Umraniye Research and Training Hospital
Istanbul, Umraniye, 34760, Turkey (Türkiye)
NCT Number: NCT06953713
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Istanbul, Umraniye, 34760, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
extracting gallbladder via umbilical port site
extracting gallbladder via epigastric port
Time frame: 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.
Time frame: 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.
Time frame: 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.
Fatih Basak
Other Gov
Umbilical Trochar Site Is The Usual Suspect For Trocar Hernia After Laparoscopic Cholecystectomy: A Prospective Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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