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3D Laparoscopy Versus 2D Laparoscopy (Lap3D)

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ClinicalTrials.gov Identifier: NCT02841657
Recruitment Status : Unknown
Verified August 2017 by Marco Inama, Casa di Cura Dott. Pederzoli.
Recruitment status was:  Recruiting
First Posted : July 22, 2016
Last Update Posted : August 7, 2017
Sponsor:
Information provided by (Responsible Party):
Marco Inama, Casa di Cura Dott. Pederzoli

Brief Summary:
  • To compare surgical and oncological outcomes in patients underwent to colorectal resection with 3D vs 2D laparoscopic technique.
  • To evaluate the visual overload in surgeons using 3D laparoscopic technique.

Condition or disease
Colorectal Cancer Inflammatory Bowel Disease

Detailed Description:

3 Dimensional (3D) Camera system is a new technique introduced into laparoscopic surgery field, adding the depth perception. Even if in the first 2000' the old 3D camera had negative results in terms of quality of images, thanks to technological progress the new 3D systems have reached high quality.

This new technology has been widely tested in pelvic trainer, not yet in live surgery. Moreover effects on surgeons visual work load are unknown.

Aim of the present study is to evaluate the potential superiority of 3D laparoscopic technique on 2D one in terms on postoperative complications and oncological radicality (in case of neoplastic disease).

Secondary aim is to study the possible major visual stress on surgeons brain caused by 3D camera rather than 2D videos.

ENROLLMENT All patients affected by neoplastic or inflammatory colorectal disease are enrolled in the study.

Preoperative, intraoperative e postoperative data are collected dividing all the patients according the camera system used during the operation: 2D group vs 3D group.

Preoperative data: sex, age, date of birth, id, date of admission, past medical history Intraoperative data: date of surgery, pathology, site of pathology, type of surgery and duration, intraoperative blood loss, other intraoperative problems, loop ileostomy, colostomy, drain positioning, intensive care unit admission Postoperative data (at 30th postoperative day): complications according to Dindo-Clavien scale (Dindo-Clavien classification of surgical complications), type of complications, transfusion, reoperation, other treatments, histology specimen report.

At the end of every operation, the 1st surgeon has to fill in the NASA (The National Aeronautics and Space Administration) task load index and the Simulator Sickness questionnaire.

Number of participants: 350 Years necessary: 2

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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: 3D vs 2D Colorectal Resections and Valuation of Visual Load of Surgeons
Study Start Date : January 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017



Primary Outcome Measures :
  1. Postoperative complications [ Time Frame: through study completion, an average of 2 years ]
    The postoperative course is evaluate in all patients undergone to colorectal laparoscopic surgery and classified according to the Dindo-Clavien scale at 30 days after surgery (Dindo-Clavien classification of surgical classification).


Secondary Outcome Measures :
  1. Oncological radicality [ Time Frame: through study completion, an average of 2 years ]
    The R0/R1 rate is evaluate in patients undergone to 3 dimensional or 2 dimensional laparoscopic colorectal surgery.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients affected by neoplastic and inflammatory disease of colorectal tract can be enrolled in the study.
Criteria

Inclusion Criteria:

  • colorectal cancer with or without preoperative radio e chemiotherapy
  • inflammatory bowel disease affected colon and rectum that need surgery

Exclusion Criteria:

  • patients under 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841657


Contacts
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Contact: Marco Inama, MD PhDs +39 0456449319 inama.marco@gmail.com
Contact: Gianluigi Moretto, MD +39 0456449319 g_moretto@libero.it

Locations
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Italy
Hospital "Dott. Pederzoli" Recruiting
Peschiera del Garda, Verona, Italy, 39100
Contact: Marco Inama, MD, PhDs       inama.marco@gmail.com   
Sponsors and Collaborators
Casa di Cura Dott. Pederzoli
Investigators
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Principal Investigator: Marco Inama, MD PhDs Hospital "Dott. Pederzoli"
Publications of Results:

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Responsible Party: Marco Inama, General Surgeon, Casa di Cura Dott. Pederzoli
ClinicalTrials.gov Identifier: NCT02841657    
Other Study ID Numbers: 3Dvs2D
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Marco Inama, Casa di Cura Dott. Pederzoli:
3 Dimensional Laparoscopy
Visual work load
Nasa Task Load Index
Simulator Sickness Questionnaire
Additional relevant MeSH terms:
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Inflammatory Bowel Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Gastroenteritis