An observational study in Colorectal Cancer, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-06-27.
Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Observational
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?
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.
5,598 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 373 studies on the registry; 270 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients underwent laparoscopic colorectal surgery with intracorporeal or extracorporeal anastomosis
Exclusion Criteria:
Patients underwent laparoscopic colorectal surgery with intracorporeal anastomosis
Procedure: Intracorporeal anastomosis
Patients underwent laparoscopic colorectal surgery with extracorporeal anastomosis
Surgeons perform totally laparoscopic intracorporeal digestive reconstruction after specimen resection
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
Time frame: 3 year
3-year overall survival
Percentage of patients who are still alive at the end of a 3-year period after surgery
Time frame: 3 year
Rate of postoperative complications
Rate of postoperative complications within 30 days after surgery
Time frame: 30 days
Time to first flatus after surgery
Time to first flatus after surgery
Time frame: 7 days
Time to first stool after surgery
Time to first stool after surgery
Time frame: 7 days
Length of stay after surgery
Length of stay after surgery
Time frame: 30 days
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.
Time frame: 3 days
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences