Colon Capsule Endoscopy in Patients With Colonic Diverticulitis

NCT ID: NCT05700981

Last Updated: 2023-09-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2024-06-30

Brief Summary

Introduction: Follow-up after colonic diverticulitis is a common indication for colonoscopy, even though studies have shown a low risk of positive findings in this population. The objective is to investigate colon capsule endoscopy (CCE) as a follow-up examination in patients with colonic diverticulitis compared to colonoscopy, on patient satisfaction and clinical performance.

Methods and Analysis: The investigators will conduct a single centre prospective randomized controlled trial. Patients seen at Odense University Hospital with acute diverticulitis confirmed by CT will be included and randomized to either follow-up by colonoscopy or CCE. Detection of suspected cancer, more than two polyps or any number of polyps larger than 9mm in CCE will generate an invitation to a diagnostic colonoscopy for biopsies or polyp removal. The investigators 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.

Detailed Description

Colon diverticulosis (CD) is extremely common and the prevalence seems to increase globally. The prevalence of CD increases with age and two-thirds of the adult population eventually develop CD. In the US the prevalence of CD was 32.6 % in patients aged 50-59 years and 71.4% in patients > 80 years of age. CD is often detected incidentally during optical colonoscopy (OC) or by computer tomography (CT). In approximately 25 % of patients with CD symptomatic colon diverticular disease develop typically comprising bloating, abdominal pain and change in bowel habits. Progression to diverticulitis is estimated to appear in approximately 1%. Most patients present with uncomplicated diverticulitis and are managed by general practitioners (GP) with the use of painkillers and oral antibiotics. Complicated diverticulitis due to perforation can be classified according to Hinchey et al. as a guidance to surgeon as to how conservative they can be. Hinchey level 1-2 can be managed conservatively. In the case of Hinchey level 3 and 4 it requires a laparoscopy with peritoneal lavage or laparotomy with colon resection and stoma formation, respectively. In patients presenting at the GP with intractable pain or signs of sepsis admission to hospital services is mandatory. Upon hospitalization, CT is the preferred diagnostic imaging modality in patients presenting with abdominal pain and suspected diverticulitis. If colonic diverticulitis is described as the symptoms-eliciting pathology without complications comprising abscess or bowel perforation patients are typically discharged from hospital with painkillers and offered an OC within 4-6 weeks, when the inflammation has resolved, to confirm the diverticulitis diagnosis. Routine OC after an episode of diverticulitis is recommended by the majority of international guidelines including Danish guidelines on handling of patients with diverticulitis. Due to a very low risk of malignancy in patients with diverticulitis the relevance of routine OC has been questioned in a recent review. The research in Colon Capsule Endoscopy (CCE) has evolved substantially since the introduction in 2006. More studies have reported a diagnostic yield equal to OC also in regard to larger polyps > 9 mm. In contrast to OC, CCE does not offer the possibility of biopsy or removal polyp. Hence, the ideal population for CCE needs to have low risk of findings with the need of endoscopic intervention. CCE is without pain and the risk of complications is extremely low compared to colonoscopy for which the estimated risk of major bleeding or perforation is 12 per 10,000 patients.

The investigators aimed to evaluate the effect of introducing CCE on patient satisfaction and discomfort compared to colonoscopy as a follow-up examination in patients with diverticulitis and the impact of introducing CCE on the need for subsequent colonoscopy.

Conditions

Diverticulitis, Colonic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Colon capsule endoscopy

Patients randomized to colon capsule endoscopy

Group Type: EXPERIMENTAL

colon capsule endoscopy

Intervention Type: DIAGNOSTIC_TEST

Patient allocated for the intervention arm will have a CCE using the PillCam Colon 2 (Medtronic, Minneapolis, Minnesota, USA). Upon inclusion and allocation to the intervention arm patients are contacted by a dedicated CCE nurse. The course of the CCE procedure and preparations are explained thoroughly. In case of additional questions patients can contact the nurses by telephone during office hours (Monday-Friday, 8am-3pm). Before the CCE participants will have to undergo a bowel preparation procedure. The bowel preparation kit will be distributed by mail and is to be completed at home, beginning 72 hours before the CCE. The kit contains polyethylene glycol (PEG) sachets (Movicol, Norgine Danmark A/S, Herlev, Denmark), PEG solutions (MoviPrep, Norgine Danmark A/S, Herlev Denmark) and instructions on how to properly perform the preparation procedures.

Colonoscopy

Patients randomized to colonoscopy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

colon capsule endoscopy

Patient allocated for the intervention arm will have a CCE using the PillCam Colon 2 (Medtronic, Minneapolis, Minnesota, USA). Upon inclusion and allocation to the intervention arm patients are contacted by a dedicated CCE nurse. The course of the CCE procedure and preparations are explained thoroughly. In case of additional questions patients can contact the nurses by telephone during office hours (Monday-Friday, 8am-3pm). Before the CCE participants will have to undergo a bowel preparation procedure. The bowel preparation kit will be distributed by mail and is to be completed at home, beginning 72 hours before the CCE. The kit contains polyethylene glycol (PEG) sachets (Movicol, Norgine Danmark A/S, Herlev, Denmark), PEG solutions (MoviPrep, Norgine Danmark A/S, Herlev Denmark) and instructions on how to properly perform the preparation procedures.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients above the age of 18 with in-hospital CT-diagnosed diverticulitis

Exclusion Criteria

1. Recent imaging of the colonic mucosa and therefore no indication for renewed endoscopy, evaluated by the attending physician.

2. Colonic CT findings that require biopsy (suspected cancer) or polyp removal.

3. CT-verified stenosis in the gastrointestinal (GI) tract.

4. Cardiac pacemaker

5. Renal insufficiency

6. Pregnancy/breastfeeding

7. Allergies towards active substances administered in the trial

8. Unable to provide oral and written informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Bjørsum-Meyer, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

Odense University Hospital

Odense, Funen, Denmark

Countries

Denmark

References

Schelde-Olesen B, Kaalby L, Deding U, Thygesen MMI, Andersen PV, Koulaouzidis A, Baatrup G, Bjorsum-Meyer T. 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. 2023 Oct 6;13(10):e073575. doi: 10.1136/bmjopen-2023-073575.

Reference Type: DERIVED

PMID: 37802611 (View on PubMed)

Other Identifiers

CACODI trial

Identifier Type: -

Identifier Source: org_study_id