The Removing Port of the Laparoscopic Cholecystectomy Material

Not Applicable

Completed

• Conditions: Wound Infection
• Interventions: Procedure: Removing from Epigastric port

• Registration Number: NCT02788942
• Lead Sponsor: Sisli Hamidiye Etfal Training and Research Hospital

Brief Summary

Laparoscopic cholecystectomy is gold standard for gallstones. In this study the investigators are investigating the effect of the removing of cholecystectomy material from different ports, to the port site infections.

Detailed Description

Laparoscopic cholecystectomy is gold standard for gallstones. But there is no consensus about which port place is optimal for the removing of the cholecystectomy material from the abdomen. There are different port site infections rates in the literature. The minimal tissue damage of laparoscopic cholecystectomy suggests a lower risk of wound infection, but there are series with an infection range of 8 %. The investigators are investigating is there any difference at the port site infection rates when the cholecystectomy material removed from different ports from the abdomen at the laparoscopic cholecystectomy.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-05-24
• Study First Submitted QC: 2016-05-27
• Study First Posted: 2016-06-02
• Primary Completion: 2016-12
• Study Completion: 2017-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-16
• Last Update Posted: 2019-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Subject has cholelithiasis

Exclusion Criteria

• Subject has perforated gallbladder
• Subject has malignancy
• Subject has increasing wall thickness of the gallbladder
• Subject has malignancy in the preoperative ultrasonography in the gallbladder
• Subject has pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epigastric	Removing from Epigastric port	The cholecystectomy material will be removed from epigastric port. This will be experimental group. Port site infection rates will be measured.

Primary Outcome Measures

Name	Time	Method
Port site infections	2 days	The cholecystectomy material will be removed from umbilical port at the control group, from the epigastric port at the experimental group. The port site infection rates will be noted.

Trial Locations

Locations (1)

Sisli Etfal Training and Research Hospital; 🇹🇷 Istanbul, Turkey