NCT02357589

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 3, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 6, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2017

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

2.4 years

First QC Date

February 3, 2015

Last Update Submit

August 27, 2017

Conditions

Cholecystolithiasis

Keywords

3Dlaparoscopycholecystectomy

Outcome Measures

Primary Outcomes (1)

  • Duration of surgery

    Expected average time of surgery 1 hour

Secondary Outcomes (10)

  • Need for conversion into open surgery

    During the operation, expected average time of surgery 1 hour

  • Intraoperative complications

    During the operation, expected average time of surgery 1 hour

  • Complications, Clavien-Dindo classification

    30 days after randomization

  • Postoperative stay in hospital

    Expected range 0-7 day

  • Bleeding

    During the operation, expected average time of surgery 1 hour

  • +5 more secondary outcomes

Other Outcomes (1)

  • Incisional hernias

    after 1, 5 and 10 year

Study Arms (2)

2D laparoscopic cholecystectomy

ACTIVE COMPARATOR

The normal laparoscopic cholecystectomy with two dimensional view

Procedure: 2D laparoscopic cholecystectomy

3D laparoscopic cholecystectomy

EXPERIMENTAL

The normal laparoscopic cholecystectomy with three dimensional view

Procedure: 3D laparoscopic cholecystectomy

Interventions

2D laparoscopic cholecystectomyPROCEDURE
2D laparoscopic cholecystectomy
3D laparoscopic cholecystectomyPROCEDURE
3D laparoscopic cholecystectomy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for laparoscopic cholecystectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Central Hospital

Helsinki, 00029, Finland

Location

Related Publications (1)

  • 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.

    PMID: 30710315DERIVED

MeSH Terms

Conditions

Cholecystolithiasis

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesGallbladder Diseases

Study Officials

  • Ville Sallinen, MD, PhD

    Helsinki University Central Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 3, 2015

First Posted

February 6, 2015

Study Start

January 1, 2015

Primary Completion

May 10, 2017

Study Completion

May 10, 2017

Last Updated

August 29, 2017

Record last verified: 2017-08

Locations

FI(1)