The Relationship Between Drainage Fluid and Anastomotic Leakage After Colorectal Cancer Surgery
Sponsor
Southwest Hospital, China (Other)
Overall Status
Recruiting
CT.gov ID
NCT05191602
Collaborator
(none)
300
1
29
10.3
Study Details
Study Description
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 | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated 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
:
Jul 1, 2021
Anticipated Primary Completion Date
:
Jun 30, 2023
Anticipated Study Completion Date
:
Dec 1, 2023
Outcome Measures
Primary Outcome Measures
- leakage [10days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- 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:
- 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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | General Surgery Center of PLA | Chongqing | China | 400038 |
Sponsors and Collaborators
- Southwest Hospital, China
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Li Chuan,
Secretary of General Surgery,
Southwest Hospital, China
ClinicalTrials.gov Identifier:
NCT05191602
Other Study ID Numbers:
- ADFofCRS
First Posted:
Jan 13, 2022
Last Update Posted:
Jan 13, 2022
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: