Anastomotic Leakage, Colorectal Cancer, Colorectal Surgery, Complications, Endoscopic Vacuum Therapy
Conditions
Brief summary
Evaluate the safety and efficacy of postoperative Pre-emptive EVT (PEVT) in reducing the incidence of anastomotic leaks within 30 days after surgery in patients with colorectal cancer. Compare the differences between the PEVT group and the control group in terms of operation time, length of hospital stay, and total medical costs. Analyze the incidence of other postoperative complications in the two groups, such as wound infection, abdominal abscess, and intestinal obstruction. Assess the impact of PEVT on postoperative recovery indicators, including time to first flatus, time to first defecation, and time to ambulation. Observe the occurrence of PEVT-related adverse events, such as device displacement, bleeding, and infection.
Interventions
DEVICEPEVT
PEVT Procedures After the anastomosis is completed and endoscopy confirms that the anastomotic site is intact and without bleeding, the following procedures are carried out immediately (usually within 30 minutes after the completion of the anastomosis): 1. EVT device selection: Use an open-pore polyurethane sponge (OPPS) connected to a 16Fr nasogastric tube, with the sponge cut to a size of 2 cm × 3 cm. 2. Placement method: Insert the sponge through the anus to the anastomotic site in the intestinal lumen, set the negative pressure to low intensity (-50 to -100 mmHg), and connect to an external negative pressure suction device for continuous suction.
Sponsors
Nanchong Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Pathologically diagnosed with colorectal cancer, planned for radical surgery (right hemicolectomy, left hemicolectomy, or anterior resection of the rectum, etc.). 2. Age 18-85 years, American Society of Anesthesiologists (ASA) classification I-III. 3. Anastomosis to be performed in a single stage (meeting anastomotic criteria). 4. Patient or legal guardian is able to understand and sign the informed consent form and comply with follow-up.
Exclusion criteria
1. Preexisting anastomotic leakage or severe intra-abdominal infection before surgery. 2. Complicated by severe cardiovascular or cerebrovascular diseases (e.g., acute myocardial infarction, acute phase of cerebral infarction). 3. Severe liver or kidney dysfunction (liver function Child-Pugh class C, creatinine clearance \<30 ml/min). 4. Coagulation disorders (platelets \<50×10⁹/L, INR \>1.5) or receiving anticoagulant therapy that cannot be adjusted. 5. History of abdominal radiotherapy or multiple abdominal surgeries leading to severe intra-abdominal adhesions. 6. Complicated by other malignant tumors and currently undergoing radiotherapy or chemotherapy. 7. Psychiatric illness or cognitive impairment preventing compliance with the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Anastomotic Leak within 30 days | 30 days | Count the number of participants who develop anastomotic leak within 30 days after colorectal cancer surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Postoperative Complications within 30 days | 30 days | Count the number of participants who develop postoperative bleeding, anastomotic stenosis, and intra-abdominal infection within 30 days after colorectal cancer surgery. |
Countries
China
Contacts
CONTACTYunhong Tian Tian, doctor
Outcome results
None listed