Crohn DiseaseHAND2ENDNCT05246917
Comparing Manual Versus Stapled Side to Side Ileocolic Anastomosis in Crohn's Disease
A study testing Handsewn anastomosis in people with Crohn Disease and IBD, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
RESEARCH QUESTION Are handsewn (end to end and Kono S side to side) anastomoses superior to side to side stapled anastomosis after ileocolic resection for Crohn's disease with respect to endoscopic recurrence, gastrointestinal function and costs. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Crohn Disease, IBD, Ileocolitis
- What is being tested?
- Handsewn anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteItaly
- Study dates
- 25 May 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged >18 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 MR enterography (or CT enterography if MR contraindicated) in last 3 months to assess extent of disease.
- 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.
- Patients undergoing repeated ileocolic resection.
- History of cancer < 5 years which might influence patients prognosis
- Emergent operation. Pregnant or breast feeding.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
irccs San Raffaele
Milan
Simona Radice, 02.26432069
Vittoria Bellato, MD
About this study
Official title: Rct in croHn's Disease: Comparing mANual (End to End and Kono-s) Versus stapleD Side TO Side Ileocolic Anastomosis (HANDTOEND)
RESEARCH QUESTION Are handsewn (end to end and Kono S side to side) anastomoses superior to side to side stapled anastomosis after ileocolic resection for Crohn's disease with respect to endoscopic recurrence, gastrointestinal function and costs.
HYPOTHESIS Stapled side anastomosis advised in ECCO guidelines heal with ulcerations on the staple line causing systematic over scoring of endoscopic recurrence leading to unjustified restarting of expensive drugs reducing QOL and increasing costs. Side to side saccular configuration causes stasis affecting recurrence and dysfunction.
Read more
DESIGN Randomised superiority study
POPULATION Patients with Crohn requiring (re)resection of the (neo)terminal ileum
INTERVENTION Kono S and end to end hand sewn anastomosis
USUAL CARE Side to side stapled anastomosis
OUTCOME Endoscopic recurrence (local and central reading) at 6 months
SAMPLE 25% reduction in 2:1 ratio -> 126 + 63 = 189 patients
KEYWORDS Crohn, ileocolic resection, recurrence
- Conditions
- Crohn Disease, IBD, Ileocolitis, Crohn's Ileocolitis
- Being tested
- Handsewn anastomosis
- Keywords
- Recurrence IBD, IBD, Endoscopic Recurrence, Rurgeers Score, Surgical recurrence, Crohn's Ileocolitis, Ileocolic Anastomosis, Crohn's disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handsewn anastomosisProcedure or surgery
To perform hand sewn anastomosis (either end to end or Kono-s) during the reconstruction face of ileocolic resection
| Study group | Role | What they receive |
|---|---|---|
| Handsewn ileocolic anastomosis | Experimental | Randomised comparison of handsewn (end-to-end and the Kono-S) with the side-to-side stapled anastomosis.
to use a manual anastomosis technique avoiding stapled technique to verify if stapled anastomosis can cause ulcers at endoscopic follow up with systematic overscoring Receives: Procedure: Handsewn anastomosis |
| Side to side stapled anastomosis | No intervention | Randomised comparison of handsewn (end-to-end and the Kono-S) with the side-to-side stapled anastomosis. to use a manual anastomosis technique avoiding stapled technique to verify if stapled anastomosis can cause ulcers at endoscopic follow up with systematic overscoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 months endoscopic recurrence of endoscopy using the modified Rutgeerts classification.
The comparison of 6 months endoscopic recurrence between local and central reading of recordings of endoscopy using the modified Rutgeerts classification.
