A Comparison of Laparoscopic Cholecystectomy Versus Ultrasonic Dissection Assisted Minilaparotomy Cholecystectomy

NCT ID: NCT01723540

Last Updated: 2012-11-08

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

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-04-30

Brief Summary

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Minilaparatomy cholecystectomy with ultrasonic dissection (UsD) is rarely considered and therefore we investigate here the contributions of UsD in early recovery.

Detailed Description

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Conditions

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Postoperative Pain

Keywords

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Cholecystectomy,minilaparotomy,laparascopy,ultrasonic dissection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Minilaparotomy cholecystectomy with ultrasonic scissors

Minilaparotomy vs laparoscopy

Group Type EXPERIMENTAL

Minilaparotomy vs laparoscopy

Intervention Type PROCEDURE

MC-group will undergo ultrasonic dissection assisted minilaparotomy cholecystectomy ans patients in the LC-grout will undergo laparoscopic cholecystectomy

Laparoscopic cholecystectomy

Minilaparotomy vs laparoscopy

Group Type ACTIVE_COMPARATOR

Minilaparotomy vs laparoscopy

Intervention Type PROCEDURE

MC-group will undergo ultrasonic dissection assisted minilaparotomy cholecystectomy ans patients in the LC-grout will undergo laparoscopic cholecystectomy

Interventions

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Minilaparotomy vs laparoscopy

MC-group will undergo ultrasonic dissection assisted minilaparotomy cholecystectomy ans patients in the LC-grout will undergo laparoscopic cholecystectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ASA physical status 1-3
* Body mass index 18-30
* AGE 18 - 75 years

Exclusion Criteria

* Pregnancy or lactating
* common bile-duct stones
* acute cholecystitis
* previous upper abdominal operation
* Chirrosis
* Renal disease
* Pancreatitis
* ASA 4-5
* Participation of any other clinical trial within 30 days before the start of the screening period
* History of uncontrolled cardiovascular, epileptic disorder, psychosis.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kuopio University Hospital

Kuopio, , Finland

Site Status

Countries

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Finland

Other Identifiers

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KUH5204520

Identifier Type: -

Identifier Source: org_study_id