Multicentre, prospective, observational study investigating the most appropriate surgical option that can prevent the recurrence of primary spontaneous pneumothorax after surgery: the PATCH study, protocol.
Ontology highlight
ABSTRACT: Introduction
Thoracoscopic surgery is performed for refractory or recurrent primary spontaneous pneumothorax (PSP). To reduce postoperative recurrence, additional treatment is occasionally adopted during surgery after bulla resection. However, the most effective method has not been fully elucidated. Furthermore, the preference for additional treatment varies among countries, and its efficacy in preventing recurrence must be evaluated based on settings tailored for the conditions of a specific country. The number of registries collecting detailed data about PSP surgery is limited. Therefore, to address this issue, a prospective multicentre observational study was performed.Methods and analysis
This multicentre, prospective, observational study will enrol 450 participants aged between 16 and 40 years who initially underwent PSP surgery. Data about demographic characteristics, disease and family history, surgical details, and CT scan findings will be collected. Follow-up must be conducted until 3 years after surgery or in the event of recurrence, whichever came first. Patients without recurrence will undergo annual follow-up until 3 years after surgery. The primary outcome is the rate of recurrence within 2 years after surgery. A multivariate analysis will be performed to compare the efficacy of different surgical options. Then, adverse outcomes correlated with various treatments and the feasibility of treatment methods will be compared.Ethics and dissemination
This study was approved by the local ethics committee of all participating centres. The findings will be available in 2025, and they can be used as a basis for clinical decision-making regarding appropriate options for the initial PSP surgery.Trial registration number
NCT04758143.
SUBMITTER: Kadomatsu Y
PROVIDER: S-EPMC8689161 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:The coverage technique using absorbable mesh was first described in a European guideline published in 2015 as a preventive method for the recurrence of spontaneous pneumothorax. We performed a meta-analysis based on a literature search of primary studies that compared the postoperative recurrence rate of primary spontaneous pneumothorax between the use and nonuse of polyglycolic acid sheet coverage. Two reviewers independently selected and evaluated the quality of the relevant studies. The risk ratio in each study was calculated in a random-effect meta-analysis. Statistical heterogeneity among the included studies was quantitatively evaluated using the I2 index, and publication bias was assessed using a funnel plot. A total of 19 retrospective cohort studies were analyzed: 1524 patients who underwent wedge resection alone (the control group) and 1579 who received additional sheet coverage. Polyglycolic acid sheet coverage was associated with a lower recurrence rate than that in the control group (risk ratio: 0.27, 95% confidence interval 0.20-0.37, P < 0.001; I2 0%). The funnel plot suggested possible publication bias. The covering technique reduced the recurrence rate of pneumothorax after thoracoscopic surgery to one-fourth.
| S-EPMC7873206 | biostudies-literature
Project description:ObjectiveNo guideline clearly prescribes an approach to management of spontaneous pneumothorax in children. The objectives of this study were to evaluate practice variation in the management of spontaneous pneumothorax in children and its probability of recurrence.MethodsThis study was a retrospective chart review followed by a phone follow-up that included all children who had visited a tertiary care paediatric hospital for a first episode of spontaneous pneumothorax between 2008 and 2017. The primary outcomes were the management of pneumothorax (observation, oxygen, needle aspiration, intercostal chest tube, surgery) and the probability of recurrence. All charts were evaluated by a rater using a standardized report form and 10% of the charts were evaluated in duplicate. All children/families were contacted by phone to assess recurrence. The primary analyses were the proportions of each treatment modalities and recurrence, respectively.ResultsDuring the study period, 76 children were deemed eligible for the study. Among them, 59 had a primary spontaneous pneumothorax while 17 were secondary. The most common first therapeutic approaches were chest tube insertion (31), oxygen alone (27), and observation (14). A total of 54 patients were available for follow-up among whom a recurrence was observed in 28 (37% of the total cohort or 52% of available children).ConclusionChest tube insertion was the first line of treatment in about 40% of children with a first spontaneous pneumothorax. In this population, the recurrence probability is established between 37 and 52% and the majority occurs in the following months.
