Rectal CancerNCT04573738
Safety and Feasibility Study of Robotic Assisted Transanal Total Mesorectal Excision for Rectal Cancer
A study testing Robotic assisted transanal total mesorectal excision and Laparoscopic assisted transanal total mesorectal excision in people with Rectal Cancer and Perioperative Complication, run by Third Military Medical University at 1 site in China.
Trial summary
Total mesorectal excision has greatly reduced the local recurrence rate of rectal cancer after colorectal surgery. Transanal total mesorectal excision(TaTME) is potentially a suitable option for patients with middle and low rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer, Perioperative Complication
- What is being tested?
- Robotic assisted transanal total mesorectal excision and Laparoscopic assisted transanal total mesorectal excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 30 Sep 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathological biopsy confirmed adenocarcinoma of the rectum.
- Preoperative assessment of tolerance to surgery without major organ dysfunction.
- Patients must be able to understand and voluntarily sign written informed consent.
- The surgical method is robotic assisted transanal total mesorectal excision
- Distance of the edge of the tumour within 8 cm
Who cannot join
- The patient cannot tolerate the operation.
- Refusal to sign informed consent.
- Patients with distant metastasis of rectal cancer.
- The surgical method was changed to miles or Hartman;
- Unable to complete the follow - up
Trial locations and contacts
1 site in 1 country.
About this study
Total mesorectal excision has greatly reduced the local recurrence rate of rectal cancer after colorectal surgery. Transanal total mesorectal excision(TaTME) is potentially a suitable option for patients with middle and low rectal cancer. Robotic systems are expected to develop the advantages of TaTME to overcome the limitations of laparoscopic surgery. This study aimed to investigate the safety and feasibility of robotic assisted transanal total mesorectal excision in patients with rectal cancer.
Read the detailed description
TaTME is potentially a suitable option for patients with middle or low rectal cancer, especially for males with obesity and a narrow pelvis.The da Vinci robotic system (Intuitive Surgical, Sunnyvale, CA, USA) is expected to overcome the limitations of the laparoscopic transanal approach for rectal surgery. Da Vinci Si Surgical System or da Vinci Xi Surgical System would be used to performed Transanal total mesorectal excision. And the surgery would performed by two-team approach. This study aimed to investigate the safety and feasibility of robotic assisted transanal total mesorectal excision in patients with rectal cancer.
- Conditions
- Rectal Cancer, Perioperative Complication
- Being tested
- Robotic assisted transanal total mesorectal excision, Laparoscopic assisted transanal total mesorectal excision
- Keywords
- Rectal Cancer, Robotic surgery
- 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 transanal total mesorectal excisionProcedure or surgery
Robotic assisted transanal total mesorectal excision for rectal cancer patients
Laparoscopic assisted transanal total mesorectal excisionProcedure or surgery
Laparoscopic assisted transanal total mesorectal excision for rectal cancer patients
| Study group | Role | What they receive |
|---|---|---|
| Robotic transanal surgery | Experimental | Robotic assisted transanal total mesorectal excision for rectal cancer patients Receives: Procedure: Robotic assisted transanal total mesorectal excision |
| Laparoscopic transanal surgery | Active comparator | Laparoscopic transanal total mesorectal excision for rectal cancer patients Receives: Procedure: Laparoscopic assisted transanal total mesorectal excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
The local recurrence rates of rectal cancer
The incidence of local recurrence rectal cancer within two years after surgery
Measured: Two years after surgery
The incidence of postoperative anastomotic leakage
The incidence of postoperative anastomotic leakage within 30 days after surgery
Measured: Within 30 days after surgery
The five-year survival rates
The 5-year survival rates of rectal cancer
Measured: Five years after surgery
The distant metastasis rates of rectal cancer
The incidence of distant metastasis rectal cancer within two years after surgery
Measured: Five 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 posted5 Oct 2020
- Study start1 May 2017
- Primary completion31 May 2020
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weidong Tong, Third Military Medical University
- Investigators
- Weidong Tong, MD, Study chair, Army Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573738
- Sponsor's protocol ID
- 20200913
- Status last verified
- Nov 2023
- First submitted
- 15 Sep 2020
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee L, de Lacy B, Gomez Ruiz M, Liberman AS, Albert MR, Monson JRT, Lacy A, Kim SH, Atallah SB. A Multicenter Matched Comparison of Transanal and Robotic Total Mesorectal Excision for Mid and Low-rectal Adenocarcinoma. Ann Surg. 2019 Dec;270(6):1110-1116. doi: 10.1097/SLA.0000000000002862.
PubMed 29916871Jayne D, Pigazzi A, Marshall H, Croft J, Corrigan N, Copeland J, Quirke P, West N, Rautio T, Thomassen N, Tilney H, Gudgeon M, Bianchi PP, Edlin R, Hulme C, Brown J. Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer: The ROLARR Randomized Clinical Trial. JAMA. 2017 Oct 24;318(16):1569-1580. doi: 10.1001/jama.2017.7219.
PubMed 29067426Atallah S, Martin-Perez B, Pinan J, Quinteros F, Schoonyoung H, Albert M, Larach S. Robotic transanal total mesorectal excision: a pilot study. Tech Coloproctol. 2014 Nov;18(11):1047-53. doi: 10.1007/s10151-014-1181-5. Epub 2014 Jun 24.
PubMed 24957360Ye J, Tian Y, Wang L, Ye Y, Zhang Y, Li F, Liu B, Tong W. [Robotic-assisted transanal total mesorectal excision for lower rectal cancer]. Zhonghua Wei Chang Wai Ke Za Zhi. 2017 Aug 25;20(8):900-903. Chinese.
PubMed 28836251
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility Study of Robotic Assisted Transanal Total Mesorectal Excision for Rectal Cancer
- ClinicalTrials.gov ID
- NCT04573738
- Acronym / sponsor ID
- 20200913
- Conditions
- Rectal Cancer, Perioperative Complication
- Keywords
- Rectal Cancer, Robotic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 5 Oct 2020 (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.
Total mesorectal excision has greatly reduced the local recurrence rate of rectal cancer after colorectal surgery. Transanal total mesorectal excision(TaTME) is potentially a suitable option for patients with middle and low rectal cancer. Robotic systems are expected to develop the advantages of TaTME to overcome the limitations of laparoscopic surgery. This study aimed to investigate the safety and feasibility of robotic assisted transanal total mesorectal excision in patients with rectal cancer.
Detailed description
TaTME is potentially a suitable option for patients with middle or low rectal cancer, especially for males with obesity and a narrow pelvis.The da Vinci robotic system (Intuitive Surgical, Sunnyvale, CA, USA) is expected to overcome the limitations of the laparoscopic transanal approach for rectal surgery. Da Vinci Si Surgical System or da Vinci Xi Surgical System would be used to performed Transanal total mesorectal excision. And the surgery would performed by two-team approach. This study aimed to investigate the safety and feasibility of robotic assisted transanal total mesorectal excision in patients with rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic transanal surgery | Experimental | Procedure: Robotic assisted transanal total mesorectal excisionRobotic assisted transanal total mesorectal excision for rectal cancer patients |
| Laparoscopic transanal surgery | Active comparator | Procedure: Laparoscopic assisted transanal total mesorectal excisionLaparoscopic transanal total mesorectal excision for rectal cancer patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pathological biopsy confirmed adenocarcinoma of the rectum.
- Preoperative assessment of tolerance to surgery without major organ dysfunction.
- Patients must be able to understand and voluntarily sign written informed consent.
- The surgical method is robotic assisted transanal total mesorectal excision
- Distance of the edge of the tumour within 8 cm
Key exclusion criteria (5 listed)
- The patient cannot tolerate the operation.
- Refusal to sign informed consent.
- Patients with distant metastasis of rectal cancer.
- The surgical method was changed to miles or Hartman;
- Unable to complete the follow - up
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 transanal total mesorectal excisionRobotic assisted transanal total mesorectal excision for rectal cancer patients | Procedure or surgery | Robotic transanal surgery |
| Laparoscopic assisted transanal total mesorectal excisionLaparoscopic assisted transanal total mesorectal excision for rectal cancer patients | Procedure or surgery | Laparoscopic transanal surgery |
Primary outcome
The local recurrence rates of rectal cancer
Time frame: Two years after surgery
The incidence of local recurrence rectal cancer within two years after surgery
The incidence of postoperative anastomotic leakage
Time frame: Within 30 days after surgery
The incidence of postoperative anastomotic leakage within 30 days after surgery
The five-year survival rates
Time frame: Five years after surgery
The 5-year survival rates of rectal cancer
The distant metastasis rates of rectal cancer
Time frame: Five years after surgery
The incidence of distant metastasis rectal cancer within two years after surgery
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 27 Nov 2023.
- Background: PubMed 29916871Lee L, de Lacy B, Gomez Ruiz M, Liberman AS, Albert MR, Monson JRT, Lacy A, Kim SH, Atallah SB. A Multicenter Matched Comparison of Transanal and Robotic Total Mesorectal Excision for Mid and Low-rectal Adenocarcinoma. Ann Surg. 2019 Dec;270(6):1110-1116. doi: 10.1097/SLA.0000000000002862.
- Background: PubMed 29067426Jayne D, Pigazzi A, Marshall H, Croft J, Corrigan N, Copeland J, Quirke P, West N, Rautio T, Thomassen N, Tilney H, Gudgeon M, Bianchi PP, Edlin R, Hulme C, Brown J. Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer: The ROLARR Randomized Clinical Trial. JAMA. 2017 Oct 24;318(16):1569-1580. doi: 10.1001/jama.2017.7219.
- Background: PubMed 24957360Atallah S, Martin-Perez B, Pinan J, Quinteros F, Schoonyoung H, Albert M, Larach S. Robotic transanal total mesorectal excision: a pilot study. Tech Coloproctol. 2014 Nov;18(11):1047-53. doi: 10.1007/s10151-014-1181-5. Epub 2014 Jun 24.
- Background: PubMed 28836251Ye J, Tian Y, Wang L, Ye Y, Zhang Y, Li F, Liu B, Tong W. [Robotic-assisted transanal total mesorectal excision for lower rectal cancer]. Zhonghua Wei Chang Wai Ke Za Zhi. 2017 Aug 25;20(8):900-903. Chinese.
- 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.
Weidong Tong, MD study chair
Army Military Medical 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 transanal total mesorectal excision and Laparoscopic assisted transanal total mesorectal excision in people with Rectal Cancer and Perioperative Complication, run by Third Military Medical 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 5 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 27 Nov 2023. 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?
The local recurrence rates of rectal cancer (time frame: Two years after surgery). 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?
On the ClinicalTrials.gov record for NCT04573738, which also lists 4 linked publications.
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 27 Nov 2023.