Crohn DiseaseRIC-2NCT06856044
Safety of Mesentery-embedding Surgery in Patients With Ileocolic Crohn's Disease on Biotherapy
A study testing ileocolic resection with extended mesenteric resection in people with Crohn Disease, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial summary
60% of patients with Crohn's disease will undergo surgery during their lifetime and without recurrence prevention treatment, 80% of patients will have an endoscopic recurrence within 1 year of surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- ileocolic resection with extended mesenteric resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Sep 2025to Mar 2028
- 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
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- Patient with histologically proven Crohn's disease
- Patient who has undergone ileocolic resection and whose disease site is accessible to endoscopic follow-up (first or repeat operation)
- Patient on anti-TNF α: infliximab or adalimumab (ECCO 2014 recommendation), vedolizumab, ustkinumab, or other biotherapy (e.g. risankizumab)
- Patient able to understand, write and read French
Who cannot join
- The patient is participating in an interventional study
- The patient is under safeguard of justice or state guardianship
- Medical treatment other than biotherapies including anti-TNF α (infliximab or adalimumab), vedolizumab, ustkinumab, risankinumab
- Contraindication to surgery, such as major cardiovascular comorbidities
- Pregnant, breast-feeding or parturient women
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHU de Montpellier Hôpital St Eloi
Montpellier
Thomas BARDOL, 04 67 33 77 31, t-bardol@chu-montpellier.fr
- Recruiting
CHU de Nîmes
Nîmes, 30029
Anissa MEGZARI, 04 66 68 42 36, drc@chu-nimes.fr
Martin BERTRAND
About this study
Official title: Etude Prospective Exploratoire Pilote de sécurité, d'Une Chirurgie Emportant le mésentère Chez Les Patients Porteurs d'Une Maladie de Crohn Avec Atteinte iléo-colique Sous biothérapie
60% of patients with Crohn's disease will undergo surgery during their lifetime and without recurrence prevention treatment, 80% of patients will have an endoscopic recurrence within 1 year of surgery. This procedure is performed as close as possible to the gastrointestinal tract, but remaining mesenteric disease is a risk factor for recurrence. Mesentery resection has encouraging results on recurrence requiring reoperation, with a reduction of over 30% in recurrences compared with the standard technique. The study authors wish to evaluate the safety of ileocolic resection surgery involving the mesentery in patients with Crohn's disease treated with biotherapy.
The study hypothesis is that mesentery surgery is no more risky than conventional (gold standard) surgery, and reduces the 6-month endoscopic recurrence rate in patients with ileocolic Crohn's disease on biotherapy requiring ileocolic resection.
- Conditions
- Crohn Disease
- Being tested
- ileocolic resection with extended mesenteric resection
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ileocolic resection with extended mesenteric resectionProcedure or surgery
The resection limits will be in healthy mesenteric areas. The restoration of continuity in one stage should be preferred. The choice of laparoscopy versus laparotomy is at the surgeon's discretion.
| Study group | Role | What they receive |
|---|---|---|
| Patient with Crohn Disease | Experimental | Not described Receives: Procedure: ileocolic resection with extended mesenteric resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-surgical complication rate
Percentage, graded according to the Clavien-Dindo Classification
Measured: 30 days after surgery
Secondary outcomes (26)
Postoperative endoscopic recurrence
Yes/No according to Rutgeerts classification (i0-i4), using a cut-off score ≥ i2
Measured: 6 months
Surgical time of the ileocolic resection technique
Minutes
Measured: End of surgery
Intraoperative bleeding
If yes, volume (ml)
Measured: End of surgery
Length of hospital stay
Days
Measured: End of hospitalization (max 1 month)
Presence of intra- and post-operative complications
Yes/no
Measured: Immediately following surgery
Number of intra- and post-operative complications
Number
Measured: Immediately following surgery
Time until resumption of transit following surgery
Number of days between surgery and resumption of transit
Measured: Following surgery (maximum 5 days)
Time until resumption of eating
Number of days between surgery and resumption of eating
Measured: Following surgery (average 1 day)
Presence of myenteric plexitis with at least one inflammatory cell at proximal ileal resection margin
Classed as: Absent; 1-3 inflammatory cells; 4-9; or 10+
Measured: Immediately following surgery
Number of lymph nodes in the histological specimen
Number
Measured: Immediately following surgery
Resection not in healthy margin
(Yes/No)
Measured: Immediately following surgery
Length of resected digestive tract
Centimeters
Measured: Immediately following surgery
Area of mesentery removed
Square centimeters
Measured: Immediately following surgery
C-reactive protein level
Measured: Day before surgery
C-reactive protein level
Measured: Day 2
C-reactive protein level
Measured: Day 4
C-reactive protein level
Measured: Month 1
C-reactive protein level
Measured: Month 6
Albuminemia
Measured: Day before surgery
Hemoglobinemia
Measured: Day before surgery
Hemoglobinemia
Measured: Day 2
Hemoglobinemia
Measured: Day 4
White blood cells
Measured: Day before surgery
White blood cells
Measured: Day 2
White blood cells
Measured: Day 4
Fecal calprotectin
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start15 Sep 2025
- Primary completionOct 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin BERTRAND, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856044
- Sponsor's protocol ID
- NIMAO/2023-2/MB-01
- Acronym
- RIC-2
- Status last verified
- Mar 2026
- First submitted
- 29 Nov 2024
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude Prospective Exploratoire Pilote de sécurité, d'Une Chirurgie Emportant le mésentère Chez Les Patients Porteurs d'Une Maladie de Crohn Avec Atteinte iléo-colique Sous biothérapie
- ClinicalTrials.gov ID
- NCT06856044
- Acronym / sponsor ID
- RIC-2 / NIMAO/2023-2/MB-01
- Conditions
- Crohn Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 4 Mar 2025 (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.