Measured: 6 months
Secondary outcomes (4)
Morbidity
postoperative morbidity measure
Measured: 1 year
Clinical Recurrence
Clinical and surgical recurrence using Clavien Dindo
Measured: 1 year
Inflammatory Bowel Disease Questionnaire (IBDQ)
Quality of life measured with IBD questionnaire
Measured: 1 year
Hospital Costs
Hospital costs per patient in both groups
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start25 May 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (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 IRCCS San RaffaeleThe 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 superiority study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vittoria Bellato, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246917
- Sponsor's protocol ID
- 5.2
- Acronym
- HAND2END
- Status last verified
- May 2022
- First submitted
- 9 Feb 2022
- Last updated
- 31 May 2022
- 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 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rct in croHn's Disease: Comparing mANual (End to End and Kono-s) Versus stapleD Side TO Side Ileocolic Anastomosis (HANDTOEND)
- ClinicalTrials.gov ID
- NCT05246917
- Acronym / sponsor ID
- HAND2END / 5.2
- Conditions
- Crohn Disease, IBD, Ileocolitis, Crohn's Ileocolitis
- Keywords
- Recurrence IBD, IBD, Endoscopic Recurrence, Rurgeers Score, Surgical recurrence, Crohn's Ileocolitis, Ileocolic Anastomosis, Crohn's disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Feb 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.
RESEARCH QUESTION Are handsewn (end to end and Kono S side to side) anastomoses superior to side to side stapled anastomosis after ileocolic resection for Crohn's disease with respect to endoscopic recurrence, gastrointestinal function and costs.
HYPOTHESIS Stapled side anastomosis advised in ECCO guidelines heal with ulcerations on the staple line causing systematic over scoring of endoscopic recurrence leading to unjustified restarting of expensive drugs reducing QOL and increasing costs. Side to side saccular configuration causes stasis affecting recurrence and dysfunction.
DESIGN Randomised superiority study
POPULATION Patients with Crohn requiring (re)resection of the (neo)terminal ileum
INTERVENTION Kono S and end to end hand sewn anastomosis
USUAL CARE Side to side stapled anastomosis
OUTCOME Endoscopic recurrence (local and central reading) at 6 months
SAMPLE 25% reduction in 2:1 ratio -> 126 + 63 = 189 patients
KEYWORDS Crohn, ileocolic resection, recurrence
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised superiority study
| Arm | Type | Receives |
|---|---|---|
| Handsewn ileocolic anastomosis | Experimental | Procedure: Handsewn anastomosisRandomised comparison of handsewn (end-to-end and the Kono-S) with the side-to-side stapled anastomosis. to use a manual anastomosis technique avoiding stapled technique to verify if stapled anastomosis can cause ulcers at endoscopic follow up with systematic overscoring |
| Side to side stapled anastomosis | No intervention | –Randomised comparison of handsewn (end-to-end and the Kono-S) with the side-to-side stapled anastomosis. to use a manual anastomosis technique avoiding stapled technique to verify if stapled anastomosis can cause ulcers at endoscopic follow up with systematic overscoring |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females aged >18 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 MR enterography (or CT enterography if MR contraindicated) in last 3 months to assess extent of disease.
- Ability to comply with protocol.
Key exclusion criteria (5 listed)
- Inability to give informed consent.
- Patients less than 16 years of age.
- Patients undergoing repeated ileocolic resection.
- History of cancer < 5 years which might influence patients prognosis
- Emergent operation. Pregnant or breast feeding.
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 |
|---|---|---|
| Handsewn anastomosisTo perform hand sewn anastomosis (either end to end or Kono-s) during the reconstruction face of ileocolic resection | Procedure or surgery | Handsewn ileocolic anastomosis |
Primary outcome
6 months endoscopic recurrence of endoscopy using the modified Rutgeerts classification.
Time frame: 6 months
The comparison of 6 months endoscopic recurrence between local and central reading of recordings of endoscopy using the modified Rutgeerts classification.
4 secondary outcomes
Morbidity
Time frame: 1 year
Clinical Recurrence
Time frame: 1 year
Inflammatory Bowel Disease Questionnaire (IBDQ)
Time frame: 1 year
Hospital Costs
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Handsewn anastomosis in people with Crohn Disease and IBD, run by IRCCS San Raffaele at 1 site in Italy.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 31 May 2022. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact vittoria bellato, MD (+447827422840, vittoria.bellato@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 months endoscopic recurrence of endoscopy using the modified Rutgeerts classification. (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 NCT05246917, 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 31 May 2022.