Abdominal Adhesions Clinical Trial
— OLTOSPAN-02Official title:
A Prospective, Randomized, Parallel, Single-blind Clinical Study of the Effectiveness, Tolerability and Safety of the Drug "Anti-spike, Gel, 100 g in Bottles in Package No. 1" Produced by the Republican Unitary Enterprise "Unitekhprom BSU", Belarus, With a Single Intraperitoneal Use After Surgical Interventions in Adult Patients With Acute Phlegmonous Appendicitis
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Presence of acute phlegmonous appendicitis requiring surgical intervention. - Presence of medium or high risk factor for the development of adhesions of the abdominal cavity; - Age of patients from 18 to 65 years. - Absence of severe concomitant diseases in decompensation stage, oncologic diseases, as well as diseases requiring steroid therapy. - Presence of written informed consent of the patient to participate in the study. - The patient's ability to fulfill the instructions of the research physician and comply with the study design. Exclusion Criteria: - At the subject own request without explaining the reasons for the behavior. - At the request of the physician-researcher if the subject violates the requirements of the protocol in terms of diet, smoking, consumption of alcoholic beverages, and use of medications without the prescription of the physician-researcher. - For reasons independent of the subject and the research physician, if the subject has drug intolerance or other life-threatening or life-threatening adverse reactions to drug administration that require emergency pharmacotherapy. |
Country | Name | City | State |
---|---|---|---|
Belarus | CITY CLINICAL EMERGENCY HOSPITAL of Minsk | Minsk | |
Belarus | CITY CLINICAL EMERGENCY HOSPITAL of Minsk | Minsk |
Lead Sponsor | Collaborator |
---|---|
Research Institute for Physical Chemical Problems of the Belarusian State University | City Clinical Hospital of Emergency Medical Care of Minsk, Unitary Enterprise UNITEHPROM BSU |
Belarus,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Primary | Number of patients with acute phlegmonous appendicitis cured | Number of patients cured | from surgery to 3 weeks | |
Secondary | absence of signs of adhesions | absence of signs of adhesions according to clinical and ultrasound studies | from surgery to 4 weeks |
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