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Modified Versus Traditional Thoracic Drainage After Thoracoscopic Surgery

Primary Purpose

Lung Neoplasms, Lung Cancer, Pulmonary Neoplasm

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
pigtail catheter
Sponsored by
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Neoplasms focused on measuring chest tube, pigtail catheters, chest tube drainage, thoracic drainage, Lung Cancer, thoracoscopic surgery, Pulmonary Neoplasm

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

modified thoracic drainage group

traditional thoracic drainage group

Arm Description

After surgery, both a chest tube and a pigtail catheter are inserted into the middle and posterior axillary lines of the 7th intercostal space, respectively.

After surgery, only a chest tube is inserted into the midaxillary line of the 7th intercostal space, traditionally.

Outcomes

Primary Outcome Measures

Chest tube drainage duration
The number of days from operation day to the day of chest tube removal
Volume of drainage
Total volume of thoracic drainage (ml)

Secondary Outcome Measures

Postoperative hospital stay
The numbers of days of patients stay in the hospital after surgery

Full Information

First Posted
March 8, 2020
Last Updated
March 16, 2020
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04309955
Brief Title
Modified Versus Traditional Thoracic Drainage After Thoracoscopic Surgery
Official Title
Randomized Clinical Trial of Modified Versus Traditional Thoracic Drainage After Thoracoscopic Surgery for Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Anticipated)
Study Completion Date
April 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, Lung Cancer, Pulmonary Neoplasm, Postoperative Pain, Thoracoscopic Surgery
Keywords
chest tube, pigtail catheters, chest tube drainage, thoracic drainage, Lung Cancer, thoracoscopic surgery, Pulmonary Neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
modified thoracic drainage group
Arm Type
Experimental
Arm Description
After surgery, both a chest tube and a pigtail catheter are inserted into the middle and posterior axillary lines of the 7th intercostal space, respectively.
Arm Title
traditional thoracic drainage group
Arm Type
No Intervention
Arm Description
After surgery, only a chest tube is inserted into the midaxillary line of the 7th intercostal space, traditionally.
Intervention Type
Procedure
Intervention Name(s)
pigtail catheter
Intervention Description
After inserting the chest tube, add a pigtail catheter into the posterior axillary lines of the 7th intercostal.
Primary Outcome Measure Information:
Title
Chest tube drainage duration
Description
The number of days from operation day to the day of chest tube removal
Time Frame
From date of operation until the date of chest tube removal, assessed up to 7 days
Title
Volume of drainage
Description
Total volume of thoracic drainage (ml)
Time Frame
From date of operation until the date of removal of the chest tube and pigtail catheter, assessed up to 7 days.
Secondary Outcome Measure Information:
Title
Postoperative hospital stay
Description
The numbers of days of patients stay in the hospital after surgery
Time Frame
From date of operation until the date of hospital discharge, assessed up to 30 days.
Other Pre-specified Outcome Measures:
Title
Postoperative pain scores
Description
Postoperative pain is evaluated by pain scores (0 [No pain] to 10 [Pain as bad as you can endure])
Time Frame
Postoperative day 1, 2, 3, 4 and 5.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Kun, MD
Phone
15023072303
Email
soloonline1981@yeah.net
Facility Information:
Facility Name
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kun Li, MD
Phone
+8615023072303
Ext
023-68757983
Email
soloonline1981@163.com
First Name & Middle Initial & Last Name & Degree
Jinghai Zhou, MD
Phone
+8613983612263
Ext
023-68757982
Email
tmmuzjh@163.com

12. IPD Sharing Statement

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Modified Versus Traditional Thoracic Drainage After Thoracoscopic Surgery

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