theglobe_02

  Criterium Logo Std Tag Line-2  

www.CriteriumInc.com

JULY 2018    A Monthly Review of Articles of Interest for the Clinical Community

.This Month's Clinical Focus:.
.NEPHROLOGY / UROLOGY.

 

Intl Lung Cancer Congress LOGO

 
MEET US AT 19th Int'l Lung Cancer Congress
JUL 26-28  Huntington Bch CA

CALL Ronny Schnel 310-619-6691
 


First major study comparing robotic to open surgery published in The Lancet


The 7-year study, conducted at 15 institutions, was published in the June 23 issue of The Lancet.

 

The first comprehensive study comparing the outcomes of robotic surgery to those of traditional open surgery in any organ has found that the surgeries are equally effective in treating bladder cancer.  The Randomized Open Versus Robotic Cystectomy (RAZOR) trial showed lower blood loss and blood transfusion rates and shorter hospital stays for patients who received minimally invasive surgery, but there were no differences in complication rates and the two-year progression-free survival was nearly the same.


"We have done more than 4 million surgeries with the robotic approach since the device came into existence, and on average we do close to a million robotic surgeries a year globally," said Parekh, who is chief clinical officer of the University of Miami Health System. "There are close to 5,000 robotic systems installed all over the world – each one costs about $2 million – and yet until we did this study there was not a single Phase 3 multicenter randomized trial comparing this expensive new technology to the traditional open approach of doing surgeries."
 

Virtual Reality OR Surgical Robot DaVinci LIC CC BY-SA 3.0


A total of 350 patients were involved in the bladder cancer study. Half received the open surgical approach and half received robotic surgery, and they were followed for two to three years so that outcomes could be compared.
 

"No one had followed these patients over a period of time to find out if you are impacting their cancer outcomes with this robotic approach," Parekh said. "We were able to prove unequivocally that we are not compromising patient outcomes by using robotic surgery." There has been an assumption that patients who receive robotic surgery will perceive a better quality of life than patients who have open surgery. Patients participating in the RAZOR study were asked about their quality of life at three and six months after surgery, and while both groups reported a significant return to their previous quality of life, there was no advantage of one group over the other.
 

Some critics of robotic surgery have expressed concern about the lack of tactile feedback – an important guide in open surgery. "When you do robotic surgery you don't feel anything," Parekh said. "It's more by visual cues. If you're doing open surgery you have the organs in your hands, you can feel them, and you assess and do these surgeries accordingly."  And while there are improvements in perioperative recovery with robotic technology, operating room time is significantly longer for robotic surgery.  It provides a magnified, three-dimensional view of the organs, and a wide range of motion and flexibility. Robotic surgery has become particularly popular with prostate cancer patients – 90 percent of them choose it – which would make it difficult if not impossible to do a randomized study of surgical results in prostate cancer.  But Parekh says that because robotic surgery is being used in many other organs, including kidney, colorectal, OB/GYN and lung cancer, more studies are needed.
 

"The findings of this study provide high-level evidence to inform a discussion between patients and their physicians regarding the benefits and risks of various approaches for a complex and often morbid surgery, like radical cystectomy," the trial description says. "It also underscores the need for further high-quality trials to critically evaluate surgical innovation.

 

SOURCE: Article usage courtesy of PRNewswire


Patients with early kidney cancer see significant benefits with robotic partial nephrectomy

 

A new study from the USC Keck School of Medicine finds that robotic partial nephrectomy decreases complications, mortality as compared with open or laparoscopic techniques.

 

  For patients with early kidney cancer, removing part of the kidney instead of the whole kidney is often a preferred treatment because the procedure can effectively remove tumors while preserving kidney function. But when it comes to the best surgical approach — robotic, laparoscopic or open — for this type of surgery, known as partial nephrectomy, the choice has been less clear. A comprehensive study by the Keck School of Medicine of USC, which has found that robotic partial nephrectomy offers significantly better patient outcomes, may help inform those decisions.
 

Kidney Illus by Ibrandify FREEPIK Free Lic CC0"Robotic partial nephrectomy has become increasingly more common, yet there's a lack of consensus among urologists about its performance vis-a-vis open or laparoscopic techniques," says the study's corresponding author Inderbir Gill, MD, chair and distinguished professor of urology at the Keck School. "Our goal with this study was to critically evaluate the impact of these three techniques on patient outcomes such as complications, cancer recurrence and mortality."
 

The systematic review and meta-analysis, published in the The Journal of Urology, combined data from 98 studies on robotic, open and laparoscopic partial nephrectomy. More than 20,000 patients were included in the analysis.
 

When comparing robotic to open partial nephrectomy, the study found that robotic partial nephrectomy offered several superior patient outcomes, including decreased complications during and after surgery, cancer recurrence, overall mortality, hospital length of stay and readmission. There was no difference in cancer-specific mortality between the two techniques.  Results also showed that robotic partial nephrectomy was equivalent to, and sometimes better than, laparoscopic partial nephrectomy. While there was no difference in cancer recurrence, cancer-specific mortality, length of hospital stay or readmission, a robotic technique was associated with lower overall mortality and fewer complications during and after surgery.
 

Gill, who is the executive director of the USC Institute of Urology at Keck Medicine of USC, believes the data suggest that the technique of robotic partial nephrectomy has now become established in the field.  "Our study shows that robotic partial nephrectomy is not only safe and effective but also a preferred approach for treating small kidney tumors," he says.
 

SOURCE: Article usage courtesy of PRNewswire


Image credits:  Robotic Davinci Surgical By Cornell Urology CC BY-SA 3.0; Kidney by ibrandify via FREEPIK Free Lic CC0

WHAT'S NEW AT CRITERIUM:
Current Global Studies
Ph II ORTHO - Knee Lesions
Ph II Pancreatic Cancer
Ph I/II Surgical Site Infections
Ph II Colorectal Cancer
Ph II Metastatic Breast Cancer
Ph II NSCLC
Ph I/II Myeloma (Amyloidosis)


SEE OUR STUDIES

CRITERIUM, Inc. Global CRO

Since 1991 Banner

OUR RESEARCH LIBRARY...
...is your access to continuing current information on successful clinical trials


FOLLOW OUR POSTS

See ALL POSTS at our BLOG

Hope for Breast Cancer w/Brain Metastases

New Trial Reducing Use of Opioids for Pain

CRISPR Used to Restore Retinal Function

Orphan Drug Designation Granted for ALS

Beneficial Skin Bacteria Prevent Cancer

 

WATCH OUR VIDEOS

Airport Network - One Minute with Criterium CRO on Excellence in Clinical Trials
Featured at Travellers Hubs in US Airports


The Clinical Data Liaison: The Key to Better, Faster Clinical Trials
Featuring John M. Hudak, Prersident & Founder


LISTEN to OUR PODCASTS

 CNN Interview with John Hudak 
Featured at
Travellers Hubs in US Airports

Criterium Celebrates 20 Years
Featuring John M. Hudak, President & Founder

The Site-Centric CRO: Best Practices for Excellent Site Relationships 
Featuring Ed Jahn, Clinical Ops Specialist & Jaime Hudak, CDL

The Clinical Data Liaison: Better, Faster Trials
Featuring John M. Hudak, President & Founder

Agile Clinical Trials and Real-Time Data
Featuring John M. Hudak, President & Founder


READ OUR PUBLICATIONS

The Evolution of the Data Management Role: The Clinical Data Liaison   Mary Stefanzick

Critical Clinical Research Factors in the Down Economy  Lawrence Reiter, Ph.D

No Longer Lost In Translation
Dr. Gavin Leong in PharmaVOICE Magazine

Maintaining Clinical Operations: It's Just Good Business  PharmaVoice View on Clinical Operations


EDC Implementation 
Greg Bailey in PharmaVOICE, View on E-Solutions

Going Global 
John M. Hudak in Future Pharmaceuticals

Trials Limber Up 
John M. Hudak in Int'l Clinical Trials Magazine


VIEW OUR PRESENTATION

Criterium Capabilities Presentation
Corporate Overview, Trials & Experience


DOWNLOAD OUR BROCHURE

Criterium:  Connect - Communicate - Control
Understand How We Do What We Do



MORE OPPORTUNITIES:


Clin Trials Insp LOGO

MEET US AT:
7th Clinical Trials
Inspection Readiness Summit 
AUG 13-14 Philadelphia PA

Call Ronny Schnel 310-619-6691



~ FOUNDED in 1991 ~
MANAGING SUCCESSFUL
Clinical Trials for over 25 years!

Resources are precious, time is the enemy, and results are paramount.

ACCELERATE
your clinical trials...
---------------------

CHANGE
the workflow paradigm...

- Information Management done right
- User-friendly technologies 
- Improved trial efficiencies
- Talented, committed in-house staff

Proprietary technology solutions 
PROVEN to improve your 
clinical trial results.


- MAXIMUM client outcomes
- Small and AGILE Global CRO
- WIDE RANGE of Indications
- Expanded Oncology Consortia

 

Contact: John Hudak, President at jmhudak@criteriuminc.com

 

 

GET TO KNOW US!

CONTACT US for an RFP or COMPETITIVE BID on your next project! 

FULL-SERVICE RESEARCH - TRIAL RESCUE SERVICES - PROJECT & DATA MANAGEMENT - BIOSTATISTICS
SITE SELECTION & MANAGEMENT - PROTOCOL DESIGN & CONSULTING - CLINICAL & MEDICAL MONITORING
CRF DESIGN - IxR & EDC - MEDICAL WRITING - SAFETY - REGULATORY CONSULTING - AND MORE!

About Criterium Inc.  Criterium Inc. www.criteriuminc.com is a global, full-service, technology-driven contract research organization that offers a unique mix of high-quality, innovative clinical research solutions for the biopharmaceutical, pharmaceutical, medical device, and CRO industries.