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Clinical Trials in China / NCT04201717
Active, not recruiting Not applicable

Intracorporeal Anastomosis Versus Extracorporeal Anastomosis for Left Colon Cancer

NCT04201717 · tracked via the Priya Life Science China tracker
Sponsor
Jilin University
Phase
Not applicable
Started
2021-01-27
Last updated
2025-05-07

Condition(s) studied

Colon Cancer

Investigational drug(s) / intervention(s)

laparoscopic assisted left colectomy (extracorporeal anastomosis group)total laparoscopic left colectomy (intracorporeal anastomosis group)

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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
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

Official registry record

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