Rectal NeoplasmsNCT05468944
Robotic Transanal Specimen Extraction Surgery Versus Robotic Transabdominal Incision Specimen Extraction Surgery for Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial
A study testing Transanal specimen extraction robotic surgery and Transabdominal specimen extraction robotic surgery in people with Rectal Neoplasms and Robotic Surgery, run by Taiyuan Li at 12 sites in China.
Trial summary
This prospective, multicenter, randomized, open-label study aims to evaluate the perioperative safety and feasibility of specimen extraction through anus regarding robotic radical excision of rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Neoplasms, Robotic Surgery, Natural Orifice Specimen Extraction Surgery
- What is being tested?
- Transanal specimen extraction robotic surgery and Transabdominal specimen extraction robotic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 556 participants
- Where
- 12 sitesChina
- Study dates
- Jan 2023to 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 to 75 years;
- Historically confirmed rectal adenocarcinoma;
- Diagnosed with rectal cancer by pelvic/rectal magnetic resonance imaging;
- cT1-4aNxM0 high rectal adenocarcinoma; cT1-3NxM0 mid/low rectal adenocarcinoma;
- No evidence of distant metastases;
- A maximum of 5cm in diameter;
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- Body mass index (BMI) ≤ 30 kg / m2;
- No local complications (no obstruction, incomplete obstruction, no massive active bleeding, no perforation, preoperatively abscess formation, no local invasion);
- Willing to undergo surgery;
- Sign the informed consent;
Who cannot join
- Presence of lateral/inguinal lymph node metastases;
- Previous history of malignant colorectal tumor;
- Multiple primary colorectal tumors;
- Neoadjuvant therapy;
- Salvage surgery for endoscopic surgery;
- History of previous abdominopelvic surgeries or extensive intra-abdominal adhesion;
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- Familial adenomatous polyposis, Lynch syndrome, and inflammatory bowel disease;
- Comorbid with other malignancies within 5 years;
- ASA ≥ IV and/or ECOG performance status score ≥ 2;
- Severe liver, kidney, cardiopulmonary insufficiency, coagulopathy or serious underlying diseases;
- Serious mental illness;
- Pregnant or lactating women;
- Uncontrolled infection;
- Abnormal anal function or anal stenosis;
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing
Xishan Wang
The Second Xiangya Hospital, Central South University
Changsha
Hongliang Yao
Three Gorges Hospital Affiliated to Chongqing University
Chongqing
Dehai Xiong
Fujian Cancer Hospital
Fuzhou
Chunkang Yang
The First Affiliated Hospital of Gannan Medical University
Ganzhou
Xiangfu Zeng
The Second Affiliated Hospital, Sun Yat-sen University
Guangzhou
Fanghai Han
The Second Affiliated Hospital of Harbin Medical University
Harbin
Guiyu Wang
The First Affiliated Hospital of Nanchang University
Nanchang
Taiyuan Li
Zhongshan Hospital, Fudan University
Shanghai
Ye Wei
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Junjun She
Zhongshan Hospital of Xiamen University
Xiamen, 361004
Jianchun Cai
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Junhong Hu
About this study
This prospective, multicenter, randomized, open-label study aims to evaluate the perioperative safety and feasibility of specimen extraction through anus regarding robotic radical excision of rectal cancer.
Read the detailed description
In this study, investigators will evaluate the perioperative safety and feasibility of robotic transanal specimen extraction surgery with robotic transabdominal incision specimen extraction surgery as a control.The study is prospective, randomized, open-label, and multicenter conducted at 12 centers. Considering the significance level and abscission rate, it is expected that a total of 556 subjects will be included in the two groups from January 2023 to June 2024, with the incidence of postoperative complications as the main study endpoint.
- Being tested
- Transanal specimen extraction robotic surgery, Transabdominal specimen extraction 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.
Transanal specimen extraction robotic surgeryProcedure or surgery
Participants in this group underwent robotic rectal cancer resection ,the specimens were extracted through anus.
Transabdominal specimen extraction robotic surgeryProcedure or surgery
Participants in this group underwent robotic assisted rectal cancer resection ,the specimens were extracted through the incision on the abdominal wall.
| Study group | Role | What they receive |
|---|---|---|
| Transanal group | Experimental | Participants in this group underwent robotic surgery with transanal specimen extraction Receives: Procedure: Transanal specimen extraction robotic surgery |
| Transabdominal group | Active comparator | Participants in this group underwent robotic surgery with transabdominal specimen extraction Receives: Procedure: Transabdominal specimen extraction robotic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate
Complication rate within 1 month postoperatively.All complications of surgery will be documented and graded by the Clavien-Dindo classification system,generally including anastomotic leakage, abdominal infection, bleeding, incision infection, incision implantation, intestinal obstruction, and rectovaginal fistula.
