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

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ClinicalTrials.gov Identifier: NCT05911152
Recruitment Status : Recruiting
First Posted : June 20, 2023
Last Update Posted : June 27, 2023
Sponsor:
Collaborators:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Shenzhen Hospital
Peking University First Hospital
Information provided by (Responsible Party):
Jianqiang Tang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Tracking Information
First Submitted Date June 12, 2023
First Posted Date June 20, 2023
Last Update Posted Date June 27, 2023
Actual Study Start Date January 1, 2016
Estimated Primary Completion Date January 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 12, 2023)
  • 3-year disease free survival [ Time Frame: 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
  • 3-year overall survival [ Time Frame: 3 year ]
    Percentage of patients who are still alive at the end of a 3-year period after surgery
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 24, 2023)
  • Rate of postoperative complications [ Time Frame: 30 days ]
    Rate of postoperative complications within 30 days after surgery
  • Time to first flatus after surgery [ Time Frame: 7 days ]
    Time to first flatus after surgery
  • Time to first stool after surgery [ Time Frame: 7 days ]
    Time to first stool after surgery
  • Length of stay after surgery [ Time Frame: 30 days ]
    Length of stay after surgery
  • Postoperative pain score [ Time Frame: 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.
Original Secondary Outcome Measures
 (submitted: June 12, 2023)
  • Rate of postoperative complications [ Time Frame: 30 days ]
    Rate of postoperative complications within 30 days after surgery
  • Time to first flatus after surgery [ Time Frame: 7 days ]
    Time to first flatus after surgery
  • Time to first stool after surgery [ Time Frame: 7 days ]
    Time to first stool after surgery
  • Length of stay after surgery [ Time Frame: 30 days ]
    Length of stay after surgery
  • Postoperative pain score [ Time Frame: 3 days ]
    Postoperative VAS score
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients underwent laparoscopic colorectal surgery with intracorporeal or extracorporeal anastomosis
Condition Colorectal Cancer
Intervention Procedure: Intracorporeal anastomosis
Surgeons perform totally laparoscopic intracorporeal digestive reconstruction after specimen resection
Study Groups/Cohorts
  • Intracorporeal anastomosis
    Patients underwent laparoscopic colorectal surgery with intracorporeal anastomosis
    Intervention: Procedure: Intracorporeal anastomosis
  • Extracorporeal anastomosis
    Patients underwent laparoscopic colorectal surgery with extracorporeal anastomosis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 12, 2023)		 2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2025
Estimated Primary Completion Date January 1, 2024   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Mingguang Zhang, Dr. +8613261967603 zmgslimshady@163.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT05911152
Other Study ID Numbers NCC4050
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Jianqiang Tang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Original Responsible Party Same as current
Current Study Sponsor Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Original Study Sponsor Same as current
Collaborators
  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Shenzhen Hospital
  • Peking University First Hospital
Investigators Not Provided
PRS Account Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Verification Date June 2023