Total Mesorectal ExcisionNCT06105203
RATME Vs LATME in Middle and Low Rectal Cancer
A study testing Robotic-assisted total mesorectal excision and laparoscopic-assisted total mesorectal excision in people with Total Mesorectal Excision and Rectal Neoplasms, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
This is a multicenter, superior, randomized controlled trial designed to compare Robotic-assisted total mesorectal excision (RATME) and laparoscopic-assisted total mesorectal excision (LATME) for middle and low rectal cancer. The primary endpoint is the incidence of intersphincteric resection (ISR). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Total Mesorectal Excision, Rectal Neoplasms, Robotic Surgical Procedures
- What is being tested?
- Robotic-assisted total mesorectal excision and laparoscopic-assisted total mesorectal excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,026 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- male patients diagnosed with rectal cancer by pathological biopsy;
- abdominal contrast-enhanced and chest computed tomography (CT) or positron emission tomography-computed tomography (PET-CT) revealed no distal metastasis;
- Preoperative rectal magnetic resistance (MR) evaluation showed that the tumor was located at or below the peritoneal reflux plane, and at least 1cm above the anal sphincter groove, and did not invade the external anal sphincter;
- Tumors located above the hiatus of levator ani muscle were evaluated by magnetic resonance imaging as cT1-3, cN0-1, M0, and MRF (-); The tumors located below the hiatus of levator ani muscle were evaluated by magnetic resonance imaging as cT1-2, cN0-1, M0, and MRF (-). After neoadjuvant treatment, the tumor above the hiatus of levator ani muscle is ycT3NxM0 or below; The tumor below the hiatus of levator ani muscle is ycT2NxM0;
- The patient underwent laparoscopic assisted TME surgery or robotic assisted TME surgery.
Who cannot join
- multiple primary cancers;
- history of open surgery;
- no preoperative MR evaluation and inadequate evaluation of tumor stage;
- Patients with rectal cancer who undergo endoscopic resection first and need subsequent transabdominal resection;
- Pregnant or patients with concomitant inflammatory bowel disease;
- Patients with preoperative complete bowel obstruction or requiring emergency surgery;
Show all 14Show fewer
- Preoperative evaluation indicates that patient may require combined organ resection;
- Recently receiving treatment for other malignant tumors;
- Bordeaux type IV low rectal cancer;
- The preoperative pathological types are signet ring cell carcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, or poorly differentiated carcinoma.
- Exit Criteria
- Refuse surgical treatment after randomization;
- Open surgery was performed for treatment after randomization;
- Patients request to withdraw from the study at any time during the entire study process after randomization
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Hospital of Jilin University
Changchun, Jilin, 130021
Yuchen Guo, Ph.D., +8613630598312, guoyuchen8688@live.com
About this study
Official title: A Multicenter Randomized Clinical Trial to Assess the Advantages of Robotic Total Mesorectal Excision in Preserving External Sphincter in Patients with Middle and Low Rectal Cancer.
This is a multicenter, superior, randomized controlled trial designed to compare Robotic-assisted total mesorectal excision (RATME) and laparoscopic-assisted total mesorectal excision (LATME) for middle and low rectal cancer. The primary endpoint is the incidence of intersphincteric resection (ISR). The secondary outcomes are coloanal anastomosis (CAA), conversion to open, conversion to transanal TME (TaTME), incidence of abdominoperineal resection (APR), postoperative morbidity and mortality within 30 days after surgery, pathological outcomes, long-term survival outcomes, functional outcomes, and quality of life.
Read the detailed description
Robotic-assisted total mesorectal excision (RATME) has been gradually applied by colorectal surgeons. Most surgeons consider RATME a safe method and believe it can facilitate total mesorectal excision (TME) in rectal cancer, especially middle and low rectal cancer with a narrow pelvis. Therefore, this trial investigates whether RATME has technical advantages and increase intersphincteric resection rate compared with laparoscopic-assisted TME (LATME) in middle and low rectal cancer.
This is a multicenter, superior, randomized controlled trial designed to compare RATME and LATME for middle and low rectal cancer. The primary endpoint is the incidence of intersphincteric resection (ISR). The secondary outcomes are coloanal anastomosis (CAA), conversion to open, conversion to transanal TME (TaTME), incidence of abdominoperineal resection (APR), postoperative morbidity and mortality within 30 days after surgery, pathological outcomes, long-term survival outcomes, functional outcomes, and quality of life. In addition, certain measures will be conducted to ensure quality and safety, including centralized photography review and semiannual assessment.
- Being tested
- Robotic-assisted total mesorectal excision, laparoscopic-assisted total mesorectal excision
- 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 total mesorectal excisionProcedure or surgery
TME will be performed with the assistance of robot in rectal cancer
laparoscopic-assisted total mesorectal excisionProcedure or surgery
TME will be performed with the assistance of laparoscopy in rectal cancer
| Study group | Role | What they receive |
|---|---|---|
| RATME | Other | In RaTME groups, the low anterior resection and TME was finished with the assistance of robot (da Vinci Xi surgical system) Receives: Procedure: Robotic-assisted total mesorectal excision |
| LATME | Other | In LaTME groups, the low anterior resection and mesorectal excision procedures was completed under laparoscopy. Receives: Procedure: laparoscopic-assisted total mesorectal excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
intersphincteric resection (ISR)
The primary outcome is the incidence of ISR. ISR is defined according to the definition by a Japanese study group. When the distal resection margin is from dentate line to the intersphincteric groove, ISR will be recorded.The distal resection line of the internal anal sphincter was at the intersphincteric groove in total ISR, between the dentate line and the intersphincteric groove in subtotal ISR and at the dentate line in partial ISR
Measured: during the operation
Secondary outcomes (15)
coloanal anastomosis (CAA)
CAA was defined as the anastomosis of distal colon and surgical anal canal. In CAA anastomosis, the distal resection margin is below the upper level of the levator ani muscle. Conversion to open was defined as an abdominal incision larger than necessary for specimen retrieval.
Measured: during the operation
conversion to open
Conversion to open surgery was defined as an abdominal incision larger than necessary for specimen retrieval extraction.
Measured: during the operation
conversion to transanal TME (TaTME)
Conversion to TaTME was defined as TME that cannot be finished via transabdominal approach, and have to be finished by transanal approach with the help of imaging system and endoscopic instruments. It should be noted that if TME was completely done via transabdominal approach, simply dissecting the internal sphincter and intersphincteric space or finish the coloanal anastomosis via transanal approach were not classified as TaTME
Measured: during the operation
30-day postoperative morbidity
The 30-day morbidity is defined as intraoperative adverse events and postoperative complications within 30 days. The intraoperative adverse events include intraoperative bleeding (>200 ml), pelvic vascular and nerve injury, vascular injury in other parts, digestive tract injury, ureteral injury, and anastomotic defect. Furthermore, the 30-day postoperative complications are evaluated according to Clavien-Dindo classification
Measured: within 30 days after operation
30-day postoperative mortality
The 30-day mortality is defined as death within 30 day after operation
Measured: within 30 days after operation
3-year disease-free survival (DFS)
DFS is defined as the time from randomization to the discovery of local recurrence, distant metastasis, or death of the tumor
Measured: 3 years after operation
3-year local recurrence rate (LR)
LR is defined as tumor recurrence (evaluated by positron emission tomography, computed tomography, or magnetic resistance) that occurs in the pelvic cavity, perineal area, root of inferior mesenteric artery, descending colon, and sigmoid mesenteric area, and is confirmed through pathological biopsy or reoperation.
Measured: 3 years after operation
3-year overall survival (OS)
OS is defined as the time from randomization to death due to any cause.
Measured: 3 years after operation
distance to distal resection margin (DRM)
The distance to the DRM is defined as the shortest length between the tumor and the DRM. DRM positivity is defined as a distal margin within 1 mm of the tumor.
Measured: within 30 days after operation
distance to circumferential resection margin (CRM)
The distance to the CRM is defined as the shortest length between the tumor and the CRM. CRM positivity is defined as tumor cells within 1 mm from the CRM by microscopy
Measured: within 30 days after operation
3-year urinary function
Urinary function will be evaluated by International consultation on incontinence questionnaire short form (ICIQ-SF). The patients will be asked to complete ICIQ-SF every 3 months in the first year after operation, and every 6 months after the first year follow-up, until we finished the 3-year follow-up.
Measured: 3 years after operation
The proportion of patients receiving abdominoperineal resection
the proportion of patients receiving abdominoperineal resection
Measured: during the operation
3-year quality of life
Quality of life will be evaluated by EORTC quality of life questionnaire-core 30 (QLQ-C30) form. The patients will be asked to complete QLQ-C30 every 3 months in the first year after operation, and every 6 months after the first year follow-up, until we finished the 3-year follow-up.
Measured: 3 years after operation
3-year sexual function
Sexual function of male will be evaluated by International Index of Erectile Function (IIEF-5). Sexual function of female will be evaluated by Female Sexual Function Index (FSFI). Evaluation will be performed every 3 months in the first year after operation, and every 6 months after the first year follow-up, until we finished the 3-year follow-up.
Measured: 3 years after operation
3-year defecation function
Defecation function will be evaluated by low anterior resection syndrome (LARS) form. The patients will be asked to complete LARS form every 3 months in the first year after operation, and every 6 months after the first year follow-up, until we finished the 3-year follow-up.
Measured: 3 years after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Nov 2025 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2031 (estimated)
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 Total Mesorectal ExcisionStudies 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
- 1,026 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Collaborators
- Jilin Provincial Tumor Hospital, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, The Second Affiliated Hospital of Dalian Medical University, The Second Affiliated Hospital of Harbin Medical University
- Responsible party
- Principal investigator, Quan Wang, The First Hospital of Jilin University
- Investigators
- Quan Wang, Ph.D., Study chair, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105203
- Sponsor's protocol ID
- STARS-RC05
- Status last verified
- Feb 2025
- First submitted
- 3 Sep 2023
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guo Y, He L, Tong W, Chi Z, Ren S, Cui B, Wang Q. A study of intersphincteric resection rate following robotic-assisted total mesorectal excision versus laparoscopic-assisted total mesorectal excision for patients with middle and low rectal cancer: study protocol for a multicenter randomized clinical trial. Trials. 2024 Oct 21;25(1):703. doi: 10.1186/s13063-024-08561-4.
PubMed 39434171
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Clinical Trial to Assess the Advantages of Robotic Total Mesorectal Excision in Preserving External Sphincter in Patients with Middle and Low Rectal Cancer.
- ClinicalTrials.gov ID
- NCT06105203
- Acronym / sponsor ID
- STARS-RC05
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,026 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Collaborators
- Jilin Provincial Tumor Hospital, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, The Second Affiliated Hospital of Dalian Medical University, The Second Affiliated Hospital of Harbin Medical University
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 27 Oct 2023 (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 is a multicenter, superior, randomized controlled trial designed to compare Robotic-assisted total mesorectal excision (RATME) and laparoscopic-assisted total mesorectal excision (LATME) for middle and low rectal cancer. The primary endpoint is the incidence of intersphincteric resection (ISR). The secondary outcomes are coloanal anastomosis (CAA), conversion to open, conversion to transanal TME (TaTME), incidence of abdominoperineal resection (APR), postoperative morbidity and mortality within 30 days after surgery, pathological outcomes, long-term survival outcomes, functional outcomes, and quality of life.
Detailed description
Robotic-assisted total mesorectal excision (RATME) has been gradually applied by colorectal surgeons. Most surgeons consider RATME a safe method and believe it can facilitate total mesorectal excision (TME) in rectal cancer, especially middle and low rectal cancer with a narrow pelvis. Therefore, this trial investigates whether RATME has technical advantages and increase intersphincteric resection rate compared with laparoscopic-assisted TME (LATME) in middle and low rectal cancer.
This is a multicenter, superior, randomized controlled trial designed to compare RATME and LATME for middle and low rectal cancer. The primary endpoint is the incidence of intersphincteric resection (ISR). The secondary outcomes are coloanal anastomosis (CAA), conversion to open, conversion to transanal TME (TaTME), incidence of abdominoperineal resection (APR), postoperative morbidity and mortality within 30 days after surgery, pathological outcomes, long-term survival outcomes, functional outcomes, and quality of life. In addition, certain measures will be conducted to ensure quality and safety, including centralized photography review and semiannual assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RATME | Other | Procedure: Robotic-assisted total mesorectal excisionIn RaTME groups, the low anterior resection and TME was finished with the assistance of robot (da Vinci Xi surgical system) |
| LATME | Other | Procedure: laparoscopic-assisted total mesorectal excisionIn LaTME groups, the low anterior resection and mesorectal excision procedures was completed under laparoscopy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- male patients diagnosed with rectal cancer by pathological biopsy;
- abdominal contrast-enhanced and chest computed tomography (CT) or positron emission tomography-computed tomography (PET-CT) revealed no distal metastasis;
- Preoperative rectal magnetic resistance (MR) evaluation showed that the tumor was located at or below the peritoneal reflux plane, and at least 1cm above the anal sphincter groove, and did not invade the external anal sphincter;
- Tumors located above the hiatus of levator ani muscle were evaluated by magnetic resonance imaging as cT1-3, cN0-1, M0, and MRF (-); The tumors located below the hiatus of levator ani muscle were evaluated by magnetic resonance imaging as cT1-2, cN0-1, M0, and MRF (-). After neoadjuvant treatment, the tumor above the hiatus of levator ani muscle is ycT3NxM0 or below; The tumor below the hiatus of levator ani muscle is ycT2NxM0;
- The patient underwent laparoscopic assisted TME surgery or robotic assisted TME surgery.
Key exclusion criteria (14 listed)
- multiple primary cancers;
- history of open surgery;
- no preoperative MR evaluation and inadequate evaluation of tumor stage;
- Patients with rectal cancer who undergo endoscopic resection first and need subsequent transabdominal resection;
- Pregnant or patients with concomitant inflammatory bowel disease;
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 total mesorectal excisionTME will be performed with the assistance of robot in rectal cancer | Procedure or surgery | RATME |
| laparoscopic-assisted total mesorectal excisionTME will be performed with the assistance of laparoscopy in rectal cancer | Procedure or surgery | LATME |
Primary outcome
intersphincteric resection (ISR)
Time frame: during the operation
The primary outcome is the incidence of ISR. ISR is defined according to the definition by a Japanese study group. When the distal resection margin is from dentate line to the intersphincteric groove, ISR will be recorded.The distal resection line of the internal anal sphincter was at the intersphincteric groove in total ISR, between the dentate line and the intersphincteric groove in subtotal ISR and at the dentate line in partial ISR
15 secondary outcomes
coloanal anastomosis (CAA)
Time frame: during the operation
conversion to open
Time frame: during the operation
conversion to transanal TME (TaTME)
Time frame: during the operation
30-day postoperative morbidity
Time frame: within 30 days after operation
30-day postoperative mortality
Time frame: within 30 days after operation
3-year disease-free survival (DFS)
Time frame: 3 years after operation
3-year local recurrence rate (LR)
Time frame: 3 years after operation
3-year overall survival (OS)
Time frame: 3 years after operation
distance to distal resection margin (DRM)
Time frame: within 30 days after operation
distance to circumferential resection margin (CRM)
Time frame: within 30 days after operation
3-year urinary function
Time frame: 3 years after operation
The proportion of patients receiving abdominoperineal resection
Time frame: during the operation
3-year quality of life
Time frame: 3 years after operation
3-year sexual function
Time frame: 3 years after operation
3-year defecation function
Time frame: 3 years after operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Derived from this study: PubMed 39434171Guo Y, He L, Tong W, Chi Z, Ren S, Cui B, Wang Q. A study of intersphincteric resection rate following robotic-assisted total mesorectal excision versus laparoscopic-assisted total mesorectal excision for patients with middle and low rectal cancer: study protocol for a multicenter randomized clinical trial. Trials. 2024 Oct 21;25(1):703. doi: 10.1186/s13063-024-08561-4.
- 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.
Quan Wang, Ph.D. study chair
The First Hospital of Jilin 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 total mesorectal excision and laparoscopic-assisted total mesorectal excision in people with Total Mesorectal Excision and Rectal Neoplasms, run by The First Hospital of Jilin 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 5 inclusion and 14 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: opening soon, as of the sponsor's last update on 19 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuchen Guo, Ph.D. (+8613630598312, guoyuchen8688@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intersphincteric resection (ISR) (time frame: during the operation). 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 NCT06105203, 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 19 Feb 2025.