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NCT Number: NCT05578235

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

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Flevoziekenhuis

Almere Stad, Flevoland, 1315 RA, Netherlands

Location status: Recruiting

Location contact

Jarmila van der Bilt, dr.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stapled side-to-side anastomosis

Procedure

Standard procedure for CD

Handsewn anastomosis

Procedure

handsewn end-to-end or Kono-s anastomosis

Primary outcomes

  1. Postoperative endoscopic recurrence at 6 months

    Time frame: 6 months

    The postoperative endoscopic recurrence at 6 months following ileocolic resection defined as Rutgeerts > i2b by central reading

Secondary outcomes

  1. Post-operative 30 days complications

    Time frame: 30 days after surgery

  2. Histologic and clinical recurrence rate at 6 months following ileocolic resection

    Time frame: 6 months after surgery

  3. 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

    • Endoscopic recurrence defined as Rutgeerts > i2b
    • Clinical recurrence difned as recurrent CD-related symptoms
  4. The 5 year reoperation rate for recurrence of disease at the anastomotic site.

    Time frame: 5 year

  5. Inflammatory Bowel Disease Questionnaire (IBDQ)

    Time frame: 1 year after surgery

    Quality of life measured with IBD questionnaire

  6. Hospital costs

    Time frame: 1 year after surgery

    Hospital costs per patients in each group

Study contacts

Contact information is provided by the study sponsor or research team.

Anouck EG Haanappel, MD

CONTACT

[email protected]

0031650828323

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study 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)

Acronym: END2END

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 13, 2022
Registry last updated
Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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