Prophylactic Endoscopic Clipping of Diverticula (PECoD)
Condition: Diverticular Disease
MeSH terms: Diverticular Diseases; Diverticulum
Study type: Interventional

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.
    

Intervention name(s): Endoscopic clipping; Placebo - colonoscopy without clipping
Intervention type(s): Procedure; Other
Intervention description(s): Endoscopic clips fired to close mucosa over diverticular defects.; Colonoscopy performed, no clipping of diverticula
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment