Colorectal CancerNCT06409403
Study on Effect of Robotic Versus Laparoscopic Surgical Technology on Genitourinary Function After Total Mesorectal Excision for Rectal Cancer
A study testing clinical application of robotic technique in people with Colorectal Cancer, run by general surgery 3 at 1 site in China.
Trial summary
Intraoperative pelvic autonomic nerve (PAN) injury is the dominant reason for genitourinary malfunction after total mesorectal excision (TME), particularly in low rectal tumours. TME necessitates meticulous, sharp dissection with an awareness of the PAN pathway. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- clinical application of robotic technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 31 Dec 2025
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: (i) lesions that were determined by histopathological examination and were staged preoperatively using pelvic MRI and CT scans; (ii) patients aged ≥18 and ≤ 75 years; and (iii) American Society of Anesthesiology (ASA) class ≤3
Exclusion Criteria: Benign prostate hyperplasia, previous bladder or prostate surgery, severe sexual dysfunction (International Index of Erectile Function (IIEF) score <10 or Female Sexual Function Index (FSFI) score ≤26.55), urgent operation, simultaneous or heterochronous multiple primary rectal tumours, distant metastasis, or other severe cardiopulmonary complications.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Bo Yi, MD, 13786179533, 1459082987@qq.com
Bo Yi, MD, 13786179533, yibo2018pro@126.com
About this study
Official title: Study on Clinical Application of Robotic Technique
Intraoperative pelvic autonomic nerve (PAN) injury is the dominant reason for genitourinary malfunction after total mesorectal excision (TME), particularly in low rectal tumours. TME necessitates meticulous, sharp dissection with an awareness of the PAN pathway. In particular, laparoscopic TME (L-TME) is technically difficult and requires advanced laparoscopic surgical skills. Comparing with the conventional laparoscopic approach, 3D vision, surgeon-manipulated camera systems, and multi-degree-of-freedom robotic instruments facilitate identification and preservation of the PAN during robotic-assisted TME (R-TME), theoretically facilitating favourable recovery of postoperative genitourinary function. Previous studies have mostly focused on the impact of advanced robotic technologies on postoperative functions. However, in addition to robotic surgical technology, postoperative function is impacted by multiple other intricate factors, such as oncology, comorbidities, postoperative complications, and adjuvant chemoradiotherapy. Consequently, the superiority of robotic surgery in terms of recovery of postoperative genitourinary function has been controversial in previous studies. Hence, to comprehensively evaluate the effect of robotic technology on postoperative genitourinary function, we conducted a prospective controlled study comparing the conventional approach and robotic surgery.
- Conditions
- Colorectal Cancer
- Being tested
- clinical application of robotic technique
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical application of robotic techniqueDevice
effect of various surgical technique on clinical efficacy of TME
| Study group | Role | What they receive |
|---|---|---|
| da Vinci robotic TME | Experimental | Not described Receives: Device: clinical application of robotic technique |
| Microhands robotic TME | Experimental | Not described Receives: Device: clinical application of robotic technique |
| laparoscopic surgery TME | Active comparator | Not described Receives: Device: clinical application of robotic technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptom Score (IPSS)
evaluation of genitourinary function
Measured: preoperation，1、3、6、12 months after operation
Secondary outcomes (9)
International Index of Erectile Function (IIEF)
evaluation of genitourinary function
Measured: preoperation，1、3、6、12 months after operation
Female Sexual Function Index (FSFI)
evaluation of genitourinary function
Measured: preoperation，1、3、6、12 months after operation
operative time
operative outcomes
Measured: perioperative
blood loose
operative outcomes
Measured: perioperative
conversion
operative outcomes
Measured: perioperative
retrieved lymph nodes
operative outcomes
Measured: perioperative
complete TME specimens
operative outcomes
Measured: perioperative
circumferential resection margins (CRMs)
operative outcomes
Measured: perioperative
complication
operative outcomes
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start1 Jan 2017
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- Participant
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- general surgery 3
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, general surgery 3, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409403
- Sponsor's protocol ID
- YB2017
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 10 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Clinical Application of Robotic Technique
- ClinicalTrials.gov ID
- NCT06409403
- Acronym / sponsor ID
- YB2017
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- general surgery 3University, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 May 2024 (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.
Intraoperative pelvic autonomic nerve (PAN) injury is the dominant reason for genitourinary malfunction after total mesorectal excision (TME), particularly in low rectal tumours. TME necessitates meticulous, sharp dissection with an awareness of the PAN pathway. In particular, laparoscopic TME (L-TME) is technically difficult and requires advanced laparoscopic surgical skills. Comparing with the conventional laparoscopic approach, 3D vision, surgeon-manipulated camera systems, and multi-degree-of-freedom robotic instruments facilitate identification and preservation of the PAN during robotic-assisted TME (R-TME), theoretically facilitating favourable recovery of postoperative genitourinary function. Previous studies have mostly focused on the impact of advanced robotic technologies on postoperative functions. However, in addition to robotic surgical technology, postoperative function is impacted by multiple other intricate factors, such as oncology, comorbidities, postoperative complications, and adjuvant chemoradiotherapy. Consequently, the superiority of robotic surgery in terms of recovery of postoperative genitourinary function has been controversial in previous studies. Hence, to comprehensively evaluate the effect of robotic technology on postoperative genitourinary function, we conducted a prospective controlled study comparing the conventional approach and robotic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| da Vinci robotic TME | Experimental | Device: clinical application of robotic technique |
| Microhands robotic TME | Experimental | Device: clinical application of robotic technique |
| laparoscopic surgery TME | Active comparator | Device: clinical application of robotic technique |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| clinical application of robotic techniqueeffect of various surgical technique on clinical efficacy of TME | Device | Microhands robotic TME, da Vinci robotic TME, laparoscopic surgery TME |
Primary outcome
International Prostate Symptom Score (IPSS)
Time frame: preoperation，1、3、6、12 months after operation
evaluation of genitourinary function
9 secondary outcomes
International Index of Erectile Function (IIEF)
Time frame: preoperation，1、3、6、12 months after operation
Female Sexual Function Index (FSFI)
Time frame: preoperation，1、3、6、12 months after operation
operative time
Time frame: perioperative
blood loose
Time frame: perioperative
conversion
Time frame: perioperative
retrieved lymph nodes
Time frame: perioperative
complete TME specimens
Time frame: perioperative
circumferential resection margins (CRMs)
Time frame: perioperative
complication
Time frame: perioperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: No
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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 clinical application of robotic technique in people with Colorectal Cancer, run by general surgery 3 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?
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 10 May 2024. 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 Bo Yi, MD (13786179533, yibo2018pro@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Prostate Symptom Score (IPSS) (time frame: preoperation，1、3、6、12 months after operation). 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 10 May 2024.