Crohn's Disease of Terminal IleumEXCEEDNCT06324838
Extended Mesenteric Resection in Ileocecal Crohn's Disease.
A study testing Standard laparoscopic ileocecal resection and Extended laparoscopic ileocecal resection in people with Crohn's Disease of Terminal Ileum, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The EXCEED project aims to study the role of the mesentery in disease recurrence in Crohn's disease (CD), as evidence suggests that including the mesentery when doing ileocecal resections can significantly reduce recurrence rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease of Terminal Ileum
- What is being tested?
- Standard laparoscopic ileocecal resection and Extended laparoscopic ileocecal resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2025to Jun 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients above the age of 18 scheduled for ileocecal resection due to Crohn's disease.
- Relevant endoscopy and imaging within the last 6 months.
- Diagnosis of "simple" ileocecal Crohn's disease (limited to ileocecal disease with a maximum of 40 cm of affected ileum).
Who cannot join
- Previous ileocecal resection.
- Inability to understand Danish or another Nordic language.
- Inability to comprehend the purpose and design of the project.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mark B Ellebæk, PhD contact
Denmark1 site, 1 recruiting
- Recruiting
Odense University Hospital
Odense, 5000
Jens Kristian Bælum, MD, +4540169388, jens.kristian.baelum@rsyd.dk
About this study
Official title: Extended Mesenteric Resection in Ileocecal Crohn's Disease to Prevent Recurrent Disease - A Randomized Controlled Trial.
The EXCEED project aims to study the role of the mesentery in disease recurrence in Crohn's disease (CD), as evidence suggests that including the mesentery when doing ileocecal resections can significantly reduce recurrence rates. The EXCEED study is a blinded randomised clinical trial with 204 participants having ileocecal Crohn's disease requiring resection. Participants will undergo either "standard" mesocolic sparing resection or extended mesocolic resection to assess its impact on reducing recurrence at the anastomotic site. The primary endpoint is endoscopic recurrence 12 months postoperatively.
Additionally, the study aims to evaluate the efficacy of different surveillance modalities in detecting anastomotic site recurrence. These examinations will be conducted pre- and postoperatively for a cohort of 20 participants.
Through this study, we seek to understand the mesentery's role in Crohn's disease recurrence and identify effective non-invasive methods for postoperative monitoring.
Read the detailed description
Surgical Procedure and Perioperative Care Laparoscopic approach with a minimum 5 cm disease-free bowel on each side. Standard stapled side-to-side isoperistaltic anastomoses. Extended mesenteric excision involves resection of inflamed mesentery up to the level of visible inflammation.
Both treatment groups will receive standard postoperative care according to the standards of the hospital treating the participant.
Postoperative Follow-up Postoperative follow-up at 6 and 12 months. This consist of an ileo-colonoscopy, chart review and questionnaires. The early follow-up at 6 months aims to detect early recurrence, enabling early medical treatment or other intervention. The 12-month follow-up will be the primary endpoint to determine recurrence. Long-term outcomes will be assessed through a chart review after 3 and 5 years, documenting reoperations, clinical symptoms, pharmacological use, and other complications.
Postoperative Medicinal Use Postoperative medical prophylaxis assessment isn't explicitly detailed in the current protocol, though it will be acknowledged. Analysis will stratify participants based on pre- and post-operative biological/non-biological treatment. The treating physician will determine postoperative medical therapy, typically maintaining pre-operative medication.
Postoperative Endoscopy Endoscopy will be regarded as the golden standard for the detection of disease recurrence. The endoscopies, including bowel preparation and possible sedation, will be preformed in accordance with local guidelines at each hospital. At least three biopsies will be taken from the ileum (5 cm proximal to the anastomosis), anastomosis, and colon (5 cm below the anastomosis). A short video of each endoscopy will be saved for validation purposes. Lesions found during the endoscopy will be classified using the modified Rutgeerts score[7].
Patient-Reported Outcome During the preoperative workup (baseline), the participant will be asked to complete 2 questionnaires (5Q-5D-5L and SIBDQ). Postoperatively, the participant will be asked to complete the same questionnaires at 6 and 12 months.
Statistical analysis plan Outcome Analysis The investigators plan to conduct a chi-square or Fisher's exact test to compare the proportion of participants with endoscopic recurrence between the intervention and control groups.
The investigators will utilize logistic regression to adjust for potential confounding variables if needed.
Demographics The Investigators will use means and standard deviations (or medians and interquartile ranges) for continuous variables. For categorical variables, frequencies and percentages will be presented and demographic characteristics between intervention and control groups will be compared.
- Conditions
- Crohn's Disease of Terminal Ileum
- Being tested
- Standard laparoscopic ileocecal resection, Extended laparoscopic ileocecal resection
- Keywords
- ileocecal resection, Mesocolic resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard laparoscopic ileocecal resectionProcedure or surgery
Also called Laparoscopic ileocecal resection
Participants will undergo standard mesocolic sparing resection.