| S-EPMC7757772 | biostudies-literature
Project description:BackgroundManagement of spontaneous pneumothorax (SP) is still subject to debate. Although encouraging results of recent studies about outpatient management with chest drains fitted with a one-way valve, no data exist concerning application of this strategy in real life conditions. We assessed how SP are managed in Emergency departments (EDs), in particular the role of outpatient management, the types of interventions and the specialty of the physicians who perform these interventions.MethodsFrom June 2009 to May 2013, all cases of spontaneous primary (PSP) and spontaneous secondary pneumothorax (SSP) from EDs of 14 hospitals in France were retrospectively included. First line treatment (observation, aspiration, thoracic drainage or surgery), type of management (admitted, discharged to home directly from the ED, outpatient management) and the specialty of the physicians were collected from the medical files of the ED.ResultsAmong 1868 SP included, an outpatient management strategy was chosen in 179 PSP (10%) and 38 SSP (2%), mostly when no intervention was performed. Only 25 PSP (1%) were treated by aspiration and discharged to home after ED admission. Observation was the chosen strategy for 985 patients (53%). In 883 patients with an intervention (47%), it was performed by emergency physicians in 71% of cases and thoracic drainage was the most frequent choice (670 patients, 76%).ConclusionsOur study showed the low level of implementation of outpatient management for PS in France. Despite encouraging results of studies concerning outpatient management, chest tube drainage and hospitalization remain preponderant in the treatment of SP.
| S-EPMC6329130 | biostudies-literature
Project description:BackgroundSeveral risk factors for postoperative recurrence of spontaneous pneumothorax have been reported, but the identified risk factors differed among studies.MethodsA total of 183 primary spontaneous pneumothorax patients were enrolled in this retrospective study, and the risk factors for postoperative recurrence were evaluated.ResultsAmong the patients, more than 80% with ipsilateral postoperative recurrence (IPR) relapsed within 3 years and more than 80% with contralateral postoperative recurrence relapsed within 4 years. Compared with patients without IPR, patients with IPR had significantly more cases with history of pneumothorax (P<0.10), more cases without preoperative drainage (P=0.02), more cases with intraoperative adhesion (P<0.01), greater upward lung volume (P=0.04), more numbers of automatic sutures (P=0.04), and more cases with contralateral recurrence (P<0.01). Furthermore, compared with patients without adhesion, patients with adhesion had significantly older age (P<0.01), and more cases with adhesion on CT images (P<0.01). Patients with adhesion also had significantly greater upward lung volume (P<0.01), more cases that received covering with polyglycolic acid (PGA) sheet covering with fibrin glue (P=0.01), and more cases that received re-do surgery (P=0.04). IPR was significantly more common in the adhesion group (P<0.01), while contralateral postoperative recurrence did not differ significantly between the groups with and without adhesion (P=0.06). Univariate analyses showed that body mass index (BMI) <15.6 kg/m2 (P<0.01), history of pneumothorax (P=0.01), intraoperative adhesion (P<0.01), upward lung volume >80% (P=0.02), lateral lung volume >80% (P=0.02), 3 fire or more of automatic sutures (P=0.03), and contralateral recurrence (P=0.01) were significant risk factors for IPR. BMI <15.6 kg/m2 (odds ratio: 20.89; 95% confidence interval: 1.55-280.70; P=0.02) and intraoperative adhesion (odds ratio: 25.58; 95% confidence interval: 1.91-342.39; P=0.01) were identified as risk factors for IPR in a multivariate analysis.ConclusionsThe present findings suggest that low BMI and intraoperative adhesion are risk factors for postoperative recurrence of spontaneous pneumothorax. For such patients, additional intraoperative procedures, such as covering with PGA sheet absorbable oxidized cellulose may be required to reduce postoperative recurrence.
| S-EPMC10797360 | biostudies-literature
Project description:ImportanceSpontaneous pneumothorax is a common disease known to have an unusual epidemiological profile, but there are limited contemporary population-based data.ObjectiveTo estimate the incidence of hospital admissions for spontaneous pneumothorax, its recurrence and trends over time using large, longstanding hospitalization data sets in England.Design, setting, and participantsA population-based epidemiological study was conducted using an English national data set and an English regional data set, each spanning 1968 to 2016, and including 170 929 hospital admission records of patients 15 years and older. Final date of the study period was December 31, 2016.ExposuresCalendar year (for incidence) and readmission to hospital for spontaneous pneumothorax (for recurrence).Main outcomes and measuresPrimary outcomes were rates of hospital admissions for spontaneous pneumothorax and recurrence, defined as a subsequent hospital readmission with spontaneous pneumothorax. Record-linkage was used to identify multiple admissions per person and comorbidity. Risk factors for recurrence over 5 years of follow-up were assessed using cumulative time-to-failure analysis and Cox proportional hazards regression.ResultsFrom 1968 to 2016, there were 170 929 hospital admissions for spontaneous pneumothorax (median age, 44 years [IQR, 26-88]; 73.0% male). In 2016, there were 14.1 spontaneous pneumothorax admissions per 100 000 population 15 years and older (95% CI, 13.7-14.4), a significant increase compared with earlier years, up from 9.1 (95% CI, 8.1-10.1) in 1968. The population-based rate per 100 000 population 15 years and older was higher for males (20.8 [95% CI, 20.2-21.4]) than for females (7.6 [95% CI, 7.2-7.9]). Of patients with spontaneous pneumothorax, 60.8% (95% CI, 59.5%-62.0%) had chronic lung disease. Record-linkage analysis demonstrated that the overall increase in admissions over time could be due in part to an increase in repeat admissions, but there were also significant increases in the annual rate of first-known spontaneous pneumothorax admissions in some population subgroups, for example in women 65 years and older (annual percentage change from 1968 to 2016, 4.08 [95% CI, 3.33-4.82], P < .001). The probability of recurrence within 5 years was similar by sex (25.5% [95% CI, 25.1%-25.9%] for males vs 26.0% [95% CI, 25.3%-26.7%] for females), but there was variation by age group and presence of chronic lung disease. For example, the probability of readmission within 5 years among males aged 15 to 34 years with chronic lung disease was 39.2% (95% CI, 37.7%-40.7%) compared with 19.6% (95% CI, 18.2%-21.1%) in men 65 years and older without chronic lung disease.Conclusions and relevanceThis study provides contemporary information regarding the trends in incidence and recurrence of inpatient-treated spontaneous pneumothorax.
