Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
DBC Protocol v1.1
Study information
Scientific title
St Mark's double balloon colonoscopy versus conventional colonoscopy: a prospective randomised controlled study designed to assess colonoscopy completion rates, patient comfort at colonoscopy and time taken to complete colonoscopy
Acronym
Study hypothesis
1. Double balloon colonoscopy (DBC) should enable faster completion of colonoscopy procedures in patients known to have or predicted to have colons that are technically challenging to colonoscopy
2. DBC should enable more comfortable colonoscopies in patients known to have or predicted to have colons that are technically challenging to colonoscopy
3. DBC should enable a higher caecal intubation rate in patients known to have or predicted to have colons that are technically challenging to colonoscopy
Ethics approval
Outer West London Research Ethics Committee (REC), March 2010, ref: 10/H0709/12
Study design
Prospective randomised parallel group controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Colonoscopy
Intervention
Patients are randomised to conventional colonoscopy (CC) or double balloon colonoscopy (DBC). The interventions will only involve a single 'routine' colonoscopy and there shall be no trial related follow-up of any length.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
1. To determine whether DBC when compared to CC will enable faster caecal intubation in patients known to have or predicted to have colons that are technically challenging to colonoscopy
2. To determine whether DBC when compared to CC will enable a more comfortable colonoscopy experience requiring less sedation in patients known to have or predicted to have colons that are technically challenging to colonoscopy
These outcomes will be measured during and immediately after the procedure. There will be no need for follow-up for the purposes of the trial.
Secondary outcome measures
To determine whether DBC when compared to CC will enable a higher caecal intubation rate in patients known to have or predicted to have colons that are technically challenging to colonoscopy.
These outcomes will be measured during and immediately after the procedure. There will be no need for follow-up for the purposes of the trial.
Overall trial start date
01/05/2010
Overall trial end date
01/05/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients referred St Mark's endoscopy unit for a colonoscopy who are known to have a colon that is technically challenging to colonoscopy, i.e. failed colonoscopy due to technical difficulties in the past or have had a 'difficult' colonoscopy in the past (as described in a previous colonoscopy report), or who fit one or more of the criteria that predict a technically challenging colonoscopy i.e.:
1. A low body mass index
2. A low waist-to-hip ratio
3. Female gender
4. Over 60 years of age
5. A past surgical history of hysterectomy
6. A longstanding history of constipation and/or haemorrhoids
7. A history of known sigmoid colon disease (e.g. known diverticular disease)
8. The presence of a known long, redundant colon as identified by diagnostic imaging
Participant type
Patient
Age group
Senior
Gender
Female
Target number of participants
44
Participant exclusion criteria
1. Patients with contraindications to conscious sedation
2. Patients with contraindications to colonoscopy
3. Patients with latex allergy (as the balloons on the DBC endoscope are made of latex)
4. Patients who are unwilling to have a colonoscopy or are unwilling to take part in the study
5. Patients lacking capacity to give informed consent
Recruitment start date
01/05/2010
Recruitment end date
01/05/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Wolfson Unit for Endoscopy
London
HA1 3UJ
United Kingdom
Sponsor information
Organisation
North West London Hospitals NHS Trust (UK)
Sponsor details
Research and Development Department
Northwick Park Hospital
Watford Road
Harrow
London
HA1 3UJ
United Kingdom
+44 20 8869 5173
research@nwlh.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Imotech/Fujinon (UK) - provided DBC equipment on a long-term loan at no additional cost
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Investigator initiated and funded (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list