Advertisement

Topics

Staple-Line Reinforcement for Prevention of Pulmonary Air Leakage

2014-08-27 03:21:17 | BioPortfolio

Summary

The aim of this study is to compare the efficacy of FORESEAL with stapling alone or associated with tissue sealant or glue in terms of air leakage duration after lung resection for cancer.

Hypothesis: to show a significant difference of 1 day in the average duration of air leakage between the 2 groups with a standard deviation of 3 (α =0.05 and β=0.10).

Description

Air leaks continue to be the most common complication after pulmonary resection even using a stapling device. Double chest tubes after lobectomy is a well established method for drainage of the pleural cavity to allow adequate expansion of the remaining lung.

FORESEAL has been developed to reduce air leaks by buttressing the staple line. It is a absorbable vegetal biopolymer in the form of sleeves, CE marked and indicated for prevention of air leakage after pulmonary resection with stapling device. It acts as a suture reinforcement as well as a sealant thanks to its jellification.

Sealants are also commonly used in addition to stapling to prevent air leakage. The aim of this study is to compare the efficacy of FORESEAL with stapling alone or associated with sealants.

This is a multi centre, prospective controlled and randomised clinical study.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Lung Neoplasms

Intervention

FOREseal, Stapling

Location

Assistance Publique Hopitaux de Paris
Paris
France
75000

Status

Not yet recruiting

Source

Assistance Publique - Hôpitaux de Paris

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:21:17-0400

Clinical Trials [668 Associated Clinical Trials listed on BioPortfolio]

Safety and Efficacy the Medigus SRS Endoscopic Stapling System in Gastroesophageal Reflux Disease (GERD)

The study is designed to test the safety and efficacy of the Medigus SRS endoscopic stapling system for the treatment of GERD. The system allows the operator to staple the stomach to the ...

NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery

After resection of diseased segments of the large intestine, the continuity of the intestine has to be restored. This can be done by suturing or with so called stapling devices. In additio...

Comparative Study of Circular Stapling Instruments

After removing the rectum at surgery, bowel continuity can sometimes be restored by an anastomosis between the anus and the bowel. This anastomosis is most commonly created by the use of s...

Radical Cystectomy: Can We Improve Our Surgical Technique With the Ligasure Impact Tissue-Sealing Device?

Evaluate the utility/safety of an FDA-approved tissue sealing device during radical cystectomy as compared to an FDA-approved stapling device.

A Study to Test Lung Function After Radiation Therapy

It is known that radiation damages lung tissue. New human studies at University of Iowa show that the radiation damage is not as expected. The purpose of this study is to document lung fun...

PubMed Articles [4510 Associated PubMed Articles listed on BioPortfolio]

Gingival Metastasis: A Case Report and Literature Review.

Secondary oral cavity neoplasms are rare. We describe a case of an indurated, nonulcerating gingival lesion in a 59-year-old nonsmoking man with no family history of lung cancer. The lesion was the pr...

KRAS and NKX2-1 mutations in invasive mucinous adenocarcinoma of the lung.

Mucinous differentiation is observed in a subset of lung adenocarcinomas with unique clinical and pathological features, but the biology of these neoplasms is poorly understood.

Pathologic Classification of Neuroendocrine Neoplasms.

The pathologic classification of neuroendocrine neoplasms has evolved over the past decades, as new understanding of the biological behavior, histologic characteristics, and genetic features have emer...

Metastatic Sarcomatoid Lung Cancer: A Rare Cutaneous Spindle Cell Neoplasm.

Cutaneous spindle cell neoplasms can be a diagnostic challenge and may require extensive immunohistochemical staining. The differential diagnoses include melanoma, squamous cell carcinoma, atypical fi...

Predilection of contralateral upper lung metastasis in upper lobe lung adenocarcinoma patients.

Lung cancer with lung to lung metastasis is common. The objective of this study was to investigate the association among the distribution of contralateral lung metastases versus primary lung tumor loc...

Medical and Biotech [MESH] Definitions

Tumors or cancer of the LUNG.

A technique of closing incisions and wounds, or of joining and connecting tissues, in which staples are used as sutures.

A collective term for precoordinated organ/neoplasm headings locating neoplasms by organ, as BRAIN NEOPLASMS; DUODENAL NEOPLASMS; LIVER NEOPLASMS; etc.

Absence of air in the entire or part of a lung, such as an incompletely inflated neonate lung or a collapsed adult lung. Pulmonary atelectasis can be caused by airway obstruction, lung compression, fibrotic contraction, or other factors.

A diverse group of lung diseases that affect the lung parenchyma. They are characterized by an initial inflammation of PULMONARY ALVEOLI that extends to the interstitium and beyond leading to diffuse PULMONARY FIBROSIS. Interstitial lung diseases are classified by their etiology (known or unknown causes), and radiological-pathological features.

More From BioPortfolio on "Staple-Line Reinforcement for Prevention of Pulmonary Air Leakage"

Quick Search
Advertisement
 

Relevant Topics

Pulmonary
Pulmonary relating to or associated with the lungs eg Asthma, chronic bronchitis, emphysema, COPD, Cystic Fibrosis, Influenza,  Lung Cancer, Pneumonia, Pulmonary Arterial Hypertension, Sleep Disorders etc Follow and track Lung Cancer News ...

Cancer Disease
Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer th...