Modified Versus Traditional Thoracic Drainage After Thoracoscopic Surgery

• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04309955
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 4
• Patients Per Site Per Month: 15

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Neoplasms; Lung Cancer; Pulmonary Neoplasm; Postoperative Pain; Thoracoscopic Surgery	Procedure: pigtail catheter	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Clinical Trial of Modified Versus Traditional Thoracic Drainage After Thoracoscopic Surgery for Lung Cancer
• Actual Study Start Date: Dec 1, 2019
• Anticipated Primary Completion Date: Apr 1, 2020
• Anticipated Study Completion Date: Apr 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Chest tube drainage duration [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

2. Volume of drainage [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)

Secondary Outcome Measures

1. Postoperative hospital stay [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

Other Outcome Measures

1. Postoperative pain scores [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])

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University	Chongqing	Chongqing	China	400042

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kun Li, MD, Kun Li, MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• ClinicalTrials.gov Identifier: NCT04309955
• Other Study ID Numbers: Kli3
• First Posted: Mar 17, 2020
• Last Update Posted: Mar 18, 2020
• Last Verified: Mar 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kun Li, MD, Kun Li, MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: chest tube; pigtail catheters; chest tube drainage; thoracic drainage; Lung Cancer; thoracoscopic surgery; Pulmonary Neoplasm
• Additional relevant MeSH terms: Lung Neoplasms; Neoplasms

Study Results

No Results Posted as of Mar 18, 2020