Endoscopic and Endoscopic-Assisted Microsurgery of Intraventricular Lesions

NCT04569201 | Unknown

• 1 other identifier: Intraventricular Endoscopy
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

• Assess the efficacy of the endoscope as a single tool or as an adjuvant tool to the microscope in intraventricular procedures.
• Evaluate the limitations of the endoscope in these procedures.
• Review the outcome of endoscopic and/or endoscopic assisted microsurgical intraventricular procedures.
• Achieve a verdict in the long-standing controversy about the most effective, least invasive, and optimal way to resect intraventricular lesions, can the endoscope rival the surgical microscope?

Conditions

Endoscopy in Intraventricular Lesions

Outcome Measures

Primary Outcomes (3)

• Early Clinical outcome using Glasgow Outcome Scale

  Assessment of the post operative mortality and morbidity using: Glasgow Outcome Scale: 1. Death:Self-explanatory 2. Persistent vegetative state: Coma or severe deficit rendering the patient totally dependent 3. Severe disability: Significant neurological deficit interfering with daily activities or prevents return to employment 4. Moderate disability:Minor neurological deficit not interfering with daily functioning or work 5. Good recovery:Returned to the original functional level with no deficit

  Early outcome: 24 hours post-operatively.

• Early Clinical outcome using Modified Rankin Scale

  The Modified Rankin Scale (mRS) is used to measure the degree of disability in patients, as follows: * 0: No symptoms at all * 1: No significant disability despite symptoms; able to carry out all usual duties and activities * 2: Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance * 3: Moderate disability; requiring some help, but able to walk without assistance * 4: Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance * 5: Severe disability; bedridden, incontinent and requiring constant nursing care and attention * 6: Dead

  Within 6 weeks after surgery.

• Late outcome assessment

  Within six months, assessment of the performance of the patient with modified rankin scale.

  within 6 months after surgery

Interventions

Endoscope PROCEDURE

The use of the neuro endoscope in excision of intraventricular lesions either alone or in assistance of the surgical microscope

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PAtients with intraventricular lesions, presented to The Neurosurgery Department, At Assiut University Hospital in Assiut, Egypt

You may qualify if:

• Intraventricular arachnoid cysts
• Intraventricular colloid cysts
• Intraventricular tumors.

You may not qualify if:

• Intraventricular lesions extending outside the ventricle (exception to arachnoid cysts)
• Patients who are unfit for any neurosurgical interventions.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (10)

• Nduom EK, Sribnick EA, Ormond DR, Hadjipanayis CG. Neuroendoscopic Resection of Intraventricular Tumors and Cysts through a Working Channel with a Variable Aspiration Tissue Resector: A Feasibility and Safety Study. Minim Invasive Surg. 2013;2013:471805. doi: 10.1155/2013/471805. Epub 2013 Jun 13.

  PMID: 23844287 BACKGROUND

• Yasargil MG, Abdulrauf SI. Surgery of intraventricular tumors. Neurosurgery. 2008 Jun;62(6 Suppl 3):1029-40; discussion 1040-1. doi: 10.1227/01.neu.0000333768.12951.9a.

  PMID: 18695523 BACKGROUND

• Barber SM, Rangel-Castilla L, Baskin D. Neuroendoscopic resection of intraventricular tumors: a systematic outcomes analysis. Minim Invasive Surg. 2013;2013:898753. doi: 10.1155/2013/898753. Epub 2013 Sep 26.

  PMID: 24191196 BACKGROUND

• Singh I, Rohilla S, Kumar P, Krishana G. Combined microsurgical and endoscopic technique for removal of extensive intracranial epidermoids. Surg Neurol Int. 2018 Feb 14;9:36. doi: 10.4103/sni.sni_392_17. eCollection 2018.

  PMID: 29527394 BACKGROUND

• Cappabianca P, Cinalli G, Gangemi M, Brunori A, Cavallo LM, de Divitiis E, Decq P, Delitala A, Di Rocco F, Frazee J, Godano U, Grotenhuis A, Longatti P, Mascari C, Nishihara T, Oi S, Rekate H, Schroeder HW, Souweidane MM, Spennato P, Tamburrini G, Teo C, Warf B, Zymberg ST. Application of neuroendoscopy to intraventricular lesions. Neurosurgery. 2008 Feb;62 Suppl 2:575-97; discussion 597-8. doi: 10.1227/01.neu.0000316262.74843.dd.

  PMID: 18596446 BACKGROUND

• Souweidane MM, Luther N. Endoscopic resection of solid intraventricular brain tumors. J Neurosurg. 2006 Aug;105(2):271-8. doi: 10.3171/jns.2006.105.2.271.

  PMID: 17219833 BACKGROUND

• Harris AE, Hadjipanayis CG, Lunsford LD, Lunsford AK, Kassam AB. Microsurgical removal of intraventricular lesions using endoscopic visualization and stereotactic guidance. Neurosurgery. 2005 Jan;56(1 Suppl):125-32; discussion 125-32. doi: 10.1227/01.neu.0000146227.75138.08.

  PMID: 15799800 BACKGROUND

• Brunori A, de Falco R, Delitala A, Schaller K, Schonauer C. Tailoring Endoscopic Approach to Colloid Cysts of the Third Ventricle: A Multicenter Experience. World Neurosurg. 2018 Sep;117:e457-e464. doi: 10.1016/j.wneu.2018.06.051. Epub 2018 Jun 26.

  PMID: 29959067 BACKGROUND

• Yadav YR, Parihar V, Sinha M, Jain N. Endoscopic treatment of the suprasellar arachnoid cyst. Neurol India. 2010 Mar-Apr;58(2):280-3. doi: 10.4103/0028-3886.63772.

  PMID: 20508350 BACKGROUND

• Romano A, Chibbaro S, Marsella M, Oretti G, Spiriev T, Iaccarino C, Servadei F. Combined endoscopic transsphenoidal-transventricular approach for resection of a giant pituitary macroadenoma. World Neurosurg. 2010 Jul;74(1):161-4. doi: 10.1016/j.wneu.2010.02.024.

  PMID: 21300008 BACKGROUND

MeSH Terms

Interventions

Endoscopes

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Surgical Equipment

Central Study Contacts

Nour Eldin H. M. K. Imam, Masters Degree in Neurosurgery

CONTACT

+201099855603; nourimam@outlook.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer (Principal Investigator)

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: September 29, 2020
• Study Start: November 1, 2020
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 29, 2020

Record last verified: 2020-09