Intracorporeal Anastomosis Versus Extracorporeal Anastomosis for Left Colon Cancer

April 20, 2025 updated by: Dong Yang, Jilin University

A Multicenter Randomized Clinical Trial Comparing Surgical Site Infection After Intracorporeal Anastomosis and Extracorporeal Anastomosis for Left Colon Cancer (STARS)

This study aims to investigate the effects of intracorporeal anastomosis and extracorporeal anastomosis in laparoscopic-assisted radical left hemicolectomy on surgical site infection. Also consider perioperative recovery, safety, and oncology outcomes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not 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

This is a prospective, randomized controlled trial. In this trial, cases in the intracorporeal anastomosis group and the extracorporeal anastomosis group are allocated at a 1:1 ratio among patients undergoing laparoscopic radical left hemicolectomy. The peri-operative recovery data, complications, oncology outcomes, and survival are compared.

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 (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.
350

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Dong Yang, doctor

Study Locations

  • China
      • Beijing, China
        • Cancer Hospital, Chinese Academy of Medical Sciences
      • Beijing, China
        • Beijing Friendship Hospital, Capital Medical University
      • Beijing, China
        • Peking Union Medical College Hospital
      • Beijing, China
        • Peking University Cancer Hospital
      • Beijing, China
        • Chinese People's Liberation Army General Hospital
      • Chang chun, China
        • The Third Hospital of Jilin University (China - Japan Union Hospital of Jilin University)
      • Chongqing, China
        • Daping Hospital of Army Medical University
      • Guangzhou, China
        • Nanfang Hospital of Southern Medical University
      • Shanghai, China
        • Fudan University Shanghai Cancer Center (Cancer Hospital Affiliated to Fudan University)
      • Shanghai, China
        • Ruijin Hospital Affiliated to Shanghai Jiao Tong University
      • Shenyang, China
        • Shengjing Hospital affiliated to China Medical University
    • Ji Lin
      • Changchun, Ji Lin, China, 130021
        • The First Hospital of Jilin University

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

Description

Inclusion criteria

  1. age between 18 and 80 years;
  2. histologically or cytologically confirmed left-sided colon cancer (distal transverse colon, left colic flexure, descending colon, or proximal sigmoid colon);
  3. clinical stage T1-4a, N0-2, and M0;
  4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
  5. suitable for laparoscopic colectomy;
  6. no previous systemic chemotherapy or radiotherapy;
  7. willing to provide written informed consent and comply with the research procedures.

Exclusion criteria

  1. Have a history of malignant colorectal tumor or have metastatic or multiple carcinoma.
  2. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery.
  3. Patients who need to undergo combined organ resection or robot-assisted colectomy.
  4. Patients who are receiving preoperative neoadjuvant therapy.
  5. ASA grade ≥ IV and/or ECOG performance status score > 2.
  6. Cardiopulmonary dysfunction (NYHA cardiac function classification II-IV), liver dysfunction (MELD score greater than 12), or kidney dysfunction (serum creatinine above the upper limit of normal);
  7. Patients with severe psychiatric illness.
  8. Pregnant or lactating women.
  9. Patients who have a history of taking hormonal drugs.
  10. Diabetic patients whose blood sugar cannot be controlled to be within 6.1 - 8.3 mmol/L.
  11. Patients with other clinical and laboratory conditions that are considered by researchers as inappropriate for participating in this trial.

Exit criteria

  1. Patients with other non-tumor diseases that prevent them from continuing to receive this treatment regimen.
  2. Patients who need emergency surgical resection due to intestinal obstruction, intestinal perforation, intestinal bleeding, etc. after being enrolled in the study.
  3. Patients with distant metastasis confirmed by intraoperative exploration or postoperative pathology, including liver, pelvic cavity, ovary, peritoneum, distant lymph node metastasis, etc.
  4. Patients who need combined organ resection as determined by intraoperative exploration.
  5. Patients who request to withdraw from this study cohort for various reasons after being enrolled in the study, or who cannot complete the study plan and follow-up for various reasons.

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: Double

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.
Active Comparator: laparoscopic assisted left colectomy (extracorporeal anastomosis group)
All patients underwent laparoscopic dissection according to the left hemicolon cancer resection standard. lymph nodes and blood vessels, are completely trimmed and resected in an en bloc fashion. A small incision is made in the middle of the abdomen to trim the mesentery, remove the specimen, and complete the anastomosis. After completing the anastomosis, the incision will be sutured.
Procedure: laparoscopic assisted left colectomy (extracorporeal anastomosis group)
For patients in the control group, the surgeon uses wound edge protectors to exteriorize the colon through a small incision in the midline of the abdomen. A ruler and methylene blue solution are employed to mark the area for colon resection. This guarantees a 10-cm margin from the tumor. Guided by these markers, the marginal vessels and mesentery are divided outside the body. The method of anastomosis is at the surgeon's discretion. A side-to-side anastomosis (including antiperistaltic, isoperistaltic, or overlapping anastomosis) is recommended. Side-to-end or end-to-end anastomosis (sewn by hand or by inserting a circular stapler through the anus or proximal colon) is also allowed. After completing the anastomosis, the incision is sutured. An abdominal drainage tube is inserted at the end of the operation.
Experimental: total laparoscopic left colectomy (intracorporeal anastomosis group)
All patients underwent laparoscopic dissection according to the left hemicolon cancer resection standard. lymph nodes and blood vessels, are completely trimmed and resected in an en bloc fashion. Mesentery resection is performed under laparoscopy, and anastomosis is completed under laparoscopy. A small incision is made to extract the specimen after the anastomosis is completed.
Procedure: total laparoscopic left colectomy (intracorporeal anastomosis group)
In the experimental group, the surgeon will use a 10-cm medical suture and methylene blue solution to mark the resection margin. The marginal vessels and mesentery will be divided inside the body. The proximal and distal colons are resected using a 60mm linear laparoscopic stapler. Side-to-side intracorporeal anastomotic techniques like anti-peristaltic, iso-peristaltic, or overlap methods will be applied. Once the anastomosis is completed, the specimen is retrieved. The surgeon can place the specimen in a sterile plastic bag for retrieval. Alternatively, the surgeon can use a disposable incision retraction fixator to protect the wound. An abdominal drainage tube is inserted.

