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

NCT ID: NCT05191602

Last Updated: 2022-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2023-12-01

Brief Summary

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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

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Conditions

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Anastomotic Leakage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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drainge fluid

including bilirubin

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southwest Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Li Chuan

Secretary of General Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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General Surgery Center of PLA

Chongqing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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TANG BO, MD

Role: CONTACT

+862368754167

LI CHUAN, MD

Role: CONTACT

+862368773074

Facility Contacts

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Tang Bo, M.D/Ph.D

Role: primary

+862368754167

Other Identifiers

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ADFofCRS

Identifier Type: -

Identifier Source: org_study_id

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