Robot-assisted Versus Laparoscopic Surgery for Mid/Low Rectal Cancer
REAL
1 other identifier
interventional
1,240
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2016
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2016
CompletedFirst Posted
Study publicly available on registry
June 29, 2016
CompletedStudy Start
First participant enrolled
July 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMarch 22, 2022
March 1, 2022
7.5 years
March 7, 2016
March 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Locoregional recurrence rate
The proportion of patients with any cancer recurrence in the pelvic or perineal area
3 years after surgery
Secondary Outcomes (13)
Circumferential resection margin positive rate
1 week after surgery
Postoperative complication rate
30 days after surgery
Overall survival time
3 years after surgery
Disease-free survival time
3 years after surgery
Operative time
Day 1
- +8 more secondary outcomes
Study Arms (2)
Robot-assisted surgery
EXPERIMENTALPatients undergo robot-assisted resections.
Laparoscopic surgery
ACTIVE COMPARATORPatients undergo laparoscopic resections.
Interventions
Arm I: Robot-assisted resection using da vinci system.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (11)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100141, China
The Southwest Hospital of Army Medical University
Chongqing, Chongqing Municipality, 671014, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Jilin Cancer Hospital
Changchun, Jilin, 130012, China
Chinese PLA General Hospital of Northern Theatre Command (former Shenyang Military General Hospital)
Shenyang, Liaoning, 123005, China
The 960th Hospital of Chinese PLA Joint Logistic Support Force (former Jinan Military General Hospital)
Jinan, Shandong, 250031, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200020, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032, China
The First Affiliated Hospital of Naval Medical University (Changhai Hospital)
Shanghai, Shanghai Municipality, 200438, China
Related Publications (2)
Feng Q, Yuan W, Li T, Tang B, Jia B, Zhou Y, Zhang W, Zhao R, Zhang C, Cheng L, Zhang X, Wei Y, Liang F, He G, Xu J; REAL Study Group. Robotic vs Laparoscopic Surgery for Middle and Low Rectal Cancer: The REAL Randomized Clinical Trial. JAMA. 2025 Jul 8;334(2):136-148. doi: 10.1001/jama.2025.8123.
PMID: 40455621DERIVEDFeng 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.
PMID: 36087608DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jianmin Xu, Ph.D., M.D.
Fudan University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Colorectal Surgery
Study Record Dates
First Submitted
March 7, 2016
First Posted
June 29, 2016
Study Start
July 10, 2016
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
March 22, 2022
Record last verified: 2022-03