Colon CancerNCT04201717
Intracorporeal Anastomosis Versus Extracorporeal Anastomosis for Left Colon Cancer
A study testing laparoscopic assisted left colectomy (extracorporeal anastomosis group) and total laparoscopic left colectomy (intracorporeal anastomosis group) in people with Colon Cancer, run by Jilin University at 12 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- laparoscopic assisted left colectomy (extracorporeal anastomosis group) and total laparoscopic left colectomy (intracorporeal anastomosis group)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 12 sitesChina
- Study dates
- 27 Jan 2021to 3 Jul 2029
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 between 18 and 80 years;
- histologically or cytologically confirmed left-sided colon cancer (distal transverse colon, left colic flexure, descending colon, or proximal sigmoid colon);
- clinical stage T1-4a, N0-2, and M0;
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
- suitable for laparoscopic colectomy;
- no previous systemic chemotherapy or radiotherapy;
- willing to provide written informed consent and comply with the research procedures.
Who cannot join
- Have a history of malignant colorectal tumor or have metastatic or multiple carcinoma.
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery.
- Patients who need to undergo combined organ resection or robot-assisted colectomy.
- Patients who are receiving preoperative neoadjuvant therapy.
- ASA grade ≥ IV and/or ECOG performance status score > 2.
- 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);
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- Patients with severe psychiatric illness.
- Pregnant or lactating women.
- Patients who have a history of taking hormonal drugs.
- Diabetic patients whose blood sugar cannot be controlled to be within 6.1 - 8.3 mmol/L.
- Patients with other clinical and laboratory conditions that are considered by researchers as inappropriate for participating in this trial.
- Exit criteria
- Patients with other non-tumor diseases that prevent them from continuing to receive this treatment regimen.
- Patients who need emergency surgical resection due to intestinal obstruction, intestinal perforation, intestinal bleeding, etc. after being enrolled in the study.
- Patients with distant metastasis confirmed by intraoperative exploration or postoperative pathology, including liver, pelvic cavity, ovary, peritoneum, distant lymph node metastasis, etc.
- Patients who need combined organ resection as determined by intraoperative exploration.
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Beijing Friendship Hospital, Capital Medical University
Beijing
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing
Chinese People's Liberation Army General Hospital
Beijing
Peking Union Medical College Hospital
Beijing
Peking University Cancer Hospital
Beijing
the First Hospital of Jilin University
Changchun, Jilin, 130021
The Third Hospital of Jilin University (China - Japan Union Hospital of Jilin University)
Changchun
Daping Hospital of Army Medical University
Chongqing
Nanfang Hospital of Southern Medical University
Guangzhou
Fudan University Shanghai Cancer Center (Cancer Hospital Affiliated to Fudan University)
Shanghai
Ruijin Hospital Affiliated to Shanghai Jiao Tong University
Shanghai
Shengjing Hospital Affiliated to China Medical University
Shenyang
About this study
Official title: 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.
Read the 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.
- Conditions
- Colon Cancer
- Being tested
- laparoscopic assisted left colectomy (extracorporeal anastomosis group), total laparoscopic left colectomy (intracorporeal anastomosis group)
- Keywords
- total laparoscopic, laparoscopic assisted, intracorporeal anastomosis, extracorporeal anastomosis
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic assisted left colectomy (extracorporeal anastomosis group)Procedure or surgery
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.
total laparoscopic left colectomy (intracorporeal anastomosis group)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic assisted left colectomy (extracorporeal anastomosis group) | Active comparator | 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. Receives: Procedure: laparoscopic assisted left colectomy (extracorporeal anastomosis group) |
| total laparoscopic left colectomy (intracorporeal anastomosis group) | Experimental | 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. Receives: Procedure: total laparoscopic left colectomy (intracorporeal anastomosis group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Count of Participants With Surgical Site Infection (SSI)
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.
Measured: one month after surgery
Secondary outcomes (13)
the Blood Loss
It is defined as the blood loss during operation and is measured in milliliters.
Measured: one hour after surgery
the Operating Time
It is defined as the period from cutting the skin to suturing the skin or doing enterostomy. It is measured in minutes
Measured: one hour after surgery
the Incidence of Complications
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.
Measured: one month after surgery
The Rate of Conversion to Open Surgery
It is defined as an abdominal incision larger than that necessary for specimen extraction.
Measured: one hour after surgery
Completeness of Specimens
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.
Measured: one hour after surgery
Number of Lymph Nodes Dissected
The number of lymph nodes in the mesentery will be calculated. Additionally, the metastatic lymph nodes will be counted.
Measured: one week after surgery
First Defecation Time
time to first defecate, measured in days.
Measured: one week after surgery
the Incision Length
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.
