Crohn Disease (CD)NCT07231601
Laparoscopic Right Hemicolectomy for Crohn's Disease of the Terminal Ileum Utilizing the Mesenteric Excision and Exclusion
An observational study of Crohn Disease (CD) and Crohn Disease of Ileum, run by Tzaneio General Hospital at 1 site in Greece.
Trial summary
This study is designed for patients requiring surgery for Crohn's disease of the terminal ileum. A combination of laparoscopic segmental right colectomy with extended mesenteric excision and the Kono-s anastomosis will be utilized. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease (CD), Crohn Disease of Ileum, Kono S Anastomosis
- What is being tested?
- Mesenteric excision and exclusion
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2022to 31 Dec 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Community based study
Who may be able to join
- Males and females aged >16 years
- Ileocolic disease or disease of the terminal 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.
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.
Greece1 site, 1 recruiting
- Recruiting
General Hospital Of Piraeus "Tzaneio"
Piraeus, Attica, 18536
About this study
Official title: Laparoscopic Mesenteric Excision and Exclusion for Crohn's Disease of the Terminal Ileum. A Greek Single Center Study.
This study is designed for patients requiring surgery for Crohn's disease of the terminal ileum. A combination of laparoscopic segmental right colectomy with extended mesenteric excision and the Kono-s anastomosis will be utilized. Since this is a fairly new technique, the intra and post operative complications will be reviewed. Also endoscopic, clinical and surgical reoccurrence will be reviewed at certain predefined time points post operatively.
Read the detailed description
Crohn's disease is a chronic inflammatory disease that can affect any part of the gastrointestinal tract. The underlying etiology is still unknown, but it is perceived multifactorial and the effect of environmental and pathophysiological factors on a genetically predisposed individual.
Although the development of new pharmacological agents has revolutionized the management of Crohn's disease, the rates of endoscopic and surgical reoccurrence still remain discouraging. It is estimated that 50% of patients with Crohn's disease will require surgical intervention and the rate of surgical reoccurrence remains as high as 30% at 10 years.
Since most reoccurrences occur near or around the anastomotic site, the type of resection and anastomosis has been extensively reviewed in the past, but no significant differences have been observed. In the later years two new surgical techniques have been developed (extended mesenteric excision and Kono-S anastomosis), and increasing data show that they could potentially reduce the rate of reoccurrence. Both techniques focus on the role of the mesentery on disease reoccurrence. The extended mesenteric excision removes the mesentery and corresponding lymphatics of the affected bowel while the Kono-S anastomosis excludes the mesentery from the overlying wide anastomosis. The combination of the two techniques has been termed "mesenteric excision and exclusion" The primary goal of this study is to assess the safety the mesenteric excision and exclusion for Crohn's diseases disease of the terminal ileum in a central hospital of Greece. All intra and postoperative complications within 30 days will be collected and reviewed.
As secondary goals, the endoscopic, clinical and surgical reoccurrence will be reviewed at 6 months, 2 years and 5 years after the operation.
- Conditions
- Crohn Disease (CD), Crohn Disease of Ileum, Kono S Anastomosis, Extended Mesenteric Excision
- Being tested
- Mesenteric excision and exclusion
- Keywords
- Kono-s, extended mesenteric excision, mesenteric excision and exclusion
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenteric excision and exclusionProcedure or surgery
Laparoscopic segmental right colectomy and excision of the affected terminal ileum with extended mesenteric excision and open Kono-s anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Crohn's disease of the terminal ileum | Patients with Crohn's disease of the terminal ileum requiring surgical intervention Receives: Procedure: Mesenteric excision and exclusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the procedure
Collection of intra and post operative complication rate
Measured: 30 days post intervention
Secondary outcomes (3)
Endoscopic reoccurence
Endoscopic reoccurrence according to Rutgeert's score
Measured: 6 months, 2 years and 5 years post intervention
Clinical reoccurrence
Clinical symptoms severe enough to require new endoscopy
Measured: Up to 5 years
Surgical reoccurrence
Repeat surgery because of reoccurrence at the proximity of the Kono-S anastomosis
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start1 Jan 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2032 (estimated)
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 Crohn Disease (CD)Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Tzaneio General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Panagiotis Dikeakos, Tzaneio General Hospital
- Investigators
- Georgios Ayiomamitis, Study director, General Hospital of Piraeus "Tzaneio"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231601
- Sponsor's protocol ID
- 15094- 23/09/2025
- Status last verified
- Nov 2025
- First submitted
- 31 Aug 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient Characteristics
Publications
Kono T, Fichera A, Maeda K, Sakai Y, Ohge H, Krane M, Katsuno H, Fujiya M. Kono-S Anastomosis for Surgical Prophylaxis of Anastomotic Recurrence in Crohn's Disease: an International Multicenter Study. J Gastrointest Surg. 2016 Apr;20(4):783-90. doi: 10.1007/s11605-015-3061-3. Epub 2015 Dec 22.
PubMed 26696531Coffey 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 29309546Holubar SD, Gunter RL, Click BH, Achkar JP, Lightner AL, Lipman JM, Hull TL, Regueiro M, Rieder F, Steele SR. Mesenteric Excision and Exclusion for Ileocolic Crohn's Disease: Feasibility and Safety of an Innovative, Combined Surgical Approach With Extended Mesenteric Excision and Kono-S Anastomosis. Dis Colon Rectum. 2022 Jan 1;65(1):e5-e13. doi: 10.1097/DCR.0000000000002287.
PubMed 34882636
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Mesenteric Excision and Exclusion for Crohn's Disease of the Terminal Ileum. A Greek Single Center Study.
- ClinicalTrials.gov ID
- NCT07231601
- Acronym / sponsor ID
- 15094- 23/09/2025
- Conditions
- Crohn Disease (CD), Crohn Disease of Ileum, Kono S Anastomosis, Extended Mesenteric Excision
- Keywords
- Kono-s, extended mesenteric excision, mesenteric excision and exclusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tzaneio General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 17 Nov 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.
This study is designed for patients requiring surgery for Crohn's disease of the terminal ileum. A combination of laparoscopic segmental right colectomy with extended mesenteric excision and the Kono-s anastomosis will be utilized. Since this is a fairly new technique, the intra and post operative complications will be reviewed. Also endoscopic, clinical and surgical reoccurrence will be reviewed at certain predefined time points post operatively.
Detailed description
Crohn's disease is a chronic inflammatory disease that can affect any part of the gastrointestinal tract. The underlying etiology is still unknown, but it is perceived multifactorial and the effect of environmental and pathophysiological factors on a genetically predisposed individual.
Although the development of new pharmacological agents has revolutionized the management of Crohn's disease, the rates of endoscopic and surgical reoccurrence still remain discouraging. It is estimated that 50% of patients with Crohn's disease will require surgical intervention and the rate of surgical reoccurrence remains as high as 30% at 10 years.
Since most reoccurrences occur near or around the anastomotic site, the type of resection and anastomosis has been extensively reviewed in the past, but no significant differences have been observed. In the later years two new surgical techniques have been developed (extended mesenteric excision and Kono-S anastomosis), and increasing data show that they could potentially reduce the rate of reoccurrence. Both techniques focus on the role of the mesentery on disease reoccurrence. The extended mesenteric excision removes the mesentery and corresponding lymphatics of the affected bowel while the Kono-S anastomosis excludes the mesentery from the overlying wide anastomosis. The combination of the two techniques has been termed "mesenteric excision and exclusion" The primary goal of this study is to assess the safety the mesenteric excision and exclusion for Crohn's diseases disease of the terminal ileum in a central hospital of Greece. All intra and postoperative complications within 30 days will be collected and reviewed.
As secondary goals, the endoscopic, clinical and surgical reoccurrence will be reviewed at 6 months, 2 years and 5 years after the operation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Crohn's disease of the terminal ileum | – | Procedure: Mesenteric excision and exclusionPatients with Crohn's disease of the terminal ileum requiring surgical intervention |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Community based study
Key inclusion criteria (6 listed)
- Males and females aged >16 years
- Ileocolic disease or disease of the terminal 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.
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 |
|---|---|---|
| Mesenteric excision and exclusionLaparoscopic segmental right colectomy and excision of the affected terminal ileum with extended mesenteric excision and open Kono-s anastomosis | Procedure or surgery | Crohn's disease of the terminal ileum |
Primary outcome
Safety of the procedure
Time frame: 30 days post intervention
Collection of intra and post operative complication rate
3 secondary outcomes
Endoscopic reoccurence
Time frame: 6 months, 2 years and 5 years post intervention
Clinical reoccurrence
Time frame: Up to 5 years
Surgical reoccurrence
Time frame: Up to 5 years
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 17 Nov 2025.
- Background: PubMed 26696531Kono T, Fichera A, Maeda K, Sakai Y, Ohge H, Krane M, Katsuno H, Fujiya M. Kono-S Anastomosis for Surgical Prophylaxis of Anastomotic Recurrence in Crohn's Disease: an International Multicenter Study. J Gastrointest Surg. 2016 Apr;20(4):783-90. doi: 10.1007/s11605-015-3061-3. Epub 2015 Dec 22.
- 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.
- Background: PubMed 34882636Holubar SD, Gunter RL, Click BH, Achkar JP, Lightner AL, Lipman JM, Hull TL, Regueiro M, Rieder F, Steele SR. Mesenteric Excision and Exclusion for Ileocolic Crohn's Disease: Feasibility and Safety of an Innovative, Combined Surgical Approach With Extended Mesenteric Excision and Kono-S Anastomosis. Dis Colon Rectum. 2022 Jan 1;65(1):e5-e13. doi: 10.1097/DCR.0000000000002287.
- Individual participant dataSharing planned: Yes. Patient Characteristics
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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.
Georgios Ayiomamitis study director
General Hospital of Piraeus "Tzaneio"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease (CD) and Crohn Disease of Ileum, run by Tzaneio General Hospital at 1 site in Greece.
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 17 Nov 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 Greece. 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 Panagiotis Dikeakos, Consultant (Greece ext. 6948517126, dikeakosp@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the procedure (time frame: 30 days post intervention). 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 NCT07231601, 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 17 Nov 2025.