ONGOING STUDIES

BARIATRIC ROBOT – ASSESSMENT OF THE CONTRIBUTION OF ROBOTICS IN BARIATRIC SURGERY
da Vinci® surgical system

One of the missions of the Institute is to conduct a clinical assessment of new technologies and procedures regarding their benefit for patients, and a medical and economical assessment of those benefits. There is an ongoing joint assessment of the clinical, medical, and economical contribution of the da Vinci® surgical system for bariatric surgery, as well as for the gastric bypass procedure, as bariatric surgery greatly benefits from the contribution of robotics.

This study aims to assess the impact of robotics (da Vinci® surgical robot) in performing gastric bypass procedures compared to performing such procedures using conventional laparoscopy. From a clinical point of view, the assessment focuses on operative pain measurement 24 hours after surgery. From a medical and economical point of view, the study assesses robot and supply costs, as well as the impact on operative time, length of hospital stay, and quality of life – particularly as it relates to resumption of normal daily activities.

This study involves 128 patients, candidates for gastric bypass. Patients are randomized to either conventional laparoscopic surgery or robot-assisted laparoscopic surgery at the time of their procedure.

This is an ongoing study. Analysis of the results is scheduled for 2015.

PILLCAM – ASSESSMENT OF COLONOSCOPIC EXAMINATION BY COLIC PILL IN PATIENTS WHO PREVIOUSLY UNDERWENT COLON SURGERY

The colonic video pill is a new exploration technique which allows for the non-invasive visualization of the whole colon without resorting to general anesthesia and inpatient care. The colonic pill shows good sensitivity and precision in the detection of colorectal lesions in patients presenting with medium or high risk for colorectal lesions. Until now, no study of the colonic pill has been conducted in the follow-up of patients who underwent colorectal surgery.

This study aims to compare diagnostic effectiveness of the colonic pill (Pillcam colon 2) to standard colonoscopy in patients who underwent colorectal surgery. The primary objective of this study is to assess the colonic pill as a diagnostic tool in patients who have undergone colorectal surgery, to evaluate for recurrent colorectal lesions instead of performing standard screening colonoscopy.

This study is intended for patients slated to undergo follow-up colonoscopy after a surgical procedure of the colon.

This study involves 100 patients who will undergo an examination using the colonic pill followed by a conventional colonoscopy to allow comparison of the findings with each method.

This is an ongoing study. Analysis of the results is scheduled for 2015.

FLARIOC – ASSESSMENT OF BILIARY TRACT VISUALIZATION BY FLUORESCENCE
FLARIOC – ASSESSMENT OF BILIARY TRACT VISUALIZATION BY FLUORESCENCE

Iatrogenic injury of the biliary tract is the most feared complication of laparoscopic cholecystectomy. In common practice, intraoperative cholangiography (radiological X-ray examination after injection of a contrast agent) is used to prevent biliary tract injury.

This study explores the use of indocyanine green fluorescence imaging to visualize the biliary tree anatomy compared to standard intraoperative cholangiography during laparoscopic cholecystectomy. The purpose of this study is to provide patients with an equivalent or superior examination that is easy to use, non-invasive, and without Xray exposure.

This study is intended for patients who will undergo a cholecystectomy (removal of the gallbladder) due to the presence of a stone in the cystic duct.

This study involves 60 patients who will undergo a cholecystectomy using fluorescence followed by a standard X-ray cholangiography to allow comparison of biliary tract visualization with each method.

This is an ongoing study. Analysis of the results is scheduled for 2015.

TRAMA – ASSESSMENT OF THE CONTRIBUTION OF CONFOCAL ENDOMISCROSCOPY IN THE VISUALIZATION OF TUMOR MARGINS IN RECTAL CANCER

Confocal endomicroscopy is an imaging technique which allows surgeons to receive real-time microscopic information on the tissues during an endoscopic procedure. With micron-level resolution, confocal endomicroscopy allows for a real-time histological and cytological study of the in vivo tissue.

In rectal cancer, the identification of tumor size and the precise determination of tumor margins can be crucial when deciding whether or not to sacrifice the sphincter during resection. An examination of tumor margins by confocal endomicroscopy would allow intraoperative evaluation, limiting exploration time during the surgical procedure.

This study aims to show that confocal endomicroscopy by mini-probe (Cellvizio®) allows identification of the deep margin of the tumor during resection, optimizing the resection margin while limiting resection of healthy tissue. The objective of this study is to use such technique to guide surgical decision-making and to preserve function of the anal sphincter where possible.

This study is intended for patients for whom rectal cancer diagnosis has been confirmed. According to the stage of the disease, patients will or will not undergo radiochemotherapy prior to surgical resection of the tumor.

This study involves 70 patients, who will undergo confocal endomicroscopy examination as well as a tissue biopsy sampling to allow comparison of diagnostic strength with each method.

This is an ongoing study. Analysis of the results is scheduled for 2015.

FFSI – STUDY OF SLEEVE GASTRECTOMY EFFECTS ON ESOPHAGOGASTRIC ANGLE FUNCTION

Laparoscopic sleeve gastrectomy is a surgical approach currently experiencing a peak of popularity because of its apparent technical simplicity making it accessible to surgeons with variable skills. However, this procedure can be burdened with significant complications resulting in problems of tissue ischemia and major functional disturbances in the proximal digestive tract. It is essential to develop new techniques to help standardize sleeve gastrectomy.

Current imaging techniques (endoscopy, radiology) do not provide an appropriate preoperative assessment of the esophagogastric dynamic. During the standard procedure, there is no means by which to assess the distensibility and pressure gradient within the created gastric tube.

A better understanding of the surgical and mechanical factors that influence postoperative results and follow-up may lead to their improvement.

This study aims to identify factors that are associated to a “successful” sleeve gastrectomy. The objective of this study is to predict the success of the procedure on the basis of preoperative functional results and to better select patients eligible for sleeve gastrectomy.

This study is intended for candidates for a sleeve gastrectomy (greater curvature gastrectomy) for the treatment of obesity.

This study involves 30 patients. In addition to standard functional exploration, examinations conducted preoperatively and postoperatively, patients will undergo an MRI with ingestion of a contrast agent allowing definition of the oesoplagogastric junction characteristics.

This is an ongoing study. Analysis of the results is scheduled for 2014