The Removing Port of the Laparoscopic Cholecystectomy Material

Sisli Hamidiye Etfal Training and Research Hospital

Status: Completed

Conditions: Wound Infection

Treatments: Procedure: Removing from Epigastric port

Study type: Interventional

Funder types: Other

Identifiers

NCT02788942

Trochar

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Umbilical

No Intervention group

Description:

The cholecystectomy material will be removed from umbilical port as usual. This will be control group. Port site infection rates will be measured.

Epigastric

Experimental group

Description:

The cholecystectomy material will be removed from epigastric port. This will be experimental group. Port site infection rates will be measured.

Treatment:

Procedure: Removing from Epigastric port