General Hospital Of Piraeus "Tzaneio"
Piraeus, Attica, 18536, Greece
Location status: Recruiting
NCT Number: NCT07231601
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.
Interested in participating?
Request Info16 year and older
All sexes
Observational
Piraeus, Attica, 18536, Greece
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Laparoscopic segmental right colectomy and excision of the affected terminal ileum with extended mesenteric excision and open Kono-s anastomosis
Time frame: 30 days post intervention
Collection of intra and post operative complication rate
Time frame: 6 months, 2 years and 5 years post intervention
Endoscopic reoccurrence according to Rutgeert's score
Time frame: Up to 5 years
Clinical symptoms severe enough to require new endoscopy
Time frame: Up to 5 years
Repeat surgery because of reoccurrence at the proximity of the Kono-S anastomosis
Contact information is provided by the study sponsor or research team.
Tzaneio General Hospital
Other
Laparoscopic Mesenteric Excision and Exclusion for Crohn's Disease of the Terminal Ileum. A Greek Single Center Study.
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