Colorectal NeoplasmsNOTRNCT04230772
Clinical Outcomes of NOSES Versus Traditional Robotic-assisted Surgery for Patients With Colorectal Cancer
A study testing Natural Orifice Specimen Extraction Surgery and Traditional Robotic-assisted Surgery in people with Colorectal Neoplasms and Neoplasms Malignant, run by Taiyuan Li at 7 sites in China.
Trial summary
In this study, the investigators will compare the clinical outcomes of the natural orifice specimen extraction surgery versus traditional robotic-assisted surgery in the treatment of colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Neoplasms, Neoplasms Malignant, Complication of Surgical Procedure
- What is being tested?
- Natural Orifice Specimen Extraction Surgery and Traditional Robotic-assisted Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 7 sitesChina
- Study dates
- 1 Feb 2021to 31 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 80 years;
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale;
- Histological or cytological confirmation of colorectal adenocarcinoma;
- High rectal and sigmoid cancer with the lower margin of the tumor greater than 10 cm from the anal dentate line;
- T1-3N0M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition, Transvaginal NOSES procedure w specimen with a circumferential diameter of <5 cm;
- Preoperative examination did not suggest distant metastasis, implantation or invasion of adjacent organs;
- Cardiopulmonary liver and kidney function can withstand surgery;
- Written informed consent for participation in the trial.
Who cannot join
- Not suitable for robot laparoscopic surgery;
- The tumor is too large to be pulled out through the anus or vagina;
- Simultaneous multiple primary cancer;
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by primary cancer
- Women with acute gynecological infections, vaginal deformities, unmarried and infertile women and women who are married and plan to get pregnant.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Chinese PLA General Hospital (301 Hospital) China
Beijing, Beijing Municipality, 100036
Baoqing Jia, M.M., Ph.D
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410008
Hongliang Yao, M.M., Ph.D, yaohl0326@163.com
- Recruiting
First Affiliated Hospital of Gannan Medical College
Ganzhou, Jiangxi, 341 000
Xiangfu Zeng, M.M., Ph.d, xiaoxiaoliu1982@163.com
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Yanan Wang, M.M., Ph.D
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 360006
Taiyuan Li, M.M., Ph.D, 13970031518, jylitaiyuan@sina.com
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 360006
Shengxun Mao, MM., Ph.D, maoshengxun@163.com
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Ye Wei, M.M.,Ph.D, 13818661815@126.com
About this study
Official title: A Randomized Controlled Trial Comparing Clinical Outcomes of Natural Orifice Specimen Extraction Surgery Versus Traditional Robotic-assisted Surgery for Patients With Colorectal Cancer
In this study, the investigators will compare the clinical outcomes of the natural orifice specimen extraction surgery versus traditional robotic-assisted surgery in the treatment of colorectal cancer.
Read the detailed description
Based on investigators' experience, compared to robotic-assisted colorectal cancer radical resection, robotic colorectal cancer radical resection with natural orifice extraction has more advantages in postoperative stress response, postoperative pain, postoperative recovery and postoperative abdominal aesthetics. However, in terms of tumor radicality, there may be no obvious differences. There are no randomized controlled trails to discuss these questions.This research is based on the above conditions. Investigators use prospective randomized controlled trial to analyze the surgical data, postoperative complications, postoperative recovery of the robotic colorectal cancer radical resection with natural orifice extraction and conventional robotic-assisted colorectal cancer radical resection in order to summarize clinical experience and explore the advantages and disadvantages of robotic colorectal cancer radical resection with natural orifice specimen extraction and to provide a new direction for the surgical treatment of colorectal cancer, which is beneficial to the promotion of NOSES(Natural Orifice Specimen Extraction Surgery ) technology and treatment of colorectal cancer.
- Conditions
- Colorectal Neoplasms, Neoplasms Malignant, Complication of Surgical Procedure, Robotic Surgical Procedures, Natural Orifice Specimen Extraction Surgery
- Being tested
- Natural Orifice Specimen Extraction Surgery, Traditional Robotic-assisted Surgery
- Medical subject headings
- Colorectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural Orifice Specimen Extraction SurgeryProcedure or surgery
In the experimental group, patients will be performed robotic colorectal resection with natural orifice specimen extraction.
