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

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Postoperative endoscopic recurrence at 6 months [Срок оценки: 6 months]

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Flevoziekenhuis — Almere Stad

Публикации

• 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

Идентификаторы

NCT: NCT05578235 · 2022.0533 · NL81981.018.22

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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