Prophylactic Endoscopic Clipping of Colonic Diverticula (PECoD) V8
Research type
Research Study
Full title
A Prospective Randomised Placebo Controlled Trial on Prophylactic Endoscopic Clipping of Colonic Diverticula (PECoD)
IRAS ID
253898
Contact name
Ann-Marie Murtagh
Contact email
Sponsor organisation
King's College Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 29 days
Research summary
Colonic diverticular disease (DD) is the presence sac-like pouches (diverticula), which form through weaknesses in the muscle layer of the bowel wall. It is increasingly common, affecting approximately 70% of people in the western world by 80 years old. Complications may be severe and include pain, inflammation, infection and bleeding which come at significant cost to the health service. King’s College Hospital (KCH) runs a clinic caring for DD patients. We increasingly find that many patients have DD with irritable bowel syndrome-like symptoms such as bloating, pain and changes in bowel habit. These symptoms are often difficult to control and can be debilitating. Presently, treatment options are limited.
We have recently completed a pilot study assessing the use of endoscopic (using a camera) ‘clipping’ to close diverticula pouches associated with bleeding. This was a safe and effective treatment. Additionally, 87% of diverticula pouches healed, and one patient reported completely resolved chronic pain. We propose the use of this technique in patients with DD to see whether clipping is effective in treating symptoms and preventing complications.
The study will take place at KCH. Patients with symptomatic DD will be eligible. Patients will undergo CT scan to assess DD severity. They will be randomly divided into two groups, ‘treatment’ or ‘control’. Patients will complete symptom questionnaires and have blood and stool tests. Patients will undergo a colonoscopy (camera test). In the control group, 5 clips will be placed into the bowel lumen. In the treatment group, all visible pouches will be cleaned and clipped closed. Follow-up colonoscopy will occur at 3 months to see how many pouches have closed. Symptoms will be re-assessed with questionnaires. Further follow-up will be at 6 months and finally at 12 months with a clinic visit, symptom questionnaire and repeat blood and stool samples.
REC name
London - Surrey Research Ethics Committee
REC reference
19/LO/1141
Date of REC Opinion
23 Jul 2019
REC opinion
Further Information Favourable Opinion