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

June 24, 2023 updated by: Jianqiang Tang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Jianqiang Tang, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients underwent laparoscopic colorectal surgery with intracorporeal or extracorporeal anastomosis

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
3 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of postoperative complications
Time Frame: 30 days
Rate of postoperative complications within 30 days after surgery
30 days
Time to first flatus after surgery
Time Frame: 7 days
Time to first flatus after surgery
7 days
Time to first stool after surgery
Time Frame: 7 days
Time to first stool after surgery
7 days
Length of stay after surgery
Time Frame: 30 days
Length of stay after surgery
30 days
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.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborators

Peking University First Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Shenzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

June 12, 2023

First Submitted That Met QC Criteria

June 12, 2023

First Posted (Actual)

June 20, 2023

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 24, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC4050

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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