Trial document




This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006859

Trial Description

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Title

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

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Trial Acronym

WOPP

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URL of the Trial

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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.

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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
criteria.

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.

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Organizational Data

  •   DRKS00006859
  •   2014/10/09
  •   2013/05/06
  •   yes
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Secondary IDs

  •   NCT01855464  (ClinicalTrials.gov)
  •   UKW-TCH-2013-001  (Wuerzburg University Hospital)
  •   German Research Foundation 
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Health Condition or Problem studied

  •   Pneumothorax
  •   Recurrent Pneumothorax
  •   J93 -  Pneumothorax
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Interventions/Observational Groups

  •   Procedure: wedge resection
  •   Procedure: parietal pleurectomy
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
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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.

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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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2013/11/30
  •   360
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   15   Years
  •   40   Years
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Additional Inclusion Criteria

- recurrence of a primary pneumothorax

- persistent primary pneumothorax

- patient preference (in primary events)

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Exclusion Criteria

- presence of a pulmonal fistula

- underlying lung disease

- previous thoracic surgery (except tube thoracostomy)

- previous pleurodesis

- conversion thoracotomy

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Wuerzburg University Hospital
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    • German Research Foundation
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    • German Federal Ministry of Education and Research
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    • Wuerzburg University Hospital
    • Thorsten Walles, MD 
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    • Thorsten Walles, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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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
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov 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.