RObotic Versus LAparoscopic Resection for Rectal Cancer (ROLARR)
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|ClinicalTrials.gov Identifier: NCT01736072|
Recruitment Status : Unknown
Verified November 2015 by Alessio Pigazzi, University of California, Irvine.
Recruitment status was: Active, not recruiting
First Posted : November 29, 2012
Last Update Posted : December 2, 2015
The purpose of this study is to compare two different surgical procedures for the treatment of Rectal Cancer: Laparoscopic Surgery and Robotic Assisted Laparoscopic Surgery. The ROLARR study is for participants with cancer of the rectum for whom a laparoscopic operation (sometimes called "keyhole surgery") has been recommended by their surgeon.
In the past most rectal cancers were removed using "open" surgery. Open surgery involves a large cut down the middle of the patient's abdomen to allow the surgeon to see and take out the cancer. On a previous study showed that using laparoscopic surgery to remove colorectal cancers was as good as open surgery for curing cancer.
There is now another option to remove rectal cancers, which involves using a robotic system with laparoscopic surgery. This type of surgery is called "robotic-assisted" laparoscopic surgery and is now becoming widely used by surgeons to remove cancers including the rectum, as well as for other non-cancer operations.
In order to perform robotic-assisted laparoscopic surgery, the surgeon sits at a robotic control unit a few feet away from the patient. Using the robotic control unit, the surgeon can see a clear video image of the patient's abdomen and the operation site. The surgeon can perform the operation from the robotic control unit by controlling the movement of a set of robotic surgical instruments, guided by the video camera.
Like standard laparoscopic surgery, the surgeon is able to carry out the entire operation through a few small cuts in the abdomen. The camera of the robotic system provides a 3D high-definition magnified view of the operation site and the robotic system is also able to translate the movements of the surgeon's hands into small precise movements inside the patient's body.
We want to test whether robotic-assisted laparoscopic surgery is as good, or even better, at removing rectal cancers as standard laparoscopic surgery (actually Robotic-assisted laparoscopic surgery is used as standard of care in rectal cancer patients at University of California, Irvine Medical Center). We also want to investigate whether using robotic-assisted laparoscopic surgery reduces the number of times a laparoscopic operation needs to be converted to an open operation, and see whether using a robotic system can also shorten the length of time patients need to stay in hospital and if it reduces the number of complications patients may have during and after their operation.
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Procedure: Standard Laparoscopic Surgery Procedure: Robotic Assisted Laparoscopic Surgery||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||520 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||RObotic Versus LAparoscopic Resection for Rectal Cancer An International, Multicentre, Prospective, Randomised, Controlled, Unblinded, Parallel-group Trial of Robotic-assisted Versus Laparoscopic Surgery for Treatment of Rectal Cancer.|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||June 2018|
Active Comparator: Laparoscopic Resection of Rectal Cancer
Research Subjects will be randomized to Surgical Resection of Rectal Cancer by Standard Laparoscopic Surgery.
Procedure: Standard Laparoscopic Surgery
The research subjects will be randomized to Standard Laparoscopic Surgical procedure to resect their Rectal Cancer.
Active Comparator: Robotic Resection of Rectal Cancer
Research Subjects will be randomized to Surgical Resection of Rectal Cancer by Robotic Assisted Laparoscopic Surgery.
Procedure: Robotic Assisted Laparoscopic Surgery
The research subjects will be randomized Robotic Assisted Laparoscopic Surgical procedure to resect their Rectal Cancer.
- End of Conversion to Open Surgery [ Time Frame: 1 day ]The primary end point is the rate of conversion to open surgery as an indicator of surgical technical difficulty. Conversion is defined as the use of a laparotomy wound for any part of the mesorectal dissection. The use of a limited laparotomy wound to facilitate a low stapled anastomosis and/or specimen extraction is permissible and not defined as an open conversion.
- Oncological Efficacy [ Time Frame: 1 day ]Pathological CRM positivity rates as recorded from local histopathology review, where resection margin positivity is defined as a distance of ≤1mm of the cancer from any resection margin.
- Intra-operative and post-operative complications [ Time Frame: 30 day and 6 months ]All the intra-operative complications will be assessed at 30 days and 6-months after the surgical procedure.
- 30-day post-operative Mortality [ Time Frame: 30 day post-surgery ]Thirty-day operative mortality is defined as deaths occurring from any cause during the first 30 post-operative days.
- Three-year disease-free and overall survival. [ Time Frame: 3 years ]Overall survival is defined as the time from date of randomization to date of death from any cause. Disease-free survival is defined according to Punt et al's definitions as the time from date of randomization to date of death from any cause, recurrent disease (locoregional or distant recurrence) or second primary cancer.
- Sexual Disfunction Assessment [ Time Frame: 6-months ]Patient self-reported bladder and sexual function as assessed by the International Prostatic Symptom Score(I-PSS©) for male and female bladder function, and the International Index of Erectile Function (IIEF) Female Sexual Function Index(FSFI©) for sexual function.
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): NCT01736072
|United States, California|
|John Muir Medical Center|
|Concord, California, United States, 94520|
|University of California, Irvine Medical Center|
|Orange, California, United States, 92868|
|United States, Florida|
|Jackson South Community Hospital|
|Miami, Florida, United States, 33157|
|United States, Michigan|
|St. Joseph Mercy Health System|
|Ypsilanti, Michigan, United States, 48197|
|United States, Missouri|
|Washington University School of Medicine in St. Louis|
|St. Louis, Missouri, United States, 63110|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19144|
|United States, Texas|
|Baylor University Medical Center|
|Dallas, Texas, United States, 75246|
|Principal Investigator:||Alessio Pigazzi, MD||University of California, Irvine|