Abdominal Adhesions
Conditions
Keywords
phlegmonous appendicitis, ketorolac tromethamine, gel, abdominal adhesions
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.
Interventions
DRUGAntispike gel, 100 g in a flask, produced by UNITEHPROM BSU, Republic of Belarus
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.
PROCEDUREantegrade appendectomy
An antegrade appendectomy is performed without using Antispike.
Sponsors
Unitary Enterprise UNITEHPROM BSU
City Clinical Hospital of Emergency Medical Care of Minsk
Research Institute for Physical Chemical Problems of the Belarusian State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with acute phlegmonous appendicitis cured | from surgery to 3 weeks | Number of patients cured |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| absence of signs of adhesions | from surgery to 4 weeks | absence of signs of adhesions according to clinical and ultrasound studies |
Other
| Measure | Time frame | Description |
|---|---|---|
| increase in the sliding distance of the cecum | from surgery to 7 days | increase in the sliding distance of the cecum, determined by the results of an ultrasound examination on the 7th day after appendectomy |
Countries
Belarus
Outcome results
None listed