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OpenTrials
Completed

NCT Number: NCT02757690

Validation of 3 Dimensional Laparoscopic System in Disral Pancreatectomy and Splenectomy

Traditionally, laparoscopy has been based on 2-dimensional (2D) imaging, which has represented a considerable challenge for those approaching this technique. Thus, 3-dimensional (3D) visualization technology for laparoscopy has been proposed, since the early 1990s, as a way to facilitate laparoscopic performance. However, early 3D laparoscopic technology was limited in terms of image quality, so that its use had not been implemented. More recently, industry has developed novel 3D systems where the imaging is similar to stereoscopic vision, in which the depth perception is achieved by different unique images received by each eye. Thus, more recent studies have suggested a possible advantage provided by these new 3D systems during laparoscopic performance. However, comparative assessments of new generation 3D vs 2D laparoscopy remain limited, especially in the hepatobiliary and pancreatic field.

To assess the benefits and harms of use of three dimensional systems versus two dimensional systems during laparoscopic distal pancreatectomy.

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Key information

Conditions

Benign Neoplasm of Body of Pancreas Benign Neoplasm of Tail of Pancreas

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

Procedures

  • the investigators will take the patient consent for this clinical trial.
  • The participants will be divided with two groups with block randomized method
  • Skillful pancreatic surgeon will perform 2D or 3D laparoscopic distal pancreatectomy.
  • The participants will be monitor the intraoperative and postoperative course.

Data collection

  • operation video : operation time, number of errors (missed grasp, loss of material)
  • Segmental operation time according to procedure
  • Numbers of errors during operation
  • clinical parameters:
  • Blood examination : complete blood count (hemoglobin, white blood cell count), amylase, lipase, etc.
  • Radiological examination: X-ray, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), etc
  • Medical records : hospital stay after operation, the time to eating, pathologic examination
  • Subjective scoring in the view of operator, 1st assist.
  • Scoring for imaging quality
  • Scoring for harms of 3D/2D laparoscopic system
  • Scoring for overall demand

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • BMI > 30 (Kg/m2)
  • History of severe or recurrent pancreatitis
  • Mass size > 10cm
  • History of low abdomen major operation
  • Additional resection for extra-pancreatic organ

Exclusion criteria

  • Participants refusal.
  • Additional resection dependent on pathological examination in intraoperative or postoperative period.

Treatment and study plan

3-dimensional distal pancreatectomy

Device

3D laparoscopy

Other names: 3D

2-dimensional distal pancreatectomy

Device

2D laparoscopy

Other names: 2D

Primary outcomes

  1. Operation time

    Time frame: expected duration: 200mins (for each operation)

    The unedited videos of the operations will be assessed from start to end of the operation by two clinicians. The average of operation time will be compare according to 2D versus 3D laparoscopic system.

Secondary outcomes

  1. Numbers of errors during operation

    Time frame: During operation (expected duration: 200mins)

    The investigators will check the error number of operator during operation with review the video record of the operation

  2. Subjective scoring in the view of operator, 1st assist

    Time frame: During operation (expected duration: 200mins)

    The investigators will check the subjective scoring of operator and 1st assist during operation. For example, depth perception, sharpness, visual strain, headache, etc.

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

  • Olympus

Registry information

Official study title

Validation and Verification of 3 Dimensional Laparoscopic System in Laparoscopic Distal Pancreatectomy & Splenectomy

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 2, 2016
Registry last updated
May 2, 2016

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.