Measured: Up to 30 days postoperatively.
Secondary outcomes (23)
C-reactive protein (CRP)
Detection of serum CRP levels (mg/L) to evaluate surgical stress response and immune function.
Measured: 1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
Interleukin
Detection of serum levels of Interleukin-1 (IL-1), interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10) (pg/L) to evaluate surgical stress response and immune function.
Measured: 1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
Cortisol
Detection of Serum Cortisol Level (nmol/L) to evaluate surgical stress response and immune function.
Measured: 1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
CD3, CD4, and CD8 lymphocyte subsets
Count CD3, CD4, and CD8 lymphocyte subsets (pieces/ul) to assess surgical stress response and immune function.
Measured: 1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
Positive rate of tumor cells
Intraoperative peritoneal lavage fluid will be collected both for aerobic culture and centrifuged ,stained and viewed to find exfoliated cancer cells.The sample will be considered positive if at least one tumor cell was detected.
Measured: Intraoperative.
bacterial positive rate
Intraoperative peritoneal lavage fluid will be collected both for aerobic culture and centrifuged ,stained and viewed to find exfoliated cancer cells.The sample will be considered positive if at least one tumor cell was detected.
Measured: Intraoperative.
Pain assessment
Visual analogue scale (VAS) will be used to evaluate the postoperative pain. If analgesics were needed, the type and dose of analgesics after operation should be recorded.
Measured: 1 day before operation, 1, 2, 3 days postoperatively, and up to 2 weeks.
Wexner scale
Wexner scale (0 are normal continence, 20 are maximum incontinence with maximum disturbance of lifestyle) will be used to evaluate the defecation function.
Measured: 1 day before operation, and 1, 3, 6 months postoperatively.
LARS scale
LARS scale(0~20 points are defined as no LARS, Scores from 21 to 29 were defined as mild LARS, and from 30 to 42 as severe LARS. The higher the score, the worse the anal bowel function) will be used to evaluate the defecation function.
Measured: 1 day before operation, and 1, 3, 6 months postoperatively.
Postoperative recovery composite
Including the time to first flatus (record the patient's first self induced exhaust time after operation, accurate to hours, and perform auscultation of bowel sounds regularly every day after operation), the time to first ambulation (hours), the time to first eating (hours) and the time to first defecation (hours).
Measured: Up to 2 weeks.
EORTC QLQ-C30
To assess the quality of life of all cancer patients.
Measured: 1 day before operation, 1, 3, 6 months postoperatively.
EORTC QLQ-C38
To assess the quality of life in patients with rectal cancer.
Measured: 1 day before operation, 1, 3, 6 months postoperatively.
Tumor size
To assess the quality of surgical specimens.
Measured: Up to 30 days postoperatively.
Number of Histopathological type
To assess the quality of surgical specimens and postoperative pathological evaluation.
Measured: Up to 30 days postoperatively.
Degree of differentiation
To assess the quality of surgical specimens and postoperative pathological evaluation.
Measured: Up to 30 days postoperatively.
Distance , positive condition of pathological margin (proximal, distal, circumferential)
To assess the quality of surgical specimens and postoperative pathological evaluation.
Measured: Up to 30 days postoperatively.
Number of lymph node dissection and metastasis
To assess the quality of surgical specimens and postoperative pathological evaluation.
Measured: Up to 30 days postoperatively.
Nerve vessel involvement rate
To assess the quality of surgical specimens and postoperative pathological evaluation.
Measured: Up to 30 days postoperatively.
Hospitalization costs
To assess the financial burden difference.
Measured: Up to 30 days.
Local recurrence rate
To assess the long-term postoperative outcomes.
Measured: 1, 3, 5 years postoperatively.
The incidence rate of distant metastasis
To assess the long-term postoperative outcomes.
Measured: 1, 3, 5 years postoperatively.
Tumor-free survival rates
To assess the long-term postoperative outcomes.
Measured: 1, 3, 5 years postoperatively.
Overall survival rate
To assess the long-term postoperative outcomes.
Measured: 1, 3, 5 years postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study startJan 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal 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
- 556 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468944
- Sponsor's protocol ID
- RO220624
- Status last verified
- Jul 2022
- First submitted
- 13 Jul 2022
- Last updated
- 21 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Transanal Specimen Extraction Surgery Versus Robotic Transabdominal Incision Specimen Extraction Surgery for Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05468944
- Acronym / sponsor ID
- RO220624
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 556 participants (estimated)
- Lead sponsor
- Taiyuan LiUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Jul 2022 (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 prospective, multicenter, randomized, open-label study aims to evaluate the perioperative safety and feasibility of specimen extraction through anus regarding robotic radical excision of rectal cancer.
Detailed description
In this study, investigators will evaluate the perioperative safety and feasibility of robotic transanal specimen extraction surgery with robotic transabdominal incision specimen extraction surgery as a control.The study is prospective, randomized, open-label, and multicenter conducted at 12 centers. Considering the significance level and abscission rate, it is expected that a total of 556 subjects will be included in the two groups from January 2023 to June 2024, with the incidence of postoperative complications as the main study endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transanal group | Experimental | Procedure: Transanal specimen extraction robotic surgeryParticipants in this group underwent robotic surgery with transanal specimen extraction |
| Transabdominal group | Active comparator | Procedure: Transabdominal specimen extraction robotic surgeryParticipants in this group underwent robotic surgery with transabdominal specimen extraction |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age between 18 to 75 years;
- Historically confirmed rectal adenocarcinoma;
- Diagnosed with rectal cancer by pelvic/rectal magnetic resonance imaging;
- cT1-4aNxM0 high rectal adenocarcinoma; cT1-3NxM0 mid/low rectal adenocarcinoma;
- No evidence of distant metastases;
Key exclusion criteria (14 listed)
- Presence of lateral/inguinal lymph node metastases;
- Previous history of malignant colorectal tumor;
- Multiple primary colorectal tumors;
- Neoadjuvant therapy;
- Salvage surgery for endoscopic surgery;
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 |
|---|---|---|
| Transanal specimen extraction robotic surgeryParticipants in this group underwent robotic rectal cancer resection ,the specimens were extracted through anus. | Procedure or surgery | Transanal group |
| Transabdominal specimen extraction robotic surgeryParticipants in this group underwent robotic assisted rectal cancer resection ,the specimens were extracted through the incision on the abdominal wall. | Procedure or surgery | Transabdominal group |
Primary outcome
Complication rate
Time frame: Up to 30 days postoperatively.
Complication rate within 1 month postoperatively.All complications of surgery will be documented and graded by the Clavien-Dindo classification system,generally including anastomotic leakage, abdominal infection, bleeding, incision infection, incision implantation, intestinal obstruction, and rectovaginal fistula.
23 secondary outcomes
C-reactive protein (CRP)
Time frame: 1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
Interleukin
Time frame: 1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
Cortisol
Time frame: 1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
CD3, CD4, and CD8 lymphocyte subsets
Time frame: 1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
Positive rate of tumor cells
Time frame: Intraoperative.
bacterial positive rate
Time frame: Intraoperative.
Pain assessment
Time frame: 1 day before operation, 1, 2, 3 days postoperatively, and up to 2 weeks.
Wexner scale
Time frame: 1 day before operation, and 1, 3, 6 months postoperatively.
LARS scale
Time frame: 1 day before operation, and 1, 3, 6 months postoperatively.
Postoperative recovery composite
Time frame: Up to 2 weeks.
EORTC QLQ-C30
Time frame: 1 day before operation, 1, 3, 6 months postoperatively.
EORTC QLQ-C38
Time frame: 1 day before operation, 1, 3, 6 months postoperatively.
Tumor size
Time frame: Up to 30 days postoperatively.
Number of Histopathological type
Time frame: Up to 30 days postoperatively.
Degree of differentiation
Time frame: Up to 30 days postoperatively.
Distance , positive condition of pathological margin (proximal, distal, circumferential)
Time frame: Up to 30 days postoperatively.
Number of lymph node dissection and metastasis
Time frame: Up to 30 days postoperatively.
Nerve vessel involvement rate
Time frame: Up to 30 days postoperatively.
Hospitalization costs
Time frame: Up to 30 days.
Local recurrence rate
Time frame: 1, 3, 5 years postoperatively.
The incidence rate of distant metastasis
Time frame: 1, 3, 5 years postoperatively.
Tumor-free survival rates
Time frame: 1, 3, 5 years postoperatively.
Overall survival rate
Time frame: 1, 3, 5 years postoperatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transanal specimen extraction robotic surgery and Transabdominal specimen extraction robotic surgery in people with Rectal Neoplasms and Robotic Surgery, run by Taiyuan Li at 12 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 10 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: status not confirmed, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
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?
Complication rate (time frame: Up to 30 days postoperatively.). 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 21 Jul 2022.