Intracorporeal Anastomosis Versus Extracorporeal Anastomosis for Left Colon Cancer

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: Active, not recruiting
• Conditions: Colon Cancer
• Intervention / Treatment: Procedure: laparoscopic assisted left colectomy (extracorporeal anastomosis group); Procedure: total laparoscopic left colectomy (intracorporeal anastomosis group)

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: Interventional
• Enrollment (Actual): 350
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	one month after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Blood Loss	It is defined as the blood loss during operation and is measured in milliliters.	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	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.	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.	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.	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.	one week after surgery
First Defecation Time	time to first defecate, measured in days.	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.	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.	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.	three years after the operation
5-year OS (Overall Survival)	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 to start food intake, measured in days	one week after surgery
Postoperative Hospital Stay	The length of hospital stay after surgery.	one month after surgery

Collaborators and Investigators

• Sponsor: Jilin University
• Investigators: Principal Investigator: Quan Wang, doctor, The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2021
• Primary Completion (Actual): July 3, 2024
• Study Completion (Estimated): July 3, 2029

Study Registration Dates

• First Submitted: December 12, 2019
• First Submitted That Met QC Criteria: December 14, 2019
• First Posted (Actual): December 17, 2019

Study Record Updates

• Last Update Posted (Actual): May 7, 2025
• Last Update Submitted That Met QC Criteria: April 20, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: total laparoscopic; laparoscopic assisted; intracorporeal anastomosis; extracorporeal anastomosis
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Colonic Neoplasms
• Other Study ID 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