Clinical trial NCT05911152: Safety and Feasibility of Laparoscopic Intracorporeal Anastomosis for Colorectal Surgery- A Multiple Center Real World Study
Official title: Safety and Feasibility of Laparoscopic Intracorporeal Anastomosis for Colorectal Surgery- A Multiple Center Real World Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Keywords: Colorectal cancer
Minimally invasive surgery
Laparoscopic surgery
Intracorporeal anastomosis
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
name: Peking University First Hospital
First posted: 2023-06-20
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients underwent laparoscopic colorectal surgery with intracorporeal or extracorporeal anastomosis

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 3-year disease free survival
timeFrame: 3 year
measure: 3-year overall survival
timeFrame: 3 year
Secondary outcomes:
measure: Rate of postoperative complications
timeFrame: 30 days
measure: Time to first flatus after surgery
timeFrame: 7 days
measure: Time to first stool after surgery
timeFrame: 7 days
measure: Length of stay after surgery
timeFrame: 30 days
measure: Postoperative pain score
timeFrame: 3 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References: