3D vs 2D HD Laparoscopy in Cholecystectomy

Cholecystolithiasis Clinical Trial

Official title:

3 Versus 2 Dimensional HD Laparoscopy in Cholecystectomy: a Prospective, Single Blinded, Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02357589
• Other study ID #: HUCH-328-150127
• Status: Completed
• Phase: N/A
• First received: February 3, 2015
• Last updated: August 27, 2017
• Start date: January 2015
• Est. completion date: May 10, 2017

Study information

• Verified date: August 2017
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: May 10, 2017
• Est. primary completion date: May 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Procedure:
• 2D laparoscopic cholecystectomy

• 3D laparoscopic cholecystectomy

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incisional hernias		after 1, 5 and 10 year
Primary	Duration of surgery		Expected average time of surgery 1 hour
Secondary	Need for conversion into open surgery		During the operation, expected average time of surgery 1 hour
Secondary	Intraoperative complications	Any complication during the operation e.g. hemorrhagic, liver, intestine or gallbladder rupture	During the operation, expected average time of surgery 1 hour
Secondary	Complications, Clavien-Dindo classification		30 days after randomization
Secondary	Postoperative stay in hospital		Expected range 0-7 day
Secondary	Bleeding		During the operation, expected average time of surgery 1 hour
Secondary	Number of participants with readmission(s)		30 days after randomization
Secondary	Total need of opioids in milligrams		Expected range 0-7 day
Secondary	Mortality		30 days after randomization
Secondary	Operation theatre time		Expected average 1,5 hours
Secondary	Postoperative pain, VAS		Expected range 0-7 day