RObotic Versus LAparoscopic Resection for Rectal Cancer

Completed · Not applicable

Conditions studied: Rectal Cancer

In brief

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.

Key facts

Study ID

NCT01736072

Run by

University of California, Irvine

People needed

471

Starts

2011-12-01

Expected to finish

2018-04-30

Last updated by the study team

2023-08-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged ≥ 18 years
• Able to provide written informed consent
• Diagnosis of rectal cancer amenable to curative surgery either by low anterior resection, high anterior resection, or abdominoperineal resection i.e. staged T1-3, N0-2, M0 by imaging as per local practice; although not mandated, CT imaging with either additional MRI or trans-rectal ultrasound is recommended to assess distant and local disease.
• Rectal cancer suitable for resection by either standard or robotic-assisted laparoscopic procedure
• Fit for robotic-assisted or standard laparoscopic rectal resection
• American Society of Anesthesiologists (ASA) physical status ≤ 3
• Capable of completing required questionnaires at time of consent (provided questionnaires are available in a language spoke fluently by the participant)

You may not qualify if…

• Benign lesions of the rectum
• Benign or malignant diseases of the anal canal
• Locally advanced cancers not amenable to curative surgery
• Locally advanced cancers requiring en bloc multi-visceral resection
• Synchronous colorectal tumors requiring multi-segment surgical resection (N.B. a benign lesion within the resection field in addition to the main cancer would not exclude a patient)
• Co-existent inflammatory bowel disease
• Clinical or radiological evidence of metastatic spread
• Concurrent or previous diagnosis of invasive cancer within 5 years that could confuse diagnosis (non- melanomatous skin cancer or superficial bladder cancer treated with curative intent are acceptable; for other cases please discuss with Chief Investigator via CTRU)
• History of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements
• Pregnancy or breastfeeding women.
• Participation in another rectal cancer clinical trial relating to surgical technique.

Where it is running

• John Muir Medical Center — Concord, California, United States
• University of California, Irvine Medical Center — Orange, California, United States
• Jackson South Community Hospital — Miami, Florida, United States
• St. Joseph Mercy Health System — Ypsilanti, Michigan, United States
• Washington University School of Medicine in St. Louis — St Louis, Missouri, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Aria Health — Philadelphia, Pennsylvania, United States
• Baylor University Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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