Traditional Robotic-assisted SurgeryProcedure or surgery
In the active comparator group, patients will be performed traditional robotic-assisted colorectal resection.
| Study group | Role | What they receive |
|---|---|---|
| Natural Orifice Specimen Extraction Surgery | Experimental | Natural orifice specimen extraction surgery will performed in patients assigned to this group. Receives: Procedure: Natural Orifice Specimen Extraction Surgery |
| Traditional Robotic-assisted Surgery | Active comparator | Traditional robotic-assisted surgery will performed in patients assigned to this group. Receives: Procedure: Traditional Robotic-assisted Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of surgical complications
Complication rate of surgery within 30 days after surgery.
Measured: 30 days
Secondary outcomes (15)
The variation of C-reactive protein
The values of C-reactive protein from peripheral blood before operation and on postoperative day 1, 3, 7 are recorded to access the surgical response stress and immune response.
Measured: Preoperative 3 days and postoperative 1, 3, and 7 days
The variation of interleukin-6(IL-6)
The values of interleukin-6(IL-6) from peripheral blood before operation and on postoperative day 1, 3, 7 are recorded to access the surgical response stress and immune response.
Measured: Preoperative 3 days and postoperative 1, 3, and 7 days
The variation of interleukin-10(IL-10)
The values of interleukin-10(IL-10) from peripheral blood before operation and on postoperative day 1, 3, 7 are recorded to access the surgical response stress and immune response.
Measured: Preoperative 3 days and postoperative 1, 3, and 7 days
The variation of cortisol
The values of cortisol from peripheral blood before operation and on postoperative day 1, 3, 7 are recorded to access the surgical response stress and immune response.
Measured: Preoperative 3 days and postoperative 1, 3, and 7 days
The variation of lymphocyte subsets count of CD3, CD4 and CD8
The values of lymphocyte subsets count of CD3, CD4 and CD8 from peripheral blood before operation and on postoperative day 1, 3, 7 are recorded to access the surgical response stress and immune response.
Measured: Preoperative 3 days and postoperative 1, 3, and 7 days
The positive rate of malignant cells in ascitic fluid specimen
Ascitic fluid specimen will be taken after surgery and tested by clinical laboratory.
Measured: 1 day
The positive rate of bacterial culture in ascitic fluid specimen
Ascitic fluid specimen will be taken after surgery and tested by clinical laboratory.
Measured: 1 day
Postoperative pain score
Postoperative pain score will be assessed by visual analog score.
Measured: 1 day
Time to first flatus
Time to first flatus is used to assess the postoperative recovery course
Measured: 30 days
Time to leave bed postoperatively
Time to first leave bed postoperatively in hours is used to assess the postoperative recovery course.
Measured: 30 days
Time to first liquid diet postoperatively
Time to first liquid diet postoperatively in days is used to assess the postoperative recovery course.
Measured: 30 days
Postoperative hospital stay
Postoperative hospital stay is used to assess the postoperative recovery course.
Measured: 30 days
Operation time
Time from start of incision to finish of abdominal closure.
Measured: 1 day
Estimated blood loss
Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation.
Measured: 1 day
Number of retrieved lymph nodes
Number of retrieved lymph nodes will be determined according to the pathological report.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Feb 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (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 Colorectal 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
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taiyuan Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Taiyuan Li, The First Affiliated Hospital of Nanchang University
- Investigators
- Taiyuan Li, M.D., Ph.D, Principal investigator, Department of General Surgery, The First Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230772
- Sponsor's protocol ID
- ndyfy660618
- Acronym
- NOTR
- Status last verified
- Jan 2020
- First submitted
- 14 Jan 2020
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luo R, Zheng F, Zhang H, Zhu W, He P, Liu D. Robotic natural orifice specimen extraction surgery versus traditional robotic-assisted surgery (NOTR) for patients with colorectal cancer: a study protocol for a randomized controlled trial. Trials. 2021 Feb 6;22(1):121. doi: 10.1186/s13063-021-05077-z.
PubMed 33549133
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Clinical Outcomes of Natural Orifice Specimen Extraction Surgery Versus Traditional Robotic-assisted Surgery for Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04230772
- Acronym / sponsor ID
- NOTR / ndyfy660618
- Conditions
- Colorectal Neoplasms, Neoplasms Malignant, Complication of Surgical Procedure, Robotic Surgical Procedures, Natural Orifice Specimen Extraction Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Taiyuan LiUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 18 Jan 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.
In this study, the investigators will compare the clinical outcomes of the natural orifice specimen extraction surgery versus traditional robotic-assisted surgery in the treatment of colorectal cancer.
Detailed description
Based on investigators' experience, compared to robotic-assisted colorectal cancer radical resection, robotic colorectal cancer radical resection with natural orifice extraction has more advantages in postoperative stress response, postoperative pain, postoperative recovery and postoperative abdominal aesthetics. However, in terms of tumor radicality, there may be no obvious differences. There are no randomized controlled trails to discuss these questions.This research is based on the above conditions. Investigators use prospective randomized controlled trial to analyze the surgical data, postoperative complications, postoperative recovery of the robotic colorectal cancer radical resection with natural orifice extraction and conventional robotic-assisted colorectal cancer radical resection in order to summarize clinical experience and explore the advantages and disadvantages of robotic colorectal cancer radical resection with natural orifice specimen extraction and to provide a new direction for the surgical treatment of colorectal cancer, which is beneficial to the promotion of NOSES(Natural Orifice Specimen Extraction Surgery ) technology and treatment of colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Natural Orifice Specimen Extraction Surgery | Experimental | Procedure: Natural Orifice Specimen Extraction SurgeryNatural orifice specimen extraction surgery will performed in patients assigned to this group. |
| Traditional Robotic-assisted Surgery | Active comparator | Procedure: Traditional Robotic-assisted SurgeryTraditional robotic-assisted surgery will performed in patients assigned to this group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 and ≤ 80 years;
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale;
- Histological or cytological confirmation of colorectal adenocarcinoma;
- High rectal and sigmoid cancer with the lower margin of the tumor greater than 10 cm from the anal dentate line;
- T1-3N0M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition, Transvaginal NOSES procedure w specimen with a circumferential diameter of <5 cm;
Key exclusion criteria (5 listed)
- Not suitable for robot laparoscopic surgery;
- The tumor is too large to be pulled out through the anus or vagina;
- Simultaneous multiple primary cancer;
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by primary cancer
- Women with acute gynecological infections, vaginal deformities, unmarried and infertile women and women who are married and plan to get pregnant.
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 |
|---|---|---|
| Natural Orifice Specimen Extraction SurgeryIn the experimental group, patients will be performed robotic colorectal resection with natural orifice specimen extraction. | Procedure or surgery | Natural Orifice Specimen Extraction Surgery |
| Traditional Robotic-assisted SurgeryIn the active comparator group, patients will be performed traditional robotic-assisted colorectal resection. | Procedure or surgery | Traditional Robotic-assisted Surgery |
Primary outcome
Incidence of surgical complications
Time frame: 30 days
Complication rate of surgery within 30 days after surgery.
15 secondary outcomes
The variation of C-reactive protein
Time frame: Preoperative 3 days and postoperative 1, 3, and 7 days
The variation of interleukin-6(IL-6)
Time frame: Preoperative 3 days and postoperative 1, 3, and 7 days
The variation of interleukin-10(IL-10)
Time frame: Preoperative 3 days and postoperative 1, 3, and 7 days
The variation of cortisol
Time frame: Preoperative 3 days and postoperative 1, 3, and 7 days
The variation of lymphocyte subsets count of CD3, CD4 and CD8
Time frame: Preoperative 3 days and postoperative 1, 3, and 7 days
The positive rate of malignant cells in ascitic fluid specimen
Time frame: 1 day
The positive rate of bacterial culture in ascitic fluid specimen
Time frame: 1 day
Postoperative pain score
Time frame: 1 day
Time to first flatus
Time frame: 30 days
Time to leave bed postoperatively
Time frame: 30 days
Time to first liquid diet postoperatively
Time frame: 30 days
Postoperative hospital stay
Time frame: 30 days
Operation time
Time frame: 1 day
Estimated blood loss
Time frame: 1 day
Number of retrieved lymph nodes
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Derived from this study: PubMed 33549133Luo R, Zheng F, Zhang H, Zhu W, He P, Liu D. Robotic natural orifice specimen extraction surgery versus traditional robotic-assisted surgery (NOTR) for patients with colorectal cancer: a study protocol for a randomized controlled trial. Trials. 2021 Feb 6;22(1):121. doi: 10.1186/s13063-021-05077-z.
- 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.
Taiyuan Li, M.D., Ph.D principal investigator
Department of General Surgery, The First Affiliated Hospital of Nanchang University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Natural Orifice Specimen Extraction Surgery and Traditional Robotic-assisted Surgery in people with Colorectal Neoplasms and Neoplasms Malignant, run by Taiyuan Li at 7 sites 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 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: status not confirmed, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 Taiyuan Li, M.D., Ph.D (+86-13970031518, jylitaiyuan@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of surgical complications (time frame: 30 days). 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 NCT04230772, 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 22 Jan 2020.