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

Surgery Clinical Trial

— STARS-CC01  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04853784
• Other study ID #: STARS-CC01
• Status: Not yet recruiting
• Start date: May 1, 2021
• Est. completion date: May 30, 2023

Study information

• Verified date: April 2021
• Source: The First Hospital of Jilin University
• Contact: Quan Wang, Prof.
• Phone: 15843073207
• Email: wquan[@]jlu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 650
• Est. completion date: May 30, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

5. 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.

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Surgery

Intervention

Procedure:
• intracorporeal anastomosis
intracorporeal anastomosis

Locations

Country	Name	City	State
China	Jilin University First Hospital	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
The First Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative complications	Complication incidence 30 days after operation	30 days after operation
Secondary	Operation time	the length between the beginning and the end of the whole operation	one hour after surgery
Secondary	number of lymphnodes dissected	one week after surgery	During the operation
Secondary	Length of surgical incision	Length of surgical incision	one week after surgery
Secondary	Intraoperative blood loss	the mount of blood loss during the whole operation(ml)	one hour after surgery
Secondary	Intraoperative conversion rate	Intraoperative conversion rate (conversion to open, conversion to laparoscopic-assisted surgery	one hour after surgery
Secondary	Rate of complete mesentery resection (CME)	Rate of complete mesentery resection (CME)	one week after surgery
Secondary	Postoperative recovery	Postoperative recovery: first exhaust, defecation time, restoring liquid diet, hospitalization days.	During the postoperative hospital stay
Secondary	3-year disease-free survival	3-year disease-free survival	3 years after operation
Secondary	5-year overall survival OS	5-year overall survival OS	5 years after operation