Prophylactic Endoscopic Clipping of Diverticula (PECoD) (PECoD)
Primary Purpose
Diverticular Disease
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Endoscopic clipping
Placebo - colonoscopy without clipping
Sponsored by
About this trial
This is an interventional treatment trial for Diverticular Disease
Eligibility Criteria
Inclusion Criteria:
- Confirmed symptomatic diverticular disease (5 or more diverticula)
- Age range 18-90 years
- Retains capacity and medically fit for colonoscopy
Exclusion Criteria:
- Does not meet inclusion criteria
- Unable to give informed consent
- Patients with severe co-morbidities and substance misuse
Sites / Locations
- King's College Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment Group
Control Group
Arm Description
All visible diverticula clipped during index colonoscopy
5 clips fired at random into colon lumen. No diverticula closed.
Outcomes
Primary Outcome Measures
Rate of diverticula closure
Number of diverticula pre and post clipping
Secondary Outcome Measures
Changes in abdominal symptoms
Changes in abdominal symptoms as assessed by the Irritable Bowel Syndrome Symptom Severity Score before and at 3, 6 and 12 months
Full Information
NCT ID
NCT03935100
First Posted
April 30, 2019
Last Updated
March 17, 2023
Sponsor
King's College Hospital NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT03935100
Brief Title
Prophylactic Endoscopic Clipping of Diverticula (PECoD)
Acronym
PECoD
Official Title
A Prospective Randomised Placebo Controlled Trial on Prophylactic Endoscopic Clipping of Colonic Diverticula (PECoD)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
March 16, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College Hospital NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diverticular Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Blinded to clipping, undergo same procedure
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
All visible diverticula clipped during index colonoscopy
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
5 clips fired at random into colon lumen. No diverticula closed.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic clipping
Intervention Description
Endoscopic clips fired to close mucosa over diverticular defects.
Intervention Type
Other
Intervention Name(s)
Placebo - colonoscopy without clipping
Intervention Description
Colonoscopy performed, no clipping of diverticula
Primary Outcome Measure Information:
Title
Rate of diverticula closure
Description
Number of diverticula pre and post clipping
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Changes in abdominal symptoms
Description
Changes in abdominal symptoms as assessed by the Irritable Bowel Syndrome Symptom Severity Score before and at 3, 6 and 12 months
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed symptomatic diverticular disease (5 or more diverticula)
Age range 18-90 years
Retains capacity and medically fit for colonoscopy
Exclusion Criteria:
Does not meet inclusion criteria
Unable to give informed consent
Patients with severe co-morbidities and substance misuse
Facility Information:
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prophylactic Endoscopic Clipping of Diverticula (PECoD)
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