Rectal CancerR-ISRNCT03597126
Short Term Outcomes of Robotic-assisted Intersphincteric Resection for Low Rectal Cancer
A study testing Robot-assisted surgery and Laparoscopic surgery in people with Rectal Cancer, run by Southwest Hospital, China at 1 site in China.
Trial summary
This study compared robot-assisted total mesorectal excision to treat very low rectal cancer within 2 cm from the dentate line to avoid permanent colostomy. improves the quality of life with better defecation function, urinary function and sexual function. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Robot-assisted surgery and Laparoscopic surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 1 Dec 2022
- 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
- 18 years < age < 80 years
- Matching the diagnostic criteria;
- tumor located 3 cm from anal verge
- Clinically diagnosed cT1-3N0-2 M0 lesions
- Tumor size of 4 cm or less
- ASA 1-3 scores;
- ECOG score is 0-1;
- Adequate preoperative sphincter function
Who cannot join
- Requiring a Mile's procedure
- Fecal incontinence;
- Previous abdominal surgery
- Severe mental disease.
- Intolerance of surgery for severe comorbidities
- Emergency operation due to complication
- Pregnant woman or lactating woman
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Southwest Hospital
Chongqing
Yu Yupeiwu, M.D/Ph.D, +8618323479228, yupeiwu01@sina.com
About this study
Official title: Short Term Outcomes of Robotic-assisted Intersphincteric Resection for Low Rectal Cancer:A Multicentric Randomized Controlled Trial
This study compared robot-assisted total mesorectal excision to treat very low rectal cancer within 2 cm from the dentate line to avoid permanent colostomy. improves the quality of life with better defecation function, urinary function and sexual function.
- Conditions
- Rectal Cancer
- Being tested
- Robot-assisted surgery, Laparoscopic surgery
- Keywords
- Robotic, Intersphincteric Resection, rectal cancer, pelvic autonomic nerve anal function
- 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 surgeryDevice
robot-assisted intersphincteric resection for low location rectal cancer(T=1\&2)
Laparoscopic surgeryDevice
laparoscopic intersphincteric resection for low location rectal cancer(T=1\&2)
| Study group | Role | What they receive |
|---|---|---|
| robot-assisted ISR | Active comparator | Patients with low rectal cancer undergo intersphincteric resection assisted by Robotic Receives: Device: Robot-assisted surgery |
| laparoscopic ISR | Active comparator | Patients with low rectal cancer undergo laparosocopic intersphincteric resection Receives: Device: Laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urinary function
The days of indwelling catheter after operation The overall efficiency of urination function
Measured: 6 months
Change in International Index of Erectile Function [IIEF] score
Alterations in IIEF scores from baseline up to 18 months postoperatively - 15 item questionnaire, each item range from 0 - 5, with total score to 30. lower score indicates more severe erectile dysfunction (ED)
Measured: 18 months
Change in FIQL scores
Alterations in Fecal Incontinence Quality of Life Instrument (FIQL) scores from baseline up to 18 months postoperatively - 29 items range from 1 (strongly agree) to 4 (strongly disagree); with a 1 indicating a lower functional status of quality of life. Scale scores are only calculated if at least half of the items have been answered
Measured: 18 months
Change in Female Sexual Function Index [FSFI]
Alterations in FSFI from baseline up to 18 months postoperatively - 19-item self-report measure, each item ranges from 0-5, with full range from 2 to 36, with low score indicating sexual function disorder.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start1 Dec 2018
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Chuan, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597126
- Sponsor's protocol ID
- RoboticISR
- Acronym
- R-ISR
- Status last verified
- Nov 2021
- First submitted
- 23 Apr 2018
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Outcomes of Robotic-assisted Intersphincteric Resection for Low Rectal Cancer:A Multicentric Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03597126
- Acronym / sponsor ID
- R-ISR / RoboticISR
- Conditions
- Rectal Cancer
- Keywords
- Robotic, Intersphincteric Resection, rectal cancer, pelvic autonomic nerve anal function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 24 Jul 2018 (actual)
- 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 to treat very low rectal cancer within 2 cm from the dentate line to avoid permanent colostomy. improves the quality of life with better defecation function, urinary function and sexual function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| robot-assisted ISR | Active comparator | Device: Robot-assisted surgeryPatients with low rectal cancer undergo intersphincteric resection assisted by Robotic |
| laparoscopic ISR | Active comparator | Device: Laparoscopic surgeryPatients with low rectal cancer undergo laparosocopic intersphincteric resection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years < age < 80 years
- Matching the diagnostic criteria;
- tumor located 3 cm from anal verge
- Clinically diagnosed cT1-3N0-2 M0 lesions
- Tumor size of 4 cm or less
Key exclusion criteria (7 listed)
- Requiring a Mile's procedure
- Fecal incontinence;
- Previous abdominal surgery
- Severe mental disease.
- Intolerance of surgery for severe comorbidities
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 surgeryrobot-assisted intersphincteric resection for low location rectal cancer(T=1\&2) | Device | robot-assisted ISR |
| Laparoscopic surgerylaparoscopic intersphincteric resection for low location rectal cancer(T=1\&2) | Device | laparoscopic ISR |
Primary outcome
Change in urinary function
Time frame: 6 months
The days of indwelling catheter after operation The overall efficiency of urination function
Change in International Index of Erectile Function [IIEF] score
Time frame: 18 months
Alterations in IIEF scores from baseline up to 18 months postoperatively - 15 item questionnaire, each item range from 0 - 5, with total score to 30. lower score indicates more severe erectile dysfunction (ED)
Change in FIQL scores
Time frame: 18 months
Alterations in Fecal Incontinence Quality of Life Instrument (FIQL) scores from baseline up to 18 months postoperatively - 29 items range from 1 (strongly agree) to 4 (strongly disagree); with a 1 indicating a lower functional status of quality of life. Scale scores are only calculated if at least half of the items have been answered
Change in Female Sexual Function Index [FSFI]
Time frame: 18 months
Alterations in FSFI from baseline up to 18 months postoperatively - 19-item self-report measure, each item ranges from 0-5, with full range from 2 to 36, with low score indicating sexual function disorder.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted surgery and Laparoscopic surgery in people with Rectal Cancer, run by Southwest Hospital, China 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 8 inclusion and 7 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 9 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tang Bo, M.D (+86 13883902288, yupeiwu1961@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in urinary function (time frame: 6 months). The study lists 4 primary outcomes in all. 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 9 Dec 2021.