60% of patients with Crohn's disease will undergo surgery during their lifetime and without recurrence prevention treatment, 80% of patients will have an endoscopic recurrence within 1 year of surgery. This procedure is performed as close as possible to the gastrointestinal tract, but remaining mesenteric disease is a risk factor for recurrence. Mesentery resection has encouraging results on recurrence requiring reoperation, with a reduction of over 30% in recurrences compared with the standard technique. The study authors wish to evaluate the safety of ileocolic resection surgery involving the mesentery in patients with Crohn's disease treated with biotherapy.
The study hypothesis is that mesentery surgery is no more risky than conventional (gold standard) surgery, and reduces the 6-month endoscopic recurrence rate in patients with ileocolic Crohn's disease on biotherapy requiring ileocolic resection.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with Crohn Disease | Experimental | Procedure: ileocolic resection with extended mesenteric resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- Patient with histologically proven Crohn's disease
- Patient who has undergone ileocolic resection and whose disease site is accessible to endoscopic follow-up (first or repeat operation)
- Patient on anti-TNF α: infliximab or adalimumab (ECCO 2014 recommendation), vedolizumab, ustkinumab, or other biotherapy (e.g. risankizumab)
Key exclusion criteria (5 listed)
- The patient is participating in an interventional study
- The patient is under safeguard of justice or state guardianship
- Medical treatment other than biotherapies including anti-TNF α (infliximab or adalimumab), vedolizumab, ustkinumab, risankinumab
- Contraindication to surgery, such as major cardiovascular comorbidities
- Pregnant, breast-feeding or parturient women
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 |
|---|---|---|
| ileocolic resection with extended mesenteric resectionThe resection limits will be in healthy mesenteric areas. The restoration of continuity in one stage should be preferred. The choice of laparoscopy versus laparotomy is at the surgeon's discretion. | Procedure or surgery | Patient with Crohn Disease |
Primary outcome
Post-surgical complication rate
Time frame: 30 days after surgery
Percentage, graded according to the Clavien-Dindo Classification
26 secondary outcomes
Postoperative endoscopic recurrence
Time frame: 6 months
Surgical time of the ileocolic resection technique
Time frame: End of surgery
Intraoperative bleeding
Time frame: End of surgery
Length of hospital stay
Time frame: End of hospitalization (max 1 month)
Presence of intra- and post-operative complications
Time frame: Immediately following surgery
Number of intra- and post-operative complications
Time frame: Immediately following surgery
Time until resumption of transit following surgery
Time frame: Following surgery (maximum 5 days)
Time until resumption of eating
Time frame: Following surgery (average 1 day)
Presence of myenteric plexitis with at least one inflammatory cell at proximal ileal resection margin
Time frame: Immediately following surgery
Number of lymph nodes in the histological specimen
Time frame: Immediately following surgery
Resection not in healthy margin
Time frame: Immediately following surgery
Length of resected digestive tract
Time frame: Immediately following surgery
Area of mesentery removed
Time frame: Immediately following surgery
C-reactive protein level
Time frame: Day before surgery
C-reactive protein level
Time frame: Day 2
C-reactive protein level
Time frame: Day 4
C-reactive protein level
Time frame: Month 1
C-reactive protein level
Time frame: Month 6
Albuminemia
Time frame: Day before surgery
Hemoglobinemia
Time frame: Day before surgery
Hemoglobinemia
Time frame: Day 2
Hemoglobinemia
Time frame: Day 4
White blood cells
Time frame: Day before surgery
White blood cells
Time frame: Day 2
White blood cells
Time frame: Day 4
Fecal calprotectin
Time frame: Month 3
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 16 Mar 2026.
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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.
Martin BERTRAND principal investigator
CHU de Nimes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ileocolic resection with extended mesenteric resection in people with Crohn Disease, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
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 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: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 Martin BERTRAND (04 66 68 31 43, martin.bertrand@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-surgical complication rate (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2026.