Suture, Complication
Conditions
Keywords
Suture, Bronchial Sleeve Resection, Central Primary Lung Cancer, Non-Small Cell Lung Cancer (NSCLC)
Brief summary
Bronchial sleeve resection is performed as an alternative to pneumonectomy for lung cancer patients with centrally located lesions and limited cardiopulmonary reserve. Intraoperative bronchial anastomosis is very complex and difficult, mainly due to the difficulty of suturing and knotting in limited space. There are currently few studies comparing the clinical effects of absorbable and non-absorbable suture in bronchial sleeve resection. So the investigator wants to conduct a prospective study, trying to figure out this problem.
Detailed description
Lung cancer has been one of the most serious life-threatening diseases of human society. It has the highest morbidity and mortality worldwide among all the malignant tumors. Although the treatment of lung cancer is increasingly diverse, surgical resection is still the mainstay. Pneumonectomy, as a surgical approach for central primary lung cancer, is very harmful to patients. Bronchial sleeve resection is performed as an alternative to pneumonectomy for lung cancer patients with centrally located lesions and limited cardiopulmonary reserve. Intraoperative bronchial anastomosis is very complex and difficult, mainly due to the difficulty of suturing and knotting in limited space. Both absorbable and non-absorbable suture are used for it. But there are currently few studies comparing the clinical effects of absorbable and non-absorbable suture in bronchial sleeve resection. So the investigator wants to conduct a prospective study, trying to figure out this problem. The investigator sets incidence rate of anastomotic complications as the primary endpoint. According to the calculation, a total of 40 patients will be enrolled (each group has 20 patients).
Interventions
DEVICEAbsorbable Suture
3-0 V-Loc
DEVICENon-absorbable Suture
3-0 Prolene
Sponsors
The Affiliated Hospital of Qingdao University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 to 75 years old. 2. The tumor is located in the opening of bronchus, or the edge of the tumor is less than 2 cm away from the opening of the bronchi, while the distance between the edge of the tumor and the carina is more than 1.5 cm. 3. Patients with pathological diagnosis of non-small cell lung cancer. 4. No distant metastasis in preoperative clinical evaluation. 5. Adequate cardiac function, pulmonary function, liver function and renal function for anesthesia and bronchial sleeve resection. 6. American Society of Anesthesiologists (ASA) score: Grade I-III. 7. Patients who can coordinate the treatment and research and sign the informed consent.
Exclusion criteria
1. Patients with a significant medical condition which is thought unlikely to tolerate the surgery or unsuitable for this study after the evaluation of the investigator. 2. Patients with psychiatric disease who are expected lack of compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of anastomotic complications | 12 months after surgery | such as anastomotic stenosis, anastomotic fistula and so on |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of bronchial anastomosis | During surgery | From the first stitch to the last stitch |
| Number of stitches | During surgery | During bronchial anastomosis |
| 5-year survival rate | 5 years after surgery | Follow up for 5 years |
Countries
China
Contacts
Primary ContactZhe Wu, PhD
Outcome results
None listed