Ileocolic Crohn DiseaseNCT07164209
The Remeasure Trial
A study testing Excision of the mesentery: the mesentery is fully dissected and excised to the limit of macroscopic "fat wrapping", where mesenteric fat is inflamed and extends beyond its normal anatomical distribut and Kono S Anastomosis in people with Ileocolic Crohn Disease and Kono S Anastomosis, run by Azienda Ospedaliera Ordine Mauriziano di Torino at 1 site in Italy.
Trial summary
Aim of the present study is to compare a stapled, functional end-to-end, ileo-colic anastomosis with removal of the mesentery vs the manual, functional end-to-end, ileo-colic Kono-S anastomosis with mesentery preservation, in terms of peri-operative safety, and efficacy in preventing endoscopic recurrence after… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ileocolic Crohn Disease, Kono S Anastomosis, Resection of the Mesentery
- What is being tested?
- Excision of the mesentery: the mesentery is fully dissected and excised to the limit of macroscopic "fat wrapping", where mesenteric fat is inflamed and extends beyond its normal anatomical distribut and Kono S Anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jan 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients > 18 years
- Histological diagnosis of Crohn's Disease
- Patient's ability to read and understand the documentation concerning the study and the Informed consent
- Ileocolic disease requiring resection
Who cannot join
- Older than 70
- Recurrent disease, previous surgery for CD
- Gastroenterologists or patients not willing to maintain a drug washout for six months
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dott Lucia Borsotti is the head of the experimetal Office in Azienda Sanitaria Ospedaliera Ordine Mauriziano and could answer about enrolling of patients and submission of the protocol to the ethicl Commette of Città della Salute e della Scienza of Torin
Torino, To, 10100
About this study
Official title: Resection of the Mesentery With Functional End-to-end Anastomosis vs Kono Anastomosis in Preventing Relapse After Ileocolic Resection for Primary Crohn Disease: a Prospective, Randomized, Controlled Trial Remeasure CD TRial
Aim of the present study is to compare a stapled, functional end-to-end, ileo-colic anastomosis with removal of the mesentery vs the manual, functional end-to-end, ileo-colic Kono-S anastomosis with mesentery preservation, in terms of peri-operative safety, and efficacy in preventing endoscopic recurrence after ileocolic resection for Crohn Disease. Patients presenting with ileocolic primary Crohn disease either not suitable for medical treatment or with contraindications for therapy i.e: occlusion, abscess, contraindications to the use of biologics
Read the detailed description
Patients who meet inclusion criteria will be randomized between two surgical procedures:
The excision of the mesentery (group A) and ileocolic anastomosis and the Kono-S anastomosis (group B) after ileocolic or ileo-cecal resection. The operation could be performed with open or laparoscopic approach.
Excision of the mesentery:
the mesentery is fully dissected and excised to the limit of macroscopic "fat wrapping", where mesenteric fat is inflamed and extends beyond its normal anatomical distribution over the surface of the contiguous intestine. The anastomosis between colon and ileum is than performed mechanically end to end.
Kono-S anastomosis:
the mesentery is not removed but cutted close to the bowel. The bowel is then divided transversely by placing a linear stapler perpendicular to the intestinal lumen and the mesentery. The corners of the two staple lines are reinforced and the two stumps are approximated using 5-7 sutures to create the column.
If the caliber of the two intestinal segments differs significantly, the sutures should be spaced to evenly distribute the surplus tissue of the larger segment, in order to achieve good approximation and stable support for the anastomosis. To create the anastomosis, an antimesenteric longitudinal enterotomy (or colostomy) is performed on each stump to allow a transverse lumen of 7 cm in diameter for the small bowel or closer to 8 cm for the colon. In this way the supporting column is located immediately behind the posterior wall of the anastomosis providing a rigid and stable support to prevent mechanical deformation and functional constriction of the lumen of the anastomosis.
