Using Polyglycolic Acid Mesh Prevents Cerebrospinal Fluid Leakage

ConditionsPituitary Tumor Cerebrospinal Fluid Leakage

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age20+

SponsorNational Taiwan University Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

polyglycolic acid(Neoveil)
Device
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.

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Using polyglycolic acid meshExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Mesurement CSF leakage grade change after surgery

Confirmation of change in CSF leakage grafe after surgery

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Taiwan University Hospital

Lead sponsor

Source ClinicalTrials.gov

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