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Completed

NCT Number: NCT02357589

3D vs 2D HD Laparoscopy in Cholecystectomy

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).

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Key information

Conditions

Cholecystolithiasis Biliary Tract Diseases Cholelithiasis Digestive System Diseases Gallbladder Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Central Hospital

Helsinki, 00029, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2D laparoscopic cholecystectomy

Procedure

3D laparoscopic cholecystectomy

Procedure

Primary outcomes

  1. Duration of surgery

    Time frame: Expected average time of surgery 1 hour

Secondary outcomes

  1. Need for conversion into open surgery

    Time frame: During the operation, expected average time of surgery 1 hour

  2. Intraoperative complications

    Time frame: During the operation, expected average time of surgery 1 hour

    Any complication during the operation e.g. hemorrhagic, liver, intestine or gallbladder rupture

  3. Complications, Clavien-Dindo classification

    Time frame: 30 days after randomization

  4. Postoperative stay in hospital

    Time frame: Expected range 0-7 day

  5. Bleeding

    Time frame: During the operation, expected average time of surgery 1 hour

  6. Number of participants with readmission(s)

    Time frame: 30 days after randomization

  7. Total need of opioids in milligrams

    Time frame: Expected range 0-7 day

  8. Mortality

    Time frame: 30 days after randomization

  9. Operation theatre time

    Time frame: Expected average 1,5 hours

  10. Postoperative pain, VAS

    Time frame: Expected range 0-7 day

Other outcomes

  1. Incisional hernias

    Time frame: after 1, 5 and 10 year

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 6, 2015
Registry last updated
Aug 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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