Extended laparoscopic ileocecal resectionProcedure or surgery
Extended mesocolic resection to assess its impact on reducing recurrence at the anastomotic site.
| Study group | Role | What they receive |
|---|---|---|
| Extended mesenteric resection | Experimental | Arm receiving ileocecal resection with extended mesenteric resection. Receives: Procedure: Extended laparoscopic ileocecal resection |
| Controls (Standard mesenteric resection) | Active comparator | Arm receiving standard ileocecal resection. Receives: Procedure: Standard laparoscopic ileocecal resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic recurrence
Endoscopic signs of recurrence, defined as a modified Rutgeerts score >i2a.
Measured: 12 months postoperative
Secondary outcomes (8)
Early endoscopic recurrence
Endoscopic signs of recurrence, defined as a modified Rutgeerts score >i2a.
Measured: 6 months postoperative
Clinical signs of recurrence / morbidity.
Resumption of medicinal treatment. Chart review will be done to identify postoperative medicinal use.
Measured: 6-48 months postoperatively
Difference in disease severity
At the time of operation according to the Montreal classification.
Measured: Perioperative
Patient reported outcome 1
5Q-5D-5L
Measured: 6 and 12 months postoperative
Patient reported outcome 2
SIBDQ
Measured: 6 and 12 months postoperative
Reoperations
Chart review will be done to identify any reoperations due to recurrence or other complications.
Measured: 6 and 12 months postoperative
Perioperative complications
Postoperative complications according to Clavien-Dindo classification.
Measured: 30 days postoperative
Cost of treatment
Difference in treatment cost between the two groups. Reported in USD.
Measured: 12 months postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 Feb 2025
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (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's Disease of Terminal IleumStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Blinded multicenter randomized controlled clinical trial (RCT).
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark B Ellebæk, PhD, Study director, Surgical Research Unit, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324838
- Sponsor's protocol ID
- 248-2021-NQ
- Acronym
- EXCEED
- Status last verified
- Jan 2026
- First submitted
- 21 Aug 2023
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The principal investigators are committed to communicating the results, negative, positive, or inconclusive results, at local, national and international scientific meetings. The findings will be published in well-established, international peer-reviewed open access journals. After end of study, de-identified patient data will be uploaded to an open repository for further use.
Publications
Baelum JK, Rosenberg J, Larsen P, Joergensen M, De La Croix H, Haglind E, Agenete E; BEAT-IBD research group; Kjeldsen J, Ellebaek MB. Extended mesenteric resection in Crohn's disease: EXCEED Study Protocol-a blinded multicenter randomized controlled clinical trial (RCT). Trials. 2025 Nov 21;26(1):532. doi: 10.1186/s13063-025-09261-3.
PubMed 41272703
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Mesenteric Resection in Ileocecal Crohn's Disease to Prevent Recurrent Disease - A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06324838
- Acronym / sponsor ID
- EXCEED / 248-2021-NQ
- Conditions
- Crohn's Disease of Terminal Ileum
- Keywords
- ileocecal resection, Mesocolic resection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 22 Mar 2024 (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 EXCEED project aims to study the role of the mesentery in disease recurrence in Crohn's disease (CD), as evidence suggests that including the mesentery when doing ileocecal resections can significantly reduce recurrence rates. The EXCEED study is a blinded randomised clinical trial with 204 participants having ileocecal Crohn's disease requiring resection. Participants will undergo either "standard" mesocolic sparing resection or extended mesocolic resection to assess its impact on reducing recurrence at the anastomotic site. The primary endpoint is endoscopic recurrence 12 months postoperatively.
Additionally, the study aims to evaluate the efficacy of different surveillance modalities in detecting anastomotic site recurrence. These examinations will be conducted pre- and postoperatively for a cohort of 20 participants.
Through this study, we seek to understand the mesentery's role in Crohn's disease recurrence and identify effective non-invasive methods for postoperative monitoring.
Detailed description
Surgical Procedure and Perioperative Care Laparoscopic approach with a minimum 5 cm disease-free bowel on each side. Standard stapled side-to-side isoperistaltic anastomoses. Extended mesenteric excision involves resection of inflamed mesentery up to the level of visible inflammation.
Both treatment groups will receive standard postoperative care according to the standards of the hospital treating the participant.
Postoperative Follow-up Postoperative follow-up at 6 and 12 months. This consist of an ileo-colonoscopy, chart review and questionnaires. The early follow-up at 6 months aims to detect early recurrence, enabling early medical treatment or other intervention. The 12-month follow-up will be the primary endpoint to determine recurrence. Long-term outcomes will be assessed through a chart review after 3 and 5 years, documenting reoperations, clinical symptoms, pharmacological use, and other complications.
