Primary objectivesTime needed for proper closure of the trocar wounds with the automated deviceSecondary objectivesDemonstrate user-friendliness of the Mediclose System
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Time needed to close the trocar wounds with the automated device .
Secondary outcome
Self-reported easiness for the surgeons to close trocar wounds
Background summary
Laparoscopy is becoming the preferred method of surgery due to its enhanced
recovery following urological, gynecologic and surgical procedure. Access to
the abdomen for surgery is done by inserting trocars through the abdominal wall
as work ports. Adequate closure of these trocar wounds is done by sutures
running through the strong abdominal fascia surrounding the muscles. This
remains a challenge, especially in obese patients. Surgical hernia*s following
trocar wounds are found in 2-10% of cases.To circumvent these postoperative
problems Corporis Medical designed the MEDICLOSE system, to automatically close
these trocar wounds safely.
Study objective
Primary objectives
Time needed for proper closure of the trocar wounds with the automated device
Secondary objectives
Demonstrate user-friendliness of the Mediclose System
Study design
Pilot trial: the trocar wounds will be closed with the automated closure
device. Following closure the wound will be checked for adequate closure by
palpating with the finger. Time for closure of the wounds will be registered,
additionally the operating surgeon will be asked to score the easiness of
closure the wounds.
Intervention
After proper inclusion, the trocar wound is closed with the automated device
incorporating a suture identical to Vicryl suture thickness *0*. Following the
closure, the wound is palpated for adequate closure by the surgeon and
subsequently reported. Time to closure of the wounds is reported for both
techniques. Patients will receive standard post-operative care as described in
hospital protocol.
Study burden and risks
No substantial risk or burden is anticipated for patients participating in this
study. The developed device is operated under camera control. The sutures used
are standard Vicryl sutures.
P. Debyelaan 25 25
Maastricht 6229 HX
NL
P. Debyelaan 25 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Oral and written informed consent (IC)
Age 18 years and older
Elective surgery
Exclusion criteria
No informed consent
Palliative surgery
Emergency surgery
Mental handicap
Pregnancy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL67234.068.18 |
| Other | NL7636 |