NCT04831554

Brief Summary

There was no evidence that the number of chest tube do effect to the recurrence of pneumothorax, which placed after thoracoscopic wedge resection together with mechanical pleurodesis.This study evaluates the efficacy of single chest tube versus multiple tubes drainage in spontaneous pneumothorax after VATS bullectomy and pleurodesis. After routine procedure the participants will randomized to either placed single chest tube or multiple chest tubes

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

April 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

October 31, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

October 18, 2021

Status Verified

April 1, 2021

Enrollment Period

1.5 years

First QC Date

April 2, 2021

Last Update Submit

October 9, 2021

Conditions

Primary Spontaneous Pneumothorax

Keywords

number of chest tubeBullectomyPleurodesisPrimary Spontaneous Pneumothorax

Outcome Measures

Primary Outcomes (1)

  • recurrence

    Recurrence of pneumothorax during 2 years follow-up

    2 years after operation

Secondary Outcomes (1)

  • complications

    30days after operation

Study Arms (2)

single chest tube group

EXPERIMENTAL
Procedure: single chest tube drainage

multiple chest tubes group

NO INTERVENTION

Interventions

single chest tube drainagePROCEDURE

place single chest tube after surgery of PSP

single chest tube group

Eligibility Criteria

Age16 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosed by chest radiograph or CT as primary spontaneous pneumothorax
  • Underwent bullectomy and pleurodesis
  • Postoperative indwelling chest tubes

You may not qualify if:

  • Secondary pneumothorax, traumatic pneumothorax and iatrogenic pneumothorax
  • Previous surgery history
  • People with severe comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Jiang L, Jiang G, Zhu Y, Hao W, Zhang L. Risk factors predisposing to prolonged air leak after video-assisted thoracoscopic surgery for spontaneous pneumothorax. Ann Thorac Surg. 2014 Mar;97(3):1008-13. doi: 10.1016/j.athoracsur.2013.10.031. Epub 2013 Dec 25.

    PMID: 24370202BACKGROUND

  • Sudduth CL, Shinnick JK, Geng Z, McCracken CE, Clifton MS, Raval MV. Optimal surgical technique in spontaneous pneumothorax: a systematic review and meta-analysis. J Surg Res. 2017 Apr;210:32-46. doi: 10.1016/j.jss.2016.10.024. Epub 2016 Nov 3.

    PMID: 28457339BACKGROUND

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2021

First Posted

April 5, 2021

Study Start

October 31, 2021

Primary Completion

May 1, 2023

Study Completion

October 31, 2023

Last Updated

October 18, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share