St Mark's double balloon colonoscopy versus conventional colonoscopy study

ISRCTN	ISRCTN77510548
DOI	https://doi.org/10.1186/ISRCTN77510548
Secondary identifying numbers	DBC Protocol v1.1

Submission date: 26/10/2010
Registration date: 16/02/2011
Last edited: 11/05/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Chris Fraser
Scientific

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

Study information

Study design	Prospective randomised parallel group controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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(s)	Outer West London Research Ethics Committee (REC), March 2010, ref: 10/H0709/12
Health condition(s) or problem(s) studied	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
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 study start date	01/05/2010
Completion date	01/05/2011

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Female
Target number of participants	44
Key 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
Key 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
Date of first enrolment	01/05/2010
Date of final enrolment	01/05/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Wolfson Unit for Endoscopy

London
HA1 3UJ
United Kingdom

Sponsor information

North West London Hospitals NHS Trust (UK)
Hospital/treatment centre

Research and Development Department
Northwick Park Hospital
Watford Road
Harrow
London
HA1 3UJ
England
United Kingdom

Phone	+44 20 8869 5173
Email	research@nwlh.nhs.uk
Website	http://www.nwlh.nhs.uk/research/gp.cfm?id=15
"ROR"	https://ror.org/04cntmc13

Funders

Funder type

Other

Imotech/Fujinon (UK) - provided DBC equipment on a long-term loan at no additional cost

No information available

Investigator initiated and funded (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

11/05/2017: No publications found in PubMed, verifying study status with principal investigator