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

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: Active, not recruiting
• Conditions: Rectal Carcinoma
• Intervention / Treatment: Procedure: Robot-assisted resection; Procedure: Laparoscopic resection

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: Interventional
• Enrollment (Actual): 1240
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Locoregional recurrence rate	The proportion of patients with any cancer recurrence in the pelvic or perineal area	3 years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circumferential resection margin positive rate	The proportion of patients with circumferential resection margin ≤ 1 mm from the tumor	1 week after surgery
Postoperative complication rate	The proportion of patients with any complications occurred within 30 days after surgery	30 days after surgery
Overall survival time	Time from surgery to death	3 years after surgery
Disease-free survival time	Time from surgery to any recurrence, metastases or death	3 years after surgery
Operative time	Time from making skin incision to suturing the incision during the surgery	Day 1
Rate of conversion to open surgery	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	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	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	The number of lymph node found from the surgical specimen	1 week after surgery
Postoperative hospital stay	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	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	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	This section is assessed using a self-rating scale "Female Sexual Function Index" (FSFI).	At postoperative 3, 6 and 12 months

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Study Chair: Jianmin Xu, Ph.D., M.D., Fudan University

Publications and helpful links

General Publications

• Feng Q, Yuan W, Li T, Tang B, Jia B, Zhou Y, Zhang W, Zhao R, Zhang C, Cheng L, Zhang X, Liang F, He G, Wei Y, Xu J; REAL Study Group. Robotic versus laparoscopic surgery for middle and low rectal cancer (REAL): short-term outcomes of a multicentre randomised controlled trial. Lancet Gastroenterol Hepatol. 2022 Nov;7(11):991-1004. doi: 10.1016/S2468-1253(22)00248-5. Epub 2022 Sep 8.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2016
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: March 7, 2016
• First Submitted That Met QC Criteria: June 25, 2016
• First Posted (Estimate): June 29, 2016

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 20, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Survival; Recurrence; Disease Progression; Rectal Cancer; Postoperative Complications; Robotic Surgical Procedures; Minimally Invasive Surgical Procedures; Laparoscopic Surgical Procedures; Intraoperative Complications; Recovery of Function
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: REAL