Using Polyglycolic Acid Mesh Prevents Cerebrospinal Fluid Leakage

NCT06472505 | Recruiting DMC

• 1 other identifier: 202011030DIPB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pituitary Tumor; Cerebrospinal Fluid Leakage

Keywords

Pituitary tumor; Endoscopic transnasal transsphenoidal; CSF leakage

Outcome Measures

Primary Outcomes (1)

• Mesurement CSF leakage grade change after surgery

  Confirmation of change in CSF leakage grafe after surgery

  6 months

Study Arms (1)

Using polyglycolic acid mesh

EXPERIMENTAL

Device: polyglycolic acid(Neoveil)

Interventions

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.

Using polyglycolic acid mesh

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Pituitary Neoplasms; Cerebrospinal Fluid Leak; Cerebrospinal Fluid Rhinorrhea

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases; Neurologic Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Rhinorrhea; Signs and Symptoms, Respiratory

Study Officials

• Abel Huang, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abel Huang, MD

CONTACT

+8860223123456; how.how0622@gmail.com

Abel Huang, MD

CONTACT

+8860223123456

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 25, 2024
• Study Start: December 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 25, 2024

Record last verified: 2024-06

Locations

TW (1)