N/A
N=79
Prospective Study on a Novel Port-site Closure Device (EZ Close): Effectiveness and Comparison With Carter-Thomason
Surgical Port Site Hernia
Bottom Line
View on ClinicalTrials.gov: NCT03374189 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Time Taken to Complete Closure — 36.8; 48.9 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EZ close (Device); Carter Thomason (Device)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Saint Vincent's Hospital, Korea
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Taken to Complete Closure |
36.8; 48.9 | — |
| SECONDARY Number of Participants With Visceral Organ Injury |
0; 0 | — |
| SECONDARY Number of Participants With Need for Additional Instrument |
0; 33 | — |
| SECONDARY Number of Participants With Port-site Hernia |
0; 0 | — |
| SECONDARY Number of Participants With Port-site Infection |
1; 2 | — |
| SECONDARY Number of Participants With Ascitic Fluid Leakage |
0; 0 | — |
| SECONDARY Number of Participants With Wound Dehiscence |
0; 0 | — |
Summary
This study aims to evaluate the efficacy and safety of a novel port-site closure device (EZ Close) by comparing it with the Carter-Thomason device.
Eligibility Criteria
Inclusion Criteria
- All patients with laparoscopic ports over 10mm
Exclusion Criteria
- Patients with laparoscopic ports under 10mm
- Patients who refused the study
- Patients who received concurrent surgery for other reason
Data sourced from ClinicalTrials.gov (NCT03374189). 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.