RecruitingNot ApplicableNCT06472505

Using Polyglycolic Acid Mesh Prevents Cerebrospinal Fluid Leakage

Using Polyglycolic Acid Mesh Prevents Cerebrospinal Fluid Leakage: Clinical Application to Endoscopic Endonasal Transsphenoidal Surgery


Sponsor

National Taiwan University Hospital

Enrollment

30 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The papers propose a new method to prevent postoperative cerebrospinal fluid leakage. Doctors use the absorbable polyglycolic acid (PGA) and fibrin glue to repair in surgery, prevent cerebrospinal fluid leakage and reduce the necessity of postoperative lumbar drainage after surgery. This study will analyze the changes in cerebrospinal fluid leakage in patients with pituitary tumors and skull base tumors after surgery, and further understand the effectiveness of Neoveil , as the basis for the development of new treatments.


Eligibility

Min Age: 20 Years

Inclusion Criteria1

  • \. Patients with primary or recurrent pituitary tumors require endoscopic nasal surgery.

Exclusion Criteria4

  • Patients with pituitary gland tumors who do not receive surgical treatment.
  • Patients with other brain tumors.
  • Patients allergic to polyglycolic acid (PGA).
  • Patients who have had previous radiation therapy or chemotherapy.

Interventions

DEVICEpolyglycolic acid(Neoveil)

This study plans to enroll patients with pituitary tumors who need to undergo surgical treatment according to current routine medical standards. After the tumor tissue is removed, the integrity of the spider web or skull base will be thoroughly checked by endoscopy during the operation to confirm whether there is any cerebrospinal fluid leakage. At the end of the operation, use a 100\*50\*0.15mm, green sheet-like Navi tissue repair patch, cut it aseptically to fit the size of the defect for repair (the common case is 2\*3.5cm defect), and place it on the spider web or skull base Tissue repair at the surgical site to prevent cerebrospinal fluid leakage.


Locations(1)

National Taiwan University Hospital

Taipei, Taiwan

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NCT06472505


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