Safety and Feasibility of the Application of Thoracic Puncture Tube After Pulmonary Lobectomy

NCT04718272 | Unknown DMC

• 1 other identifier: CDTM UNION
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

There have been several reports on the feasibility of a no-drain policy after pneumonectomy, but the policy is not widely accepted because silent massive hemorrhage, delayed air leaks, and chylothorax would always be major worries for thoracic surgeons, and all of the researches were retrospective case studies with small sample size and insufficient evidence. Therefore, the purpose of this study is to to evaluate safety and feasibility of an improved policy, the application of a small thoracic puncture tube after pulmonary lobectomy.

Conditions

Chest Tubes; Pneumonectomy; Minimally Invasive Surgery

Keywords

Chest Tubes; Pneumonectomy; Minimally Invasive Surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative complications

  The incidence of complications within 30 days after surgery in each arm

  within 30 days after surgery

Secondary Outcomes (2)

• Incidence of subcutaneous emphysema after operation

  within 30 days after surgery

• Incidence of postoperative pneumothorax

  within 30 days after surgery

Study Arms (2)

Puncture tube group

EXPERIMENTAL

After the operation, the traditional traditional silicone tube which placed through the surgical incision was removed in the operating room, and the small puncture tube was retained for thoracic drainage.

Procedure: thoracic drainage management

Traditional tubes group

NO INTERVENTION

Routine thoracic drainage management measures were adopted, that is, both of the small puncture tube and traditional silicone tube were retained after surgery.

Interventions

thoracic drainage management PROCEDURE

After uniportal VATS pulmonary lobectomy, the traditional silicone tube which placed through the surgical incision was removed in the operating room in the experimental group.

Puncture tube group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age and gender: 18-70 years old, male and female unlimited;
• Cardiopulmonary function can tolerate operation;
• Primary non-small cell lung cancer was diagnosed by preoperative or intraoperative pathology. The surgical ranges are uni-portal VATS lobectomy with or without mediastinal lymph node dissection or sampling. In cases with multiple nodules in other lobes of the same side, small wedge resections are allowed;
• No air leakage was observed intraoperatively. Meanwhile, after operation, there are also no air leakage observed in water seal bottle when patients are changed from lateral decubitus to horizontal position.
• Patients and their family members can understand and are willing to participate in this clinical study and sign the informed consent..

You may not qualify if:

• Patients with a severe emphysema or pulmonary bullae;
• Patients with a history of chemotherapy or chemo-radiotherapy;
• Patients with a history of chest surgery;
• Extensive thoracic adhesion ;
• A history of serious mental illness;
• Patients with other conditions considered by the researcher should not participate in the study.

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Study Officials

• Chun Chen, MD

  Fujian Medical University Union Hospital

  STUDY DIRECTOR

Central Study Contacts

Guobing Xu, MD

CONTACT

15880005394; 15880005394@163.com

Chun Chen, MD

CONTACT

13365910325; chenchun0209@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 22, 2021
• Study Start: January 25, 2021
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

CN (1)