Intracorporeal Anastomosis Versus Extracorporeal Anastomosis for Left Colon Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
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.
Study 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.
Eligibility
Primary outcome measure(s)
- The Count of Participants With Surgical Site Infection (SSI) — 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.
Trial sites (12)
| Facility | City | Region | Status |
|---|---|---|---|
| the First Hospital of Jilin University | Changchun | Jilin | |
| 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 |
More Jilin University trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04201717 on ClinicalTrials.gov ↗ ← All trials in China