Amsterdam UMC - Location AMC
Amsterdam, Meibergdreef 9, 1105 AZ, Netherlands
NCT Number: NCT04538638
The aim of this multicenter randomised controlled trial is to analyse the six month endoscopic recurrence following a mesenteric sparing versus a central mesenterectomy performing an ileocolic resection for CD.
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Notify Me16 year and older
All sexes
Interventional
Not applicable
Amsterdam, Meibergdreef 9, 1105 AZ, Netherlands
There is emerging evidence to suggest that Crohn's disease (CD) may be a disease of the mesentery rather than just of the bowel alone. A more extensive central mesenterectomy (up to the level of the ileocolic artery), in order to remove an increased volume of affected mesentery to prevent postoperative CD, has been suggested to lead to beneficial results. It is hypothesised that patients who undergo a central mesenterectomy during an ileocolic resection compared to a mesenteric sparing ileocolic resection will have decreased recurrence rates.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
Mesentery left in situ
Mesentery is taken up to the level of the ileocolic trunk
Time frame: 6 months after surgery
Time frame: 30 days after surgery
Number of patients with Postoperative morbidity
Time frame: 1 year after surgery
Number of patients with Clinical recurrence rate following ileocolic resection
Time frame: 1 year after surgery
.The need for restarting immunosuppressive medication within the first year postoperatively for endoscopic or clinical recurrence
Time frame: 5 years
The 5 year reoperation rate for recurrence of disease at the anastomotic site.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Other
Acronym: SPICY
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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