Comparison of the results of ventriculoperitoneal shunt insertion and Endoscopic Third Ventriculostomy in obstractive hydrocephalus in infants less one year in children medical center hospital between 2013-2016

A randomized controlled trial to compare the effect of endoscopic third ventriculostomy versus ventriculoperitoneal shunt insertion in infants less than one year of age with obstructive hydrocephalus

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014020416483N1

Enrollment

Registered

2016-04-18

Start date

2013-03-21

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive hydrocephalus.

Interventions

Intervention 1: Endoscopic third ventriculostomy. Intervention 2: Ventriculoperitoneal Shunt.

Treatment - Surgery

Endoscopic third ventriculostomy

Ventriculoperitoneal Shunt

Eligibility

Sex/Gender

All

Age

No minimum to 1 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: All infants less than 1 year of age with obstructive hydrocephalus without any previous intervention for treatment of hydrocephalus Exclusion criteria: 1. Presence of active infection 2. Parent of legal guardian discontent to sing the informed consent form

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Absence of ?abnormal increase in head circumference. Timepoint: 6 months. Method of measurement: Clinical examination and Imaging.;?bsence of raiseed intracranial pressure (rICP) signs. Timepoint: 6 months. Method of measurement: Clinical examination and Imaging.	—

Secondary

Measure	Time frame
CSF leakage. Timepoint: Daily for 7 days and then monthly. Method of measurement: Clinical examination and Imaging.;Wound dehiscence. Timepoint: Daily for 7 days and then monthly. Method of measurement: Clinical examination.;Bleeding. Timepoint: Daily for 7 days and then monthly. Method of measurement: Clinical examination and Imaging.;Temporary ICP Rising. Timepoint: Daily for 7 days and then monthly. Method of measurement: Clinical examination and Imaging.;Requiring ETV reoperation. Timepoint: Monthly. Method of measurement: Clinical examination and Imaging.;Requiring VP shunt. Timepoint: Monthly. Method of measurement: Clinical examination and Imaging.;Permanent ICP Rising. Timepoint: Monthly. Method of measurement: Clinical examination and Imaging.;EVD. Timepoint: Daily for 7 days and then monthly. Method of measurement: Clinical examination and Imaging.;Shunt exposure. Timepoint: Daily for 7 days and then monthly. Method of measurement: Clinical examination.;Obstruction of shunt proximal end. Timepoint: Daily for 7 days and then monthly. Method of measurement: Clinical examination and Imaging.;Abdominal pseudocyst. Timepoint: Monthly. Method of measurement: Clinical examination and Imaging.;Infection. Timepoint: Daily for 7 days and then monthly. Method of measurement: Clinical examination.;Meningitis. Timepoint: Daily for 7 days and then monthly. Method of measurement: Clinical examination.;Subdural hematoma. Timepoint: Daily for 7 days and then monthly. Method of measurement: Clinical examination and Imaging.;CSF collection. Timepoint: Daily for 7 days and then monthly. Method of measurement: Clinical examination.;Shunt dehiscence. Timepoint: Daily for 7 days and then monthly. Method of measurement: Imaging.	—

Measure

Time frame

CSF leakage. Timepoint: Daily for 7 days and then monthly. Method of measurement: Clinical examination and Imaging.;Wound dehiscence. Timepoint: Daily for 7 days and then monthly. Method of measurement: Clinical examination.;Bleeding. Timepoint: Daily for 7 days and then monthly. Method of measurement: Clinical examination and Imaging.;Temporary ICP Rising. Timepoint: Daily for 7 days and then monthly. Method of measurement: Clinical examination and Imaging.;Requiring ETV reoperation. Timepoint: Monthly. Method of measurement: Clinical examination and Imaging.;Requiring VP shunt. Timepoint: Monthly. Method of measurement: Clinical examination and Imaging.;Permanent ICP Rising. Timepoint: Monthly. Method of measurement: Clinical examination and Imaging.;EVD. Timepoint: Daily for 7 days and then monthly. Method of measurement: Clinical examination and Imaging.;Shunt exposure. Timepoint: Daily for 7 days and then monthly. Method of measurement: Clinical examination.;Obstruction of shunt proximal end. Timepoint: Daily for 7 days and then monthly. Method of measurement: Clinical examination and Imaging.;Abdominal pseudocyst. Timepoint: Monthly. Method of measurement: Clinical examination and Imaging.;Infection. Timepoint: Daily for 7 days and then monthly. Method of measurement: Clinical examination.;Meningitis. Timepoint: Daily for 7 days and then monthly. Method of measurement: Clinical examination.;Subdural hematoma. Timepoint: Daily for 7 days and then monthly. Method of measurement: Clinical examination and Imaging.;CSF collection. Timepoint: Daily for 7 days and then monthly. Method of measurement: Clinical examination.;Shunt dehiscence. Timepoint: Daily for 7 days and then monthly. Method of measurement: Imaging.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Amir Amini Navai

Department of neurosurgery, Shariati Hospital, Tehran university of medical sciences, Tehran, Iran

Dr.amini62@gmail+98 912 646 6585

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026