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

Anastomotic Leakage Clinical Trial

Official title:

A Prospective and Analytical Study on the Detection of Early Anastomotic Leakage With Abdominal Drainage Fluid After Colorectal Cancer Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05191602
• Other study ID #: ADFofCRS
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: December 2021
• Source: Southwest Hospital, China
• Contact: TANG BO, MD
• Phone: +862368754167
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 1, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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: =?; 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.

Related Conditions & MeSH terms

• Anastomotic Leak
• Anastomotic Leakage

Intervention

Diagnostic Test:
• drainge fluid
including bilirubin

Locations

Country	Name	City	State
China	General Surgery Center of PLA	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	leakage		10days