Measured: one hour after surgery
Visual Analogue Scale/Score (VAS)
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.
Measured: 2 days after surgery
3-year DFS (Disease-free Survival)
DFS was defined as the time from randomization until the discovery of local recurrence, distant metastasis, or death from the tumor.
Measured: three years after the operation
5-year OS (Overall Survival)
OS was defined as the time from randomization to death due to any cause.
Measured: five years after the operation
First Time for Fluid Diet
time to start food intake, measured in days
Measured: one week after surgery
Postoperative Hospital Stay
The length of hospital stay after surgery.
Measured: one month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start27 Jan 2021
- Primary completion3 Jul 2024
- Study completion3 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Yang, Jilin University
- Investigators
- Quan Wang, doctor, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201717
- Sponsor's protocol ID
- STARS
- Status last verified
- Apr 2025
- First submitted
- 12 Dec 2019
- Last updated
- 7 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
He L, Li M, Zhang JX, Tong WH, Chen Y, Wang Q. Surgical site infection after intracorporeal anastomosis for left-sided colon cancer: study protocol for a non-inferiority multicenter randomized controlled trial (STARS). Trials. 2022 Nov 22;23(1):954. doi: 10.1186/s13063-022-06914-5.
PubMed 36415000
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Clinical Trial Comparing Surgical Site Infection After Intracorporeal Anastomosis and Extracorporeal Anastomosis for Left Colon Cancer (STARS)
- ClinicalTrials.gov ID
- NCT04201717
- Acronym / sponsor ID
- STARS
- Conditions
- Colon Cancer
- Keywords
- total laparoscopic, laparoscopic assisted, intracorporeal anastomosis, extracorporeal anastomosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Jilin UniversityUniversity, hospital or other
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 3 Jul 2029 (estimated)
- First posted
- 17 Dec 2019 (actual)
- Results
- Posted 26 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic assisted left colectomy (extracorporeal anastomosis group) | Active comparator | Procedure: 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. |
| total laparoscopic left colectomy (intracorporeal anastomosis group) | Experimental | Procedure: 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age between 18 and 80 years;
- histologically or cytologically confirmed left-sided colon cancer (distal transverse colon, left colic flexure, descending colon, or proximal sigmoid colon);
- clinical stage T1-4a, N0-2, and M0;
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
- suitable for laparoscopic colectomy;
Key exclusion criteria (17 listed)
- Have a history of malignant colorectal tumor or have metastatic or multiple carcinoma.
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery.
- Patients who need to undergo combined organ resection or robot-assisted colectomy.
- Patients who are receiving preoperative neoadjuvant therapy.
- ASA grade ≥ IV and/or ECOG performance status score > 2.
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 |
|---|---|---|
| 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. | Procedure or surgery | laparoscopic assisted left colectomy (extracorporeal anastomosis group) |
| 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. | Procedure or surgery | total laparoscopic left colectomy (intracorporeal anastomosis group) |
Primary outcome
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.
13 secondary outcomes
the Blood Loss
Time frame: one hour after surgery
the Operating Time
Time frame: one hour after surgery
the Incidence of Complications
Time frame: one month after surgery
The Rate of Conversion to Open Surgery
Time frame: one hour after surgery
Completeness of Specimens
Time frame: one hour after surgery
Number of Lymph Nodes Dissected
Time frame: one week after surgery
First Defecation Time
Time frame: one week after surgery
the Incision Length
Time frame: one hour after surgery
Visual Analogue Scale/Score (VAS)
Time frame: 2 days after surgery
3-year DFS (Disease-free Survival)
Time frame: three years after the operation
5-year OS (Overall Survival)
Time frame: five years after the operation
First Time for Fluid Diet
Time frame: one week after surgery
Postoperative Hospital Stay
Time frame: one month after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36415000He L, Li M, Zhang JX, Tong WH, Chen Y, Wang Q. Surgical site infection after intracorporeal anastomosis for left-sided colon cancer: study protocol for a non-inferiority multicenter randomized controlled trial (STARS). Trials. 2022 Nov 22;23(1):954. doi: 10.1186/s13063-022-06914-5.
- Individual participant dataSharing planned: Yes. 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.
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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.
Quan Wang, doctor principal investigator
The First Hospital of Jilin University
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic assisted left colectomy (extracorporeal anastomosis group) and total laparoscopic left colectomy (intracorporeal anastomosis group) in people with Colon Cancer, run by Jilin University 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 7 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 7 May 2025. 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?
Yes. Results are posted in the registry (first posted 26 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Count of Participants With Surgical Site Infection (SSI) (time frame: one month after surgery). 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 NCT04201717, 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 7 May 2025.