The Clinical Acceptability of Unsedated Colonoscopy

Valduce Hospital

Status: Completed

Conditions: Colonoscopy

Treatments: Procedure: Unsedated colonoscopy

Study type: Observational

Funder types: Other

Identifiers

NCT01434927

07CE2009

Details and patient eligibility

About

The study was aimed to prospectively evaluate the acceptance rate of unsedated colonoscopy, in a setting where routine sedation for colonoscopy is standard practice and to characterize the subset of patients willing to try and potentially completing an unsedated procedure.

Full description

Patients were offered to undergo colonoscopy without routine premedication. In case of both acceptance and refusal, a brief questionnaire recording demographics (gender, age, level of education) and clinical features was prospectively recorded in a standard data sheet by one of the four endoscopists at enrollment. Clinical features recorded for each patient included: indication to the procedure, history of abdominal surgery or irritable bowel syndrome, presence of pain as main symptom, chronic use of sedative medications, level of patient's anxiety (none, mild, moderate or severe), main concern about the examination and reason for willing to attempt unsedated procedure.

Enrollment: 964 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult outpatients

Exclusion criteria

1. previous colorectal surgery
2. indication to a bi-directional endoscopy
3. indication to a partial examination
4. patients' refusal or inability to provide informed consent and
5. advanced heart, lung, liver or renal disease (American Society of Anesthesiology risk class III-IV)

Trial design

964 participants in 1 patient group

Colonoscopy outpatients

Description:

All patients referred to our Unit to undergo colonoscopy for any indication

Treatment:

Procedure: Unsedated colonoscopy

Procedure: Unsedated colonoscopy