The Removing Port of the Laparoscopic Cholecystectomy Material

NCT ID: NCT02788942

Last Updated: 2019-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-01-31

Brief Summary

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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

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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.

Conditions

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Wound Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Umbilical

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Epigastric

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

Group Type EXPERIMENTAL

Removing from Epigastric port

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ufuk Oguz Idiz

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cemal Kaya

Role: PRINCIPAL_INVESTIGATOR

Sisli Etfal Training and Research Hospital

Locations

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Sisli Etfal Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 27177957 (View on PubMed)

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.

Reference Type RESULT
PMID: 26411129 (View on PubMed)

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.

Reference Type RESULT
PMID: 24112669 (View on PubMed)

Other Identifiers

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Trochar

Identifier Type: -

Identifier Source: org_study_id

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