Condition category
Surgery
Date applied
26/10/2010
Date assigned
16/02/2011
Last edited
01/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Chris Fraser

ORCID ID

Contact details

Wolfson Unit for Endoscopy
St Mark's Hospital
Harrow
London
HA1 3UJ
United Kingdom

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 measures

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

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 (0)20 8869 5173
research@nwlh.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.nwlh.nhs.uk/research/gp.cfm?id=15

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes