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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02817126
Recruitment Status : Active, not recruiting
First Posted : June 29, 2016
Last Update Posted : March 22, 2022
Information provided by (Responsible Party):
Xu jianmin, Fudan University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rectal Carcinoma Procedure: Robot-assisted resection Procedure: Laparoscopic resection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Robot-assisted Versus Laparoscopic Surgery for Mid/Low Rectal Cancer (REAL): A Multicenter Randomized Controlled Trial
Actual Study Start Date : July 10, 2016
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Locoregional recurrence rate [ Time Frame: 3 years after surgery ]
    The proportion of patients with any cancer recurrence in the pelvic or perineal area

Secondary Outcome Measures :
  1. Circumferential resection margin positive rate [ Time Frame: 1 week after surgery ]
    The proportion of patients with circumferential resection margin ≤ 1 mm from the tumor

  2. Postoperative complication rate [ Time Frame: 30 days after surgery ]
    The proportion of patients with any complications occurred within 30 days after surgery

  3. Overall survival time [ Time Frame: 3 years after surgery ]
    Time from surgery to death

  4. Disease-free survival time [ Time Frame: 3 years after surgery ]
    Time from surgery to any recurrence, metastases or death

  5. Operative time [ Time Frame: Day 1 ]
    Time from making skin incision to suturing the incision during the surgery

  6. 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

  7. 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.

  8. 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.

  9. Number of retrieved lymph nodes [ Time Frame: 1 week after surgery ]
    The number of lymph node found from the surgical specimen

  10. 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.

  11. 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).

  12. 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).

  13. 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).

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02817126

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China, Beijing
Chinese PLA General Hospital
Beijing, Beijing, China, 100141
China, Chongqing
The Southwest Hospital of Army Medical University
Chongqing, Chongqing, China, 671014
China, Henan
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
China, Jiangxi
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
China, Jilin
Jilin Cancer Hospital
Changchun, Jilin, China, 130012
China, Liaoning
Chinese PLA General Hospital of Northern Theatre Command (former Shenyang Military General Hospital)
Shenyang, Liaoning, China, 123005
China, Shandong
The 960th Hospital of Chinese PLA Joint Logistic Support Force (former Jinan Military General Hospital)
Jinan, Shandong, China, 250031
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266003
China, Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai, China, 200020
Zhongshan Hospital, Fudan University
Shanghai, Shanghai, China, 200032
The First Affiliated Hospital of Naval Medical University (Changhai Hospital)
Shanghai, Shanghai, China, 200438
Sponsors and Collaborators
Fudan University
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Study Chair: Jianmin Xu, Ph.D., M.D. Fudan University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Xu jianmin, Head of Colorectal Surgery, Fudan University
ClinicalTrials.gov Identifier: NCT02817126    
Other Study ID Numbers: REAL
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: March 22, 2022
Last Verified: March 2022
Keywords provided by Xu jianmin, Fudan University:
Minimally Invasive Surgical Procedures
Robotic Surgical Procedures
Laparoscopic Surgical Procedures
Rectal Cancer
Intraoperative Complications
Postoperative Complications
Recovery of Function
Disease Progression
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases