TSH Risk by Extraction Site in Lap Cholecystectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Gallstone
• Intervention / Treatment: Procedure: gallbladder extraction umbilical; Procedure: extracting gallbladder via epigastric port

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Umraniye
    • İstanbul, Umraniye, Turkey, 34760
      • Ümraniye Research and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Umbilical group (Group U); Gallbladder retrieved via the umbilical trocar following standard 4-port laparoscopic cholecystectomy	Procedure: gallbladder extraction umbilical; extracting gallbladder via umbilical port site
Active Comparator: Epigastric group (Group E); Gallbladder retrieved via the epigastric trocar following standard 4-port laparoscopic cholecystectomy	Procedure: extracting gallbladder via epigastric port; extracting gallbladder via epigastric port

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Trocar Site Hernia Following Laparoscopic Cholecystectomy	The primary outcome is to determine whether the site of gallbladder retrieval influences the incidence of postoperative incisional hernia following laparoscopic cholecystectomy.	From operation to end of follow-up period at 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Assessed by Visual Analog Scale (VAS) at 6 and 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.	From end of operation to postoperative 24 hours
Incidence of Trocar Site Hernia in Relation to Patient- and Surgery-Related Risk Factors	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.	From operation to end of follow-up period at 1 year

Collaborators and Investigators

• Sponsor: Fatih Basak

Publications and helpful links

General Publications

• Sood S, Imsirovic A, Sains P, Singh KK, Sajid MS. Epigastric port retrieval of the gallbladder following laparoscopic cholecystectomy is associated with the reduced risk of port site infection and port site incisional hernia: An updated meta-analysis of randomized controlled trials. Ann Med Surg (Lond). 2020 May 25;55:244-251. doi: 10.1016/j.amsu.2020.05.017. eCollection 2020 Jul.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2022
• Primary Completion (Actual): June 15, 2024
• Study Completion (Actual): April 4, 2025

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: April 23, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: laparoscopic cholecystectomy; incisional hernia; Trocar site hernia; port site hernia
• Additional Relevant MeSH Terms: Calculi; Pathological Conditions, Anatomical; Digestive System Diseases; Biliary Tract Diseases; Gallbladder Diseases; Cholelithiasis; Cholecystolithiasis; Gallstones
• Other Study ID Numbers: B.10.1.TKH.4.34.H.GP.0.01/27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Raw data, consent forms, CSR, SAP
• IPD Sharing Time Frame: Unending (e.g., "Beginning 1 year after publication with no end date")
• IPD Sharing Access Criteria: Statistical methods for those analyses must be approved by independent review. A proposal that describes planned analyses must be submitted
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No