Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease
NCT ID: NCT02631967
Last Updated: 2017-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
132 participants
INTERVENTIONAL
2015-11-30
2022-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparing Hand-sewn (END-TO-END or Kono-S) to Stapled Anastomosis in Ileocolic Resection for Crohn's Disease
NCT05578235
Ileocolic Resection for Complex Crohn's Disease
NCT03950726
Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy
NCT03019016
A Study to Investigate the Ileo Neo Rectal Anastomosis Compared to the Ileo Pouch Anal Anastomosis for Patients With Ulcerative Colitis
NCT00922103
Outcomes of Transanal Tran-section and Single-stapled (TTSS) Ileal Pouch-Anal Anastomosis
NCT06331637
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Kono anastomosis
Patients receiving Kono anastomosis
Kono anastomosis
Kono anastomosis
Stapled side-to-side anastomosis
Patients receiving stapled side-to-side anastomosis
Stapled side-to-side anastomosis
Stapled side-to-side anastomosis
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Kono anastomosis
Kono anastomosis
Stapled side-to-side anastomosis
Stapled side-to-side anastomosis
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* age \< 18 years
* inability to give the consent to the participation in the trial
* refusal to participate in the trial after receiving accurate information
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Federico II University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Luigi Bucci
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Luigi Bucci, Prof
Role: PRINCIPAL_INVESTIGATOR
Federico II University of Naples
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UOC Colonproctologia Chirurgica - Dipartimento di Medicina Clinica e Chirurgia - Università degli Studi di Napoli Federico II
Napoli, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Luglio 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
211/15
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.