Safer & More Efficient Closure of Trocar Wounds; Manual vs. Automated, a Pilot Trial

SUMMARY

Rationale
Laparoscopy is becoming the preferred method of surgery due to its enhanced recovery following urological, gynecologic and surgical procedure. For surgery, access to the abdomen is done by inserting trocars as work ports, through the abdominal wall. Adequate closure of these trocar wounds is done by running sutures 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%1 of cases. The Mediclose system has been designed to prevent herniation. The innovative mechanism of the Mediclose system places the fascia directly into the path of the needles, by reshaping the trocar wound into an ellipse. After the Mediclose system fires the needles, the suture is passed through the fascia, enabling wound closure.

Patients and Study Design
Patients undergoing laparoscopic surgery in the described participating hospitals, necessitating at least 1 trocars (not with open introduction) size 10-12mm will be asked to participate in this trial. Patients must be 18 years and older. Informed consent must be obtained from all patients. Patients undergoing palliative treatment or emergency surgery will be excluded from this study.

In total 40 patients will be included in the PILOT trial and the trocar wounds will be closed by the Mediclose system. 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

Data analyses
Data will be coded and prospectively collected and entered into a protected online database through eCRF’s. Data management is performed via an independent agency.

Study Endpoints
Primary objectives
1. Time needed for proper closure of the trocar wounds with the automated device

Secondary objectives
1. Demonstrate user-friendliness of the Mediclose System

Evaluation
Analysis of use of the Mediclose System and satisfaction with the device from professional perspective, including well-being of patient.

automatic closure of 10-12mm trocar wounds is faster and more efficient compared to manual suturing

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