Study of the Inflammatory Reaction in Standard vs Single Port Cholecystectomy for Uncomplicated Cholelithiasis

NCT ID: NCT01116492

Last Updated: 2010-05-21

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-05-31

Brief Summary

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This is a study of the inflammatory reaction in standard 4 port laparoscopic cholecystectomy vs Single Port Laparoscopic (SIL) cholecystectomy. It is assumed that the reduced trauma in SIL Cholecystectomy causes reduced inflammatory reaction compared to the 4 port laparoscopic cholecystectomy.

Detailed Description

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Two groups of 20 patients each are included in this study. Pre operatively, 6 and 24 hours postoperatively, blood is taken from these patients, it is centrifuged and the plasma is taken. IL-6, a-defensins and CRP are measured for each sample.

Conditions

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Cholelithiasis Inflammatory Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants 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

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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Single incision laparoscopic cholecystectomy

One port placed through the umbilicus

Intervention Type OTHER

Laparoscopic cholecystectomy

Standard 4 port laparoscopic cholecystectomy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Uncomplicated cholelithiasis
* American Society of Anesthesiologists (ASA) I or II
* No previous operations in upper abdomen
* Body mass index (BMI) \<30

Exclusion Criteria

* Cholecystitis
* ASA \> II
* BMI\>30
* Previous operations in upper abdomen
* Previous operations in intestine
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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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, , Greece

Site Status

Countries

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Greece

Other Identifiers

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GH-1948-05

Identifier Type: -

Identifier Source: org_study_id

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