NCT02788942

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 2, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

February 19, 2019

Status Verified

February 1, 2019

Enrollment Period

9 months

First QC Date

May 24, 2016

Last Update Submit

February 16, 2019

Conditions

Wound Infection

Keywords

PortInfectioncholecystectomy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Umbilical

NO INTERVENTION

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

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

Procedure: Removing from Epigastric port

Interventions

Removing from Epigastric portPROCEDURE

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

Epigastric

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has cholelithiasis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sisli Etfal Training and Research Hospital

Istanbul, 34371, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 27177957RESULT

  • 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.

    PMID: 26411129RESULT

  • 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.

    PMID: 24112669RESULT

MeSH Terms

Conditions

Wound InfectionInfections

Study Officials

  • Cemal Kaya

    Sisli Etfal Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

May 24, 2016

First Posted

June 2, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

February 19, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will share

Once a three months time

Locations

TU(1)