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Today, there is no available equipment specifically designed for the procedure of instillation of fibrin glue for the repair of perianal fistulae. The currently used equipment involves surgical tools generally used for fistula surgeries, and injection syringes designed for general use. The injection of biological adhesives is performed using standard adhesive syringes that are not specially designed for use in perianal fistulae. The use of the semi-flexible metal probes can cause trauma to tissue and injure the fistula tract, creating an additional path, and the injection syringe and catheter are often inconvenient for perianal use. This study was design to test the use of Halevy kit, by gastroenterology specialist, as a non traumatic probing, mechanical debridement and injecting or inserting device for treatment substances in perianal fistulas. In this study a gastroenterologist will perform the procedure, in each procedure a trained colorectal surgeon will be present during the surgery to oversee the procedure and to provide surgical help if required.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Halevy kit | Device | the use of Halevy kit in Crohn patients with Fistulas |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success of cannulation of the perianal fistula using the Pathway Probe Catheter will be evaluated | after sugery | |
| Success in using the cleaning brush in preparing the fistula for biologic adhesive injection will be evaluated | after surgery | |
| Success in inserting a draining Seton into the fistula tract by the Halevy kit | after surgery | |
| Success of injecting biologic adhesive into the fistula tract using the designated catheter will be evaluated | after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Control of sphincter will be evaluated by -the Cleveland continence score | after follow up | |
| Discharge from fistula will be evaluated by a questionnaire comparing the situation before and after surgery. | after follow up |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant or lactating woman. Woman of childbearing potential will undergo a pregnancy test at the beginning of the trial
Known immunodeficiency.
Exclusion Criteria for injecting biologic adhesive:
Known Alcohol or drug abuse
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eran Mr Goldin, Prof | Contact | 02-6776848 | ||
| Haim Mr Halevi, Dr. | Contact | 052-2479211 |
| Name | Affiliation | Role |
|---|---|---|
| Eran MR Goldin, Prof | Hadassah Medical Organization | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah medical center | Jerusalem | Israel |
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| Healing of the fistula will be evaluated by a physical examination | after follow up |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D005402 | Fistula |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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