| S-EPMC6233798 | biostudies-literature
Project description:PurposeSpontaneous 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.MethodsSingle-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.ResultsFollow-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.ConclusionIn 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.
| S-EPMC5833137 | biostudies-literature
Project description:BackgroundPrimary spontaneous pneumothorax is managed initially with observation and chest tube placement, followed by surgical intervention in select cases. With little currently published evidence, the role of surgical pleurodesis or pleurectomy to reduce primary spontaneous pneumothorax recurrence is unclear. This study compares the recurrence rates of primary spontaneous pneumothorax following bullectomy alone versus bullectomy with pleurodesis or pleurectomy.MethodsA retrospective review was performed at a quaternary hospital for all patients undergoing surgery for primary spontaneous pneumothorax between June 2006 and December 2018. Patient demographics, disease severity, operative technique, and time between initial surgery and recurrence were recorded. Standard statistical techniques were used for univariable and multivariable analyses.ResultsOf 222 total included patients, 28 required a second surgery: 4 (1.8%) for prolonged air leak and 24 (10.8%) for recurrent pneumothorax. The median time from first to second surgery was 363 days and 35.7% of recurrences did not present until after two years. Age, sex, smoking, year of initial surgery, disease severity, and surgical technique did not significantly affect recurrence rate on univariable analysis. On multivariable analysis, the odds ratios of recurrence for bullectomy with mechanical pleurodesis or pleurectomy were respectively 0.82 and 0.15 (P=0.218), compared to bullectomy alone. Combined bullectomy, pleurectomy, and pleurodesis was most effective (0/18, 0%).ConclusionsBullectomy with pleurectomy and pleurodesis demonstrated a 0% recurrence rate for the treatment of primary spontaneous pneumothorax in this study. Statistical significance was not achieved in univariable or multivariable analyses comparing recurrence rates for the surgical approaches. A multi-center randomized controlled trial with longer follow-up than previously performed is needed to confirm these preliminary findings and optimize surgical management of primary spontaneous pneumothorax.
| S-EPMC8024846 | biostudies-literature
Project description:BackgroundAlthough recurrence is included in surgical indications, there is no definitive guideline for managing recurrent spontaneous pneumothorax (SP) according to characteristics of recurrence, such as the type [primary SP (PSP) or secondary SP (SSP)] and recurrence-free interval (RFI). Actually, some patients with early cessation of air leak after closed thoracostomy tubes, a long RFI, or medical comorbidities are often managed conservatively without surgery. However, the validity of this management is unclear. The aims of the present study are to analyze treatment outcomes for recurrent SP according to the type of SP and RFI, and to check the validity of conservative treatment for patients according to type of SP and RFI.MethodsWe included 1,250 consecutive cases (624 right sided and 626 left side cases for the first episode) who were hospitalized and treated from January 2012 to June 2018. To investigate recurrence according to treatment modality (surgical or conservative treatment), we estimated RFI in each group during the observation period. RFI was measured from the completion of treatment to recurrence or last follow-up. We divided patients into two groups [the early (EG) and the late (LG) recurrence group] according to 1-year. Recurrence was defined as a subsequent episode of an ipsilateral SP, while a contralateral SP was regarded as an independent case in the present study. RFI between subgroups was compared using the Kaplan-Meier method with the log-rank test. A P value less than 0.05 (two-sided) was regarded as statistically significant.ResultsRecurrence occurred in 47 cases after surgical intervention for the first episode (585 cases). Recurrence occurred in 265 cases after conservative treatment for the first episode of SP (665 cases). For the first episode, the surgical group (SG) had a significantly longer RFI than the conservative group (CG), regardless of the type (both, P<0.001). Conservative treatment and surgical intervention for the second episode after conservative treatment for the first episode were performed in 98 and 167 cases, respectively. For the second episode after conservative treatment for the first episode, SG also had a significantly longer RFI than CG, regardless of the types (PSP P<0.001, SSP P=0.031). To check the validity of conservative treatment for patients with a long RFI, we analyzed recurrence by dividing patients into two groups according to one-year RFI. For PSP, the early recurrence group (EG, RFI ?1 year) had 99 cases and the late recurrent group (LG, RFI >1 year) had 67 cases. SG had a significantly longer RFI than CG in both EG and LG (EG, P<0.001 and LG, P=0.001). In addition, for SSP, there were 67 cases of EG and 32 cases of LG, SG had significantly longer RFIs than CG in EG (P=0.007). However, there was no significant difference in RFI between SG and CG in LG (P=0.748).ConclusionsThe present study revealed diversity of management outcomes according to characteristics of recurrence and provides some evidences of the validity of conservative treatment in recurrent SSP with a long RFI. Further large-scale prospective randomized trials are required to validate these findings.
