Safety and Feasibility of Laparoscopic Intracorporeal Anastomosis for Colorectal Surgery- A Multiple Center Real World Study

Colorectal Cancer Clinical Trial

— SELECTED  

Official title:

Safety and Feasibility of Laparoscopic Intracorporeal Anastomosis for Colorectal Surgery- A Multiple Center Real World Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05911152
• Other study ID #: NCC4050
• Status: Recruiting
• Start date: January 1, 2016
• Est. completion date: January 1, 2025

Study information

• Verified date: June 2023
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Mingguang Zhang, Dr.
• Phone: +8613261967603
• Email: zmgslimshady[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to explore the safety and feasibility of laparoscopic intracorporeal anastomosis in colorectal cancer surgery. The main questions it aims to answer are: 1. If intracorporeal anastomosis is safe in terms of short-term outcome? 2. If intracorporeal anastomosis can achieve the same oncological outcome as conventional extracorporeal anastomosis?

Description:

This study is a retrospective real-world research initiated by the Chinese Academy of Medical Sciences Cancer Hospital, including Cancer Hospital of the Chinese Academy of Medical Sciences, Shenzhen Hospital and Peking University First Hospital. The study aims to retrospectively analyze the clinical data of approximately 2,000 patients who underwent laparoscopic surgery with preoperative imaging staging of cT1-4aNanyM0 and pathological diagnosis of adenocarcinoma or high-grade intraepithelial neoplasia from April 2016 to April 2020. The patients will be divided into the intracorporeal anastomosis group (IA) and extracorporeal anastomosis group (EA) based on the surgical records. The primary endpoints of the study are 3-year disease-free survival (DFS) and 3-year overall survival (OS). The secondary endpoints include overall complication rate within 30 days, postoperative pain score, time to first flatus after surgery, time to first bowel movement after surgery, time to first oral intake after surgery, length of hospital stay, and postoperative quality of life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients voluntarily enrolled in this study and signed an informed consent form;

2. Age: 18-75 years;

3. Completion of colonoscopy and biopsy, with pathological confirmation of adenocarcinoma or high-grade intraepithelial neoplasia;

4. Preoperative enhanced CT or MRI examination showing no evidence of distant metastasis;

5. Preoperative staging as cT1-3NanyM0;

6. Underwent laparoscopic surgery.

Exclusion Criteria:

1. Contraindications to laparoscopic surgery;

2. Cases requiring emergency surgery due to acute bowel obstruction, perforation, or bleeding;

3. Patients with distant metastasis;

4. Patients with multiple primary colorectal cancers;

5. Patients with a history of malignancy;

6. Patients unwilling to sign the informed consent or unwilling to follow the study protocol for follow-up.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• Intracorporeal anastomosis
Surgeons perform totally laparoscopic intracorporeal digestive reconstruction after specimen resection

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Shenzhen Hospital, Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year disease free survival	Proportion of patients who remain alive without any signs or symptoms of disease recurrence or progression for a period of 3 years after surgery	3 year
Primary	3-year overall survival	Percentage of patients who are still alive at the end of a 3-year period after surgery	3 year
Secondary	Rate of postoperative complications	Rate of postoperative complications within 30 days after surgery	30 days
Secondary	Time to first flatus after surgery	Time to first flatus after surgery	7 days
Secondary	Time to first stool after surgery	Time to first stool after surgery	7 days
Secondary	Length of stay after surgery	Length of stay after surgery	30 days
Secondary	Postoperative pain score	VAS (Visual Analog Scale) score is used to assess the postoperative pain level in patients. It is a measurement tool used to assess the intensity or severity of a subjective experience, typically related to pain or discomfort. The VAS score involves a straight line or a numerical scale ranging from 0 to 10, where 0 represents no pain or discomfort and 10 represents the worst possible pain or discomfort. Individuals are asked to indicate their level of pain or discomfort by marking a point on the scale, and the score is determined by measuring the distance from the 0 mark to the marked point. The VAS score provides a subjective assessment of pain or discomfort experienced by an individual.	3 days