Colon CApsule endoscopy compared to conventional COlonoscopy in patients with colonic DIverticulitis: the study protocol for a randomised controlled superiority trial (CACODI trial)
Introduction Follow-up after an episode of colonic diverticulitis is a common indication for colonoscopy, even though studies have shown a low risk of positive findings in this population. Our objective is to investigate colon capsule endoscopy (CCE) as a follow-up examination in patients with colon...
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| Format: | Article |
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BMJ Publishing Group
2023-10-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/10/e073575.full |
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| author | Anastasios Koulaouzidis Lasse Kaalby Ulrik Deding Thomas Bjørsum-Meyer Gunnar Baatrup Benedicte Schelde-Olesen Maja M I Thygesen Per Vadgaard Andersen |
| author_facet | Anastasios Koulaouzidis Lasse Kaalby Ulrik Deding Thomas Bjørsum-Meyer Gunnar Baatrup Benedicte Schelde-Olesen Maja M I Thygesen Per Vadgaard Andersen |
| author_sort | Anastasios Koulaouzidis |
| collection | DOAJ |
| description | Introduction Follow-up after an episode of colonic diverticulitis is a common indication for colonoscopy, even though studies have shown a low risk of positive findings in this population. Our objective is to investigate colon capsule endoscopy (CCE) as a follow-up examination in patients with colonic diverticulitis compared with colonoscopy, particularly regarding patient satisfaction and clinical performance.Methods and analysis We will conduct a single-centre prospective randomised controlled trial. Patients seen at Odense University Hospital with acute diverticulitis confirmed by CT will be included and randomised to either follow-up by colonoscopy or CCE. Detection of suspected cancer, more than two polyps or any number of polyps larger than 9 mm in CCE will generate an invitation to a diagnostic colonoscopy for biopsies or polyp removal. We will compare colonoscopy and CCE regarding patient satisfaction and tolerance, the number of complete examinations, the number of patients referred to a subsequent colonoscopy after CCE and the prevalence of diverticula, polyps, cancers and other abnormal findings.Ethics and dissemination Informed consent will be obtained from all participants before randomisation. The study was approved by the regional ethics committee (ref. S-20210127) and the Danish Data Protection Agency (ref. 22/43235). After completion of the trial, we plan to publish two articles in high-impact journals. One article on both primary and secondary outcomes.Trial registration number NCT05700981. |
| first_indexed | 2024-03-11T12:11:32Z |
| format | Article |
| id | doaj.art-4476d4d34a8b4ed09445a2cc08e7c457 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2025-03-20T13:42:46Z |
| publishDate | 2023-10-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-4476d4d34a8b4ed09445a2cc08e7c4572024-09-11T23:25:10ZengBMJ Publishing GroupBMJ Open2044-60552023-10-01131010.1136/bmjopen-2023-073575Colon CApsule endoscopy compared to conventional COlonoscopy in patients with colonic DIverticulitis: the study protocol for a randomised controlled superiority trial (CACODI trial)Anastasios Koulaouzidis0Lasse Kaalby1Ulrik Deding2Thomas Bjørsum-Meyer3Gunnar Baatrup4Benedicte Schelde-Olesen5Maja M I Thygesen6Per Vadgaard Andersen7Department of Clinical Research, University of Southern Denmark, Odense, DenmarkDepartment of Surgery, Odense University Hospital, Svendborg, DenmarkDepartment of Surgery, Odense University Hospital, Svendborg, DenmarkDepartment of Clinical Research, University of Southern Denmark, Odense, DenmarkDepartment of Surgery, Odense University Hospital, Svendborg, DenmarkDepartment of Clinical Research, University of Southern Denmark, Odense, DenmarkDepartment of Surgery, Odense University Hospital, Odense, DenmarkDepartment of Clinical Research, University of Southern Denmark, Odense, DenmarkIntroduction Follow-up after an episode of colonic diverticulitis is a common indication for colonoscopy, even though studies have shown a low risk of positive findings in this population. Our objective is to investigate colon capsule endoscopy (CCE) as a follow-up examination in patients with colonic diverticulitis compared with colonoscopy, particularly regarding patient satisfaction and clinical performance.Methods and analysis We will conduct a single-centre prospective randomised controlled trial. Patients seen at Odense University Hospital with acute diverticulitis confirmed by CT will be included and randomised to either follow-up by colonoscopy or CCE. Detection of suspected cancer, more than two polyps or any number of polyps larger than 9 mm in CCE will generate an invitation to a diagnostic colonoscopy for biopsies or polyp removal. We will compare colonoscopy and CCE regarding patient satisfaction and tolerance, the number of complete examinations, the number of patients referred to a subsequent colonoscopy after CCE and the prevalence of diverticula, polyps, cancers and other abnormal findings.Ethics and dissemination Informed consent will be obtained from all participants before randomisation. The study was approved by the regional ethics committee (ref. S-20210127) and the Danish Data Protection Agency (ref. 22/43235). After completion of the trial, we plan to publish two articles in high-impact journals. One article on both primary and secondary outcomes.Trial registration number NCT05700981.https://bmjopen.bmj.com/content/13/10/e073575.full |
| spellingShingle | Anastasios Koulaouzidis Lasse Kaalby Ulrik Deding Thomas Bjørsum-Meyer Gunnar Baatrup Benedicte Schelde-Olesen Maja M I Thygesen Per Vadgaard Andersen Colon CApsule endoscopy compared to conventional COlonoscopy in patients with colonic DIverticulitis: the study protocol for a randomised controlled superiority trial (CACODI trial) BMJ Open |
| title | Colon CApsule endoscopy compared to conventional COlonoscopy in patients with colonic DIverticulitis: the study protocol for a randomised controlled superiority trial (CACODI trial) |
| title_full | Colon CApsule endoscopy compared to conventional COlonoscopy in patients with colonic DIverticulitis: the study protocol for a randomised controlled superiority trial (CACODI trial) |
| title_fullStr | Colon CApsule endoscopy compared to conventional COlonoscopy in patients with colonic DIverticulitis: the study protocol for a randomised controlled superiority trial (CACODI trial) |
| title_full_unstemmed | Colon CApsule endoscopy compared to conventional COlonoscopy in patients with colonic DIverticulitis: the study protocol for a randomised controlled superiority trial (CACODI trial) |
| title_short | Colon CApsule endoscopy compared to conventional COlonoscopy in patients with colonic DIverticulitis: the study protocol for a randomised controlled superiority trial (CACODI trial) |
| title_sort | colon capsule endoscopy compared to conventional colonoscopy in patients with colonic diverticulitis the study protocol for a randomised controlled superiority trial cacodi trial |
| url | https://bmjopen.bmj.com/content/13/10/e073575.full |
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