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Day Case Laparoscopic Cholecystectomy: Fundus First With Ultrasonic Dissection or Conventional Diathermy Hook

NCT ID: NCT01553331

Last Updated: 2014-12-11

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

169 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-10-31

Brief Summary

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Day case laparoscopic cholecystectomy can be made with conventional diathermy hook starting at triangle of Calot´s. Ultrasonic dissection starting from the gallbladder fundus is another option. The aim is to test the hypothesis that with ultrasonic dissection technique a better same day discharge and a shorter operative time can be achieved.

Detailed Description

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After initiation of general anesthesia patients are randomized either to conventional or ultrasonic dissection group. The patients and recovery room personnel are blinded to the operative technique used.

Conditions

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Cholecystolithiasis

Keywords

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laparoscopic cholecystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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conventional diathermy hook

Laparoscopic cholecystectomy made with diathermy hook starting from Calot´s triangle

Group Type ACTIVE_COMPARATOR

dissection of gallbladder in laparoscopic cholecystectomy

Intervention Type PROCEDURE

Laparoscopic cholecystectomy with diathermy hook starting from triangle of Calot

ultrasonic dissection

Laparoscopic cholecystectomy made with ultrasonic dissection starting from gallbladder fundus

Group Type ACTIVE_COMPARATOR

dissection of gallbladder in laparoscopic cholecystectomy

Intervention Type PROCEDURE

laparoscopic cholecystectomy with ultrasonic scissors starting from fundus

Interventions

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dissection of gallbladder in laparoscopic cholecystectomy

Laparoscopic cholecystectomy with diathermy hook starting from triangle of Calot

Intervention Type PROCEDURE

dissection of gallbladder in laparoscopic cholecystectomy

laparoscopic cholecystectomy with ultrasonic scissors starting from fundus

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ASA I-II
* BMI under 35
* normal liver enzymes
* no bile duct dilatation in ultrasound
* cholecystolithiasis

Exclusion Criteria

* NSAID allergy
* previous upper gi-surgery
* common bile duct stones in preoperative imaging
* history of severe acute pancreatitis
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Finland Hospital District

OTHER

Sponsor Role lead

Responsible Party

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Anne Mattila

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ilmo Kellokumpu, Docent

Role: STUDY_DIRECTOR

Jyvaskyla Central Hospital

Anne K Mattila, MD

Role: PRINCIPAL_INVESTIGATOR

Jyvaskyla Central Hospital

Locations

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Jyvaskyla Central Hospital

Jyväskylä, Jyvaskyla, Finland

Site Status

Countries

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Finland

References

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Cengiz Y, Janes A, Grehn A, Israelsson LA. Randomized trial of traditional dissection with electrocautery versus ultrasonic fundus-first dissection in patients undergoing laparoscopic cholecystectomy. Br J Surg. 2005 Jul;92(7):810-3. doi: 10.1002/bjs.4982.

Reference Type BACKGROUND
PMID: 15880649 (View on PubMed)

Cengiz Y, Dalenback J, Edlund G, Israelsson LA, Janes A, Moller M, Thorell A. Improved outcome after laparoscopic cholecystectomy with ultrasonic dissection: a randomized multicenter trial. Surg Endosc. 2010 Mar;24(3):624-30. doi: 10.1007/s00464-009-0649-2. Epub 2009 Aug 18.

Reference Type BACKGROUND
PMID: 19688393 (View on PubMed)

Other Identifiers

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KSSHPB10208

Identifier Type: -

Identifier Source: org_study_id