Fifty patients (14 males and 36 females) who underwent laparoscopic surgery were included in the study. The mean age was 40 years old (SD 15.73) and the mean body mass index (BMI) of all study patients was 39.21 (SD 9.20). Thirty-one patients were diagnosed with morbid obesity and were scheduled for bariatric laparoscopic surgery. The mean BMI of the morbidly obese patients was 42.74 (SD 6.86) and their mean weight was 118.71 kg (SD 24) (Table 1). Patients enrolled in the study were scheduled for laparoscopic procedures as detailed in Table 2.
Table 1
criteria | |
All patients (50) |
Gender | Male, N (%) | 14 (28%) |
| Female, N (%) | 36 (72%) |
Age (years) | Mean ± SD | 40.00 ± 15.73 |
median | 38.0 |
range | 19–84 |
Height (cm) | Mean ± SD | 165.33 ± 10.46 |
median | 164.0 |
range | 142–185 |
Weight (kg) | Mean ± SD | 102.37 ± 30.60 |
median | 104.0 |
range | 52–192 |
BMI (kg/m2) | Mean ± SD | 39.21 ± 9.20 |
median | 41.40 |
range | 21.40–65.10 |
Bariatric patients data (31) |
Height (cm) | Mean ± SD | 166.39 ± 9.29 |
median | 165.00 |
range | 150.00-185.00 |
Weight (kg) | Mean ± SD | 118.71 ± 24.00 |
median | 118.00 |
range | 55.00-192.00 |
BMI (kg/m2) | Mean ± SD | 42.74 ± 6.86 |
median | 42.10 |
range | 21.40–65.10 |
*SD- standard deviation |
Table 2
Procedure | N |
Sleeve gastrectomy | 24 |
Cholecystectomy | 9 |
Gastric bypass | 7 |
Gynecological | 4 |
Colorectal | 3 |
Nissen fundoplication | 2 |
Umbilical hernia | 1 |
*N-number |
All enrolled patients underwent laparoscopic surgery, during which at least one TroClose1200 device was used per patient. Thirty-two patients had three ports greater than or equal to 12 mm, four patients had two ports greater than or equal to 12 mm and only one patient had four ports greater than or equal to 12 mm. Twenty-three patients had one 12 mm port closed manually and four patients had two12mm ports closed manually. Five mm ports were not routinely sutured. Thirty-three patients had one port using the TroClose1200 device, 16 patients had two ports using the TroClose1200 device and one patient had three ports using the TroClose1200 device. Suturing was performed on ports of 12 mm and greater, ports that were widened due to tissue removal and ports located in the lower abdomen or in the midlines, all according to surgeon decision.
In 17 out of 19 cases in which tissue was extracted through a TroClose1200 port, the surgeons managed to close the port site with the previously deployed TroClose1200 closure system.
In three cases, the TroClose1200 was replaced successfully during the procedure with a 15 mm trocar. In these cases, the TroClose1200 cannula was removed patient and a 15 mm trocar was inserted into the existing port site without removing the anchors. At the end of the procedure, the 15 mm trocar was removed and the port site was closed using the TroClose1200 closure system.
Four cases of technical failure were reported: One minor gas leak, two incomplete closures following tissue extraction and one stopcock failure.
No severe adverse event (SAE) of any kind were observed and no device related adverse events were reported. A list of procedure related and general adverse events is detailed in Table 3.
Table 3
| Type of Event | Number of Events | Patients (50) | Patients (%) |
Procedure related adverse event | Incisional hernia | 1 | 1 | 2 |
Bleeding | 1 | 1 | 2 |
Other: epigastric pain, vomiting, abdominal pain, weakness, recurrent epigastric pain, dysphagia, abdominal wall pain (trocar site 5 mm) and suspected internal hernia | 9 | 6 | 12 |
Blood and lymphatic system disorders | Iron deficiency anemia | 1 | 1 | 2 |
Eye disorders | Blurred vision | 1 | 1 | 2 |
Gastrointestinal disorders | Abdominal pain | 7 | 5 | 10 |
Abdominal pain upper | 1 | 1 | 2 |
Pancreatitis acute | 1 | 1 | 2 |
General disorders and administration site conditions | Induration | 1 | 1 | 2 |
Pyrexia | 1 | 1 | 2 |
Hepatobiliary disorders | Biliary colic | 1 | 1 | 2 |
Biliary cyst | 1 | 1 | 2 |
Infections and infestations | Gastroenteritis | 1 | 1 | 2 |
Pneumonia | 1 | 1 | 2 |
Urinary tract infection | 2 | 1 | 2 |
Injury, poisoning and procedural complications | Drain site complication | 1 | 1 | 2 |
Medical device site induration | Medical device site induration | 2 | 2 | 4 |
Musculoskeletal and connective tissue disorders | Back pain | 2 | 2 | 4 |
Flank pain | 1 | 1 | 2 |
Musculoskeletal pain | 1 | 1 | 2 |
Nervous system disorders | Syncope | 1 | 1 | 2 |
Surgical and medical procedures | Hysterectomy | 1 | 1 | 2 |
*N-number |
The primary efficacy endpoint was defined as the ability of the TroClose1200 to serve as a working channel as well as the capability to close the abdominal fascia at the end of the procedure.
Surgeons were asked to evaluate the use of the trocar with a 1 to 5 score questionnaire. A score of 5 out of 5 was given in 46/50 patients for abdominal wall entry, 48/50 patients for deployment of the anchors, 41/50 patients for instrument use and replacement and in 47q50 patients for closure of the fascia. (Table 4).
Table 4
Surgeon assessment of ease of use of the TroClose1200
Ease of Use Question (Score 1–5) | No. | Mean | SD* | Median | Range | Percentage of 5/5 score [CI**] |
Penetrating the abdominal wall | 50 | 4.88 | 0.44 | 5.00 | 3.00–5.00 | 92.0% [80.8%-97.8%] |
Deployment of the anchors and sutures | 50 | 4.96 | 0.20 | 5.00 | 4.00–5.00 | 96.0% [86.3%-99.5%] |
Instrument use and replacement | 50 | 4.82 | 0.39 | 5.00 | 4.00–5.00 | 82.0% [68.6%-91.4%] |
Closure of the fascia | 50 | 4.92 | 0.34 | 5.00 | 3.00–5.00 | 94.0% [83.5%-98.7%] |
* SD- standard deviation |
** Confidence interval |
Patients were examined for PSH during the follow up meeting at two and six weeks (attendance rate of 47/50 and 44/50 patients, respectively) as well as at the one-year follow-up (attendance rate of 40/50).
Thirty-four patients (68%) also had an ultrasound at the one year.
One PSH was diagnosed at a 12 mm regular trocar port site which according to the data was sutured manually during the procedure. No PSH was diagnosed in port sites created and closed with the TroClose1200 device.