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Medical and Economic Evaluation of FORESEAL Versus the Current Therapeutic Approach (Stapling Alone or Associated With Tissue Sealant) in Terms of Air Leakage Duration After Lung Resection for Cancer.


Phase 4
18 Years
85 Years
Not Enrolling
Both
Lung Neoplasms, Pulmonary Surgical Procedures, Surgical Staplers, Tissue Adhesives, Chest Tubes

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Trial Information

Medical and Economic Evaluation of FORESEAL Versus the Current Therapeutic Approach (Stapling Alone or Associated With Tissue Sealant) in Terms of Air Leakage Duration After Lung Resection for Cancer.


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.


Inclusion Criteria:



- Patient 18 years old or over.

- Patient that undergoes a lobectomy or bilobectomy for lung cancer,

- Patient presenting an incomplete fissure, requiring stapling of at least 50% of the
fissure and/or an emphysematous lung at the fissure point, requiring stapling.

- Patient that has signed the informed consent before the operation.

- Patient that benefits from a social security regime.

Exclusion Criteria:

- Patient with history of thoracotomy on the side operated on.

- Patient with severe pleural infection and/or infection of parenchyma.

- Presence of air leakage after liberation of lung in cases of pleural symphysis.

- Patient pregnant, giving birth or nursing.

- Patient presenting a contra indication to the aerostatic products used.

- Patient already participating in biomedical research.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Air leak (presence or absence of bubbles) will be assessed from T0: one hour after extubation, and then twice daily (morning and evening). The mean duration of post-operative air leakage will be calculated from T0 to the last day air leak observed.

Outcome Time Frame:

from T0 to the last day air leak observed

Safety Issue:

No

Principal Investigator

Jean Fran├žois REGNARD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Hospitalier Hotel Dieu

Authority:

France: Ministry of Health

Study ID:

P080204

NCT ID:

NCT00925444

Start Date:

June 2009

Completion Date:

June 2011

Related Keywords:

  • Lung Neoplasms
  • Pulmonary Surgical Procedures
  • Surgical Staplers
  • Tissue Adhesives
  • Chest Tubes
  • Absorbable implants
  • Humans
  • Alginates
  • Pneumonectomy/methods
  • Pneumonectomy/instrumentation
  • Surgical Stapling
  • Thoracic surgery
  • Tissue Adhesives
  • Prospective studies
  • Neoplasms
  • Lung Neoplasms

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