Wedge Resection or Parietal Pleurectomy for the Treatment of Recurrent Pneumothorax (WOPP)

Pneumothorax Clinical Trial

— WOPP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01855464
• Other study ID #: UKW-TCH-2013-001
• Secondary ID: German Research
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2013
• Est. completion date: August 2024

Study information

• Verified date: November 2023
• Source: Otto-von-Guericke University Magdeburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 360
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumothorax
• Recurrence
• Recurrent Pneumothorax

Intervention

Procedure:
• wedge resection
Complementary to parietal pleurectomy lung tissue is resected.
• parietal pleurectomy
The parietal pleura is resected for treating primary pneumothorax.

Locations

Country	Name	City	State
Germany	Charité	Berlin
Germany	DRK Kliniken Berlin	Berlin
Germany	Evangelische Lungenklinik Berlin	Berlin
Germany	Vivantes Thoraxzentrum	Berlin
Germany	Universitätsklinikum Carl Gustav Carus Dresden	Dresden
Germany	Universitätsklinikum Erlangen	Erlangen
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	LungenClinic Grosshansdorf	Großhansdorf
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg-Eppendorf
Germany	Thoraxklinik am Universitätsklinikum Heidelberg	Heidelberg
Germany	Lungenklinik Köln Merheim	Köln
Germany	Asklepios Klinik Langen	Langen
Germany	Universitätsklinikum Magdeburg A. ö. R.	Magdeburg	Saxony-Anhalt
Germany	Klinikum rechts der Isar München	München	Bavaria
Germany	LMU München	München
Germany	Asklepios Fachklinik	München-Gauting
Germany	Thoraxzentrum Bezirk Unterfranken	Münnerstadt
Germany	Krankenhaus Barmherzige Brüder	Regensburg
Germany	Universitätsklinikum Regensburg	Regensburg
Germany	Robert Bosch Krankenhaus	Stuttgart
Germany	Johanniter-Krankenhaus im Fläming Treuenbrietzen GmbH	Treuenbrietzen
Germany	Universitätsklinik Tübingen	Tübingen
Germany	Universitätsklinikum Würzburg	Wuerzburg

Sponsors (2)

Lead Sponsor	Collaborator
Otto-von-Guericke University Magdeburg	German Research Foundation

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate of primary pneumothorax following VAT surgery	Patients are followed to identify all incidents of recurrent lung collapse following VAT surgery. Suspected recurrences will be confirmed by chest X-ray.	2 years
Secondary	postoperative morbidity	postoperative complications	30 days
Secondary	postoperative pain	rest and stress with a pain scale ranging from 1 to 10 (measured with the Visual Analogue Scale - VAS)	7 days
Secondary	function quality of life	measured with SF-36 Health Survey (The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections:Vitality;Physical functioning;Bodily pain;General health perceptions;Physical role functioning;Emotional role functioning;Social role functioning;Mental Health)	2 years
Secondary	costs of treatment	documentation of postoperative Hospitalization, the number of trocars	up to 30 days

External Links

•   Click here for information on German Research Foundation Grant
•   Official Trial Website