Modified Versus Traditional Thoracic Drainage After Thoracoscopic Surgery

March 16, 2020 updated by: Kun Li, MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Randomized Clinical Trial of Modified Versus Traditional Thoracic Drainage After Thoracoscopic Surgery for Lung Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Recruiting
        • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: modified thoracic drainage group
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.
Procedure: pigtail catheter
After inserting the chest tube, add a pigtail catheter into the posterior axillary lines of the 7th intercostal.
NO_INTERVENTION: traditional thoracic drainage group
After surgery, only a chest tube is inserted into the midaxillary line of the 7th intercostal space, traditionally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chest tube drainage duration
Time Frame: From date of operation until the date of chest tube removal, assessed up to 7 days
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
Time Frame: From date of operation until the date of removal of the chest tube and pigtail catheter, assessed up to 7 days.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative hospital stay
Time Frame: From date of operation until the date of hospital discharge, assessed up to 30 days.
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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain scores
Time Frame: Postoperative day 1, 2, 3, 4 and 5.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2019

Primary Completion (ANTICIPATED)

April 1, 2020

Study Completion (ANTICIPATED)

April 1, 2020

Study Registration Dates

First Submitted

March 8, 2020

First Submitted That Met QC Criteria

March 13, 2020

First Posted (ACTUAL)

March 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 16, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kli3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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