Robot-assisted Versus Laparoscopic Surgery for Mid/Low Rectal Cancer (REAL)

March 20, 2022 updated by: Xu jianmin, Fudan University

Robot-assisted Versus Laparoscopic Surgery for Mid/Low Rectal Cancer (REAL): A Multicenter Randomized Controlled Trial

The purpose of this study is to evaluate the safety and oncological feasibility of robot-assisted surgery for mid/low rectal carcinoma compared with laparoscopic surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Laparoscopic surgery as the treatment for colon cancer has been widely recognized. But its use for rectal cancer is still controversial. Previous trials have shown that although the long-term survival outcomes were similar, laparoscopic surgery did not reach the non-inferiority in terms of local tumor radical resection, compared with open surgery. Robotic techniques are considered to improve the quality of surgery with three-dimensional vision, stable camera platform and flexible robotic arms. Meta-analyses have shown that compared with laparoscopic surgery, robotic surgery could improve surgical quality in terms of open conversion, circumferential resection margin, postoperative complications, postoperative recovery, and quality of life, with similar long-term survival. However, these evidences mainly came from retrospective studies and small-scale randomized controlled trials with low quality. There still needs high-quality clinical trials to confirm the advantages of robotic surgery for rectal cancer.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100141
        • Chinese PLA General Hospital
    • Chongqing
      • Chongqing, Chongqing, China, 671014
        • The Southwest Hospital of Army Medical University
    • Henan
      • Zhengzhou, Henan, China, 450052
        • The First Affiliated Hospital of Zhengzhou University
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University
    • Jilin
      • Changchun, Jilin, China, 130012
        • Jilin Cancer Hospital
    • Liaoning
      • Shenyang, Liaoning, China, 123005
        • Chinese PLA General Hospital of Northern Theatre Command (former Shenyang Military General Hospital)
    • Shandong
      • Jinan, Shandong, China, 250031
        • The 960th Hospital of Chinese PLA Joint Logistic Support Force (former Jinan Military General Hospital)
      • Qingdao, Shandong, China, 266003
        • The Affiliated Hospital of Qingdao University
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Zhongshan hospital, Fudan University
      • Shanghai, Shanghai, China, 200020
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
      • Shanghai, Shanghai, China, 200438
        • The First Affiliated Hospital of Naval Medical University (Changhai Hospital)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) class I - III;
  • Histologically proved rectal adenocarcinoma;
  • Inferior tumor edge ≤ 10 cm from anal verge, measured by rigid rectoscopy;
  • Tumor assessed as cT1-T3 (mesorectal fascia not involved) N0-1, or ycT1-T3 Nx after preoperative radio- or chemoradiotherapy, measured by pelvic MRI;
  • No evidence of distant metastases;
  • No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri;
  • Suitable for both robotic and laparoscopic surgery;
  • Informed consent.

Exclusion Criteria:

  • Tumors assessed as clinical complete response after preoperative radio- or chemoradiotherapy;
  • Tumors assessed as cT1N0 and suitable for local excision;
  • Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery;
  • Multiple colorectal tumors or other schedules needing for synchronous colon surgery;
  • Hereditary colorectal cancer (familial adenomatosis polyposis, Lynch Syndrome, etc.);
  • Co-existent inflammatory bowel disease;
  • Pregnancy or lactation;
  • Patients received treatment other than preoperative radio- or chemoradiotherapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Robot-assisted surgery
Patients undergo robot-assisted resections.
Procedure: Robot-assisted resection
Arm I: Robot-assisted resection using da vinci system.
Active Comparator: Laparoscopic surgery
Patients undergo laparoscopic resections.
Procedure: Laparoscopic resection
Arm II: Traditional laparoscopic resection.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Locoregional recurrence rate
Time Frame: 3 years after surgery
The proportion of patients with any cancer recurrence in the pelvic or perineal area
3 years after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Circumferential resection margin positive rate
Time Frame: 1 week after surgery
The proportion of patients with circumferential resection margin ≤ 1 mm from the tumor
1 week after surgery
Postoperative complication rate
Time Frame: 30 days after surgery
The proportion of patients with any complications occurred within 30 days after surgery
30 days after surgery
Overall survival time
Time Frame: 3 years after surgery
Time from surgery to death
3 years after surgery
Disease-free survival time
Time Frame: 3 years after surgery
Time from surgery to any recurrence, metastases or death
3 years after surgery
Operative time
Time Frame: Day 1
Time from making skin incision to suturing the incision during the surgery
Day 1
Rate of conversion to open surgery
Time Frame: Day 1
The proportion of patients with the use of a laparotomy incision for any part of the TME procedure or lymph nodes dissection during the surgery
Day 1
Estimated blood loss
Time Frame: Day 1
Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation.
Day 1
Proximal/distal resection margin
Time Frame: 1 week after surgery
The proximal/distal resection margin will be reported as "positive" or "negative" to define whether tumor is radically resected. It will be reported according to the post-operative pathology. Details are based on NCCN and Chinese guidelines for colorectal cancer.
1 week after surgery
Number of retrieved lymph nodes
Time Frame: 1 week after surgery
The number of lymph node found from the surgical specimen
1 week after surgery
Postoperative hospital stay
Time Frame: 30 days after surgery
The postoperative hospital stay is defined as the number of date from the first day after operation to discharge.
30 days after surgery
Self reported bladder function
Time Frame: At postoperative 3, 6 and 12 months
This section is assessed using a self-rating scale "International prostate symptom score" (IPSS).
At postoperative 3, 6 and 12 months
Self reported sexual function for male patients
Time Frame: At postoperative 3, 6 and 12 months
This section is assessed using a self-rating scale "International Index of Erectile Function" (IIEF-5).
At postoperative 3, 6 and 12 months
Self reported sexual function for female patients
Time Frame: At postoperative 3, 6 and 12 months
This section is assessed using a self-rating scale "Female Sexual Function Index" (FSFI).
At postoperative 3, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fudan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jianmin Xu, Ph.D., M.D., Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 10, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REAL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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