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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kono anastomosis | Experimental | Patients receiving Kono anastomosis |
|
| Stapled side-to-side anastomosis | Experimental | Patients receiving stapled side-to-side anastomosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kono anastomosis | Procedure | Kono anastomosis |
| |
| Stapled side-to-side anastomosis |
| Measure | Description | Time Frame |
|---|---|---|
| Grade of endoscopic recurrence | Severity of endoscopic recurrence (graded according to Rutgeerts' score) at the site of anastomosis at 6 months after surgery. | 6 Months |
| Surgical recurrence | Rate of patients requiring resection for anastomotic recurrence within 5 years after surgery | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic recurrence | Presence of endoscopic recurrence | 6 months up to 5 years |
| Grade of endoscopic recurrence | Severity of endoscopic recurrence at the site of anastomosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luigi Bucci, Prof | Contact | 00390817462850 | luigi.bucci@unina.it |
| Name | Affiliation | Role |
|---|---|---|
| Luigi Bucci, Prof | Federico II University of Naples | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UOC Colonproctologia Chirurgica - Dipartimento di Medicina Clinica e Chirurgia - Università degli Studi di Napoli Federico II | Recruiting | Naples | 80121 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21471760 | Background | 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. | |
| 32675483 | Derived |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Procedure |
Stapled side-to-side anastomosis |
|
| 6 months up to 5 years |
| Clinical recurrence | Presence of clinical recurrence (according to Crohn's disease activity index) | Up to 5 years |
| Operating time | Duration of the operation (min) | Intraoperatively |
| Anastomosis time | Time (min) required to perform the anastomosis | Intraoperatively |
| Anastomotic leak | Incidence of anastomotic leak | Up to 30 days |
| Surgical re-intervention | Rate of patients requiring surgical re-intervention | 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 | 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 | Participants will be followed for the duration of hospital stay, an expected average of 5 days |
| 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. |
| D007410 | Intestinal Diseases |