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ACTIVE NOT RECRUITING
NCT04201717
NA

Intracorporeal Anastomosis Versus Extracorporeal Anastomosis for Left Colon Cancer

Sponsor: Jilin University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

350

Start Date

2021-01-27

Completion Date

2029-07-03

Last Updated

2025-05-07

Healthy Volunteers

No

Conditions

Interventions

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.

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.

Locations (12)

the First Hospital of Jilin University

Changchun, Jilin, China

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

Chinese People's Liberation Army General Hospital

Beijing, China

Peking Union Medical College Hospital

Beijing, China

Peking University Cancer Hospital

Beijing, China

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

Changchun, China

Daping Hospital of Army Medical University

Chongqing, China

Nanfang Hospital of Southern Medical University

Guangzhou, China

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

Shanghai, China

Ruijin Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, China

Shengjing Hospital Affiliated to China Medical University

Shenyang, China