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RObotic Versus LAparoscopic Resection for Rectal Cancer (ROLARR)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Leeds
Information provided by (Responsible Party):
Alessio Pigazzi, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01736072
First received: November 15, 2012
Last updated: November 6, 2014
Last verified: November 2014
  Purpose

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 Intervention
Rectal Cancer
Procedure: Standard Laparoscopic Surgery
Procedure: Robotic Assisted Laparoscopic Surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • End of Conversion to Open Surgery [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Oncological Efficacy [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Intra-operative and post-operative complications [ Time Frame: 30 day and 6 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 520
Study Start Date: December 2011
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • Laparoscopic Rectal Cancer Resection
  • Laparoscopic Cancer Resection
  • Rectal Cancer Surgery
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.
Other Names:
  • Robotic Cancer Resection
  • Robotic Assisted Laparoscopic Rectal Cancer Resection
  • da Vinci Robotic System
  • Rectal Cancer Surgery

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged ≥ 18 years
  2. Able to provide written informed consent
  3. 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.
  4. Rectal cancer suitable for resection by either standard or robotic-assisted laparoscopic procedure
  5. Fit for robotic-assisted or standard laparoscopic rectal resection
  6. American Society of Anesthesiologists (ASA) physical status ≤ 3
  7. Capable of completing required questionnaires at time of consent (provided questionnaires are available in a language spoke fluently by the participant)

Exclusion Criteria:

  1. Benign lesions of the rectum
  2. Benign or malignant diseases of the anal canal
  3. Locally advanced cancers not amenable to curative surgery
  4. Locally advanced cancers requiring en bloc multi-visceral resection
  5. 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)
  6. Co-existent inflammatory bowel disease
  7. Clinical or radiological evidence of metastatic spread
  8. 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)
  9. 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
  10. Pregnancy or breastfeeding women.
  11. Participation in another rectal cancer clinical trial relating to surgical technique.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01736072

Locations
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
Aria Health
Philadelphia, Pennsylvania, United States, 19144
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
University of California, Irvine
University of Leeds
Investigators
Principal Investigator: Alessio Pigazzi, MD University of California, Irvine
  More Information

Additional Information:
Publications:

Responsible Party: Alessio Pigazzi, Associate Clinical Professor of Surgery, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01736072     History of Changes
Other Study ID Numbers: HS#2011-8537
Study First Received: November 15, 2012
Last Updated: November 6, 2014
Health Authority: United Kingdom: National Institute for Health Research
United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Rectal Cancer
Colorectal Cancer
Laparoscopic Surgery
Robotic Surgery
Robotic Assisted Laparoscopic Surgery

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on November 24, 2014