Prospective Registration Study of Totally Laparoscopy Versus Laparoscopy Assisted Colon Cancer Surgery

• Conditions: Surgery; Colon Cancer; Intracorporeal Anastomosis; Totally Laparoscopic
• Interventions: Procedure: intracorporeal anastomosis

• Registration Number: NCT04853784
• Lead Sponsor: The First Hospital of Jilin University

Brief Summary

This is a comparison of totally laparoscopic and laparoscopic-assisted colon cancer resection, a prospective registration study comparing the safety and benefits of the two operations

Detailed Description

Colorectal cancer is one of the most common malignant tumors in China. With the advancement of medical science and technology, the treatment of colorectal cancer has become more mature, forming a comprehensive and individualized treatment model focusing on surgery. The promotion of the principles of TME and CME surgery has greatly standardized the operation of colorectal surgery. COLOR II, COREAN and CLASICC studies have all confirmed the safety and effectiveness of laparoscopic colorectal cancer surgery.

In traditional laparoscopic-assisted surgery, a small incision in the abdominal wall is used to assist in trimming the mesangium to remove the specimen, and the anastomosis is completed outside the abdominal wall, which will still cause postoperative incision pain and may lead to complications such as incisional infection and incisional hernia. However, in some obese patients, the mesangium is thick and short. The above operations are more difficult, and may even cause the risk of mesangial tears and bleeding, which will weaken the minimally invasive advantages of laparoscopic surgery.

The total laparoscopic radical resection of colon cancer is performed under laparoscopic free dissection and dissected reconstruction of the operation area. The small incision of the abdominal wall Trocar is used to take out the specimen, which not only guarantees a sufficient range of dissection and resection, but also avoids the troubles caused by the auxiliary abdominal wall incision. Postoperative recovery may be faster, but it also raises questions about the increased risk of infection in the surgical area. Total laparoscopic radical resection of colon cancer still lacks corresponding high-quality clinical research. In response to this problem, this study compares related surgical methods, verifies the safety and effectiveness of the corresponding surgical methods, and provides better guidance for subsequent clinical practice.

Taking laparoscopic-assisted radical resection of colon cancer as a control, the short-term and long-term effects of full laparoscopic radical resection of colon cancer were evaluated, so as to choose a more effective and safe operation method.

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-04-06
• Study First Submitted QC: 2021-04-18
• Last Update Submitted: 2021-04-18
• Study First Posted: 2021-04-21
• Last Update Posted: 2021-04-21
• Study Start: 2021-05-01
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

1. Age: 18-80 years old, male or female;

2. Colon cancer (ascending colon, transverse colon, descending colon, sigmoid colon) is diagnosed by histology or cytology;

3. The clinical stage is T1-4aN0-2M0; 4 No multiple distant metastases;

4. ECOG score 0-2; 6. Heart, lung, liver, and kidney functions can tolerate surgery; 7. Patients and their families can understand and are willing to participate in this clinical study, and sign an informed consent.

Exclusion Criteria

1. Past history of malignant colorectal tumors or recent diagnosis combined with other malignant tumors;
2. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery;
3. Neighboring organs need to be combined with organ resection;
4. New adjuvant therapy before surgery;
5. ASA grade ≥ grade IV and/or ECOG physical status score> 2 points;
6. Those who have severe liver and kidney function, cardiopulmonary function, blood coagulation dysfunction, or combined with serious underlying diseases that cannot tolerate surgery;
7. History of severe mental illness;
8. Pregnant or lactating women;
9. Patients with other clinical and laboratory conditions considered by the investigator should not participate in the trial.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Laparoscopic-assited colon surgery	intracorporeal anastomosis	Laparoscopic-assited colon surgery/extracorporeal anastomosis
Totally laparoscopic colon surgery	intracorporeal anastomosis	Totally laparoscopic colon surgery/intracorporeal anastomosis

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative complications	30 days after operation	Complication incidence 30 days after operation

Secondary Outcome Measures

Name	Time	Method
Rate of complete mesentery resection (CME)	one week after surgery	Rate of complete mesentery resection (CME)
5-year overall survival OS	5 years after operation	5-year overall survival OS
Operation time	one hour after surgery	the length between the beginning and the end of the whole operation
Postoperative recovery	During the postoperative hospital stay	Postoperative recovery: first exhaust, defecation time, restoring liquid diet, hospitalization days.
Length of surgical incision	one week after surgery	Length of surgical incision
3-year disease-free survival	3 years after operation	3-year disease-free survival
number of lymphnodes dissected	During the operation	one week after surgery
Intraoperative blood loss	one hour after surgery	the mount of blood loss during the whole operation(ml）
Intraoperative conversion rate	one hour after surgery	Intraoperative conversion rate (conversion to open, conversion to laparoscopic-assisted surgery

Trial Locations

Locations (1)

Jilin University First Hospital; 🇨🇳 Changchun, Jilin, China