Robotic Transanal Specimen Extraction Surgery Versus Robotic Transabdominal Incision Specimen Extraction Surgery for Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial

July 20, 2022 updated by: Taiyuan Li
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
556

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
        • Contact:
          • Xishan Wang
      • Changsha, China
        • The Second Xiangya Hospital, Central South University
        • Contact:
          • Hongliang Yao
      • Chongqing, China
        • Three Gorges Hospital Affiliated to Chongqing University
        • Contact:
          • Dehai Xiong
      • Fuzhou, China
        • Fujian Cancer Hospital
        • Contact:
          • Chunkang Yang
      • Ganzhou, China
        • The First Affiliated Hospital of Gannan Medical University
        • Contact:
          • Xiangfu Zeng
      • Guangzhou, China
        • The Second Affiliated Hospital, Sun Yat-Sen University
        • Contact:
          • Fanghai Han
      • Harbin, China
        • The Second Affiliated Hospital of Harbin Medical University
        • Contact:
          • Guiyu Wang
      • Nanchang, China
        • The First Affiliated Hospital of Nanchang University
        • Contact:
          • Taiyuan Li
      • Shanghai, China
        • Zhongshan hospital, Fudan university
        • Contact:
          • Ye Wei
      • Xi'an, China
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Junjun She
      • Xiamen, China, 361004
        • Zhongshan Hospital of Xiamen University
        • Contact:
          • Jianchun Cai
      • Zhengzhou, China
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Junhong Hu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age between 18 to 75 years;
  2. Historically confirmed rectal adenocarcinoma;
  3. Diagnosed with rectal cancer by pelvic/rectal magnetic resonance imaging;
  4. cT1-4aNxM0 high rectal adenocarcinoma; cT1-3NxM0 mid/low rectal adenocarcinoma;
  5. No evidence of distant metastases;
  6. A maximum of 5cm in diameter;
  7. Body mass index (BMI) ≤ 30 kg / m2;
  8. No local complications (no obstruction, incomplete obstruction, no massive active bleeding, no perforation, preoperatively abscess formation, no local invasion);
  9. Willing to undergo surgery;
  10. Sign the informed consent;

Exclusion Criteria:

  1. Presence of lateral/inguinal lymph node metastases;
  2. Previous history of malignant colorectal tumor;
  3. Multiple primary colorectal tumors;
  4. Neoadjuvant therapy;
  5. Salvage surgery for endoscopic surgery;
  6. History of previous abdominopelvic surgeries or extensive intra-abdominal adhesion;
  7. Familial adenomatous polyposis, Lynch syndrome, and inflammatory bowel disease;
  8. Comorbid with other malignancies within 5 years;
  9. ASA ≥ IV and/or ECOG performance status score ≥ 2;
  10. Severe liver, kidney, cardiopulmonary insufficiency, coagulopathy or serious underlying diseases;
  11. Serious mental illness;
  12. Pregnant or lactating women;
  13. Uncontrolled infection;
  14. Abnormal anal function or anal stenosis;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Transanal group
Participants in this group underwent robotic surgery with transanal specimen extraction
Procedure: Transanal specimen extraction robotic surgery
Participants in this group underwent robotic rectal cancer resection ,the specimens were extracted through anus.
Active Comparator: Transabdominal group
Participants in this group underwent robotic surgery with transabdominal specimen extraction
Procedure: Transabdominal specimen extraction robotic surgery
Participants in this group underwent robotic assisted rectal cancer resection ,the specimens were extracted through the incision on the abdominal wall.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 30 days postoperatively.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
C-reactive protein (CRP)
Time Frame: 1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
Detection of serum CRP levels (mg/L) to evaluate surgical stress response and immune function.
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.
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.
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.
Detection of Serum Cortisol Level (nmol/L) to evaluate surgical stress response and immune function.
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.
Count CD3, CD4, and CD8 lymphocyte subsets (pieces/ul) to assess surgical stress response and immune function.
1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
Positive rate of tumor cells
Time Frame: Intraoperative.
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.
Intraoperative.
bacterial positive rate
Time Frame: Intraoperative.
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.
Intraoperative.
Pain assessment
Time Frame: 1 day before operation, 1, 2, 3 days postoperatively, and up to 2 weeks.
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.
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.
Wexner scale (0 are normal continence, 20 are maximum incontinence with maximum disturbance of lifestyle) will be used to evaluate the defecation function.
1 day before operation, and 1, 3, 6 months postoperatively.
LARS scale
Time Frame: 1 day before operation, and 1, 3, 6 months postoperatively.
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.
1 day before operation, and 1, 3, 6 months postoperatively.
Postoperative recovery composite
Time Frame: Up to 2 weeks.
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).
Up to 2 weeks.
EORTC QLQ-C30
Time Frame: 1 day before operation, 1, 3, 6 months postoperatively.
To assess the quality of life of all cancer patients.
1 day before operation, 1, 3, 6 months postoperatively.
EORTC QLQ-C38
Time Frame: 1 day before operation, 1, 3, 6 months postoperatively.
To assess the quality of life in patients with rectal cancer.
1 day before operation, 1, 3, 6 months postoperatively.
Tumor size
Time Frame: Up to 30 days postoperatively.
To assess the quality of surgical specimens.
Up to 30 days postoperatively.
Number of Histopathological type
Time Frame: Up to 30 days postoperatively.
To assess the quality of surgical specimens and postoperative pathological evaluation.
Up to 30 days postoperatively.
Degree of differentiation
Time Frame: Up to 30 days postoperatively.
To assess the quality of surgical specimens and postoperative pathological evaluation.
Up to 30 days postoperatively.
Distance , positive condition of pathological margin (proximal, distal, circumferential)
Time Frame: Up to 30 days postoperatively.
To assess the quality of surgical specimens and postoperative pathological evaluation.
Up to 30 days postoperatively.
Number of lymph node dissection and metastasis
Time Frame: Up to 30 days postoperatively.
To assess the quality of surgical specimens and postoperative pathological evaluation.
Up to 30 days postoperatively.
Nerve vessel involvement rate
Time Frame: Up to 30 days postoperatively.
To assess the quality of surgical specimens and postoperative pathological evaluation.
Up to 30 days postoperatively.
Hospitalization costs
Time Frame: Up to 30 days.
To assess the financial burden difference.
Up to 30 days.
Local recurrence rate
Time Frame: 1, 3, 5 years postoperatively.
To assess the long-term postoperative outcomes.
1, 3, 5 years postoperatively.
The incidence rate of distant metastasis
Time Frame: 1, 3, 5 years postoperatively.
To assess the long-term postoperative outcomes.
1, 3, 5 years postoperatively.
Tumor-free survival rates
Time Frame: 1, 3, 5 years postoperatively.
To assess the long-term postoperative outcomes.
1, 3, 5 years postoperatively.
Overall survival rate
Time Frame: 1, 3, 5 years postoperatively.
To assess the long-term postoperative outcomes.
1, 3, 5 years postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taiyuan Li

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RO220624

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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