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

Primary Purpose

Pneumothorax, Recurrent Pneumothorax

Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
wedge resection
parietal pleurectomy
Sponsored by
Otto-von-Guericke University Magdeburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumothorax focused on measuring pneumothorax, primary pneumothorax, lung collapse

Eligibility Criteria

15 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

wedge resection+parietal pleurectomy

parietal pleurectomy

Arm Description

Surgical treatment includes parietal pleurectomy and wedge resection of the tip of the lung.

Surgical therapy is limited to parietal pleurectomy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

postoperative morbidity
postoperative complications
postoperative pain
rest and stress with a pain scale ranging from 1 to 10 (measured with the Visual Analogue Scale - VAS)
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)
costs of treatment
documentation of postoperative Hospitalization, the number of trocars

Full Information

First Posted
May 6, 2013
Last Updated
September 20, 2022
Sponsor
Otto-von-Guericke University Magdeburg
Collaborators
German Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01855464
Brief Title
Wedge Resection or Parietal Pleurectomy for the Treatment of Recurrent Pneumothorax (WOPP)
Acronym
WOPP
Official Title
Pulmonary Wedge Resection Plus Parietal Pleurectomy (WRPP) Versus Parietal Pleurectomy (PP) for the Treatment of Recurrent Primary Pneumothorax
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2013 (undefined)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Otto-von-Guericke University Magdeburg
Collaborators
German Research Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumothorax, Recurrent Pneumothorax
Keywords
pneumothorax, primary pneumothorax, lung collapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
wedge resection+parietal pleurectomy
Arm Type
Experimental
Arm Description
Surgical treatment includes parietal pleurectomy and wedge resection of the tip of the lung.
Arm Title
parietal pleurectomy
Arm Type
Active Comparator
Arm Description
Surgical therapy is limited to parietal pleurectomy.
Intervention Type
Procedure
Intervention Name(s)
wedge resection
Intervention Description
Complementary to parietal pleurectomy lung tissue is resected.
Intervention Type
Procedure
Intervention Name(s)
parietal pleurectomy
Intervention Description
The parietal pleura is resected for treating primary pneumothorax.
Primary Outcome Measure Information:
Title
Recurrence rate of primary pneumothorax following VAT surgery
Description
Patients are followed to identify all incidents of recurrent lung collapse following VAT surgery. Suspected recurrences will be confirmed by chest X-ray.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
postoperative morbidity
Description
postoperative complications
Time Frame
30 days
Title
postoperative pain
Description
rest and stress with a pain scale ranging from 1 to 10 (measured with the Visual Analogue Scale - VAS)
Time Frame
7 days
Title
function quality of life
Description
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)
Time Frame
2 years
Title
costs of treatment
Description
documentation of postoperative Hospitalization, the number of trocars
Time Frame
up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thorsten Walles, MD
Organizational Affiliation
Magdeburg University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Klinikum rechts der Isar München
City
München
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitätsklinikum Magdeburg A. ö. R.
City
Magdeburg
State/Province
Saxony-Anhalt
ZIP/Postal Code
39120
Country
Germany
Facility Name
Charité
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Vivantes Thoraxzentrum
City
Berlin
ZIP/Postal Code
12351
Country
Germany
Facility Name
Evangelische Lungenklinik Berlin
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
DRK Kliniken Berlin
City
Berlin
ZIP/Postal Code
13359
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
LungenClinic Grosshansdorf
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg-Eppendorf
ZIP/Postal Code
20246
Country
Germany
Facility Name
Thoraxklinik am Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Lungenklinik Köln Merheim
City
Köln
ZIP/Postal Code
51109
Country
Germany
Facility Name
Asklepios Klinik Langen
City
Langen
ZIP/Postal Code
63225
Country
Germany
Facility Name
Asklepios Fachklinik
City
München-Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
LMU München
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Thoraxzentrum Bezirk Unterfranken
City
Münnerstadt
ZIP/Postal Code
97702
Country
Germany
Facility Name
Krankenhaus Barmherzige Brüder
City
Regensburg
ZIP/Postal Code
93049
Country
Germany
Facility Name
Universitätsklinikum Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Robert Bosch Krankenhaus
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Facility Name
Johanniter-Krankenhaus im Fläming Treuenbrietzen GmbH
City
Treuenbrietzen
ZIP/Postal Code
14929
Country
Germany
Facility Name
Universitätsklinik Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitätsklinikum Würzburg
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12728149
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.
Results Reference
background
PubMed Identifier
19966346
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.
Results Reference
background
PubMed Identifier
14752638
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.
Results Reference
background
PubMed Identifier
26620271
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.
Results Reference
derived
Links:
URL
http://gepris.dfg.de/gepris/OCTOPUS/;jsessionid=E6A2D8650C043C03A91FE2EC2CE5C091?context=projekt&id=209750507&module=gepris&task=showDetail
Description
Click here for information on German Research Foundation Grant
URL
http://www.wopp-studie.de
Description
Official Trial Website

Learn more about this trial

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

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