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

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Procedure: Intracorporeal anastomosis

• Registration Number: NCT05911152
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief 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?

Detailed 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.

Study Timeline

• Study Start: 2016-01-01
• Status Verified: 2023-06
• Study First Submitted: 2023-06-12
• Study First Submitted QC: 2023-06-12
• Study First Posted: 2023-06-20
• Last Update Submitted: 2023-06-24
• Last Update Posted: 2023-06-27
• Primary Completion: 2024-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intracorporeal anastomosis	Intracorporeal anastomosis	Patients underwent laparoscopic colorectal surgery with intracorporeal anastomosis

Primary Outcome Measures

Name	Time	Method
3-year overall survival	3 year	Percentage of patients who are still alive at the end of a 3-year period after surgery
3-year disease free survival	3 year	Proportion of patients who remain alive without any signs or symptoms of disease recurrence or progression for a period of 3 years after surgery

Secondary Outcome Measures

Name	Time	Method
Length of stay after surgery	30 days	Length of stay after surgery
Rate of postoperative complications	30 days	Rate of postoperative complications within 30 days after surgery
Time to first flatus after surgery	7 days	Time to first flatus after surgery
Time to first stool after surgery	7 days	Time to first stool after surgery
Postoperative pain score	3 days	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.

Trial Locations

Locations (1)

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China