Rectal CancerRLAPRNCT01985698
A Trial of Robotic-assisted Versus Laparoscopic Abdominoperineal Resection for Treating Low Rectal Cancer
A study testing Robotic-assisted resection. and Laparoscopic resection in people with Rectal Cancer, run by Fudan University at 1 site in China.
Trial summary
In this study, the investigators assessed the difference in efficacy and safety among robotic-assisted versus laparoscopic abdominoperineal resection for patients with low rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Robotic-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
- 347 participants
- Where
- 1 siteChina
- Study dates
- Dec 2013to Dec 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven rectal adenocarcinoma
- Inferior edge of the tumor located within 5 cm from the anal verge as determined by colonoscopy withdrawing and digital rectal examination
- No evidence of distant metastases (including pelvis, peritoneum, liver, lung, brain, bone, distant lymph node, etc) according to ultrasound, CT, PET-CT, etc
- Tumor assessed as cT1-T3 or ycT1-T3 after preoperative neoadjuvant chemoradiotherapy by pelvic MRI
- 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 robot-assisted and laparoscopic surgery
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- American Society of Anesthesiologists (ASA) class I - III
- No other preoperative treatment except neoadjuvant chemoradiotherapy
- Informed consent
Who cannot join
- Tumors assessed as cT1N0 and suitable for local excision
- Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery
- More than one colorectal tumor
- Familial Adenomatosis Polyposis, Lynch Syndrome, acute inflammatory bowel disease
- Schedules need for other synchronous colon surgery
- Absolute contraindications to general anesthesia or prolonged pneumoperitoneum (ASA class > III)
Show all 9Show fewer
- Pregnancy or lactation
- Patients and/or family members can not understand and accept this study
- Patients received chemoradiotherapy or other anti-tumor therapy before surgery
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Single-centre, Prospective, Randomised, Controlled, Unblinded, Parallel-group Trial of Robotic-assisted Versus Laparoscopic Abdominoperineal Resection for the Curative Treatment of Low Rectal Cancer
In this study, the investigators assessed the difference in efficacy and safety among robotic-assisted versus laparoscopic abdominoperineal resection for patients with low rectal cancer.
Read the detailed description
Patients will be eligible for inclusion if their primary tumors is low rectal cancer.
Eligible patients will be randomly assigned to robotic-assisted (arm A) versus laparoscopic (arm B) abdominoperineal resection.
- Conditions
- Rectal Cancer
- Being tested
- Robotic-assisted resection., Laparoscopic resection
- Keywords
- Low rectal cancer, Robotic, Laparoscopic, Abdominoperineal resection
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted resection.Procedure or surgery
Robotic-assisted abdominoperineal resection.
Laparoscopic resectionProcedure or surgery
Laparoscopic abdominoperineal resection
| Study group | Role | What they receive |
|---|---|---|
| Robotic-assisted resection | Experimental | patients with low rectal cancer receiving robotic-assisted abdominoperineal resection. Receives: Procedure: Robotic-assisted resection. |
| Laparoscopic resection | Active comparator | patients with low rectal cancer receiving laparoscopic abdominoperineal resection. Receives: Procedure: Laparoscopic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications
postoperative complications related to operation
Measured: 30 days post operatively
Secondary outcomes (4)
operative mortality
death occurred 30 days after operation
Measured: 30 days post operatively
disease-free survival
disease-free survival rate at 3 years after operation
Measured: 3 years
overall survival
overall survival rate at 3 and 5 years after operation
Measured: 3 and 5 years
locoregional recurrence rate
local recurrence rate at 3 and 5 years after operation
Measured: 3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2016
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies 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
- 347 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, MD, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985698
- Sponsor's protocol ID
- RLAPR
- Acronym
- RLAPR
- Status last verified
- Mar 2021
- First submitted
- 9 Nov 2013
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Feng Q, Tang W, Zhang Z, Wei Y, Ren L, Chang W, Zhu D, Liang F, He G, Xu J. Robotic versus laparoscopic abdominoperineal resections for low rectal cancer: A single-center randomized controlled trial. J Surg Oncol. 2022 Dec;126(8):1481-1493. doi: 10.1002/jso.27076. Epub 2022 Aug 29.
PubMed 36036889
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Prospective, Randomised, Controlled, Unblinded, Parallel-group Trial of Robotic-assisted Versus Laparoscopic Abdominoperineal Resection for the Curative Treatment of Low Rectal Cancer
- ClinicalTrials.gov ID
- NCT01985698
- Acronym / sponsor ID
- RLAPR / RLAPR
- Conditions
- Rectal Cancer
- Keywords
- Low rectal cancer, Robotic, Laparoscopic, Abdominoperineal resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 15 Nov 2013 (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.
In this study, the investigators assessed the difference in efficacy and safety among robotic-assisted versus laparoscopic abdominoperineal resection for patients with low rectal cancer.
Detailed description
Patients will be eligible for inclusion if their primary tumors is low rectal cancer.
Eligible patients will be randomly assigned to robotic-assisted (arm A) versus laparoscopic (arm B) abdominoperineal resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic-assisted resection | Experimental | Procedure: Robotic-assisted resection.patients with low rectal cancer receiving robotic-assisted abdominoperineal resection. |
| Laparoscopic resection | Active comparator | Procedure: Laparoscopic resectionpatients with low rectal cancer receiving laparoscopic abdominoperineal resection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically proven rectal adenocarcinoma
- Inferior edge of the tumor located within 5 cm from the anal verge as determined by colonoscopy withdrawing and digital rectal examination
- No evidence of distant metastases (including pelvis, peritoneum, liver, lung, brain, bone, distant lymph node, etc) according to ultrasound, CT, PET-CT, etc
- Tumor assessed as cT1-T3 or ycT1-T3 after preoperative neoadjuvant chemoradiotherapy by pelvic MRI
- No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri
Key exclusion criteria (9 listed)
- Tumors assessed as cT1N0 and suitable for local excision
- Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery
- More than one colorectal tumor
- Familial Adenomatosis Polyposis, Lynch Syndrome, acute inflammatory bowel disease
- Schedules need for other synchronous colon surgery
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 |
|---|---|---|
| Robotic-assisted resection.Robotic-assisted abdominoperineal resection. | Procedure or surgery | Robotic-assisted resection |
| Laparoscopic resectionLaparoscopic abdominoperineal resection | Procedure or surgery | Laparoscopic resection |
Primary outcome
postoperative complications
Time frame: 30 days post operatively
postoperative complications related to operation
4 secondary outcomes
operative mortality
Time frame: 30 days post operatively
disease-free survival
Time frame: 3 years
overall survival
Time frame: 3 and 5 years
locoregional recurrence rate
Time frame: 3 and 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Derived from this study: PubMed 36036889Feng Q, Tang W, Zhang Z, Wei Y, Ren L, Chang W, Zhu D, Liang F, He G, Xu J. Robotic versus laparoscopic abdominoperineal resections for low rectal cancer: A single-center randomized controlled trial. J Surg Oncol. 2022 Dec;126(8):1481-1493. doi: 10.1002/jso.27076. Epub 2022 Aug 29.
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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, MD study chair
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-assisted resection. and Laparoscopic resection in people with Rectal Cancer, run by Fudan University at 1 site 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 9 inclusion and 9 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: finished, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
postoperative complications (time frame: 30 days post operatively). 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 NCT01985698, which also lists 1 linked publication.
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 9 Mar 2021.