Clinical trial NCT06365632: 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", With a Single Intraperitoneal Use After Surgery in Adult Patients With Acute Phlegmonous Appendicitis
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Abdominal Adhesions
Keywords: phlegmonous appendicitis
ketorolac tromethamine
gel
abdominal adhesions
Lead sponsor: Research Institute for Physical Chemical Problems of the Belarusian State University
Sponsor class: OTHER
Collaborators: name: Unitary Enterprise UNITEHPROM BSU
name: City Clinical Hospital of Emergency Medical Care of Minsk
First posted: 2024-04-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with acute phlegmonous appendicitis cured
timeFrame: from surgery to 3 weeks
Secondary outcomes:
measure: absence of signs of adhesions
timeFrame: from surgery to 4 weeks
Other outcomes:
measure: increase in the sliding distance of the cecum
timeFrame: from surgery to 7 days
Locations:
city: Minsk
country: Belarus
facility: CITY CLINICAL EMERGENCY HOSPITAL of Minsk
Study officials:
References: