St Mark's double balloon colonoscopy versus conventional colonoscopy study

Not Applicable

Completed

• Conditions: Surgery; Colonoscopy

• Registration Number: ISRCTN77510548
• Lead Sponsor: orth West London Hospitals NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-16
• Last Update Posted: 5 June 2017

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 44

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>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<br><br>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

Name	Time	Method
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.<br><br>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.