Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03935100 |
| Other study ID # |
253898 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2019 |
| Est. completion date |
March 16, 2023 |
Study information
| Verified date |
March 2023 |
| Source |
King's College Hospital NHS Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study will evaluate the effect of endoscopic clipping of colonic diverticula in
treatment of symptoms related to diverticular disease. Half of the participants will undergo
colonoscopy without the clipping procedure and half will have colonoscopy with clipping of
all visible diverticula.
Description:
Colonic diverticular disease (DD) is characterised by the presence of sac-like protrusions
(diverticula), which form through defects in the muscle layer of the colon wall. It is
prevalent in western countries, affecting approximately 70% of individuals by the age of 80.
The risk of acquiring diverticular disease increases uniformly with age, with approximately
40% of people aged over 60 years affected in western countries. Diverticular complications
may be severe and include pain, inflammation, infection and bleeding. Although the majority
of people with diverticular disease are asymptomatic, approximately 25% will experience an
episode of acute diverticulitis (the principal inflammatory complication of diverticulosis);
of these, 15% will develop other significant and often serious complications such as abscess,
fistula or perforation.
King's College Hospital operates a tertiary referral service for patients with diverticular
disease that integrates a gastroenterological and colorectal surgical approach to treatment.
The investigators increasingly find that many patients have characteristic DD pain and IBS
like symptoms with or without a clearly defined episode of diverticulitis. The link between
symptomatic diverticular disease and Irritable Bowel Symptoms is reflected to some extent in
the literature, however, it remains a matter of significant controversy. Nevertheless, these
symptoms are often difficult to control and can be debilitating. Current treatment options
for the IBS like symptoms in symptomatic uncomplicated DD are limited. In this age group, a
low FODMAP diet, the mainstay treatment for IBS, is impractical and there are few if any
controlled studies that address these issues. There is hence a need for alternative
therapeutic options. Secondly, complications related to DD are associated with significant
morbidity and mortality and comes at significant cost to the health service. At present there
is no proven prophylactic intervention to prevent the complications.
The investigators have recently published the results of a feasibility study carried out at
King's College Hospital, which assessed the effectiveness of elective endoscopic clipping of
diverticula in patients with a history of significant diverticular bleeding. Here, all
visible diverticula were closed endoscopically using 'Instinct' endoclips. A diverticula
closure rate of 87.2% (129/148) was demonstrated at follow up colonoscopy. In this group,
there were no post-procedural complications and no diverticula-associated symptoms reported
up to the follow-up colonoscopy. Notably, incidental complete resolution of chronic left
sided abdominal pain was noted in one of our subjects.
The investigators now propose the use of elective diverticular clipping in patients with
symptomatic diverticulosis with a view to alter the natural history of the disease i.e. to
prevent complications of the disease. At the same time the investigators wish to assess their
symptomatic response. Patients with symptomatic diverticular disease will be eligible. The
trial will be carried out at King's College Hospital endoscopy suite, a tertiary referral
centre for endoscopic procedures. The study will include 84 patients. Each patient will be in
the study for a period of 12 months.
