Back to resultsThe Removing Port of the Laparoscopic Cholecystectomy Material
Primary Purpose
Wound Infection
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Removing from Epigastric port
Sponsored by
About this trial
This is an interventional screening trial for Wound Infection focused on measuring Port, Infection, cholecystectomy
Eligibility Criteria
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
Sites / Locations
- Sisli Etfal Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Umbilical
Epigastric
Arm Description
The cholecystectomy material will be removed from umbilical port as usual. This will be control group. Port site infection rates will be measured.
The cholecystectomy material will be removed from epigastric port. This will be experimental group. Port site infection rates will be measured.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02788942
First Posted
May 24, 2016
Last Updated
February 16, 2019
Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02788942
Brief Title
The Removing Port of the Laparoscopic Cholecystectomy Material
Official Title
The Relationship Between the Removing Port of the Laparoscopic Cholecystectomy Material and the Port Site Infections
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infection
Keywords
Port, Infection, cholecystectomy
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Umbilical
Arm Type
No Intervention
Arm Description
The cholecystectomy material will be removed from umbilical port as usual. This will be control group. Port site infection rates will be measured.
Arm Title
Epigastric
Arm Type
Experimental
Arm Description
The cholecystectomy material will be removed from epigastric port. This will be experimental group. Port site infection rates will be measured.
Intervention Type
Procedure
Intervention Name(s)
Removing from Epigastric port
Intervention Description
The cholecystectomy material will be removed from epigastric port. This will be experimental group. Port site infection rates will be measured
Primary Outcome Measure Information:
Title
Port site infections
Description
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.
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cemal Kaya
Organizational Affiliation
Sisli Etfal Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sisli Etfal Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34371
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Once a three months time
Citations:
PubMed Identifier
27177957
Citation
Comajuncosas J, Hermoso J, Jimeno J, Gris P, Orbeal R, Cruz A, Pares 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 Jan;31(1):249-254. doi: 10.1007/s00464-016-4965-z. Epub 2016 May 13.
Results Reference
result
PubMed Identifier
26411129
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.
Results Reference
result
PubMed Identifier
24112669
Citation
Comajuncosas J, Hermoso J, Gris P, Jimeno J, Orbeal R, Vallverdu H, Lopez Negre JL, Urgelles J, Estalella L, Pares D. Risk factors for umbilical trocar site incisional hernia in laparoscopic cholecystectomy: a prospective 3-year follow-up study. Am J Surg. 2014 Jan;207(1):1-6. doi: 10.1016/j.amjsurg.2013.05.010. Epub 2013 Oct 7.
Results Reference
result
Learn more about this trial
The Removing Port of the Laparoscopic Cholecystectomy Material
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