Colonoscopy Techniques Clinical Trial
| NCT number | NCT01816126 |
| Other study ID # | 01-2013 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | March 12, 2013 |
| Last updated | March 18, 2013 |
| Start date | February 2013 |
| Verified date | March 2013 |
| Source | Valduce Hospital |
| Contact | silvia paggi, MD |
| Phone | 0039031324145 |
| Is FDA regulated | No |
| Health authority | Italy: Ethics Committee |
| Study type | Observational |
Colonoscopy can be performed by a one-operator technique with endoscopist personally advancing and withdrawing the scope or by a two-operators technique, with the GI-assistant doing the physical insertion and withdrawal of the scope directed by the endoscopist. Uncontrolled data report that 1 operator technique is associated with a higher adenoma detection rate, although it is also characterized by a lowwer cecal intubation rate and longer intubation time. The aim of present randomized controlled study was to assess whether one technique is better than the other one in terms of colonoscopy quality performances.
| Status | Recruiting |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | May 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - adult outpatients colonoscopy for screening or surveillance indications Exclusion Criteria: - previous colonic surgery - poor bowel prep - inability to provide consent |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Italy | Valduce Hospital | Como |
| Lead Sponsor | Collaborator |
|---|---|
| Valduce Hospital |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | tolerability | pain assessed by nurse (by means a 4 classes 0 to 4 categorical scale) pain judged by patients (by means a 4 classes 0 to 4 categorical scale ) |
4 months | No |
| Primary | adenoma detection rate | 4 months | No | |
| Secondary | cecal intubation time | 4 months | No |