Clinical trial NCT01855464: Wedge Resection or Parietal Pleurectomy for the Treatment of Recurrent Pneumothorax (WOPP)
Official title: Pulmonary Wedge Resection Plus Parietal Pleurectomy (WRPP) Versus Parietal Pleurectomy (PP) for the Treatment of Recurrent Primary Pneumothorax
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pneumothorax
Recurrent Pneumothorax
Keywords: pneumothorax
primary pneumothorax
lung collapse
Lead sponsor: Otto-von-Guericke University Magdeburg
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2013-05-16
Enrollment: 360
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* recurrence of a primary pneumothorax
* persistent primary pneumothorax
* patient preference (in primary events)

Exclusion Criteria:

* presence of a pulmonal fistula
* underlying lung disease
* previous thoracic surgery (except tube thoracostomy)
* previous pleurodesis
* conversion thoracotomy

Primary outcomes:
measure: Recurrence rate of primary pneumothorax following VAT surgery
timeFrame: 2 years
Secondary outcomes:
measure: postoperative morbidity
timeFrame: 30 days
measure: postoperative pain
timeFrame: 7 days
measure: function quality of life
timeFrame: 2 years
measure: costs of treatment
timeFrame: up to 30 days
Other outcomes:
Locations:
city: München
country: Germany
facility: Klinikum rechts der Isar München
state: Bavaria
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg A. ö. R.
state: Saxony-Anhalt
city: Berlin
country: Germany
facility: Charité
city: Berlin
country: Germany
facility: Vivantes Thoraxzentrum
city: Berlin
country: Germany
facility: Evangelische Lungenklinik Berlin
city: Berlin
country: Germany
facility: DRK Kliniken Berlin
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Dresden
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Großhansdorf
country: Germany
facility: LungenClinic Grosshansdorf
city: Hamburg-Eppendorf
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Heidelberg
country: Germany
facility: Thoraxklinik am Universitätsklinikum Heidelberg
city: Köln
country: Germany
facility: Lungenklinik Köln Merheim
city: Langen
country: Germany
facility: Asklepios Klinik Langen
city: München-Gauting
country: Germany
facility: Asklepios Fachklinik
city: München
country: Germany
facility: LMU München
city: Münnerstadt
country: Germany
facility: Thoraxzentrum Bezirk Unterfranken
city: Regensburg
country: Germany
facility: Krankenhaus Barmherzige Brüder
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Stuttgart
country: Germany
facility: Robert Bosch Krankenhaus
city: Treuenbrietzen
country: Germany
facility: Johanniter-Krankenhaus im Fläming Treuenbrietzen GmbH
city: Tübingen
country: Germany
facility: Universitätsklinik Tübingen
city: Wuerzburg
country: Germany
facility: Universitätsklinikum Würzburg
Study officials:
affiliation: Magdeburg University Hospital
name: Thorsten Walles, MD
role: STUDY_CHAIR
References:
citation: 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(Suppl 2):ii39-52. doi: 10.1136/thorax.58.suppl_2.ii39. No abstract available.
citation: 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.
citation: 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. doi: 10.1007/s00464-003-9067-z. Epub 2004 Feb 2.
citation: Neudecker J, Malzahn U, Heuschmann P, Behrens U, Walles T. Pulmonary wedge resection plus parietal pleurectomy (WRPP) versus parietal pleurectomy (PP) for the treatment of recurrent primary pneumothorax (WOPP trial): study protocol for a randomized controlled trial. Trials. 2015 Nov 30;16:540. doi: 10.1186/s13063-015-1060-z.