TSH Risk by Extraction Site in Lap Cholecystectomy

NCT06953713 | Completed

• 1 other identifier: B.10.1.TKH.4.34.H.GP.0.01/27
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Gallstone

Keywords

Trocar site hernia; laparoscopic cholecystectomy; incisional hernia; port site hernia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  From end of operation to postoperative 24 hours

• 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

Study Arms (2)

Umbilical group (Group U)

EXPERIMENTAL

Gallbladder retrieved via the umbilical trocar following standard 4-port laparoscopic cholecystectomy

Procedure: gallbladder extraction umbilical

Epigastric group (Group E)

ACTIVE COMPARATOR

Gallbladder retrieved via the epigastric trocar following standard 4-port laparoscopic cholecystectomy

Procedure: extracting gallbladder via epigastric port

Interventions

gallbladder extraction umbilical PROCEDURE

extracting gallbladder via umbilical port site

Umbilical group (Group U)

extracting gallbladder via epigastric port PROCEDURE

extracting gallbladder via epigastric port

Epigastric group (Group E)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years,
• Gallbladder stones
• No known systemic comorbidities (e.g., cardiovascular, pulmonary, metabolic, or immunologic conditions)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fatih Basak: lead

Study Sites (1)

Umraniye Research and Training Hospital

Istanbul, Umraniye, 34760, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 32528673 BACKGROUND

MeSH Terms

Conditions

Gallstones; Incisional Hernia

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Hernia; Postoperative Complications; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: May 1, 2025
• Study Start: April 15, 2022
• Primary Completion: June 15, 2024
• Study Completion: April 4, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Unending (e.g., "Beginning 1 year after publication with no end date")
• Access Criteria: Statistical methods for those analyses must be approved by independent review. A proposal that describes planned analyses must be submitted

Locations

TU (1)