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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crohn's disease of the terminal ileum | Patients with Crohn's disease of the terminal ileum requiring surgical intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenteric excision and exclusion | Procedure | Laparoscopic segmental right colectomy and excision of the affected terminal ileum with extended mesenteric excision and open Kono-s anastomosis |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the procedure | Collection of intra and post operative complication rate | 30 days post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic reoccurence | Endoscopic reoccurrence according to Rutgeert's score | 6 months, 2 years and 5 years post intervention |
| Clinical reoccurrence | Clinical symptoms severe enough to require new endoscopy |
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Inclusion Criteria:
Exclusion Criteria:
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Community based study
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Panagiotis Dikeakos, Consultant | Contact | Greece | 6948517126 | dikeakosp@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Georgios Ayiomamitis | General Hospital of Piraeus "Tzaneio" | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital Of Piraeus "Tzaneio" | Recruiting | Piraeus | Attica | 18536 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26696531 | Background | 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. | |
| 29309546 | Background |
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Patient Characteristics
01/01/2022- 31/12/2032
The information is freely available
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| Up to 5 years |
| Surgical reoccurrence | Repeat surgery because of reoccurrence at the proximity of the Kono-S anastomosis | Up to 5 years |
| Coffey 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. |
| 34882636 | Background | Holubar 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. |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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