Comparing Hand-sewn (END-TO-END or Kono-S) to Stapled Anastomosis in Ileocolic Resection for Crohn's Disease

Crohn Disease Clinical Trial

— END2END  

Official title:

Optimising Surgical Anastomosis in Ileocolic Resection for Crohn's Disease to Reduce Recurrent Disease: A Randomised Controlled Trial Comparing Hand-sewn (END-TO-END or Kono-S) to Stapled Anastomosis (END-to-END Study)

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
• 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
• 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.

Related Conditions & MeSH terms

• Crohn Disease

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