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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

Study Description
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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?

Condition or disease Intervention/treatment
Colorectal Cancer Procedure: Intracorporeal 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 Design
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Safety and Feasibility of Laparoscopic Intracorporeal Anastomosis for Colorectal Surgery- A Multiple Center Real World Study
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2025
Groups and Cohorts
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Group/Cohort Intervention/treatment
Intracorporeal anastomosis
Patients underwent laparoscopic colorectal surgery with intracorporeal anastomosis
 Procedure: Intracorporeal anastomosis
Surgeons perform totally laparoscopic intracorporeal digestive reconstruction after specimen resection
Extracorporeal anastomosis
Patients underwent laparoscopic colorectal surgery with extracorporeal anastomosis


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Rate of postoperative complications [ Time Frame: 30 days ]
    Rate of postoperative complications within 30 days after surgery

  2. Time to first flatus after surgery [ Time Frame: 7 days ]
    Time to first flatus after surgery

  3. Time to first stool after surgery [ Time Frame: 7 days ]
    Time to first stool after surgery

  4. Length of stay after surgery [ Time Frame: 30 days ]
    Length of stay after surgery

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients underwent laparoscopic colorectal surgery with intracorporeal or extracorporeal anastomosis
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05911152


Contacts
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Contact: Mingguang Zhang, Dr. +8613261967603 zmgslimshady@163.com

Locations
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China, Beijing
Cancer Hospital Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Contact: Jianqiang Tang, Dr.    +8613661090026    doc_tjq@hotmail.com   
Principal Investigator: Jianqiang Tang, Dr.         
Sponsors and Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Shenzhen Hospital
Peking University First Hospital
More Information
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Responsible Party: Jianqiang Tang, Associate professor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT05911152    
Other Study ID Numbers: NCC4050
First Posted: June 20, 2023    Key Record Dates
Last Update Posted: June 27, 2023
Last Verified: June 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jianqiang Tang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences:
Colorectal cancer
Minimally invasive surgery
Laparoscopic surgery
Intracorporeal anastomosis
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases