Effectiveness of the Video-assisted Umbilical Fascial Closure in Laparoscopic Cholecystectomy: Prospective Randomized Clinical Trial of 240 Patients
Phase: NA
Conditions: Cholelithiasis (Without Cholecystitis), Pain, Postoperative, Hernia Incisional
Sponsor: Samsun Education and Research Hospital

 
 
Study Protocol  
 
 
 
Protocol Title: Effectiveness of the video-assisted umbilical fascial closure in 
laparoscopic cholecystectomy: Prospective randomized clinical trial  
 
 
Protocol Version: v1.1/KAEK2020/3 /1 
 
 
Protocol Date:01/03/2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
I. Abstract 
 
This prospective randomized trial aims to compare two umbilical closure techniques for 
trocar site hernia (TSH) in laparoscopic cholecystectomy. A prospective randomized 
study will be performed including consecutive patients who underwent an elective 
laparoscopic cholecystectomy for symptomatic cholelithiasis during the 18 months. 
 
 
II. Background and Significance/Preliminary Studies 
 
Laparoscopic cholecystectomy is currently the gold standard in the treatment for 
symptomatic cholelithiasis that offers a variety of advantages over conventional open 
surgery such as shorter recovery time, better cosmesis, less wound complication rates, 
and less pain.1,2 Despite these advantages, LC can result in unique complications. Among 
these complications, trocar site hernia (TSH) is one of the most important complications 
because laparoscopic cholecystectomy promises smaller abdominal incisions and better 
cosmetic outcomes. A second surgical intervention due to TSH may overshadow the 
gains of the previous laparoscopic surgery. In studies conducted to date, the rate of trocar 
hernia in laparoscopic cholecystectomy has been presented at very different rates. Many 
studies have shown that the most frequent site of TSH is the umbilical trocar site.3-6  
To avoid this important complication of laparoscopic cholecystectomy, many different 
techniques have been described to date for trocar port fascia repair. 7-12 Most of these 
techniques require special devices. In addition, a few studies compare these techniques 
with standard fascial closure, which is mostly used by surgeons.11,12 
 
 
 
 
 
III. Study Aims 
 
We hypothesized that the fascial closure of the umbilical trocar incision under the 
intraabdominal vision with the laparoscopic camera could be reduced TSH. This 
prospective randomized controlled study aims to assess whether fascial closure of 
umbilical trocar site under direct laparoscopic vision in LC can reduce the incidence of 
TSH. 
 
 
IV. Administrative Organization 
 
Department of General Surgery, Samsun Training and Research Hospital 
 
V. Study Design 
All consecutive patients with symptomatic cholelithiasis who underwent elective LC 
between January 2020 and June 2021 will be considered for enrolment in the study. 

 
 
Patients who required urgent surgery due to acute cholecystitis will be excluded. The 
other exclusion criteria will be age under 18 years, previous umbilical hernia repair, 
and pre-existing umbilical hernia. All patients who enrolled in the trial will be 
provided an informed consent form 
 
The sample size calculation was based on the data of a previous study. TSH rate was 
6.6% in patients who underwent laparoscopic cholecystectomy. With a statistical power 
of 80% and a significance level of p <0.05, the required sample size was 92 patients. 
Statistical analysis was performed using IBM SPSS Statistics version 20.0 (SPSS Inc., 
Chicago, IL, 2011) for Windows. Results were compared by the Student-t test or Mann-
Whitney-U test for continuous variables and Chi-square or Fisher exact tests were used 
categorical variables. A p-value <0.05 was considered to represent statistical significance.  
 
The primary outcome endpoint in the study is the presence of a TSH. Secondary 
endpoints are operative complications, wound infection, hematoma, pain, and length of 
hospital stay. Patients will be evaluated by clinical examination. If the surgeon suspected 
a TSH, abdominal ultrasound and/or abdominal computed tomography will be carried 
out. Any wound hematoma will be considered as a postoperative complication when they 
limited daily activities or required drainage. Wound infection will be defined as the 
presence of pain, redness, and purulent discharge at the umbilical trocar incision. 
 
 
 
VI. Study Procedures 
 
All consecutive patients with symptomatic cholelithiasis who underwent elective LC 
between January 2020 and June 2021 will be considered for enrolment in the study. 
Patients who required urgent surgery due to acute cholecystitis will be excluded. The 
other exclusion criteria will be age under 18 years, previous umbilical hernia repair, and 
pre-existing umbilical hernia. 
 
Operations will be performed by four experienced surgeons. A supraumbilical transverse 
skin incision followed by an open technique with a vertical incision will be performed. 
Four trocars will be used. One 10-mm trocar was placed, and pneumoperitoneum will be 
obtained. A 30-degree endoscope will be inserted through this trocar. One 10-mm trocar 
(at the epigastrium) and two 5-mm trocars (at the right subcostal and lower right 
quadrant) were inserted under direct visualization. The gallbladder will be removed 
through the umbilical incision with an endo bag. The umbilical incision will be enlarged 
if needed to be for extraction of the gallbladder. After the extraction of the gallbladder, 
the size of the fascial defect will be measured directly using a ruler. The method of 
umbilical fascial closure for each patient will be determined using the computerized 
random generation of a number just before the operation. The number was given to the 
surgeon and the previously assigned umbilical fascial closure technique (assigned to that 
number) will be used. Patients will be randomly assigned to the umbilical closure non-
video-assisted (UC) and umbilical closure with video-assisted (UCVA) groups. 

 
 
 In the UC group, the umbilicus incision will be closed with an interrupted suture with 
synthetic absorbable 0 suture (Pedesente®, Dogsan A.S., Trabzon, Turkey). In the 
UCVA group, the laparoscope will be inserted the epigastric trocar and the umbilical 
fascial defect will be visualized intraabdominal. Then the defect will be closed an 
interrupted suture with synthetic absorbable 0 suture (Pedesente®, Dogsan A.S., 
Trabzon, Turkey) including all layers of the abdominal wall under the direct reverse 
vision of the defect with a 30° laparoscopic camera.  
The skin closure will be performed using a 3/0 polypropylene suture (Sterilen®, Dogsan 
A.S., Trabzon, Turkey). Patients' operative characteristics will be recorded after the 
operations. 
All patients will receive standard postoperative care, including mobilization and returning 
to a normal diet as quickly as possible. Patient-controlled analgesia (tramadol 100 mg) 
will be provided for the first 24 h after surgery. A nonsteroidal anti-inflammatory agent 
(diclofenac 25 mg, intramuscular, two times daily) will be given until discharge from the 
hospital.  
Visual analog scale (VAS; range 0- 10) will be evaluated one day before the surgery 
(VASP). Also, postoperative (PO) first day (VAS1) were recorded. 
Follow-up 
All patients will be scheduled to return for an outpatient visit in the second week and 
every three months after the surgery.  
 
 
VII. 
References 
 
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