Crohn DiseaseEND2ENDNCT05578235
Comparing Hand-sewn (END-TO-END or Kono-S) to Stapled Anastomosis in Ileocolic Resection for Crohn's Disease
A study testing stapled side-to-side anastomosis and Handsewn anastomosis in people with Crohn Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- stapled side-to-side anastomosis and Handsewn anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Jul 2023to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Flevoziekenhuis
Almere Stad, Flevoland, 1315 RA
Jarmila van der Bilt, dr.
About this study
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)
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.
Read the 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.
- Conditions
- Crohn Disease
- Being tested
- stapled side-to-side anastomosis, Handsewn anastomosis
- Keywords
- Crohn's disease, Ileocolic, Endoscopic Recurrence, Ileocolic Anastomosis
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stapled side-to-side anastomosisProcedure or surgery
Standard procedure for CD
Handsewn anastomosisProcedure or surgery
handsewn end-to-end or Kono-s anastomosis
| Study group | Role | What they receive |
|---|---|---|
| stapled side-to-side anastomosis | Active comparator | Standard procedure for CD, ileocolic resection with side-to-side anastomosis is done according to local practice with a linear stapler either aniso- or isoperistaltic as advised by the ECCO guidelines Receives: Procedure: stapled side-to-side anastomosis |
| Handsewn anastomosis: handsewn end-to-end or Kono-s anastomosis | Active comparator | * Kono-S (anti-mesenteric functionel end-to-end handsewn) anastomosis is done according to the description by Kono
* End-to-end handsewen anastomosis is fashioned either by enlarging the small bowel diameter by an antimesenteric incision to fit the large bowel lumen or by tailored resection of a part of the staple line of the cross stapled colon Receives: Procedure: Handsewn anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative endoscopic recurrence at 6 months
The postoperative endoscopic recurrence at 6 months following ileocolic resection defined as Rutgeerts > i2b by central reading
Measured: 6 months
Secondary outcomes (6)
Post-operative 30 days complications
Measured: 30 days after surgery
Histologic and clinical recurrence rate at 6 months following ileocolic resection
Measured: 6 months after surgery
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
Measured: 1 year after surgery
The 5 year reoperation rate for recurrence of disease at the anastomotic site.
Measured: 5 year
Inflammatory Bowel Disease Questionnaire (IBDQ)
Quality of life measured with IBD questionnaire
Measured: 1 year after surgery
Hospital costs
Hospital costs per patients in each group
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start13 Jul 2023
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial. Patients with Crohn's disease will be randomised in a 1:2 ratio for stapled side-to-side anastomose versus handsewn anastomosis (either end-to-end or Kono-S) when performing an ileocolic resection for Crohn's disease.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Willem A. Bemelman, Amsterdam UMC, location AMC
- Investigators
- W.A. Bemelman, Prof. dr., Principal investigator, Amsterdam UMC, location AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578235
- Sponsor's protocol ID
- 2022.0533
- Other IDs
- NL81981.018.22
- Acronym
- END2END
- Status last verified
- Nov 2023
- First submitted
- 1 Oct 2022
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 controlled trials comparing handsewn (END-to-end or Kono-S) to stapled anastomosis (HAND2END and the End2End STUDIES). BMC Surg. 2024 Feb 26;24(1):71. doi: 10.1186/s12893-024-02340-3.
PubMed 38408943
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05578235
- Acronym / sponsor ID
- END2END / 2022.0533
- Conditions
- Crohn Disease
- Keywords
- Crohn's disease, Ileocolic, Endoscopic Recurrence, Ileocolic Anastomosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled trial. Patients with Crohn's disease will be randomised in a 1:2 ratio for stapled side-to-side anastomose versus handsewn anastomosis (either end-to-end or Kono-S) when performing an ileocolic resection for Crohn's disease.
| Arm | Type | Receives |
|---|---|---|
| stapled side-to-side anastomosis | Active comparator | Procedure: stapled side-to-side anastomosisStandard procedure for CD, ileocolic resection with side-to-side anastomosis is done according to local practice with a linear stapler either aniso- or isoperistaltic as advised by the ECCO guidelines |
| Handsewn anastomosis: handsewn end-to-end or Kono-s anastomosis | Active comparator | Procedure: Handsewn anastomosis* Kono-S (anti-mesenteric functionel end-to-end handsewn) anastomosis is done according to the description by Kono * End-to-end handsewen anastomosis is fashioned either by enlarging the small bowel diameter by an antimesenteric incision to fit the large bowel lumen or by tailored resection of a part of the staple line of the cross stapled colon |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stapled side-to-side anastomosisStandard procedure for CD | Procedure or surgery | stapled side-to-side anastomosis |
| Handsewn anastomosishandsewn end-to-end or Kono-s anastomosis | Procedure or surgery | Handsewn anastomosis: handsewn end-to-end or Kono-s anastomosis |
Primary outcome
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
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Derived from this study: PubMed 38408943Haanappel 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 controlled trials comparing handsewn (END-to-end or Kono-S) to stapled anastomosis (HAND2END and the End2End STUDIES). BMC Surg. 2024 Feb 26;24(1):71. doi: 10.1186/s12893-024-02340-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
W.A. Bemelman, Prof. dr. principal investigator
Amsterdam UMC, location AMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stapled side-to-side anastomosis and Handsewn anastomosis in people with Crohn Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anouck EG Haanappel, MD (0031650828323, a.e.g.haanappel@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative endoscopic recurrence at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05578235, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.