Phase 1
Completed N=50
Safety and Tolerability of Seroguard Use
Adhesion
Source: ClinicalTrials.gov NCT03640559 ↗
Enrolled (actual)
50
Serious AEs
6.4%
Results posted
May 2019
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) — 16; 17 Participants
Summary
The performed study of safety and tolerability of Seroguard, solution (JSC Pharmasyntez, Russia) in patients, undergoing planned laparoscopic cholecystectomy, demonstrated that patients from the both groups had the similar safety profile
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
16; 17 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female patients.
- Age from 18 to 75 years, inclusive.
- Signed informed consent form.
- One of the following diagnoses as per International classification of diseases -10:
4.1. K80.1 Calculus of gallbladder with other cholecystitis 4.2. K80.2 Calculus of gallbladder without cholecystitis
- Indications for planned laparoscopic cholecystectomy.
Exclusion Criteria
- Recall of informed consent by patient.
- Non-compliance with the rules of participating in the study by patient.
- Getting pregnant.
- Required conversion during surgery.
- Required repeated surgery.
- Development of diseases described in non-inclusion criteria, required use of drugs not provided by the protocol in patient.
- Another reasons appeared during the study and interfering conduction of the study as per the protocol.
Data sourced from ClinicalTrials.gov (NCT03640559). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.