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
The Count of Participants With Surgical Site Infection (SSI)
Time Frame: one month after surgery
The primary outcome was the incidence of SSI based on the Definitions of CDC guidelines: superficial incisional, deep incisional, and organ/space infections . Infections involving both organ/space and the incisional site (superficial or deep) were categorized as organ/space infections. Surgeons and nurses assessed the presence of infection daily during hospitalization. After hospital discharge, all patients were followed up until 30 days after surgery at outpatient clinics to check the wound.
one month after surgery

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
the Blood Loss
Time Frame: one hour after surgery
It is defined as the blood loss during operation and is measured in milliliters.
one hour after surgery
the Operating Time
Time Frame: one hour after surgery
It is defined as the period from cutting the skin to suturing the skin or doing enterostomy. It is measured in minutes
one hour after surgery
the Incidence of Complications
Time Frame: one month after surgery
It includes fever of unknown origin, bowel obstruction, anastomotic leakage, SSI, other incisional complications, respiratory complications, urinary complications, cardiovascular and cerebrovascular complications, diarrhea, chylous fistula, intraperitoneal hemorrhage, digestive hemorrhage, gastroparesis, and others (including bacteremia, cholecystitis, ion discharge, pancreatitis, and mental and behavioral abnormalities). Complications are graded according to the Clavien-Dindo classification.
one month after surgery
The Rate of Conversion to Open Surgery
Time Frame: one hour after surgery
It is defined as an abdominal incision larger than that necessary for specimen extraction.
one hour after surgery
Completeness of Specimens
Time Frame: one hour after surgery
It is evaluated according to the West classification. The resected specimens will be classified into three groups according to the plane of dissection: mesocolic plane, intramesocolic plane, and muscularis propria plane.
one hour after surgery
Number of Lymph Nodes Dissected
Time Frame: one week after surgery
The number of lymph nodes in the mesentery will be calculated. Additionally, the metastatic lymph nodes will be counted.
one week after surgery
First Defecation Time
Time Frame: one week after surgery
time to first defecate, measured in days.
one week after surgery
the Incision Length
Time Frame: one hour after surgery
The incision length is measured with an aseptic ruler at the end of the surgery, after the incision is sutured. It is measured in millimeters.
one hour after surgery
Visual Analogue Scale/Score (VAS)
Time Frame: 2 days after surgery
Pain severity was assessed 48 hours after the operation using a ruler about 10 cm long. The ruler is numbered from 0 to 10. 0-3 points indicate no to mild pain. 4-6 points represent moderate pain. 7-10 points stand for severe pain.
2 days after surgery
3-year DFS (Disease-free Survival)
Time Frame: three years after the operation
DFS was defined as the time from randomization until the discovery of local recurrence, distant metastasis, or death from the tumor.
three years after the operation
5-year OS (Overall Survival)
Time Frame: five years after the operation
OS was defined as the time from randomization to death due to any cause.
five years after the operation
First Time for Fluid Diet
Time Frame: one week after surgery
time to start food intake, measured in days
one week after surgery
Postoperative Hospital Stay
Time Frame: one month after surgery
The length of hospital stay after surgery.
one month 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.
Jilin University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Quan Wang, doctor, The First Hospital of Jilin University

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.
January 27, 2021

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.
July 3, 2024

Study Completion (Estimated)

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.
July 3, 2029

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).
December 12, 2019

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.
December 14, 2019

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.
December 17, 2019

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.
May 7, 2025

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.
April 20, 2025

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.
April 1, 2025

More Information

Terms related to this study

Keywords

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.
  • STARS (STaRS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

If other researchers want to get the individual participant data of this study and have proper reasons, we'll share the data after the study is completed. Researchers can send an email to the Principal Investigator to ask for permission to use the data.

IPD Sharing Time Frame

The Study Protocol, SAP (Statistical Analysis Plan), ICF (Informed Consent Form), and analytic code will be made available following the publication of the primary outcomes. The Individual Participant Data (IPD) will be accessible after the publication of all the long-term secondary outcomes.

IPD Sharing Access Criteria

Researchers can send an email to the Principal Investigator to apply for the right to use the data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

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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