The Removing Port of the Laparoscopic Cholecystectomy Material

Wound Infection Clinical Trial

Official title:

The Relationship Between the Removing Port of the Laparoscopic Cholecystectomy Material and the Port Site Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02788942
• Other study ID #: Trochar
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: January 2017

Study information

• Verified date: February 2019
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Wound Infection

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Turkey	Sisli Etfal Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Comajuncosas J, Hermoso J, Gris P, Jimeno J, Orbeal R, Vallverdú H, López Negre JL, Urgellés J, Estalella L, Parés D. Risk factors for umbilical trocar site incisional hernia in laparoscopic cholecystectomy: a prospective 3-year follow-up study. Am J Surg — View Citation

Comajuncosas J, Hermoso J, Jimeno J, Gris P, Orbeal R, Cruz A, Parés D. Effect of bag extraction to prevent wound infection on umbilical port site wound on elective laparoscopic cholecystectomy: a prospective randomised clinical trial. Surg Endosc. 2017 J — View Citation

Farooq U, Rashid T, Naheed A, Barkat N, Iqbal M, Sultana Q. COMPLICATIONS OF LAPAROSCOPIC CHOLECYSTECTOMY: AN EXPERIENCE OF 247 CASES. J Ayub Med Coll Abbottabad. 2015 Apr-Jun;27(2):407-10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Port site infections	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.	2 days