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

Sundsvall Hospital

Status: Completed

Conditions: Cholecystectomy

Treatments: Procedure: Laparoscopic cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00689663

YC11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 233 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• laparoscopic cholecystectomy

Exclusion criteria

• age >Z65
• ASA >3
• obesity
• previous extensive gastrointestinal surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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233 participants in 3 patient groups

1

Active Comparator group

Description:

Dissection staring at the triangle of calots. Dissection with electrocautery.

Treatment:

Procedure: Laparoscopic cholecystectomy

2

Active Comparator group

Description:

Dissection as fundus first with electrocautery.

Treatment:

Procedure: Laparoscopic cholecystectomy

3

Active Comparator group

Description:

Dissection as fundus first with ultrasonic dissection.

Treatment:

Procedure: Laparoscopic cholecystectomy