Robotic Versus Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision

July 18, 2022 updated by: Weidong Tong, Third Military Medical University

Robotic Versus Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision: a Retrospective Multicenter Study With Propensity Score Matching

the investigators performed a retrospective multicenter propensity score matching study. From July 2016 to July 2021, 382 consecutive patients from different Chinese surgical departments were available for inclusion out of an initial cohort of 412, who underwent robotic or laparoscopic right hemicolectomy with CME.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

All consecutive patients who underwent robotic or laparoscopic right hemicolectomy with CME from July 2016 to July 2021 at three Chinese surgical departments (Department of General Surgery, Army Medical Center, Chongqing;Department of Colorectum, Chongqing University Three Gorges Hospital, Chongqing;Department of Colorectum, the 940th Hospital of Joint Logistics Support Force of Chinese People's Liberation Army, Lanzhou) were included in the study. A retrospective review of multicenter institutional database was conducted. The Da Vinci Surgical System (Intuitive Surgical, Sunnyvale, CA, USA) has been employed since 2016 in three centers. From July 2016 to July 2021, an initial cohort of 412 consecutive patients underwent robotic or laparoscopic right hemicolectomy with CME in three departments. With 30 cases meeting the exclusion criteria, 382 cases, including 204 males and 178 females, were available for inclusion. Of these, 149 cases by robotic right hemicolectomy with CME were classified as the robotic group, while the other 233 cases by laparoscopic right hemicolectomy with CME as the laparoscopic group.

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.
Observational

Enrollment (Actual)

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.
382

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
    • Chongqing
      • Wanzhou, Chongqing, China, 404031
        • Chongqing University Three Gorges Hospital
      • Yuzhong, Chongqing, China, 400042
        • Army Medical Center
    • Gansu
      • Lanzhou, Gansu, China, 730050
        • No. 940 Hospital of Joint Logistics Support Foce of Chinese People's Liberation Army

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All consecutive patients who underwent robotic or laparoscopic right hemicolectomy with CME from July 2016 to July 2021 at three Chinese surgical departments (Department of General Surgery, Army Medical Center, Chongqing; Department of Colorectum, Chongqing University Three Gorges Hospital, Chongqing; Department of Colorectum, the 940th Hospital of Joint Logistics Support Force of Chinese People's Liberation Army, Lanzhou) were included in the study

Description

Inclusion Criteria:

  1. Adenocarcinoma was confirmed by preoperative colonoscopy and it was located in the right colon.
  2. Preoperative enhanced abdominal CT examination showed no invasion of abdominal wall or adjacent organs.
  3. The patient underwent robotic or laparoscopic right hemicolectomy with CME.

Exclusion Criteria:

  1. Multiple primary colorectal tumors
  2. Metastasis to abdominal
  3. Pelvic or distant organs
  4. Accompanied with bowel obstruction or perforation
  5. Neuroendocrine tumors
  6. Lymphomas
  7. Other malignant tumors.

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
robotic right hemicolectomy with CME
The robot was set to come and dock from the right shoulder of the patient. Three robotic 8-mm trocars (R1, R2 and R3) and two 12-mm trocars (camera and assistant port) were used for the robotic procedure. One working arm carrying a monopolar cautery hook/scissors for dissection was located in the left upper quadrant port (R1). The other two working arms carried bipolar forceps in the suprapubic port (R2), and Cadiere's fenestrated forceps in the right lower quadrant port (R3) that was used to keep the superior mesenteric axis in traction. After gentle cephalad traction on the transverse mesocolon with the grasp in R3, the assistant grasped the ileocecal valve through the assistant port to put the ileocolic vascular pedicle on tension and the ileocolic vessels were identified and lifted up with R2. All procedures were performed keeping the principle of complete mesocolic excision.
Procedure: robotic right hemicolectomy with CME
The distribution of trocars was placed according to the position of Intuitive Surgical Inc. for robotic colectomy. The robot was set to come and dock from theright shoulder of the patient. Three robotic 8-mm trocars (R1, R2 and R3) and two 12-mm trocars (camera and assistant port) were used for the robotic procedure. One working arm carrying a monopolar cautery hook for dissection was located in the left upper quadrant port (R1). The other two working arms carried bipolar forceps in the suprapubic port (R3), and Cadiere's fenestrated forceps in the right lower quadrant port (R2) that was used to keep the superior mesenteric axis in traction. After gentle cephalad traction on the transversemesocolon with the grasp in R2, the assistant grasped the ileocecal valve through the assistant port to put the ileocolic vascular pedicle on tension and the ileocolic vessels were identified and lifted up with R3.
laparoscopic right hemicolectomy with CME
In the aparoscopic group, five trocars were used: a periumbilical incision and left upper quadrant for 12-mm trocars, both lower quadrants for 5-mm trocars, and the right quadrant for one more 5-mm trocar. A 30 degrees laparoscope was inserted through the periumbilical trocar site. After insertion of the trocars, the patient was placed in the Trendelenburg position with a 15 degrees rightward tilt. An ultrasonic device was used for dissection. All procedures were performed keeping the principle of complete mesocolic excision.

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
diseasefree survival(months)
Time Frame: until July 2021
Collect outcomes of follow-up and use Kaplan-Meier survival analysis to analyze it.
until July 2021
overall survival(months)
Time Frame: until July 2021
Collect outcomes of follow-up and use Kaplan-Meier survival analysis to analyze it.
until July 2021

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
conversion rates
Time Frame: during the surgery
the incidence of a conversion to open surgery
during the surgery
operative time
Time Frame: during the surgery
the miniutes of surgery from skin to skin
during the surgery
estimated blood loss
Time Frame: during the surgery
the mililiter of the blood loss during surgery
during the surgery
oral retake
Time Frame: up to 30 days after surgery
the patients begin to recover intake
up to 30 days after surgery
time to return to bowel function
Time Frame: up to 30 days after surgery
the patients begin to recover bowel function
up to 30 days after surgery
length of stay
Time Frame: up to 30 days after surgery
the days of hospital stay
up to 30 days after surgery
total hospitalization cost
Time Frame: up to 30 days after surgery
the total cost of this treatment by RMB
up to 30 days after surgery
complications
Time Frame: up to 30 days after surgery
Postoperative complications, such as ileus, anastomotic leak, small intestinal obstruction, bleeding and so on. Number of Participants with complications will be recorded.
up to 30 days after surgery
harvest lymph nodes
Time Frame: up to 7 days after surgery
the number of harvest lymph nodes in postoperative pathological report
up to 7 days after surgery
lymph node metastasis
Time Frame: up to 7 days after surgery
the number of patients with lymph node metastasis
up to 7 days after surgery

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.
Third Military Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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.
April 1, 2022

Primary Completion (Actual)

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.
June 1, 2022

Study Completion (Actual)

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.
June 22, 2022

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).
June 23, 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 9, 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 14, 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 18, 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

Keywords

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.
  • 20220623

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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