Intracorporeal Anastomosis Versus Extracorporeal Anastomosis for Left Colon Cancer

NCT04201717 | Active Not Recruiting Results DMC

• 1 other identifier: STARS
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Colon Cancer

Keywords

total laparoscopic; laparoscopic assisted; intracorporeal anastomosis; extracorporeal anastomosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• the Blood Loss

  one hour after surgery

• the Operating Time

  one hour after surgery

• the Incidence of Complications

  one month after surgery

• The Rate of Conversion to Open Surgery

  one hour after surgery

• Completeness of Specimens

  one hour after surgery

Study Arms (2)

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.

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.

Procedure: total laparoscopic left colectomy (intracorporeal anastomosis group)

Interventions

laparoscopic assisted left colectomy (extracorporeal anastomosis group) PROCEDURE

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.

laparoscopic assisted left colectomy (extracorporeal anastomosis group)

total laparoscopic left colectomy (intracorporeal anastomosis group) PROCEDURE

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.

total laparoscopic left colectomy (intracorporeal anastomosis group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Jilin University: lead

Study Sites (12)

the First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Location

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

Chinese People's Liberation Army General Hospital

Beijing, China

Location

Peking Union Medical College Hospital

Beijing, China

Location

Peking University Cancer Hospital

Beijing, China

Location

The Third Hospital of Jilin University (China - Japan Union Hospital of Jilin University)

Changchun, China

Location

Daping Hospital of Army Medical University

Chongqing, China

Location

Nanfang Hospital of Southern Medical University

Guangzhou, China

Location

Fudan University Shanghai Cancer Center (Cancer Hospital Affiliated to Fudan University)

Shanghai, China

Location

Ruijin Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, China

Location

Shengjing Hospital Affiliated to China Medical University

Shenyang, China

Location

Related Publications (1)

• 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.

  PMID: 36415000 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Dr. Quan Wang
• Organization: FIrst Hospital of Jilin University

wquan@jlu.edu.cn

+86 ‭15843073207‬

Study Officials

• Quan Wang, doctor

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The clinical surgeons, outcome assessors, data recorders, and statisticians will all operate independently. Due to the nature of the surgical interventions, the surgeons will not be blinded to treatment allocation. However, the outcomes assessor who assess or analyze the end point will be blinded. The patients will also be blinded to group allocation to reduce the risk of bias. Unblinding will not be performed unless the finalization of the main data analysis or required for patient's safety. After the data analysis, we will have a blinded interpretation of the study results to minimize misleading data interpretation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisted Investigator

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 17, 2019
• Study Start: January 27, 2021
• Primary Completion: July 3, 2024
• Study Completion (Estimated): July 3, 2029
• Last Updated: May 7, 2025
• Results First Posted: February 26, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• 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.
• Access Criteria: Researchers can send an email to the Principal Investigator to apply for the right to use the data.

Locations

CN (12)