Clinical trial NCT02841657: 3D Laparoscopy Versus 2D Laparoscopy
Official title: 3D vs 2D Colorectal Resections and Valuation of Visual Load of Surgeons
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Inflammatory Bowel Disease
Keywords: 3 Dimensional Laparoscopy
Visual work load
Nasa Task Load Index
Simulator Sickness Questionnaire
Lead sponsor: Casa di Cura Dott. Pederzoli
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients affected by neoplastic and inflammatory disease of colorectal tract can be enrolled in the study.

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.

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

Eligibility 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

Primary outcomes:
measure: Postoperative complications
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Oncological radicality
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Peschiera del Garda
country: Italy
facility: Hospital "Dott. Pederzoli"
state: Verona
Study officials:
affiliation: Hospital "Dott. Pederzoli"
name: Marco Inama, MD PhDs
role: PRINCIPAL_INVESTIGATOR
References:
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