RObotic Versus LAparoscopic Resection for Rectal Cancer

NCT01736072 | Completed DMC

• 1 other identifier: 20118537
• Study Type: interventional
• Target: 471
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Rectal Cancer

Keywords

Rectal Cancer; Colorectal Cancer; Laparoscopic Surgery; Robotic Surgery; Robotic Assisted Laparoscopic Surgery

Outcome Measures

Primary Outcomes (1)

• End of Conversion to Open Surgery

  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.

  1 day

Secondary Outcomes (1)

• Oncological Efficacy

  1 day

Other Outcomes (4)

• Intra-operative and post-operative complications

  30 day and 6 months

• 30-day post-operative Mortality

  30 day post-surgery

• Three-year disease-free and overall survival.

  3 years

Study Arms (2)

Laparoscopic Resection of Rectal Cancer

ACTIVE COMPARATOR

Research Subjects will be randomized to Surgical Resection of Rectal Cancer by Standard Laparoscopic Surgery.

Procedure: Standard Laparoscopic Surgery

Robotic Resection of Rectal Cancer

ACTIVE COMPARATOR

Research Subjects will be randomized to Surgical Resection of Rectal Cancer by Robotic Assisted Laparoscopic Surgery.

Procedure: Robotic Assisted Laparoscopic Surgery

Interventions

Standard Laparoscopic Surgery PROCEDURE

The research subjects will be randomized to Standard Laparoscopic Surgical procedure to resect their Rectal Cancer.

Also known as: Laparoscopic Rectal Cancer Resection, Laparoscopic Cancer Resection, Rectal Cancer Surgery

Laparoscopic Resection of Rectal Cancer

Robotic Assisted Laparoscopic Surgery PROCEDURE

The research subjects will be randomized Robotic Assisted Laparoscopic Surgical procedure to resect their Rectal Cancer.

Also known as: Robotic Cancer Resection, Robotic Assisted Laparoscopic Rectal Cancer Resection, da Vinci Robotic System, Rectal Cancer Surgery

Robotic Resection of Rectal Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of California, Irvine: lead
• University of Leeds: collaborator

Study Sites (8)

John Muir Medical Center

Concord, California, 94520, United States

Location

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Jackson South Community Hospital

Miami, Florida, 33157, United States

Location

St. Joseph Mercy Health System

Ypsilanti, Michigan, 48197, United States

Location

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Aria Health

Philadelphia, Pennsylvania, 19144, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Related Publications (27)

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Related Links

• ROLARR Trial CTRU University of Leeds

MeSH Terms

Conditions

Rectal Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colonic Diseases

Study Officials

• Alessio Pigazzi, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Interim Chair of Surgery

Study Record Dates

• First Submitted: November 15, 2012
• First Posted: November 29, 2012
• Study Start: December 1, 2011
• Primary Completion: January 30, 2018
• Study Completion: April 30, 2018
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)