Crohn DiseaseSuPREMeCDNCT02631967
Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease
A study testing Kono anastomosis and Stapled side-to-side anastomosis in people with Crohn Disease, run by Federico II University at 1 site in Italy.
Trial summary
Kono and collegues have described a new anastomotic technique to restore bowel contintuity after ileocecal resection for Crohn's disease (CD). This tecnique implies a hand-sewn ileocolic anastomosis, that involves exclusively the antimesenteric side of the bowel and that functionally acts as an end-to-end anastomosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Kono anastomosis and Stapled side-to-side anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2015to Nov 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Crohn's disease requiring ileocecal resection
Who cannot join
- age > 75 years
- age < 18 years
- inability to give the consent to the participation in the trial
- refusal to participate in the trial after receiving accurate information
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
UOC Colonproctologia Chirurgica - Dipartimento di Medicina Clinica e Chirurgia - Università degli Studi di Napoli Federico II
Naples, 80121
Luigi Bucci, Prof, 00390817462850, luigi.bucci@unina.it
Mariano Cesare Giglio, Dr
About this study
Official title: A New Anastomotic Technique After Ileocecal Resection for Crohn's Disease. Kono-s Anastomosis vs Stapled Side-to-side Anastomosis: a Randomized Controlled Trial
Kono and collegues have described a new anastomotic technique to restore bowel contintuity after ileocecal resection for Crohn's disease (CD).
This tecnique implies a hand-sewn ileocolic anastomosis, that involves exclusively the antimesenteric side of the bowel and that functionally acts as an end-to-end anastomosis.
Read more
In a retrospective study, the authors have shown that this anastomotic tecnique, when compared to stapled side-to-side anastomosis, significantly reduces the severity of endoscopic recurrence at 1 year after surgery and the rate of reoperation for anastomotic recurrence at 5 years after surgery.
Aim of this trial is to compare the outcomes of the Kono anastomosis with the ones achieved by the stapled side-to-side anastomosis, within a prospective randomized study.
- Conditions
- Crohn Disease
- Being tested
- Kono anastomosis, Stapled side-to-side anastomosis
- Keywords
- Crohn disease, ileocecal resection, anastomosis, Kono
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kono anastomosisProcedure or surgery
Kono anastomosis
Stapled side-to-side anastomosisProcedure or surgery
Stapled side-to-side anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Kono anastomosis | Experimental | Patients receiving Kono anastomosis Receives: Procedure: Kono anastomosis |
| Stapled side-to-side anastomosis | Experimental | Patients receiving stapled side-to-side anastomosis Receives: Procedure: Stapled side-to-side anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade of endoscopic recurrence
Severity of endoscopic recurrence (graded according to Rutgeerts' score) at the site of anastomosis at 6 months after surgery.
Measured: 6 Months
Surgical recurrence
Rate of patients requiring resection for anastomotic recurrence within 5 years after surgery
Measured: Up to 5 years
Secondary outcomes (9)
Endoscopic recurrence
Presence of endoscopic recurrence
Measured: 6 months up to 5 years
Grade of endoscopic recurrence
Severity of endoscopic recurrence at the site of anastomosis
Measured: 6 months up to 5 years
Clinical recurrence
Presence of clinical recurrence (according to Crohn's disease activity index)
Measured: Up to 5 years
Operating time
Duration of the operation (min)
Measured: Intraoperatively
Anastomosis time
Time (min) required to perform the anastomosis
Measured: Intraoperatively
Anastomotic leak
Incidence of anastomotic leak
Measured: Up to 30 days
Surgical re-intervention
Rate of patients requiring surgical re-intervention
Measured: Up to 30 days
Postoperative morbidity rate
Postoperative surgical (bleeding, obstruction, postoperative ileus, abdominal collection, wound infection) and medical morbidity as well as mortality will be documented and graded according to the Dindo Clavien classification
Measured: Up to 30 days
Recovery times
Length of post-operative hospital stay, time to first flatus, time to first defecation, time to tolerance of liquid and solid diet will be documented
Measured: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2017 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Federico II UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Bucci, Federico II University
- Investigators
- Luigi Bucci, Prof, Principal investigator, Federico II University of Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631967
- Sponsor's protocol ID
- 211/15
- Acronym
- SuPREMeCD
- Status last verified
- Feb 2017
- First submitted
- 29 Nov 2015
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Kono T, Ashida T, Ebisawa Y, Chisato N, Okamoto K, Katsuno H, Maeda K, Fujiya M, Kohgo Y, Furukawa H. A new antimesenteric functional end-to-end handsewn anastomosis: surgical prevention of anastomotic recurrence in Crohn's disease. Dis Colon Rectum. 2011 May;54(5):586-92. doi: 10.1007/DCR.0b013e318208b90f.