| S-EPMC7330374 | biostudies-literature
Project description:Background: Primary spontaneous pneumothorax is potentially life-threatening, and its recurrence is always a serious problem. Pathological examination provides molecular insights into the pathophysiology of primary spontaneous pneumothorax. Objectives: To investigate the association of histopathologic features of primary spontaneous pneumothorax with matrix metalloproteinase expression and their relevance to the recurrence. Methods: A total of 217 tissue section slides in 172 adolescent patients with primary spontaneous pneumothorax were retrospectively reviewed from January 2001 to June 2020. All histopathologic features were recorded and pathologic findings related to ipsilateral recurrence and second surgery were analyzed. Serum levels of matrix metalloproteinases were prospectively measured in 25 primary spontaneous pneumothorax patients receiving surgery and 18 healthy controls. Their relevance to the histopathologic features of primary spontaneous pneumothorax related to its recurrence was also examined. Results: The major presenting histopathologic findings of primary spontaneous pneumothorax were bleb/bulla (98%) followed by fibrosis (68%). Low prevalence of the pathologic findings of granulation tissue and macrophage accumulation were significantly associated with recurrent primary spontaneous pneumothorax, whereas fibrosis was significantly higher in patients receiving more than once surgery. Furthermore, the ratios of matrix metalloproteinase-2/tissue inhibitor of metalloproteinase-1 and matrix metalloproteinase-9/tissue inhibitor of metalloproteinase-1 were significantly higher in theses pathological findings as well as multinucleated giant cells and mesothelial cell hyperplasia in comparison with healthy controls. Conclusions: Low prevalence of macrophage accumulation and granulation tissue related to the overexpression of matrix metalloproteinase-2 and-9 activities may contribute to healing impairment and primary spontaneous pneumothorax recurrence.
| S-EPMC8671608 | biostudies-literature
Project description:Despite elevated incidence and recurrence rates for Primary Spontaneous Pneumothorax (PSP), little is known about its etiology, and the genetics of idiopathic PSP remains unexplored. To identify genetic variants contributing to sporadic PSP risk, we conducted the first PSP genome-wide association study. Two replicate pools of 92 Portuguese PSP cases and of 129 age- and sex-matched controls were allelotyped in triplicate on the Affymetrix Human SNP Array 6.0 arrays. Markers passing quality control were ranked by relative allele score difference between cases and controls (|RASdiff|), by a novel cluster method and by a combined Z-test. 101 single nucleotide polymorphisms (SNPs) were selected using these three approaches for technical validation by individual genotyping in the discovery dataset. 87 out of 94 successfully tested SNPs were nominally associated in the discovery dataset. Replication of the 87 technically validated SNPs was then carried out in an independent replication dataset of 100 Portuguese cases and 425 controls. The intergenic rs4733649 SNP in chromosome 8 (between LINC00824 and LINC00977) was associated with PSP in the discovery (P = 4.07E-03, ORC[95% CI] = 1.88[1.22-2.89]), replication (P = 1.50E-02, ORC[95% CI] = 1.50[1.08-2.09]) and combined datasets (P = 8.61E-05, ORC[95% CI] = 1.65[1.29-2.13]). This study identified for the first time one genetic risk factor for sporadic PSP, but future studies are warranted to further confirm this finding in other populations and uncover its functional role in PSP pathogenesis.
| S-EPMC4874577 | biostudies-literature