Skip to main content
OpenTrials
Completed

NCT Number: NCT06953713

TSH Risk by Extraction Site in Lap Cholecystectomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Umraniye Research and Training Hospital

Istanbul, Umraniye, 34760, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

gallbladder extraction umbilical

Procedure

extracting gallbladder via umbilical port site

extracting gallbladder via epigastric port

Procedure

extracting gallbladder via epigastric port

Primary outcomes

  1. Incidence of Trocar Site Hernia Following Laparoscopic Cholecystectomy

    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.

Secondary outcomes

  1. Postoperative Pain Assessed by Visual Analog Scale (VAS) at 6 and 24 Hours

    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.

  2. Incidence of Trocar Site Hernia in Relation to Patient- and Surgery-Related Risk Factors

    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.

Sponsors and collaborators

Lead sponsor

Fatih Basak

Other Gov

Registry information

Official study title

Umbilical Trochar Site Is The Usual Suspect For Trocar Hernia After Laparoscopic Cholecystectomy: A Prospective Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
May 1, 2025
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.