Surgical Port Site Hernia
Conditions
Brief 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.
Detailed description
Port-site closure is a critical procedure after every laparoscopic surgery. Complications such as visceral organ injury, port-site hernia, infection, ascitic fluid leakage may occur during and after the procedure. Many devices were developed and utilized for the procedure and Carter-Thomason is one of the most commonly used device and validated with several studies. 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.
Interventions
DEVICEEZ close
EZ close used.
DEVICECarter Thomason
Carter Thomason used.
Sponsors
Saint Vincent's Hospital, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Taken to Complete Closure | At the time of surgery | The start of the procedure was defined as the point when the device was first inserted through the port-site and the end of the procedure was defined as the point when the port-site was removed from the port-site. A stopwatch was used to measure the time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Need for Additional Instrument | At the time of surgery | Need for additional instrument during procedure |
| Number of Participants With Port-site Hernia | 3 days post-op and within one months of surgery | Herniation of bowel segments through port-site |
| Number of Participants With Visceral Organ Injury | At the time of surgery | Any inadvertent injury to organs or bleeding during procedure. |
| Number of Participants With Ascitic Fluid Leakage | 3 days post-op and within one months of surgery | Non-infective fluid leakage |
| Number of Participants With Wound Dehiscence | 3 days post-op and within one months of surgery | Wound dehiscence that required further treatment |
| Number of Participants With Port-site Infection | 3 days post-op and within one months of surgery | Redness, purulent discharge, tenderness at port-site |
Countries
South Korea
Participant flow
Recruitment details
Eligible patients recruited between July 2017 and June 2018 at St. Vincent's Hospital.
Participants by arm
| Arm | Count |
|---|---|
| EZ Close Arm EZ close used for port-site closure.
EZ close: EZ close used. | 39 |
| Carter Thomason Arm Carter Thomason used for port-site closure.
Carter Thomason: Carter Thomason used. | 39 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | EZ Close Arm | Carter Thomason Arm | Total |
|---|---|---|---|
| Age, Continuous | 65.3 years STANDARD_DEVIATION 10 | 58.8 years STANDARD_DEVIATION 16.2 | 62.1 years STANDARD_DEVIATION 13.8 |
| Body mass index | 23.2 kg/m^2 STANDARD_DEVIATION 2.8 | 23.6 kg/m^2 STANDARD_DEVIATION 3.1 | 23.4 kg/m^2 STANDARD_DEVIATION 2.9 |
| Operation time | 211.7 minutes STANDARD_DEVIATION 90 | 217.3 minutes STANDARD_DEVIATION 77.6 | 214.5 minutes STANDARD_DEVIATION 83.6 |
| Operation type Laparoscopic partial nephrectomy | 1 Participants | 1 Participants | 2 Participants |
| Operation type Laparoscopic radical cystectomy | 2 Participants | 3 Participants | 5 Participants |
| Operation type Laparoscopic radical nephrectomy | 4 Participants | 6 Participants | 10 Participants |
| Operation type Laparoscopic radical prostatectomy | 4 Participants | 5 Participants | 9 Participants |
| Operation type Others | 2 Participants | 4 Participants | 6 Participants |
| Operation type Robot-assisted partial nephrectomy | 8 Participants | 8 Participants | 16 Participants |
| Operation type Robot-assisted radical cystectomy | 2 Participants | 1 Participants | 3 Participants |
| Operation type Robot-assisted radical nephrectomy | 0 Participants | 1 Participants | 1 Participants |
| Operation type Robot-assisted radical prostatectomy | 16 Participants | 10 Participants | 26 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 8 Participants | 11 Participants | 19 Participants |
| Sex: Female, Male Male | 31 Participants | 28 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 39 |
| other Total, other adverse events | 0 / 39 | 0 / 39 |
| serious Total, serious adverse events | 0 / 39 | 0 / 39 |
Outcome results
Primary
Time Taken to Complete Closure
The start of the procedure was defined as the point when the device was first inserted through the port-site and the end of the procedure was defined as the point when the port-site was removed from the port-site. A stopwatch was used to measure the time.
Time frame: At the time of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EZ Close Arm | Time Taken to Complete Closure | 36.8 seconds | Standard Deviation 10.1 |
| Carter Thomason Arm | Time Taken to Complete Closure | 48.9 seconds | Standard Deviation 21.5 |
Secondary
Number of Participants With Ascitic Fluid Leakage
Non-infective fluid leakage
Time frame: 3 days post-op and within one months of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EZ Close Arm | Number of Participants With Ascitic Fluid Leakage | 0 Participants |
| Carter Thomason Arm | Number of Participants With Ascitic Fluid Leakage | 0 Participants |
Secondary
Number of Participants With Need for Additional Instrument
Need for additional instrument during procedure
Time frame: At the time of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EZ Close Arm | Number of Participants With Need for Additional Instrument | 0 Participants |
| Carter Thomason Arm | Number of Participants With Need for Additional Instrument | 33 Participants |
Secondary
Number of Participants With Port-site Hernia
Herniation of bowel segments through port-site
Time frame: 3 days post-op and within one months of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EZ Close Arm | Number of Participants With Port-site Hernia | 0 Participants |
| Carter Thomason Arm | Number of Participants With Port-site Hernia | 0 Participants |
Secondary
Number of Participants With Port-site Infection
Redness, purulent discharge, tenderness at port-site
Time frame: 3 days post-op and within one months of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EZ Close Arm | Number of Participants With Port-site Infection | 1 Participants |
| Carter Thomason Arm | Number of Participants With Port-site Infection | 2 Participants |
Secondary
Number of Participants With Visceral Organ Injury
Any inadvertent injury to organs or bleeding during procedure.
Time frame: At the time of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EZ Close Arm | Number of Participants With Visceral Organ Injury | 0 Participants |
| Carter Thomason Arm | Number of Participants With Visceral Organ Injury | 0 Participants |
Secondary
Number of Participants With Wound Dehiscence
Wound dehiscence that required further treatment
Time frame: 3 days post-op and within one months of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EZ Close Arm | Number of Participants With Wound Dehiscence | 0 Participants |
| Carter Thomason Arm | Number of Participants With Wound Dehiscence | 0 Participants |