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| Name | Class |
|---|---|
| Unitary Enterprise UNITEHPROM BSU | UNKNOWN |
| City Clinical Hospital of Emergency Medical Care of Minsk | UNKNOWN |
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The purpose of the clinical trials is the evaluation of the effectiveness and safety of a single intraperitoneal use of the drug "Antispike, gel, 100 g in a bottle" produced by Unitary Enterprise Unitehprom BSU, Belarus in patients after surgical control of acute phlegmonous appendicitis to prevent abdominal adhesions.
The prospective, randomized, placebo-controlled, single-blind clinical trial of the effectiveness, tolerability and safety of the drug "Antispike, gel, 100 g in a bottle" produced by Unitary Enterprise Unitehprom BGU, Republic of Belarus, in adult patients after surgery for acute phlegmonous appendicitis.
Research objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical intervention due to acute phlegmanous appendicitis using the drug antispike | Experimental | Placebo-controlled, single-blind clinical trial of the effectiveness, tolerability and safety of the drug "Antispike, gel, 100 g in a bottle" produced by Unitary Enterprise Unitehprom BGU, Republic of Belarus, in adult patients after surgery for acute phlegmonous appendicitis. An antegrade appendectomy is performed, after which the drug Antispike is used. |
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| surgical intervention due to acute phlegmanous appendicitis | Sham Comparator | An antegrade appendectomy is performed without using Antispike. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antispike gel, 100 g in a flask, produced by UNITEHPROM BSU, Republic of Belarus | Drug | An antegrade appendectomy is performed, after which 50 to 100 ml of Antispike is applied in a thin layer to the surface of the cecum, the surface of adjacent organs and the parietal peritoneum of the right iliac region. The wound is sutured tightly. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with acute phlegmonous appendicitis cured | Number of patients cured | from surgery to 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| absence of signs of adhesions | absence of signs of adhesions according to clinical and ultrasound studies | from surgery to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| increase in the sliding distance of the cecum | increase in the sliding distance of the cecum, determined by the results of an ultrasound examination on the 7th day after appendectomy | from surgery to 7 days |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CITY CLINICAL EMERGENCY HOSPITAL of Minsk | Minsk | 220024 | Belarus |
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| antegrade appendectomy | Procedure | An antegrade appendectomy is performed without using Antispike. |
|