Postoperative Medicinal Use Postoperative medical prophylaxis assessment isn't explicitly detailed in the current protocol, though it will be acknowledged. Analysis will stratify participants based on pre- and post-operative biological/non-biological treatment. The treating physician will determine postoperative medical therapy, typically maintaining pre-operative medication.
Postoperative Endoscopy Endoscopy will be regarded as the golden standard for the detection of disease recurrence. The endoscopies, including bowel preparation and possible sedation, will be preformed in accordance with local guidelines at each hospital. At least three biopsies will be taken from the ileum (5 cm proximal to the anastomosis), anastomosis, and colon (5 cm below the anastomosis). A short video of each endoscopy will be saved for validation purposes. Lesions found during the endoscopy will be classified using the modified Rutgeerts score[7].
Patient-Reported Outcome During the preoperative workup (baseline), the participant will be asked to complete 2 questionnaires (5Q-5D-5L and SIBDQ). Postoperatively, the participant will be asked to complete the same questionnaires at 6 and 12 months.
Statistical analysis plan Outcome Analysis The investigators plan to conduct a chi-square or Fisher's exact test to compare the proportion of participants with endoscopic recurrence between the intervention and control groups.
The investigators will utilize logistic regression to adjust for potential confounding variables if needed.
Demographics The Investigators will use means and standard deviations (or medians and interquartile ranges) for continuous variables. For categorical variables, frequencies and percentages will be presented and demographic characteristics between intervention and control groups will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Blinded multicenter randomized controlled clinical trial (RCT).
| Arm | Type | Receives |
|---|---|---|
| Extended mesenteric resection | Experimental | Procedure: Extended laparoscopic ileocecal resectionArm receiving ileocecal resection with extended mesenteric resection. |
| Controls (Standard mesenteric resection) | Active comparator | Procedure: Standard laparoscopic ileocecal resectionArm receiving standard ileocecal resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients above the age of 18 scheduled for ileocecal resection due to Crohn's disease.
- Relevant endoscopy and imaging within the last 6 months.
- Diagnosis of "simple" ileocecal Crohn's disease (limited to ileocecal disease with a maximum of 40 cm of affected ileum).
Key exclusion criteria (4 listed)
- Previous ileocecal resection.
- Inability to understand Danish or another Nordic language.
- Inability to comprehend the purpose and design of the project.
- Pregnancy or lactation.
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 |
|---|---|---|
| Standard laparoscopic ileocecal resectionAlso: Laparoscopic ileocecal resectionParticipants will undergo standard mesocolic sparing resection. | Procedure or surgery | Controls (Standard mesenteric resection) |
| Extended laparoscopic ileocecal resectionExtended mesocolic resection to assess its impact on reducing recurrence at the anastomotic site. | Procedure or surgery | Extended mesenteric resection |
Primary outcome
Endoscopic recurrence
Time frame: 12 months postoperative
Endoscopic signs of recurrence, defined as a modified Rutgeerts score >i2a.
8 secondary outcomes
Early endoscopic recurrence
Time frame: 6 months postoperative
Clinical signs of recurrence / morbidity.
Time frame: 6-48 months postoperatively
Difference in disease severity
Time frame: Perioperative
Patient reported outcome 1
Time frame: 6 and 12 months postoperative
Patient reported outcome 2
Time frame: 6 and 12 months postoperative
Reoperations
Time frame: 6 and 12 months postoperative
Perioperative complications
Time frame: 30 days postoperative
Cost of treatment
Time frame: 12 months postoperative.
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 15 Jan 2026.
- Derived from this study: PubMed 41272703Baelum JK, Rosenberg J, Larsen P, Joergensen M, De La Croix H, Haglind E, Agenete E; BEAT-IBD research group; Kjeldsen J, Ellebaek MB. Extended mesenteric resection in Crohn's disease: EXCEED Study Protocol-a blinded multicenter randomized controlled clinical trial (RCT). Trials. 2025 Nov 21;26(1):532. doi: 10.1186/s13063-025-09261-3.
- Individual participant dataSharing planned: Yes. The principal investigators are committed to communicating the results, negative, positive, or inconclusive results, at local, national and international scientific meetings. The findings will be published in well-established, international peer-reviewed open access journals. After end of study, de-identified patient data will be uploaded to an open repository for further use.
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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.
Mark B Ellebæk, PhD contact
Mark B Ellebæk, PhD study director
Surgical Research Unit, Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard laparoscopic ileocecal resection and Extended laparoscopic ileocecal resection in people with Crohn's Disease of Terminal Ileum, run by Odense University Hospital at 1 site in Denmark.
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 3 inclusion and 4 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 15 Jan 2026. 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 Denmark. 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 Jens K Bælum, MD (+4521758114, jens.kristian.baelum@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoscopic recurrence (time frame: 12 months postoperative). 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 NCT06324838, 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 15 Jan 2026.