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

• ClinicalTrials.gov Identifier: NCT05191602
• Recruitment Status: Unknown
• First Posted: January 13, 2022
• Last Update Posted: January 13, 2022
• Sponsor: Southwest Hospital, China
• Information provided by (Responsible Party): Li Chuan, Southwest Hospital, China

Tracking Information

• First Submitted Date: December 29, 2021
• First Posted Date: January 13, 2022
• Last Update Posted Date: January 13, 2022
• Actual Study Start Date: July 1, 2021
• Estimated Primary Completion Date: June 30, 2023 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 29, 2021): leakage [ Time Frame: 10days ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Relationship Between Drainage Fluid and Anastomotic Leakage After Colorectal Cancer Surgery
• Official Title: A Prospective and Analytical Study on the Detection of Early Anastomotic Leakage With Abdominal Drainage Fluid After Colorectal Cancer Surgery
• 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
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: colorectal cancer surgery patients
• Condition: Anastomotic Leakage

Intervention

Diagnostic Test: drainge fluid

including bilirubin

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: December 29, 2021): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 1, 2023
• Estimated Primary Completion Date: June 30, 2023 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05191602
• Other Study ID Numbers: ADFofCRS
• 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: Li Chuan, Southwest Hospital, China
• Original Responsible Party: Same as current
• Current Study Sponsor: Southwest Hospital, China
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Southwest Hospital, China
• Verification Date: December 2021