PubMed 21471760Luglio 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 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Anastomotic Technique After Ileocecal Resection for Crohn's Disease. Kono-s Anastomosis vs Stapled Side-to-side Anastomosis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02631967
- Acronym / sponsor ID
- SuPREMeCD / 211/15
- Conditions
- Crohn Disease
- Keywords
- Crohn disease, ileocecal resection, anastomosis, Kono
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 16 Dec 2015 (estimated)
- 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.
Kono and collegues have described a new anastomotic technique to restore bowel contintuity after ileocecal resection for Crohn's disease (CD).
This tecnique implies a hand-sewn ileocolic anastomosis, that involves exclusively the antimesenteric side of the bowel and that functionally acts as an end-to-end anastomosis.
In a retrospective study, the authors have shown that this anastomotic tecnique, when compared to stapled side-to-side anastomosis, significantly reduces the severity of endoscopic recurrence at 1 year after surgery and the rate of reoperation for anastomotic recurrence at 5 years after surgery.
Aim of this trial is to compare the outcomes of the Kono anastomosis with the ones achieved by the stapled side-to-side anastomosis, within a prospective randomized study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kono anastomosis | Experimental | Procedure: Kono anastomosisPatients receiving Kono anastomosis |
| Stapled side-to-side anastomosis | Experimental | Procedure: Stapled side-to-side anastomosisPatients receiving stapled side-to-side anastomosis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Crohn's disease requiring ileocecal resection
Key exclusion criteria (4 listed)
- age > 75 years
- age < 18 years
- inability to give the consent to the participation in the trial
- refusal to participate in the trial after receiving accurate information
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 |
|---|---|---|
| Kono anastomosisKono anastomosis | Procedure or surgery | Kono anastomosis |
| Stapled side-to-side anastomosisStapled side-to-side anastomosis | Procedure or surgery | Stapled side-to-side anastomosis |
Primary outcome
Grade of endoscopic recurrence
Time frame: 6 Months
Severity of endoscopic recurrence (graded according to Rutgeerts' score) at the site of anastomosis at 6 months after surgery.
Surgical recurrence
Time frame: Up to 5 years
Rate of patients requiring resection for anastomotic recurrence within 5 years after surgery
9 secondary outcomes
Endoscopic recurrence
Time frame: 6 months up to 5 years
Grade of endoscopic recurrence
Time frame: 6 months up to 5 years
Clinical recurrence
Time frame: Up to 5 years
Operating time
Time frame: Intraoperatively
Anastomosis time
Time frame: Intraoperatively
Anastomotic leak
Time frame: Up to 30 days
Surgical re-intervention
Time frame: Up to 30 days
Postoperative morbidity rate
Time frame: Up to 30 days
Recovery times
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Background: PubMed 21471760Kono T, Ashida T, Ebisawa Y, Chisato N, Okamoto K, Katsuno H, Maeda K, Fujiya M, Kohgo Y, Furukawa H. A new antimesenteric functional end-to-end handsewn anastomosis: surgical prevention of anastomotic recurrence in Crohn's disease. Dis Colon Rectum. 2011 May;54(5):586-92. doi: 10.1007/DCR.0b013e318208b90f.
- Derived from this study: 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.
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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.
Luigi Bucci, Prof principal investigator
Federico II University of Naples
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kono anastomosis and Stapled side-to-side anastomosis in people with Crohn Disease, run by Federico II University 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 1 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: status not confirmed, as of the sponsor's last update on 15 Feb 2017. 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 Luigi Bucci, Prof (00390817462850, luigi.bucci@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade of endoscopic recurrence (time frame: 6 Months). The study lists 2 primary outcomes in all. 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 NCT02631967, which also lists 2 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 15 Feb 2017.