3D Laparoscopy Versus 2D Laparoscopy

Study Purpose

  • - To compare surgical and oncological outcomes in patients underwent to colorectal resection with 3D vs.#46;2D laparoscopic technique.
  • - To evaluate the visual overload in surgeons using 3D laparoscopic technique.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Study Type
Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT02841657

Phase 0: Exploratory study involving very limited human exposure to the drug to determine whether a drug is modulating its target.

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
N/A

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Casa di Cura Dott. Pederzoli

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Recruiting
Countries Italy

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Colorectal Cancer, Inflammatory Bowel Disease
Additional Details

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.#46;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

Contact a Trial Team

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International Sites

Hospital "Dott. Pederzoli", Peschiera del Garda, Verona, Italy

Status

Recruiting

Address

Hospital "Dott. Pederzoli"

Peschiera del Garda, Verona, 39100

Site Contact

Marco Inama, MD, PhDs

inama.marco@gmail.com

+39 0456449319

Nearest Location

Site Contact

Marco Inama, MD, PhDs

inama.marco@gmail.com

+39 0456449319

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