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
- 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|
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
|Study Type :||Observational|
|Estimated Enrollment :||350 participants|
|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|
- 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).
- 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.
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
|Contact: Marco Inama, MD PhDs||+39 email@example.com|
|Contact: Gianluigi Moretto, MD||+39 firstname.lastname@example.org|
|Hospital "Dott. Pederzoli"||Recruiting|
|Peschiera del Garda, Verona, Italy, 39100|
|Contact: Marco Inama, MD, PhDs email@example.com|
|Principal Investigator:||Marco Inama, MD PhDs||Hospital "Dott. Pederzoli"|