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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05578235
Other study ID # 2022.0533
Secondary ID NL81981.018.22
Status Recruiting
Phase N/A
First received
Last updated
Start date July 13, 2023
Est. completion date October 1, 2027

Study information

Verified date November 2023
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact Anouck EG Haanappel, MD
Phone 0031650828323
Email a.e.g.haanappel@amsterdamumc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this multicenter randomised controlled trial is to compare the handsewn (end-to-end and Kono-S) to the stapled side-to-side ileocolic anastomosis after ileocolic resection for Crohn's disease with respect to 6 months endoscopic recurrence, functional outcome and health care consumption.


Description:

Within the surgical IBD society there has been a lot of attention to technical aspects of ileocolic resection aiming to reduce recurrent Crohn's disease after surgery. Despite optimal surgical and medical management, recurrent disease after surgery is common. Different types of anastomoses with respect to configuration and construction can be made after resection e.g., handsewn (end-to-end and Kono-S) and stapled (side-to-side). The various types of anastomoses might affect endoscopic recurrence and its assessment, the functional outcome, and costs. It is hypothesised that patients who had an end to end reconstruction will have less endoscopic recurrence (less overscoring, and less stases), a better function and consequently health care consumption than the stapled side to side anastomosis.


Recruitment information / eligibility

Status Recruiting
Enrollment 165
Est. completion date October 1, 2027
Est. primary completion date October 1, 2027
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - Males and females aged >16 years - Ileocolic disease or disease of the neoterminal ileum with an indication for resection - Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, and anti-TNF therapy are permitted. - All patients should have undergone a colonoscopy and a recent update of imaging (e.g. Ultrasound, MR enterography (or CT enterography if MR is contraindicated))- Ability to comply with protocol. - Competent and able to provide written informed consent. - Patient must have been discussed in the local MDT Exclusion Criteria: - Inability to give informed consent. - Patients less than 16 years of age. - Clinically significant medical conditions within the six months before the operation : e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient. - History of cancer < 5 years which might influence patients prognosis - Emergent operation. - Pregnant or breast feeding. - Inability to follow up at 3, 6 and 12 months for postoperative assessment, imaging and endoscopy.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
stapled side-to-side anastomosis
Standard procedure for CD
Handsewn anastomosis
handsewn end-to-end or Kono-s anastomosis

Locations

Country Name City State
Netherlands Flevoziekenhuis Almere Flevoland

Sponsors (2)

Lead Sponsor Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative endoscopic recurrence at 6 months The postoperative endoscopic recurrence at 6 months following ileocolic resection defined as Rutgeerts > i2b by central reading 6 months
Secondary Post-operative 30 days complications 30 days after surgery
Secondary Histologic and clinical recurrence rate at 6 months following ileocolic resection 6 months after surgery
Secondary Number of patients in need for restarting immunosuppressive medication within the first year postoperatively for endoscopic or clinical recurrence Endoscopic recurrence defined as Rutgeerts > i2b
Clinical recurrence difned as recurrent CD-related symptoms
1 year after surgery
Secondary The 5 year reoperation rate for recurrence of disease at the anastomotic site. 5 year
Secondary Inflammatory Bowel Disease Questionnaire (IBDQ) Quality of life measured with IBD questionnaire 1 year after surgery
Secondary Hospital costs Hospital costs per patients in each group 1 year after surgery
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