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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.

Neudecker J, Malzahn U, Heuschmann P, Behrens U, Walles T - Trials (2015)

Bottom Line: Consecutively, all study participants will be followed up for two years to evaluate the surgical long-term effect.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.

View Article: PubMed Central - PubMed

Affiliation: Department of General, Visceral, Vascular and Thoracic Surgery, Surgical Regional Centre Berlin of CHIR-Net, Charité University Medicine Berlin, Campus Charité Mitte, Charitéplatz 1, 10117, Berlin, Germany. jens.neudecker@charite.de.

ABSTRACT

Background: For the surgical treatment of recurrent primary spontaneous pneumothoraces (rPSP) different operative therapies are applied to achieve permanent freedom from recurrence.

Methods/design: 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.

Discussion: 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.

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Related in: MedlinePlus

Course of the WOPP trial
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Fig1: Course of the WOPP trial

Mentions: Patients who are suitable after verification of the inclusion and exclusion criteria will be thoroughly informed about the WOPP study by a study physician. After approval of the study and submission of the written informed consent, patients are randomized. Randomization is done electronically via a web-based software tool (SecuTrial, interActive Systems GmbH, Berlin, Germany). We chose an allocation ratio of 1:1 because it maximizes statistical power for a given total sample size and there are no ethical or practical objections to this ratio. To minimize random error, 750 patients are to be screened and 360 patients (n = 180 per arm) will be randomized. Twenty centers have declared their participation in the study. The study design is shown in Fig. 1.Fig. 1


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.

Neudecker J, Malzahn U, Heuschmann P, Behrens U, Walles T - Trials (2015)

Course of the WOPP trial
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4663732&req=5

Fig1: Course of the WOPP trial
Mentions: Patients who are suitable after verification of the inclusion and exclusion criteria will be thoroughly informed about the WOPP study by a study physician. After approval of the study and submission of the written informed consent, patients are randomized. Randomization is done electronically via a web-based software tool (SecuTrial, interActive Systems GmbH, Berlin, Germany). We chose an allocation ratio of 1:1 because it maximizes statistical power for a given total sample size and there are no ethical or practical objections to this ratio. To minimize random error, 750 patients are to be screened and 360 patients (n = 180 per arm) will be randomized. Twenty centers have declared their participation in the study. The study design is shown in Fig. 1.Fig. 1

Bottom Line: Consecutively, all study participants will be followed up for two years to evaluate the surgical long-term effect.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.

View Article: PubMed Central - PubMed

Affiliation: Department of General, Visceral, Vascular and Thoracic Surgery, Surgical Regional Centre Berlin of CHIR-Net, Charité University Medicine Berlin, Campus Charité Mitte, Charitéplatz 1, 10117, Berlin, Germany. jens.neudecker@charite.de.

ABSTRACT

Background: For the surgical treatment of recurrent primary spontaneous pneumothoraces (rPSP) different operative therapies are applied to achieve permanent freedom from recurrence.

Methods/design: 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.

Discussion: 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.

Show MeSH
Related in: MedlinePlus