Gallstone
Conditions
Keywords
Trocar site hernia, laparoscopic cholecystectomy, incisional hernia, port site hernia
Brief summary
The main purpose of this study is to determine whether removing the gallbladder through different incision sites (ports) during laparoscopic surgery affects the risk of developing an incisional hernia. All patients undergo the same number of incisions, and the surgical technique remains standardized. The study also aims to identify other factors that may contribute to the risk of hernia formation following gallbladder surgery.
Detailed description
Patients were blinded to group assignment. Randomization was conducted on the day of surgery by a surgical nurse using the Alea Randomisation mobile application (Alea Clinical Services, Abcoude, Netherlands). Group allocation (U for umbilical or E for epigastric) was placed in a sealed envelope and delivered to the operating room. The envelope was opened by the attending surgeon immediately prior to gallbladder retrieval. Due to the nature of the intervention, the operating surgeon could not be blinded; however, surgeons remained unaware of group allocation until the moment of specimen retrieval. All procedures were performed by one of three experienced surgeons. A conventional four-port laparoscopic cholecystectomy was performed in all cases, using a 10 mm umbilical camera trocar, a 10 mm epigastric trocar, and two 5 mm subcostal trocars. Gallbladder retrieval was performed using a laparoscopic specimen bag through one of the following approaches: Group U: Gallbladder retrieved through the umbilical trocar Group E: Gallbladder retrieved through the epigastric trocar After retrieval and hemostasis, all trocars were removed under direct laparoscopic vision. The umbilical fascia was closed using two interrupted polyglactin 910 sutures (Vicryl, Ethicon Inc., Edinburgh, Scotland), while the epigastric trocar fascia was left unsutured. Fascia closure practices were standardized and unrelated to group allocation. Total operation time and gallbladder retrieval time were recorded. All patients received paracetamol (Parol, Atabay İlaç, Istanbul, Türkiye) three times daily and tramadol (Contramal, Abdi İbrahim İlaç, Istanbul, Türkiye) twice daily for postoperative pain control. Pain was assessed using the Visual Analogue Scale (VAS) at 6 and 24 hours postoperatively, with the assistance of a ward nurse. Patients without complications were discharged on postoperative day 1. Those with complications were discharged following resolution of their condition. All patients were followed for one year postoperatively. Patients presenting with hernia-related symptoms (e.g., bulge or pain) underwent ultrasonography (USG) at symptom onset, while asymptomatic patients received routine USG at the six-month and one-year follow-ups. Radiologists performing USGs were not affiliated with the study and were not standardized. Incisional hernia was defined as a pathological fascial defect at a postoperative trocar site with protrusion of intraabdominal contents. Both clinically and radiologically diagnosed hernias were considered incisional hernias.
Interventions
PROCEDUREgallbladder extraction umbilical
extracting gallbladder via umbilical port site
PROCEDUREextracting gallbladder via epigastric port
extracting gallbladder via epigastric port
Sponsors
Fatih Basak
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A standard four-trocar LC was performed using a 10 mm umbilical camera trocar, a 10 mm epigastric trocar, and two 5 mm subcostal trocars. The gallbladder was retrieved using a laparoscopic specimen bag through either: Group U: Gallbladder retrieved via the umbilical trocar, Group E: Gallbladder retrieved via the epigastric trocar.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years, * Gallbladder stones * No known systemic comorbidities (e.g., cardiovascular, pulmonary, metabolic, or immunologic conditions)
Exclusion criteria
* Age \< 18 years, * Open cholecystectomy or conversion from laparoscopy to open surgery, * Acute cholecystitis * Prior intervention involving the common bile duct, * Presence of clinical or radiologic diastasis recti, * Presence of clinical or radiologic umbilical hernia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Trocar Site Hernia Following Laparoscopic Cholecystectomy | From operation to end of follow-up period at 1 year | The primary outcome is to determine whether the site of gallbladder retrieval influences the incidence of postoperative incisional hernia following laparoscopic cholecystectomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Assessed by Visual Analog Scale (VAS) at 6 and 24 Hours | From end of operation to postoperative 24 hours | This outcome evaluates the relationship between the gallbladder extraction site and postoperative pain, measured using the Visual Analog Scale (VAS) at 6 and 24 hours after surgery. The VAS is a 10-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain severity. |
| Incidence of Trocar Site Hernia in Relation to Patient- and Surgery-Related Risk Factors | From operation to end of follow-up period at 1 year | This outcome measures the incidence of trocar site hernia during a one-year follow-up and evaluates its statistical correlation with various clinical and surgical risk factors. These include age (years), sex (male/female), BMI (kg/m²), diabetes status (yes/no), extraction site location (umbilical or epigastric), fascial closure status (closed/open), and intraoperative widening of the extraction site (yes/no). The hernia diagnosis will be based on clinical evaluation and ultrasonographic confirmation. Data will be analyzed using correlation or regression methods to assess the strength of association between these variables and hernia development. |
Countries
Turkey (Türkiye)
Outcome results
None listed