RObotic Versus LAparoscopic Resection for Rectal Cancer (ROLARR)
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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 UCI 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 | Phase |
|---|---|---|
|
Rectal Cancer |
Procedure: Surgical Resection of the Colorectal Cancer |
Phase 4 |
| 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. |
- 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.
- 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.
- 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 I-PSS© for male and female bladder function, and the IIEF and FSFI© for sexual function.
| Estimated Enrollment: | 400 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | November 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Standard Laparoscopic Resection
Research Subjects will be randomized to Surgical Resection of Colorectal Cancer by Standard Laparoscopic Surgery.
|
Procedure: Surgical Resection of the Colorectal Cancer
The research subjects will be randomized to either Robotic Assisted or Standard Laparoscopic Surgical procedure to resect their Colorectal Cancer.
Other Names:
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Active Comparator: Robotic Assisted Laparoscopic Resection
Research Subjects will be randomized to Surgical Resection of Colorectal Cancer by Robotic Assisted Laparoscopic Surgery.
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Procedure: Surgical Resection of the Colorectal Cancer
The research subjects will be randomized to either Robotic Assisted or Standard Laparoscopic Surgical procedure to resect their Colorectal Cancer.
Other Names:
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Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Contacts and Locations| Contact: Carlos Chavez, MD | 714-456-5396 | rolarr@uci.edu |
| United States, California | |
| University of California, Irvine Medical Center | Recruiting |
| Orange, California, United States, 92868 | |
| Contact: Carlos Chavez, MD 714-456-5396 chavezc@uci.edu | |
| Principal Investigator: Alessio Pigazzi, MD | |
| 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: | January 3, 2013 |
| 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 Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013