NCT04201717

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)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: Jilin University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-27
• Primary completion: 2024-07-03
• Completion: 2029-07-03
• First posted: 2019-12-17
• Last updated: 2025-05-07
• Results posted: 2025-02-26

Locations

12 sites across 1 country: China