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 [846 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 ...

Comparison of Energy Instruments and Stapling Device to Dissect Intersegmental Plane in Segmentectomy

According to published studies, there are two main approaches in the dissection of intersegmental plane: stapling devices and energy instrument separation. However, only a few retrospectiv...

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...

EUS-guided RFA for Pancreatic Neoplasms

Radiofrequency ablation has been used for treatment of solid neoplasms of the liver, lung, kidney and adrenal. Recently, EUS-guided RFA has become available and the device allows EUS-guide...

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...

PubMed Articles [4698 Associated PubMed Articles listed on BioPortfolio]

Medical and Economic Evaluation of FOREseal Bioabsorbable Reinforcement Sleeves Compared With Current Standard of Care for Reducing Air Leakage Duration After Lung Resection for Malignancy: A Randomized Trial.

The objective of this study was to determine the efficacy of alginate staple-line reinforcement of fissure openings as compared with stapling alone, with or without tissue sealant or glue, in reducing...

Thoracic Neoplasms in Children: Contemporary Perspectives and Imaging Assessment.

This article focuses on commonly encountered primary lung, airway, mediastinal, and chest wall neoplasms that occur in the pediatric population. Although primary pediatric thoracic neoplasms are rare,...

Linear stapled gastrojejunostomy results in fewer strictures compared to circular stapled gastrojejunostomy in laparoscopic gastric bypass surgery.

Currently, there are two laparoscopic stapling techniques to perform the gastrojejunostomy in gastric bypass surgery: the linear stapling and circular stapling techniques. The aim of the study was to ...

Natural Orifice Specimen Extraction With Single Stapling Colorectal Anastomosis for Laparoscopic Anterior Resection: Feasibility, Outcomes, and Technical Considerations.

Double and triple stapling techniques to close the rectal stump in laparoscopic anterior resection are fraught with technical drawbacks that could possibly be avoided with the use of the single stapli...

A Novel Methodology for the Incorporation of Chiral Linkers in Stapled Peptides.

Stapled peptides have arisen as a new class of chemical probe and potential therapeutic agents to modulate protein-protein interactions. Here, we report the first two-component i,i+7 stapling methodol...

Medical and Biotech [MESH] Definitions

Tumors or cancer of the LUNG.

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

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

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...


Searches Linking to this Trial