3-midline-ports Cholecystectomy

NCT ID: NCT01378819

Last Updated: 2011-06-22

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

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-12-31

Brief Summary

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The 3-midline-ports technique is a safety approach and associates lower postoperative pain, when compared with the standard "French" technique.

Detailed Description

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The patients will be randomized into 2 groups: those patients undergoing laparoscopic cholecystectomy following the "French" technique (Group 1) and those ones undergoing the 3-midline-ports approach (Group 2).

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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3-midline-ports laparoscopic cholecystectomy

The laparoscopic cholecystectomy will be performed through 3 ports placed in the line alba.

Intervention Type PROCEDURE

3-midline-ports laparoscopic cholecystectomy

Laparoscopic cholecystectomy will be performed through 3 ports placed in the line alba.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing elective cholecystectomy for symptomatic gallstones.

Exclusion Criteria

* Diagnosis of acute cholecystitis
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role lead

Responsible Party

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Hospital General de Elche

Other Identifiers

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UMH

Identifier Type: -

Identifier Source: org_study_id

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