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The Relationship Between Drainage Fluid and Anastomotic Leakage After Colorectal Cancer Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05191602
Recruitment Status : Unknown
Verified December 2021 by Li Chuan, Southwest Hospital, China.
Recruitment status was:  Recruiting
First Posted : January 13, 2022
Last Update Posted : January 13, 2022
Sponsor:
Information provided by (Responsible Party):
Li Chuan, Southwest Hospital, China

Study Description
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Brief Summary:
A prospective and analytical study on the detection of early anastomotic leakage by abdominal drainage fluid after colorectal cancer surgery. pay attention to indicators including bilirubin

Condition or disease Intervention/treatment
Anastomotic Leakage Diagnostic Test: drainge fluid

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective and Analytical Study on the Detection of Early Anastomotic Leakage With Abdominal Drainage Fluid After Colorectal Cancer Surgery
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : December 1, 2023
Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: drainge fluid
    including bilirubin

Outcome Measures
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Primary Outcome Measures :
  1. leakage [ Time Frame: 10days ]

Eligibility Criteria
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Information from the National Library of Medicine

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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:   Non-Probability Sample
Study Population
colorectal cancer surgery patients
Criteria

Inclusion Criteria:

1) Preoperative pathologically confirmed colorectal adenocarcinoma; 2) Patients undergoing minimally invasive (robot or laparoscopic) tumor resection + bowel anastomosis; 3) Age: 18 to 80 years old; 4) Preoperative TNM staging (whole abdomen) Enhanced CT or MRI, laparoscopic exploration): cT1-3bN0-2M0; 5) Preoperative ASA score: ≤Ⅲ; 6) No history of malignant tumors and no other malignant tumors by preoperative examination; 7) Not accepted before surgery Deterministic treatment, such as radiotherapy, chemotherapy or immunotherapy; 8) No pre-existing ascites was found before and during the operation; 9) Informed consent signed by the patient or his agent

Performance status (ECOG) 0~1

Exclusion Criteria:

1) Patients with obstructive jaundice or other congenital disorders of bile acid synthesis and metabolism; 2) Severe abdominal cavity infection and other infections; 3) A large amount of abdominal effusion was found before and during the operation; 4) Tumor was confirmed during the operation For T4b or intraoperative detection of other tumors, joint resection or distant metastasis is required; 5) Intraoperative conversion to laparotomy; 6) Intraoperative change of surgical method to perform Miles or Hartmann surgery; 7) Intraoperative and postoperative abdominal cavity Hyperthermic perfusion chemotherapy.

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): NCT05191602


Contacts
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Contact: TANG BO, MD +862368754167
Contact: LI CHUAN, MD +862368773074 lee_tran@126.com

Locations
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China
General Surgery Center of PLA Recruiting
Chongqing, China, 400038
Contact: Tang Bo, M.D/Ph.D    +862368754167    tangtbo@sina.com   
Sponsors and Collaborators
Southwest Hospital, China
More Information
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Responsible Party: Li Chuan, Secretary of General Surgery, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT05191602    
Other Study ID Numbers: ADFofCRS
First Posted: January 13, 2022    Key Record Dates
Last Update Posted: January 13, 2022
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anastomotic Leak
Postoperative Complications
Pathologic Processes