- Being tested
- Excision of the mesentery: the mesentery is fully dissected and excised to the limit of macroscopic "fat wrapping", where mesenteric fat is inflamed and extends beyond its normal anatomical distribut, Kono S Anastomosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excision of the mesentery: the mesentery is fully dissected and excised to the limit of macroscopic "fat wrapping", where mesenteric fat is inflamed and extends beyond its normal anatomical distributProcedure or surgery
The resection of mesentery could take off the inflammatory tissue who may increase the risk of anastomotic recurrence The Kono anastomosis achieves a column of support (made with the bowel ) located immediately behind the posterior wall of the anastomosis providing a rigid and stable support to prevent mechanical deformation and functional constriction of the lumen of the anastomosis being a barrier between anastomosis and mesentery
Kono S AnastomosisProcedure or surgery
ono-S anastomosis: the mesentery is not removed but cutted close to the bowel. The bowel is then divided transversely by placing a linear stapler perpendicular to the intestinal lumen and the mesentery. The corners of the two staple lines are reinforced and the two stumps are approximated using 5-7 sutures to create the column. If the caliber of the two intestinal segments differs significantly, the sutures should be spaced to evenly distribute the surplus tissue of the larger segment, in order to achieve good approximation and stable support for the anastomosis. To create the anastomosis, an antimesenteric longitudinal enterotomy (or colostomy) is performed on each stump to allow a transverse lumen of 7 cm in diameter for the small bowel or closer to 8 cm for the colon. In this way the supporting column is located immediately behind the posterior wall of the anastomosis providing a rigid and stable support to prevent mechanical deformation and functional constriction of the lum
| Study group | Role | What they receive |
|---|---|---|
| resection of the mesentery | Other | Excision of the mesentery:
the mesentery is fully dissected and excised to the limit of macroscopic "fat wrapping", where mesenteric fat is inflamed and extends beyond its normal anatomical distribution over the surface of the contiguous intestine. The anastomosis between colon and ileum is than performed mechanically end to end Receives: Procedure: Excision of the mesentery: the mesentery is fully dissected and excised to the limit of macroscopic "fat wrapping", where mesenteric fat is inflamed and extends beyond its normal anatomical distribut |
| Kono S Anastomosis | Experimental | Kono-S anastomosis:
the mesentery is not removed but cutted close to the bowel. The bowel is then divided transversely by placing a linear stapler perpendicular to the intestinal lumen and the mesentery. The corners of the two staple lines are reinforced and the two stumps are approximated using 5-7 sutures to create the column.
If the caliber of the two intestinal segments differs significantly, the sutures should be spaced to evenly distribute the surplus tissue of the larger segment, in order to achieve good approximation and stable support for the anastomosis. To create the anastomosis, an antimesenteric longitudinal enterotomy (or colostomy) is performed on each stump to allow a transverse lumen of 7 cm in diameter for the small bowel or closer to 8 cm for the colon. In this way the supporting column is located immediately behind the posterior wall of the anastomosis providing a rigid and stable support to prevent mechanical deformation and functional constriction of the lum Receives: Procedure: Kono S Anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
endoscopic recurrence (Rutgeerts score i2 or greater) at 6,12, 18 months.Endoscopic recurrence was defined if Rutgeerts > i2 (>5 aphthous lesions or larger lesions confined to anastomosis), i3 (diffuse ileitis), or i4 (diffuse inflammation with large ulc
Measured: From the treatment a close follow up is performed at 6, 12 and 18 months.The majority of endoscopic examinations were centrally performed. In few cases check was performed in separated centers and a "recording video clip" of the endoscopy was assessed fo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start2 Jan 2022
- Primary completion30 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ileocolic Crohn DiseaseStudies of the same condition, open and under way.
- 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
- Monocentric, prospective, randomized, controlled trial.
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Ordine Mauriziano di Torino
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucia Borsotti, Azienda Ospedaliera Ordine Mauriziano di Torino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164209
- Sponsor's protocol ID
- 0122316, 14/12/2020
- Status last verified
- Oct 2025
- First submitted
- 2 Sep 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We surely consider to share individual participant data (IPD) during the study and often it is necessary. At the moment of the study design we dis not fix a precise plane of sharing data. During the follow up clinical and endoscopic examinations of patients have been scheduled in order to avoid missing data or drop-out from the study. The first role of all investigators in this study was to follow each patients operated on and enrolled in this specific study
Publications
Coffey CJ, Kiernan MG, Sahebally SM, Jarrar A, Burke JP, Kiely PA, Shen B, Waldron D, Peirce C, Moloney M, Skelly M, Tibbitts P, Hidayat H, Faul PN, Healy V, O'Leary PD, Walsh LG, Dockery P, O'Connell RP, Martin ST, Shanahan F, Fiocchi C, Dunne CP. Inclusion of the Mesentery in Ileocolic Resection for Crohn's Disease is Associated With Reduced Surgical Recurrence. J Crohns Colitis. 2018 Nov 9;12(10):1139-1150. doi: 10.1093/ecco-jcc/jjx187.
PubMed 29309546Mineccia M, Maconi G, Daperno M, Cigognini M, Cherubini V, Colombo F, Perotti S, Baldi C, Massucco P, Ardizzone S, Ferrero A, Sampietro GM. Has the Removing of the Mesentery during Ileo-Colic Resection an Impact on Post-Operative Complications and Recurrence in Crohn's Disease? Results from the Resection of the Mesentery Study (Remedy). J Clin Med. 2022 Apr 1;11(7):1961. doi: 10.3390/jcm11071961.
PubMed 35407568Luglio G, Rispo A, Imperatore N, Giglio MC, Amendola A, Tropeano FP, Peltrini R, Castiglione F, De Palma GD, Bucci L. Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease: The SuPREMe-CD Study - A Randomized Clinical Trial. Ann Surg. 2020 Aug;272(2):210-217. doi: 10.1097/SLA.0000000000003821.
PubMed 32675483
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resection of the Mesentery With Functional End-to-end Anastomosis vs Kono Anastomosis in Preventing Relapse After Ileocolic Resection for Primary Crohn Disease: a Prospective, Randomized, Controlled Trial Remeasure CD TRial
- ClinicalTrials.gov ID
- NCT07164209
- Acronym / sponsor ID
- 0122316, 14/12/2020
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Ordine Mauriziano di TorinoUniversity, hospital or other
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 10 Sep 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.
Aim of the present study is to compare a stapled, functional end-to-end, ileo-colic anastomosis with removal of the mesentery vs the manual, functional end-to-end, ileo-colic Kono-S anastomosis with mesentery preservation, in terms of peri-operative safety, and efficacy in preventing endoscopic recurrence after ileocolic resection for Crohn Disease. Patients presenting with ileocolic primary Crohn disease either not suitable for medical treatment or with contraindications for therapy i.e: occlusion, abscess, contraindications to the use of biologics
Detailed description
Patients who meet inclusion criteria will be randomized between two surgical procedures:
The excision of the mesentery (group A) and ileocolic anastomosis and the Kono-S anastomosis (group B) after ileocolic or ileo-cecal resection. The operation could be performed with open or laparoscopic approach.
Excision of the mesentery:
the mesentery is fully dissected and excised to the limit of macroscopic "fat wrapping", where mesenteric fat is inflamed and extends beyond its normal anatomical distribution over the surface of the contiguous intestine. The anastomosis between colon and ileum is than performed mechanically end to end.
Kono-S anastomosis:
the mesentery is not removed but cutted close to the bowel. The bowel is then divided transversely by placing a linear stapler perpendicular to the intestinal lumen and the mesentery. The corners of the two staple lines are reinforced and the two stumps are approximated using 5-7 sutures to create the column.
If the caliber of the two intestinal segments differs significantly, the sutures should be spaced to evenly distribute the surplus tissue of the larger segment, in order to achieve good approximation and stable support for the anastomosis. To create the anastomosis, an antimesenteric longitudinal enterotomy (or colostomy) is performed on each stump to allow a transverse lumen of 7 cm in diameter for the small bowel or closer to 8 cm for the colon. In this way the supporting column is located immediately behind the posterior wall of the anastomosis providing a rigid and stable support to prevent mechanical deformation and functional constriction of the lumen of the anastomosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Monocentric, prospective, randomized, controlled trial.
| Arm | Type | Receives |
|---|---|---|
| resection of the mesentery | Other | Procedure: Excision of the mesentery: the mesentery is fully dissected and excised to the limit of macroscopic "fat wrapping", where mesenteric fat is inflamed and extends beyond its normal anatomical distributExcision of the mesentery: the mesentery is fully dissected and excised to the limit of macroscopic "fat wrapping", where mesenteric fat is inflamed and extends beyond its normal anatomical distribution over the surface of the contiguous intestine. The anastomosis between colon and ileum is than performed mechanically end to end |
| Kono S Anastomosis | Experimental | Procedure: Kono S AnastomosisKono-S anastomosis: the mesentery is not removed but cutted close to the bowel. The bowel is then divided transversely by placing a linear stapler perpendicular to the intestinal lumen and the mesentery. The corners of the two staple lines are reinforced and the two stumps are approximated using 5-7 sutures to create the column. If the caliber of the two intestinal segments differs significantly, the sutures should be spaced to evenly distribute the surplus tissue of the larger segment, in order to achieve good approximation and stable support for the anastomosis. To create the anastomosis, an antimesenteric longitudinal enterotomy (or colostomy) is performed on each stump to allow a transverse lumen of 7 cm in diameter for the small bowel or closer to 8 cm for the colon. In this way the supporting column is located immediately behind the posterior wall of the anastomosis providing a rigid and stable support to prevent mechanical deformation and functional constriction of the lum |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Patients > 18 years
Key exclusion criteria (4 listed)
- Older than 70
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 |
|---|---|---|
| Excision of the mesentery: the mesentery is fully dissected and excised to the limit of macroscopic "fat wrapping", where mesenteric fat is inflamed and extends beyond its normal anatomical distributThe resection of mesentery could take off the inflammatory tissue who may increase the risk of anastomotic recurrence The Kono anastomosis achieves a column of support (made with the bowel ) located immediately behind the posterior wall of the anastomosis providing a rigid and stable support to prevent mechanical deformation and functional constriction of the lumen of the anastomosis being a barrier between anastomosis and mesentery | Procedure or surgery | resection of the mesentery |
| Kono S Anastomosisono-S anastomosis: the mesentery is not removed but cutted close to the bowel. The bowel is then divided transversely by placing a linear stapler perpendicular to the intestinal lumen and the mesentery. The corners of the two staple lines are reinforced and the two stumps are approximated using 5-7 sutures to create the column. If the caliber of the two intestinal segments differs significantly, the sutures should be spaced to evenly distribute the surplus tissue of the larger segment, in order to achieve good approximation and stable support for the anastomosis. To create the anastomosis, an antimesenteric longitudinal enterotomy (or colostomy) is performed on each stump to allow a transverse lumen of 7 cm in diameter for the small bowel or closer to 8 cm for the colon. In this way the supporting column is located immediately behind the posterior wall of the anastomosis providing a rigid and stable support to prevent mechanical deformation and functional constriction of the lum | Procedure or surgery | Kono S Anastomosis |
Primary outcome
endoscopic recurrence (Rutgeerts score i2 or greater) at 6,12, 18 months.Endoscopic recurrence was defined if Rutgeerts > i2 (>5 aphthous lesions or larger lesions confined to anastomosis), i3 (diffuse ileitis), or i4 (diffuse inflammation with large ulc
Time frame: From the treatment a close follow up is performed at 6, 12 and 18 months.The majority of endoscopic examinations were centrally performed. In few cases check was performed in separated centers and a "recording video clip" of the endoscopy was assessed fo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Background: PubMed 29309546Coffey CJ, Kiernan MG, Sahebally SM, Jarrar A, Burke JP, Kiely PA, Shen B, Waldron D, Peirce C, Moloney M, Skelly M, Tibbitts P, Hidayat H, Faul PN, Healy V, O'Leary PD, Walsh LG, Dockery P, O'Connell RP, Martin ST, Shanahan F, Fiocchi C, Dunne CP. Inclusion of the Mesentery in Ileocolic Resection for Crohn's Disease is Associated With Reduced Surgical Recurrence. J Crohns Colitis. 2018 Nov 9;12(10):1139-1150. doi: 10.1093/ecco-jcc/jjx187.
- Results publication: PubMed 35407568Mineccia M, Maconi G, Daperno M, Cigognini M, Cherubini V, Colombo F, Perotti S, Baldi C, Massucco P, Ardizzone S, Ferrero A, Sampietro GM. Has the Removing of the Mesentery during Ileo-Colic Resection an Impact on Post-Operative Complications and Recurrence in Crohn's Disease? Results from the Resection of the Mesentery Study (Remedy). J Clin Med. 2022 Apr 1;11(7):1961. doi: 10.3390/jcm11071961.
- Results publication: PubMed 32675483Luglio G, Rispo A, Imperatore N, Giglio MC, Amendola A, Tropeano FP, Peltrini R, Castiglione F, De Palma GD, Bucci L. Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease: The SuPREMe-CD Study - A Randomized Clinical Trial. Ann Surg. 2020 Aug;272(2):210-217. doi: 10.1097/SLA.0000000000003821.
- Individual participant dataSharing planned: No. We surely consider to share individual participant data (IPD) during the study and often it is necessary. At the moment of the study design we dis not fix a precise plane of sharing data. During the follow up clinical and endoscopic examinations of patients have been scheduled in order to avoid missing data or drop-out from the study. The first role of all investigators in this study was to follow each patients operated on and enrolled in this specific study
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Excision of the mesentery: the mesentery is fully dissected and excised to the limit of macroscopic "fat wrapping", where mesenteric fat is inflamed and extends beyond its normal anatomical distribut and Kono S Anastomosis in people with Ileocolic Crohn Disease and Kono S Anastomosis, run by Azienda Ospedaliera Ordine Mauriziano di Torino 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 4 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: finished, as of the sponsor's last update on 8 Oct 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endoscopic recurrence (Rutgeerts score i2 or greater) at 6,12, 18 months.Endoscopic recurrence was defined if Rutgeerts > i2 (>5 aphthous lesions or larger lesions confined to anastomosis), i3 (diffuse ileitis), or i4 (diffuse inflammation with large ulc (time frame: From the treatment a close follow up is performed at 6, 12 and 18 months.The majority of endoscopic examinations were centrally performed. In few cases check was performed in separated centers and a "recording video clip" of the endoscopy was assessed fo). 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 NCT07164209, which also lists 3 linked publications.
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 8 Oct 2025.