Trial document

This study has been imported from without additional data checks.
drksid header


Trial Description

start of 1:1-Block title


Pulmonary Wedge Resection Plus Parietal Pleurectomy (WRPP) Versus Parietal Pleurectomy (PP) for the Treatment of Recurrent Primary Pneumothorax

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym


end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial


end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Primary spontaneous pneumothoraces (PSP) represent a significant public health problem,
occurring in young healthy subjects without pre-existing lung disease or precedent medical
intervention or trauma with a reported incidence of up to 18-28/100 000 per year. PSP
treatment often requires thoracic surgery to restore lung expansion and to prevent de novo
lung collapse. Despite the presence of elaborated guidelines by the British Thoracic Society
(BTS) postulating apical wedge resection of the lung and total parietal pleurectomy (WRPP),
the majority of German hospitals gathered experience especially in limiting surgery to
cost-saving partial apical parietal pleurectomy or yet apical pleural abrasion (PP). Until
today, hardly any reliable data exist to analyze and compare the varying treatment
approaches regarding efficacy and efficiency. In this randomized, multi-centric clinical
trial, both treatment approaches will be compared. For this purpose, candidates for surgery
will be randomized into one of the two treatment groups after informed consent has been
obtained. Patients will be followed for 2 years by the participating centres to be able to
evaluate the long-term effect of the surgical interventions.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The trial will be conducted at the major thoracic surgery units in Germany. Each centre can
include patients on the basis of the presence of a PSP and the inclusion and exclusion

After informed consent has been obtained from the study participants, each has to fill out
the standardized short-form health survey (SF-36) questionnaire and the visual analogue
scale (VAS) to determine baseline parameters for the (current) state of health and pain
level.Randomization into the two interventional groups is carried out before surgery.

Patients are operated according to good clinical practice either by pleurectomy alone (PP)
or total parietal pleurectomy with apical wedge resection of the pulmonary apex (WRPP).
Procedure related parameters (like operation time, applied suture materials including
staplers) are documented.

The postoperative care is subject to each participating centre's standards. The
postoperative course is evaluated (mortality, morbidity, duration of tube drainage,
re-interventions or operations, length of stay, need for blood substitutions).

To evaluate the long term effect of the surgical intervention, all study participants are
followed for 2 years.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00006859
  •   2014/10/09
  •   2013/05/06
  •   yes
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT01855464  (
  •   UKW-TCH-2013-001  (Wuerzburg University Hospital)
  •   German Research Foundation 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Pneumothorax
  •   Recurrent Pneumothorax
  •   J93 -  Pneumothorax
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Procedure: wedge resection
  •   Procedure: parietal pleurectomy
end of 1:N-Block interventions
start of 1:1-Block design


  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Recurrence rate of primary pneumothorax following VAT surgery; time frame: 2 years; Patients are followed to identify all incidents of recurrent lung collapse following VAT surgery. Suspected recurrences will be confirmed by chest X-ray.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- postoperative morbidity; time frame: 30 days
- postoperative pain; time frame: 7 days
- quality of life; time frame: 2 years
- costs of treatment; time frame: up to 30 days

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

end of 1:n-Block recruitment locations
start of 1:1-Block recruitment


  •   [---]*
  •   2013/11/30
  •   360
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   15   Years
  •   40   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- recurrence of a primary pneumothorax

- persistent primary pneumothorax

- patient preference (in primary events)

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- presence of a pulmonal fistula

- underlying lung disease

- previous thoracic surgery (except tube thoracostomy)

- previous pleurodesis

- conversion thoracotomy

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses


  • start of 1:1-Block address primary-sponsor
    • Wuerzburg University Hospital
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • German Research Foundation
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • German Federal Ministry of Education and Research
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Wuerzburg University Hospital
    • Thorsten Walles, MD 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Thorsten Walles, MD 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state


  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   Click here for information on German Research Foundation Grant
  •   Official Trial Website
  •   Henry M, Arnold T, Harvey J; Pleural Diseases Group, Standards of Care Committee, British Thoracic Society. BTS guidelines for the management of spontaneous pneumothorax. Thorax. 2003 May;58 Suppl 2:ii39-52. No abstract available.; 12728149
  •   Chan JW, Ko FW, Ng CK, Yeung AW, Yee WK, So LK, Lam B, Wong MM, Choo KL, Ho AS, Tse PY, Fung SL, Lo CK, Yu WC. Management of patients admitted with pneumothorax: a multi-centre study of the practice and outcomes in Hong Kong. Hong Kong Med J. 2009 Dec;15(6):427-33.; 19966346
  •   Gossot D, Galetta D, Stern JB, Debrosse D, Caliandro R, Girard P, Grunenwald D. Results of thoracoscopic pleural abrasion for primary spontaneous pneumothorax. Surg Endosc. 2004 Mar;18(3):466-71. Epub 2004 Feb 2. Review.; 14752638
end of 1:n-Block publications
The parameters in and DRKS are not identical. Therefore the data import from required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2014/10/07
* This entry means the parameter is not applicable or has not been set.