Rectal CarcinomaREALNCT02817126
Robot-assisted Versus Laparoscopic Surgery for Mid/Low Rectal Cancer
A study testing Robot-assisted resection and Laparoscopic resection in people with Rectal Carcinoma, run by Fudan University at 11 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Carcinoma
- What is being tested?
- Robot-assisted resection and Laparoscopic resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,240 participants
- Where
- 11 sitesChina
- Study dates
- 10 Jul 2016to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100141
Jilin Cancer Hospital
Changchun, Jilin, 130012
The Southwest Hospital of Army Medical University
Chongqing, Chongqing Municipality, 671014
The 960th Hospital of Chinese PLA Joint Logistic Support Force (former Jinan Military General Hospital)
Jinan, Shandong, 250031
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200020
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
The First Affiliated Hospital of Naval Medical University (Changhai Hospital)
Shanghai, Shanghai Municipality, 200438
Chinese PLA General Hospital of Northern Theatre Command (former Shenyang Military General Hospital)
Shenyang, Liaoning, 123005
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: 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.
Read the 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.
- Conditions
- Rectal Carcinoma
- Being tested
- Robot-assisted resection, Laparoscopic resection
- Keywords
- Minimally Invasive Surgical Procedures, Robotic Surgical Procedures, Laparoscopic Surgical Procedures, Rectal Cancer, Intraoperative Complications, Postoperative Complications, Recovery of Function, Recurrence, Disease Progression, Survival
- Medical subject headings
- Rectal Neoplasms, Intraoperative Complications, Postoperative Complications, Recurrence, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted resectionProcedure or surgery
Arm I: Robot-assisted resection using da vinci system.
Laparoscopic resectionProcedure or surgery
Arm II: Traditional laparoscopic resection.
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted surgery | Experimental | Patients undergo robot-assisted resections. Receives: Procedure: Robot-assisted resection |
| Laparoscopic surgery | Active comparator | Patients undergo laparoscopic resections. Receives: Procedure: Laparoscopic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional recurrence rate
The proportion of patients with any cancer recurrence in the pelvic or perineal area
Measured: 3 years after surgery
Secondary outcomes (13)
Circumferential resection margin positive rate
The proportion of patients with circumferential resection margin ≤ 1 mm from the tumor
Measured: 1 week after surgery
Postoperative complication rate
The proportion of patients with any complications occurred within 30 days after surgery
Measured: 30 days after surgery
Overall survival time
Time from surgery to death
Measured: 3 years after surgery
Disease-free survival time
Time from surgery to any recurrence, metastases or death
Measured: 3 years after surgery
Operative time
Time from making skin incision to suturing the incision during the surgery
Measured: 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
Measured: 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.
Measured: 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.
Measured: 1 week after surgery
Number of retrieved lymph nodes
The number of lymph node found from the surgical specimen
Measured: 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.
Measured: 30 days after surgery
Self reported bladder function
This section is assessed using a self-rating scale "International prostate symptom score" (IPSS).
Measured: 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).
Measured: 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).
Measured: At postoperative 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study start10 Jul 2016
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rectal CarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu jianmin, Fudan University
- Investigators
- Jianmin Xu, Ph.D., M.D., Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817126
- Sponsor's protocol ID
- REAL
- Acronym
- REAL
- Status last verified
- Mar 2022
- First submitted
- 7 Mar 2016
- Last updated
- 22 Mar 2022
- Results posted
- No
Publications
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.
PubMed 40455621Feng 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.
PubMed 36087608
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-assisted Versus Laparoscopic Surgery for Mid/Low Rectal Cancer (REAL): A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02817126
- Acronym / sponsor ID
- REAL / REAL
- Conditions
- Rectal Carcinoma
- Keywords
- Minimally Invasive Surgical Procedures, Robotic Surgical Procedures, Laparoscopic Surgical Procedures, Rectal Cancer, Intraoperative Complications, Postoperative Complications, Recovery of Function, Recurrence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,240 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 10 Jul 2016 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted surgery | Experimental | Procedure: Robot-assisted resectionPatients undergo robot-assisted resections. |
| Laparoscopic surgery | Active comparator | Procedure: Laparoscopic resectionPatients undergo laparoscopic resections. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (8 listed)
- 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.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-assisted resectionArm I: Robot-assisted resection using da vinci system. | Procedure or surgery | Robot-assisted surgery |
| Laparoscopic resectionArm II: Traditional laparoscopic resection. | Procedure or surgery | Laparoscopic surgery |
Primary outcome
Locoregional recurrence rate
Time frame: 3 years after surgery
The proportion of patients with any cancer recurrence in the pelvic or perineal area
13 secondary outcomes
Circumferential resection margin positive rate
Time frame: 1 week after surgery
Postoperative complication rate
Time frame: 30 days after surgery
Overall survival time
Time frame: 3 years after surgery
Disease-free survival time
Time frame: 3 years after surgery
Operative time
Time frame: Day 1
Rate of conversion to open surgery
Time frame: Day 1
Estimated blood loss
Time frame: Day 1
Proximal/distal resection margin
Time frame: 1 week after surgery
Number of retrieved lymph nodes
Time frame: 1 week after surgery
Postoperative hospital stay
Time frame: 30 days after surgery
Self reported bladder function
Time frame: At postoperative 3, 6 and 12 months
Self reported sexual function for male patients
Time frame: At postoperative 3, 6 and 12 months
Self reported sexual function for female patients
Time frame: At postoperative 3, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Derived from this study: PubMed 40455621Feng 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.
- Derived from this study: PubMed 36087608Feng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianmin Xu, Ph.D., M.D. study chair
Fudan University
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted resection and Laparoscopic resection in people with Rectal Carcinoma, run by Fudan University at 11 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Locoregional recurrence rate (time frame: 3 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02817126, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.