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Recruiting NCT05578235

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

No phase Interventional Crohn Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: stapled side-to-side anastomosis, Handsewn anastomosis.
Who it may be relevant to
Registry conditions: Crohn Disease. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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)

Overview

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.

Detailed 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.

Interventions

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

Primary outcome measures

  • Postoperative endoscopic recurrence at 6 months [Time frame: 6 months]
Secondary outcome measures (6)
  • Post-operative 30 days complications [Time frame: 30 days after surgery]
  • Histologic and clinical recurrence rate at 6 months following ileocolic resection [Time frame: 6 months after surgery]
  • Number of patients in need for restarting immunosuppressive medication within the first year postoperatively for endoscopic or clinical recurrence [Time frame: 1 year after surgery]
  • The 5 year reoperation rate for recurrence of disease at the anastomotic site. [Time frame: 5 year]
  • Inflammatory Bowel Disease Questionnaire (IBDQ) [Time frame: 1 year after surgery]
  • Hospital costs [Time frame: 1 year after surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • Flevoziekenhuis — Almere Stad

Publications

  • Haanappel AEG, Bellato V, Buskens CJ, Armuzzi A, van der Bilt JDW, de Boer NKH, Danese S, van der Does de Willebois EML, Duijvestein M, van der Horst D, Pellino G, Richir MC, Selvaggi F, Spinelli A, Vignali A, Rosati R, Bemelman WA. Optimising surgical anastomosis in ileocolic resection for Crohn's disease with respect to recurrence and functionality: two international parallel randomized controll PMID 38408943

Identifiers

NCT: NCT05578235 · 2022.0533 · NL81981.018.22

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