Staple-Line Reinforcement for Prevention of Pulmonary Air Leakage

00:47 EDT 1st November 2014 | 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

Clinical Trials [415 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...

Protocol for Radiofrequency Ablation of Pulmonary Neoplasms

This research trial involves the development of a new treatment for lung tumors. It is for patients whose tumor cannot be surgically removed, have refused surgery, or the tumor has not res...

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 [4723 Associated PubMed Articles listed on BioPortfolio]

Pulmonary Segmentectomy with Tunneling Stapler Technique.

Pulmonary segmentectomy necessitates dissection of the lung parenchyma. Stapling is one method of dissecting the lung parenchyma. However, simple stapling of the segmental plane might result in restri...

Protein stapling via azide-alkyne ligation.

Here we demonstrate a methodology, termed protein stapling, for the introduction of covalent constraints into recombinant proteins. Using the azide-alkyne click reaction as the stapling chemistry, we ...

Alterations in the Expression of p53, KLF4, and p21 in Neuroendocrine Lung Tumors.

Context.-Neuroendocrine lung neoplasms are a heterogeneous group of tumors with different clinical behavior and prognosis. Objectives.-To evaluate the expression of p53, KLF4, and p21 in neuroendocrin...

Changes in High-sensitivity C-reactive Protein Levels after Laparoscopic Gastric Stapling Procedures versus Laparoscopic Gastric Banding.

Obesity, hypertension, diabetes, and hyperlipidemia are risk factors for the development of coronary artery disease. High-sensitivity C-reactive protein (hs-CRP) is an inflammatory biomarker that has ...

Pulmonary neuroendocrine neoplasms.

The pulmonary neuroendocrine neoplasms originate from the enterochromaffin cells which are diffusely distributed in the body. The incidence of these tumors has increased significantly in recent decade...

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"

Search BioPortfolio:
Loading
Advertisement

Relevant Topics

Pulmonary
Latest News Clinical Trials Research Drugs Reports Corporate
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
Latest News Clinical Trials Research Drugs Reports Corporate
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...

Advertisement