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

NCT05191602 | Unknown

• 1 other identifier: ADFofCRS
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Anastomotic Leakage

Outcome Measures

Primary Outcomes (1)

• leakage

  10days

Interventions

drainge fluid DIAGNOSTIC_TEST

including bilirubin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

colorectal cancer surgery patients

You may qualify if:

• \) 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

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Southwest Hospital, China: lead

Study Sites (1)

General Surgery Center of PLA

Chongqing, 400038, China

RECRUITING

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

TANG BO, MD

CONTACT

+862368754167

LI CHUAN, MD

CONTACT

+862368773074; lee_tran@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Secretary of General Surgery

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 13, 2022
• Study Start: July 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 1, 2023
• Last Updated: January 13, 2022

Record last verified: 2021-12

Locations

CN (1)