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Trial Title:
Safety and Feasibility of Laparoscopic Intracorporeal Anastomosis for Colorectal Surgery- A Multiple Center Real World Study
NCT ID:
NCT05911152
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Colorectal cancer
Minimally invasive surgery
Laparoscopic surgery
Intracorporeal anastomosis
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Procedure
Intervention name:
Intracorporeal anastomosis
Description:
Surgeons perform totally laparoscopic intracorporeal digestive reconstruction after
specimen resection
Arm group label:
Intracorporeal anastomosis
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.
Criteria for eligibility:
Study pop:
Patients underwent laparoscopic colorectal surgery with intracorporeal or extracorporeal
anastomosis
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianqiang Tang, Dr.
Phone:
+8613661090026
Email:
doc_tjq@hotmail.com
Investigator:
Last name:
Jianqiang Tang, Dr.
Email:
Principal Investigator
Start date:
January 1, 2016
Completion date:
January 1, 2025
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Agency class:
Other
Collaborator:
Agency:
Peking University First Hospital
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05911152
