Rectal NeoplasmsTRVLNCT02673177
Trial of Robotic Versus Laparoscopic-assisted Radical Resection for Rectal Cancer
A study testing robot-assisted total mesorectal excision and laparoscopic total mesorectal excision in people with Rectal Neoplasms, run by Southwest Hospital, China.
Trial summary
This study compared robot-assisted total mesorectal excision (RTME) and laparoscopic total mesorectal excision (LTME) with regard to urinary function, sexual function and sphincter- preservation outcomes for low rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- robot-assisted total mesorectal excision and laparoscopic total mesorectal excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to May 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients who are acceptable to two surgical procedures for the robot- assisted or laparoscopy-assisted rectal cancer, are willing to randomized trial;
- 2. Matching the diagnostic criteria;
- 3. Aged 18-70 years old;
- 4. Preoperative TNM staging (CT, laparoscopic exploration): cT1-3N0-3M0 (excluding M1, T4);
- 5. Preoperative ASA 3 scores;
- 6. There was no history of malignancy, no other malignant tumors by preoperative examination;
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- 7. Without undergoing definitive treatment, such as radiotherapy, chemotherapy or immunotherapy preoperatively;
- 8. The informed consent form was signed by the patient himself(herself)or his principal agent;
- 9. In accordance with the international erectile function questionnaire (IIEF) urinary function scale, The urinary sexual function are normal.
Who cannot join
- 1. Age less than 18 years old or more than 70 years old;
- 2. Previous psychiatric patients or patients refused to sign the informed consent;
- 3. Attending other related clinical studies on surgical treatment of rectal cancer;
- 4. The patient has a history of malignant tumor, or a combination of other malignant tumors;
- 5. Patients have been treated with definitive treatment: radiotherapy, chemotherapy or immunotherapy;
- 6. Patients had received otherper abdominal operations (except for laparoscopic cholecystectomy);
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- 7. ASA >3;
- 8. Laparoscopic surgical contraindications: such as severe heart lung disease; abdominal wall hernia; diaphragmatic hernia; coagulation disorder; portal hypertension; pregnancy, etc.;
- 9. Those who has been confirmed to be unable to do a radical resection (T4 stage) for local advanced tumor;
- 10. Those who have urination sexual dysfunction preoperatively.
About this study
Official title: A Randomized, Prospective Trial of Robotic Versus Laparoscopic-assisted Radical Resection for Rectal Cancer in Urinary, Erectile Function and Anal Function
This study compared robot-assisted total mesorectal excision (RTME) and laparoscopic total mesorectal excision (LTME) with regard to urinary function, sexual function and sphincter- preservation outcomes for low rectal cancer.
Read the detailed description
Urinary and sexual dysfunction are recognized complications of rectal cancer surgery in men. This study compared robot-assisted total mesorectal excision (RTME) and laparoscopic total mesorectal excision(LTME) with regard to these functional outcomes.Sphincter- preservation outcomes for low rectal cancer was observed as well.
- Conditions
- Rectal Neoplasms
- Being tested
- robot-assisted total mesorectal excision, laparoscopic total mesorectal excision
- Keywords
- robot-assisted total mesorectal excision(RTME), laparoscopic total mesorectal excision(LTME), urinary function, sexual function, sphincter- preservation, low rectal cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robot-assisted total mesorectal excisionProcedure or surgery
The Da Vinci Surgical System may help to protect subtle anatomical structure and provide more functional protection when compared to laparoscopic surgery. This study aimed to compare RTME and laparoscopic total mesorectal excision (LTME) for rectal cancer with regard to Urinary, sexual function and sphincter- preservation outcomes.
laparoscopic total mesorectal excisionProcedure or surgery
Traditional laparoscopic total mesorectal excision (LTME) for rectal cancer.
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted total mesorectal excision | Experimental | Robot-assisted total mesorectal excision (RTME) for rectal cancer. Two different RTME procedures were chose to personalized patients. Generally, when the tumor located within 5-15cm from the anal verge, low anterior resection (LAR) was employed, and tumor located below 5cm, abdominoperineal resection (APR) was applied usually. Receives: Procedure: robot-assisted total mesorectal excision |
| Laparoscopic total mesorectal excision | Active comparator | Traditional laparoscopic total mesorectal excision (LTME) for rectal cancer was performed. The Urinary, sexual function and sphincter- preservation outcomes were evaluated. Receives: Procedure: laparoscopic total mesorectal excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of sexual and urinary dysfunction
Measured: One years after surgery
Secondary outcomes (2)
disease-free survival(DFS )
DFS was defined as from the date of randomization to the date of tumor recurrence or death from any cause
Measured: 3 years disease-free survival
Anus preservation rate
Measured: One years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2018 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- 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
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tang Bo, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673177
- Sponsor's protocol ID
- 2015(43)
- Acronym
- TRVL
- Status last verified
- Feb 2016
- First submitted
- 27 Jan 2016
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective Trial of Robotic Versus Laparoscopic-assisted Radical Resection for Rectal Cancer in Urinary, Erectile Function and Anal Function
- ClinicalTrials.gov ID
- NCT02673177
- Acronym / sponsor ID
- TRVL / 2015(43)
- Conditions
- Rectal Neoplasms
- Keywords
- robot-assisted total mesorectal excision(RTME), laparoscopic total mesorectal excision(LTME), urinary function, sexual function, sphincter- preservation, low rectal cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 3 Feb 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.
This study compared robot-assisted total mesorectal excision (RTME) and laparoscopic total mesorectal excision (LTME) with regard to urinary function, sexual function and sphincter- preservation outcomes for low rectal cancer.
Detailed description
Urinary and sexual dysfunction are recognized complications of rectal cancer surgery in men. This study compared robot-assisted total mesorectal excision (RTME) and laparoscopic total mesorectal excision(LTME) with regard to these functional outcomes.Sphincter- preservation outcomes for low rectal cancer was observed as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted total mesorectal excision | Experimental | Procedure: robot-assisted total mesorectal excisionRobot-assisted total mesorectal excision (RTME) for rectal cancer. Two different RTME procedures were chose to personalized patients. Generally, when the tumor located within 5-15cm from the anal verge, low anterior resection (LAR) was employed, and tumor located below 5cm, abdominoperineal resection (APR) was applied usually. |
| Laparoscopic total mesorectal excision | Active comparator | Procedure: laparoscopic total mesorectal excisionTraditional laparoscopic total mesorectal excision (LTME) for rectal cancer was performed. The Urinary, sexual function and sphincter- preservation outcomes were evaluated. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Patients who are acceptable to two surgical procedures for the robot- assisted or laparoscopy-assisted rectal cancer, are willing to randomized trial;
- 2. Matching the diagnostic criteria;
- 3. Aged 18-70 years old;
- 4. Preoperative TNM staging (CT, laparoscopic exploration): cT1-3N0-3M0 (excluding M1, T4);
- 5. Preoperative ASA 3 scores;
Key exclusion criteria (10 listed)
- 1. Age less than 18 years old or more than 70 years old;
- 2. Previous psychiatric patients or patients refused to sign the informed consent;
- 3. Attending other related clinical studies on surgical treatment of rectal cancer;
- 4. The patient has a history of malignant tumor, or a combination of other malignant tumors;
- 5. Patients have been treated with definitive treatment: radiotherapy, chemotherapy or immunotherapy;
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 total mesorectal excisionThe Da Vinci Surgical System may help to protect subtle anatomical structure and provide more functional protection when compared to laparoscopic surgery. This study aimed to compare RTME and laparoscopic total mesorectal excision (LTME) for rectal cancer with regard to Urinary, sexual function and sphincter- preservation outcomes. | Procedure or surgery | Robot-assisted total mesorectal excision |
| laparoscopic total mesorectal excisionTraditional laparoscopic total mesorectal excision (LTME) for rectal cancer. | Procedure or surgery | Laparoscopic total mesorectal excision |
Primary outcome
Incidence of sexual and urinary dysfunction
Time frame: One years after surgery
2 secondary outcomes
disease-free survival(DFS )
Time frame: 3 years disease-free survival
Anus preservation rate
Time frame: One years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing robot-assisted total mesorectal excision and laparoscopic total mesorectal excision in people with Rectal Neoplasms, run by Southwest Hospital, 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 10 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 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of sexual and urinary dysfunction (time frame: One years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2016.