WOPP Study

Goal: Clinical study on the surgical treatment of primary pneumothorax.

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Thorsten Walles
added 8 research items
For the surgical treatment of recurrent primary spontaneous pneumothoraces (rPSP) different operative therapies are applied to achieve permanent freedom from recurrence. This multicenter clinical trial evaluates the long-term results of two commonly applied surgical techniques for the treatment of rPSP. Based on the inclusion and exclusion criteria, and after obtaining the patients’ informed consent, participants are randomized into the two surgical treatment arms: pulmonary wedge resection plus parietal pleurectomy (WRPP) or parietal pleurectomy alone (PP). Consecutively, all study participants will be followed up for two years to evaluate the surgical long-term effect. The primary efficacy endpoint is the recurrence rate of pneumothorax within 24 months after surgery. The calculated sample size is 360 patients (n = 180 per treatment arm) to prove superiority of one of the two treatments. So far, 22 surgical sites have submitted their declaration of commitment, giving the estimated number of participating patients. A prospective randomized clinical trial has been started to compare two established surgical therapies to evaluate the long-term results regarding recurrence rates. Furthermore, cost of treatment, and influence on the perioperative morbidity and mortality as well as on quality of life are analyzed. If the study reveals equivalence for both surgical techniques, unnecessary pulmonary resections could be avoided. Trial registration ClinicalTrials gov: NCT01855464, 06.05 2013.
In Germany, 10,000 cases of spontaneous pneumothorax are treated inpatient every year. The German Society for Thoracic Surgery, in co-operation with the German Society for Pulmonology, the German Radiological Society, and the German Society of Internal Medicine has developed an S3 guideline on spontaneous pneumothorax and post-interventional pneumothorax moderated by the German Association of Scientific Medical Societies. Method: Based on the source guideline of the British Thoracic Society (2010) for spontaneous pneumothorax, a literature search on spontaneous pneumothorax was carried out from 2008 onwards, for post-interventional pneumothorax from 1960 onwards. Evidence levels according to the Oxford Center for Evidence-Based Medicine (2011) were assigned to the relevant studies found. Recommendations according to grade (A: "we recommend"/"we do not recommend," B: "we suggest"/"we do not suggest") were determined in 3 consensus conferences by the nominal group process. Results: The algorithms for primary and secondary pneumothorax differ in the indication for CT scan as well as in the indication for chest drainage application and video-assisted thoracic surgery. Indication for surgery is recommended individually taking into account the risk of recurrence, life circumstances, patient preferences, and procedure risks. For some forms of secondary pneumothorax, a reserved indication for surgery is recommended. Therapy of post-interventional spontaneous pneumothorax is similar to that of primary spontaneous pneumothorax. Discussion: The recommendations of the S3 Guideline provide assistance in managing spontaneous pneumothorax and post-interventional pneumothorax. Whether this will affect existing deviant diagnostic and therapeutic measures will be demonstrated by future epidemiological studies.
Thorsten Walles
added 2 research items
SINGLE CENTER COHORT ANALYSIS Die Grundprinzipien der Behandlung des spontanen Pneumothorax sind: 1. Die Lunge so schnell wie möglich zur Ausdehnung zu bringen. 2. Einem Rezidiv vorzubeugen. Zahlreiche Studien zeigen, dass man durch die video-assistierte thorakoskopische (VATS) bzw. die offen-chirurgische (OC) Therapie die Rezidivrate des spontanen Pneumothorax in einen Bereich von 5 bis 8 % senken kann. Das Operationsziel bei der Behandlung besteht darin, das Luftleck zu verschließen und im Sinne einer Rezidivprophylaxe Verwachsungen zwischen der Lunge und der Pleura parietalis durch mechanische oder chemische Pleurareizung zu induzieren.
Der rezidivierende bzw. therapierefraktäre juvenile Pneumothorax sollte entsprechend den Empfehlungen der British Thoracic Society durch eine Lungenspitzenresektion und eine totale parietale Pleurektomie operativ behandelt werden. Die Eingriffe werden heutzutage in der Regel videothorakoskopisch durchgeführt. In der klinischen Praxis wurde jedoch aus unterschiedlichen Gründen mitunter auf die Lungenspitzenresektion verzichtet. Kohortenanalysen aus einzelnen Zentren mit diesem abweichenden Vorgehen weisen mitunter vergleichbar gute Ergebnisse wie die großen Kohortenstudien mit Lungenspitzenresektion aus. Andere Arbeiten kommen bei alleiniger Pleurektomie ohne Lungenspitzenresektion zu einer um 7% höheren Pneumothorax-Rezidivrate. Wissenschaftliche Fragestellung: Liefert die alleinige totale parietale Pleurektomie bei Patienten mit einem rezidivierenden juvenilen Pneumothorax und fehlenden relevanten Lungenparenchymveränderungen (Blebbs bzw. Bullae) die gleichen Langzeitbehandlungsergebnisse wie die totale parietale Pleurektomie mit zusätzlicher Lungenspitzenresektion?
Thorsten Walles
added a research item
Purpose: Spontaneous pneumothorax (PNTX) is a common disease frequently operated at specialized thoracic surgery units. Videothoracoscopic surgery (VATS) has become the standard for treatment and recurrence prevention. While there is broad consensus regarding indications and techniques of PNTX surgery, postoperative risks and consecutive patient behavioral advice have not been sufficiently elucidated. Methods: Single-center cohort analysis of 641 patients operated for primary PNTX by VATS over 10 years. Putatively recurrence-prone lifestyle activities (smoking status, flying habits, and scuba diving) and actual occurrence of recurrences were correlated. Results: Follow-up rate was 46% (279/607 patients). Mean time interval between primary operation and follow-up was 61 (range: 5-177) months. In 10 patients (3.6%), a PNTX recurrence was observed. Regarding postoperative risk behavior reported at follow-up, 28% of patients were active smokers (15 ± 7 cigarettes/day), 59% traveled by plane repeatedly, and only two patients did scuba diving (0.7%). Low body-mass-index was associated with an increase in PNTX recurrence, whereas smoking, flying, and scuba diving could not be identified as risk factors. Conclusion: In our study, none of the supposed "classic" lifestyle-associated risk factors for PNTX recurrence after VATS proved to be a significant threat. Postoperative patient behavior might not be constrained by overcautious medical advice.
Thorsten Walles
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WOPP Newsletter 2016
Thorsten Walles
added a project goal
Clinical study on the surgical treatment of primary pneumothorax.