Clinical trial NCT02357589: 3D vs 2D HD Laparoscopy in Cholecystectomy
Official title: 3 Versus 2 Dimensional HD Laparoscopy in Cholecystectomy: a Prospective, Single Blinded, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystolithiasis
Keywords: 3D
laparoscopy
cholecystectomy
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2015-02-06
Enrollment: 210
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Duration of surgery
timeFrame: Expected average time of surgery 1 hour
Secondary outcomes:
measure: Need for conversion into open surgery
timeFrame: During the operation, expected average time of surgery 1 hour
measure: Intraoperative complications
timeFrame: During the operation, expected average time of surgery 1 hour
measure: Complications, Clavien-Dindo classification
timeFrame: 30 days after randomization
measure: Postoperative stay in hospital
timeFrame: Expected range 0-7 day
measure: Bleeding
timeFrame: During the operation, expected average time of surgery 1 hour
measure: Number of participants with readmission(s)
timeFrame: 30 days after randomization
measure: Total need of opioids in milligrams
timeFrame: Expected range 0-7 day
measure: Mortality
timeFrame: 30 days after randomization
measure: Operation theatre time
timeFrame: Expected average 1,5 hours
measure: Postoperative pain, VAS
timeFrame: Expected range 0-7 day
Other outcomes:
measure: Incisional hernias
timeFrame: after 1, 5 and 10 year
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Ville Sallinen, MD, PhD
role: STUDY_CHAIR
References:
citation: Koppatz H, Harju J, Siren J, Mentula P, Scheinin T, Sallinen V. Three-dimensional versus two-dimensional high-definition laparoscopy in cholecystectomy: a prospective randomized controlled study. Surg Endosc. 2019 Nov;33(11):3725-3731. doi: 10.1007/s00464-019-06666-5. Epub 2019 Feb 1.