Laparoscopic Cholecystectomy - Fundus First and Harmonic Ace Compared With Conventional Technique

Cholecystectomy Clinical Trial

Official title:

Randomized Multicentre Trial: Comparison of Harmonic Ace and Eletrocautery; Comparison of Fundus First and Conventional Dissection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00689663
• Other study ID #: YC11
• Status: Completed
• Phase: N/A
• First received: May 26, 2008
• Last updated: May 29, 2008
• Start date: May 2006
• Est. completion date: December 2007

Study information

• Verified date: May 2008
• Source: Sundsvall Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

Laparoscopic cholecytectomy can be by starting the dissection at the triangle of calots or as a fundus first dissection.

Dissection can be with electrocutery or ultrasonic. The optimal technique or the optimal way of dissection has to be established. Patients are at 4 hospitals randomised to the different techniques and the different methods of dissection.

Description:

Patients at the participating hospitals are randomized to:

1. dissection starting at the triangle of Calots with electrocautery.

2. dissection by fundus first technique with electrocautery.

3. dissection by fundus first technique with ultrasonic dissection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• laparoscopic cholecystectomy

Exclusion Criteria:

• age >Z65

• ASA >3

• obesity

• previous extensive gastrointestinal surgery

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystectomy

Intervention

Procedure:
• Laparoscopic cholecystectomy
Randomized to three arm.

Locations

Country	Name	City	State
Sweden	Sundsvall Hospital	Sundsvall

Sponsors (1)

Lead Sponsor	Collaborator
Sundsvall Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Cengiz Y, Jänes 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operation time, bleeding, pain, nausea, quality of life, analgetics, sick leave, surgical complications, conversion rate		30 days	Yes
Secondary	surgical complications		3 months	Yes