Modified Versus Traditional Thoracic Drainage After Thoracoscopic Surgery
Randomized Clinical Trial of Modified Versus Traditional Thoracic Drainage After Thoracoscopic Surgery for Lung Cancer
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2019
CompletedFirst Submitted
Initial submission to the registry
March 8, 2020
CompletedFirst Posted
Study publicly available on registry
March 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedMarch 18, 2020
March 1, 2020
4 months
March 8, 2020
March 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (1)
Postoperative hospital stay
From date of operation until the date of hospital discharge, assessed up to 30 days.
Other Outcomes (1)
Postoperative pain scores
Postoperative day 1, 2, 3, 4 and 5.
Study Arms (2)
modified thoracic drainage group
EXPERIMENTALAfter surgery, both a chest tube and a pigtail catheter are inserted into the middle and posterior axillary lines of the 7th intercostal space, respectively.
traditional thoracic drainage group
NO INTERVENTIONAfter surgery, only a chest tube is inserted into the midaxillary line of the 7th intercostal space, traditionally.
Interventions
After inserting the chest tube, add a pigtail catheter into the posterior axillary lines of the 7th intercostal.
Eligibility Criteria
You may qualify if:
- \<age\<80;
- Patients with lung cancer;
- Thoracoscopic lung resection;
- Single chest-tube insertion.
You may not qualify if:
- A history of preoperative chemotherapy or radiotherapy;
- Presence of distant tumor metastasis;
- Pneumonectomy;
- Dysfunction of cardiorespiratory system or other surgical contraindications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing, Chongqing Municipality, 400042, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Kun Li, MD
Study Record Dates
First Submitted
March 8, 2020
First Posted
March 17, 2020
Study Start
December 1, 2019
Primary Completion
April 1, 2020
Study Completion
April 1, 2020
Last Updated
March 18, 2020
Record last verified: 2020-03