TSH Risk by Extraction Site in Lap Cholecystectomy

NCT ID: NCT06953713

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-15
• Study Completion Date: 2025-04-04

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.

Conditions

Gallstone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Umbilical group (Group U)

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

Group Type: EXPERIMENTAL

gallbladder extraction umbilical

Intervention Type: PROCEDURE

extracting gallbladder via umbilical port site

Epigastric group (Group E)

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

Group Type: ACTIVE_COMPARATOR

extracting gallbladder via epigastric port

Intervention Type: PROCEDURE

extracting gallbladder via epigastric port

Interventions

gallbladder extraction umbilical

extracting gallbladder via umbilical port site

Intervention Type: PROCEDURE

extracting gallbladder via epigastric port

extracting gallbladder via epigastric port

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fatih Basak

OTHER_GOV

Sponsor Role: lead

Responsible Party

Fatih Basak

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Umraniye Research and Training Hospital

Istanbul, Umraniye, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 32528673 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

B.10.1.TKH.4.34.H.GP.0.01/27

Identifier Type: -

Identifier Source: org_study_id