pain During Unsedated Colonoscopy

NCT03420612 | Completed DMC

• 1 other identifier: KY20163066-1
• Study Type: observational
• Target: 607
• Locations: 1 country
• Sites: 1

Brief Summary

Colonoscopy is the gold standard in the diagnosis and treatment colorectal disease, but due to the uncomfortable or even painful procedure, a part of people unwilling to undergoing the examination and giving analgesic agents were recommended in several guidelines. However, use of analgesic agents have their own drawbacks, and nearly 70% patients felt no pain or only mild discomfort with the unsedated colonoscopy, routine administration of sedative or analgesic agents to all patients was considered as unnecessary. However, unsedated colonoscopy was thought to be an option for some but not for all, therefore a method to identify which patients at high risk for painful colonoscopy in preoperational stage is necessary.

Conditions

Colonoscopy; Unsedated; Pain

Outcome Measures

Primary Outcomes (1)

• risk factor associated with painful colonoscopy rate

  Abdominal pain during the examination was evaluated by a previously validated 4-point verbal rating scale (no, slight, moderate, severe pain)\[14\], and moderate or severe pain during the procedure was defined as a "painful colonoscopy"

  2 hours

Study Arms (2)

training

The training cohort was used to determine the influencing factors of the pain during the colonoscopy and establish the intubation discomfort score (IDS)

validation

The validation cohort was used to verify the IDS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients of the training cohort were enrolled form Xijing Hospital of Digestive Diseases. The patients of the validation cohort were enrolled from the Shaanxi Second People's Hospital.

You may qualify if:

• aged 18-80 years
• underwent unsedated colonoscopy

You may not qualify if:

• no bowel preparation or colon cleansing by enema only
• no need to reach cecum
• prior finding of severe colon stenosis or obstructing tumor
• history of colectomy
• unstable hemodynamics
• pregnant
• unable to give informed consent.

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, 710032, China

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 5, 2018
• Study Start: February 2, 2017
• Primary Completion: May 12, 2017
• Study Completion: June 30, 2017
• Last Updated: February 5, 2018

Record last verified: 2018-01

Locations

CN (1)