3D vs 2D HD Laparoscopy in Cholecystectomy

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Cholecystolithiasis

Treatments: Procedure: 2D laparoscopic cholecystectomy; Procedure: 3D laparoscopic cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02357589

HUCH-328-150127

Details and patient eligibility

About

The 3D-systems have emerged also to the world of surgery, and the three-dimensional laparoscopic systems are gradually entering the operating rooms. In the normal laparoscopy there are only two-dimensional view, which is somewhat challenging when operating in three-dimensional environment. Even though the 3D-systems have been widely studied in laboratory circumstances, there are still no evidence of benefits of 3D vs 2D in clinical point of view and no prospective randomized trials have been published. Therefore, the purpose of this study is to investigate is there something to gain in changing into 3D laparoscopic system for cholecystectomy (LCC).

Enrollment: 210 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for laparoscopic cholecystectomy

Exclusion criteria

• Some other surgical operation planned during LCC
• Expected major risk of conversion (e.g. multiple previous abdominal operation, previous peritonitis, previous cholecystitis)
• Operating surgeon experience less than 5 3D laparoscopy operations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

210 participants in 2 patient groups

2D laparoscopic cholecystectomy

Active Comparator group

Description:

The normal laparoscopic cholecystectomy with two dimensional view

Treatment:

Procedure: 2D laparoscopic cholecystectomy

3D laparoscopic cholecystectomy

Experimental group

Description:

The normal laparoscopic cholecystectomy with three dimensional view

Treatment:

Procedure: 3D laparoscopic cholecystectomy