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Oxidative Stress in Standard Laparoscopic vs Single Port Cholecystectomy

NCT ID: NCT01211743

Last Updated: 2010-09-29

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

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-09-30

Brief Summary

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Study of Oxidative Stress Markers in order to assess whether there are differences between standard laparoscopic cholecystectomy vs single port cholecystectomy for uncomplicated cholelithiasis

Detailed Description

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Conditions

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Uncomplicated Cholelithiasis Cholecystectomy Laparoscopy Standard Technique Single Port Laparoscopy

Keywords

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SILS Oxidative Stress 8-epiPGF2a SILS vs standard laparoscopic cholecystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lap Group

Patients in this group are operated for uncomplicated cholelithiasis with standard 4 port laparoscopic cholecystectomy

Group Type ACTIVE_COMPARATOR

Laparoscopic cholecystectomy

Intervention Type OTHER

Standard 4 port laparoscopic cholecystectomy

Single incision laparoscopic cholecystectomy

Intervention Type OTHER

One port placed through the umbilicus

SILS group

Patients in this group are operated for uncomplicated cholelithiasis with Single Incision Laparoscopic Cholecystectomy

Group Type ACTIVE_COMPARATOR

Single incision laparoscopic cholecystectomy

Intervention Type OTHER

One port placed through the umbilicus

Interventions

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Laparoscopic cholecystectomy

Standard 4 port laparoscopic cholecystectomy

Intervention Type OTHER

Single incision laparoscopic cholecystectomy

One port placed through the umbilicus

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Demokrition University of Thrace

OTHER

Sponsor Role collaborator

University of Ioannina

OTHER

Sponsor Role collaborator

G. Hatzikosta General Hospital

OTHER

Sponsor Role lead

Responsible Party

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G Hatzikosta General Hospital of Ioannina

Locations

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G Hatzikosta General Hospital of Ioannina

Ioannina, Epirus, Greece

Site Status

Countries

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Greece

References

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Pappas-Gogos G, Tellis CC, Trypsianis G, Tsimogiannis KE, Tsimoyiannis EC, Simopoulos CE, Pitiakoudis M, Tselepis AD. Oxidative stress in multi-port and single-port cholecystectomy. J Surg Res. 2015 Mar;194(1):101-6. doi: 10.1016/j.jss.2014.09.020. Epub 2014 Sep 28.

Reference Type DERIVED
PMID: 25438954 (View on PubMed)

Other Identifiers

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GH-1948-06

Identifier Type: -

Identifier Source: org_study_id