Clinical trial NCT06472505: Using Polyglycolic Acid Mesh Prevents Cerebrospinal Fluid Leakage
Official title: Using Polyglycolic Acid Mesh Prevents Cerebrospinal Fluid Leakage: Clinical Application to Endoscopic Endonasal Transsphenoidal Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pituitary Tumor
Cerebrospinal Fluid Leakage
Keywords: Pituitary tumor
Endoscopic transnasal transsphenoidal
CSF leakage
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Neoveil, the main component, is polyglycolic acid (PGA), which is a kind of absorbable material, and is made into a soft and tension non-woven material by special processing with good tissue compatibility and degradability. In the human body, its strength will gradually decrease due to hydrolysis, and will eventually be absorbed and metabolized. In the process of absorption, at first its strength is reduced, then the mass will gradually decrease, and it will be completely absorbed after about 15 weeks. At present, the United States, Europe, Australia, China and South Korea have been marketed, it is applied to the spine , pituitary tumors , skull base tumors and aneurysm surgery,etc. inthe related field of Neurosurgery in foreign countries. It can prevent the leakage of cerebrospinal fluid, and reduce the postoperative hospital stay and the probability of complications after surgery. There is a license from the TFDA. In clinical, it can be used in the sutures of parts or fragile organs that do not need to be healed for a long time, such as the lung, liver, and digestive tract, by suture (thick slice and tube type) or adhesion (Sheet) In the tissue, it can strengthen the compressive ability of the local tissue, prevent the suture thread from splitting the suture tissue, prevent the lung tissue from leaking, reduce the blood and fluid leakage from the surgical site, and reduce the postoperative hospital stay and after the operation The complication rate .

Eligibility criteria: A. Inclusion criteria

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

B. Exclusion criteria

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

Primary outcomes:
measure: Mesurement CSF leakage grade change after surgery
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Abel Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: