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
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of patients with acute phlegmonous appendicitis cured
研究概览
简要总结
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.
详细描述
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:
- To evaluate the immediate, rapid and long-term results of using Antispike as a drug for preventive adhesions in patients who have a medium and high risk factor for the development of adhesions and are undergoing surgery for acute phlegmonous appendicitis;
- Identify the possibility of undesirable effects that may occur when using the drug;
- to conduct a comparative assessment of the immediate results of using the drug Antispike as a means of preventing adhesions in patients with minor phlegmonous appendicitis with an effect in the control group, in patients in whom anti-adhesion drugs were not used;
- Detailed description of the conditions and method of use of the Antispike drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Surgical intervention due to acute phlegmanous appendicitis using the drug antispike
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.
干预措施: Antispike gel, 100 g in a flask, produced by UNITEHPROM BSU, Republic of Belarus (Drug)
Surgical intervention due to acute phlegmanous appendicitis using the drug antispike
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.
干预措施: antegrade appendectomy (Procedure)
surgical intervention due to acute phlegmanous appendicitis
An antegrade appendectomy is performed without using Antispike.
干预措施: antegrade appendectomy (Procedure)
结局指标
主要结局
Number of patients with acute phlegmonous appendicitis cured
时间窗: from surgery to 3 weeks
Number of patients cured
次要结局
- absence of signs of adhesions(from surgery to 4 weeks)