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The Removing Port of the Laparoscopic Cholecystectomy Material

S

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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