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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04309955
Other study ID # Kli3
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2019
Est. completion date April 1, 2020

Study information

Verified date March 2020
Source Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Contact Li Kun, MD
Phone 15023072303
Email soloonline1981@yeah.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Lung cancer is the leading cause of cancer-related death worldwide. Thoracoscopic pulmonary resection is a prevalent management for early stage of lung cancer. Placement of traditional chest tube is the standard procedure after surgery, which causes pain that cannot be ignored. We aimed to determine whether a modified thoracic drainage strategy based on pigtail catheter associated with better clinical results compared with traditional methods after thoracoscopic surgery for lung cancer.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date April 1, 2020
Est. primary completion date April 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- 18<age<80;

- Patients with lung cancer;

- Thoracoscopic lung resection;

- Single chest-tube insertion.

Exclusion Criteria:

- A history of preoperative chemotherapy or radiotherapy;

- Presence of distant tumor metastasis;

- Pneumonectomy;

- Dysfunction of cardiorespiratory system or other surgical contraindications.

Study Design


Intervention

Procedure:
pigtail catheter
After inserting the chest tube, add a pigtail catheter into the posterior axillary lines of the 7th intercostal.

Locations

Country Name City State
China Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Chongqing Chongqing

Sponsors (1)

Lead Sponsor Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Postoperative pain scores Postoperative pain is evaluated by pain scores (0 [No pain] to 10 [Pain as bad as you can endure]) Postoperative day 1, 2, 3, 4 and 5.
Primary Chest tube drainage duration The number of days from operation day to the day of chest tube removal From date of operation until the date of chest tube removal, assessed up to 7 days
Primary Volume of drainage Total volume of thoracic drainage (ml) From date of operation until the date of removal of the chest tube and pigtail catheter, assessed up to 7 days.
Secondary Postoperative hospital stay The numbers of days of patients stay in the hospital after surgery From date of operation until the date of hospital discharge, assessed up to 30 days.
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