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Improvement of Peritoneal Catheter Placement in VPS With a Splitable Trocar

Hydrocephalus Clinical Trial

Official title:
Clinical Study on Improvement of Peritoneal Catheter Placement in Ventriculoperitoneal Shunt Surgery With a Splitable Trocar

Clinical Trial Summary

This study is a phase I/IIa, single-center, open-labeled, randomized, controlled clinical trial. The aim of this study is to evaluate the safety and efficacy of a modified ventriculoperitoneal catheter placement using a splitable trocar for ventriculoperitoneal shunt.

Clinical Trial Description

This study is a phase I/IIa, single-center, open-labeled, randomized, controlled clinical trial. Patients hospitalized with hydrocephalus will be enrolled and randomly allocated into open mini-laparotomy group (OLG) or abdominal puncture group (APG) for insertion of the peritoneal catheter. Observe will followed for up to at least 6 months after surgery. The primary endpoint is the rate of overall shunt complication or failure within the first 6 months after surgery, and duration of the abdominal catheterization. The secondary endpoints are rate of distal shunt failure, the overall incidence of various adverse reactions, abdominal incision size, analgesic use as evaluated on Day 5 postoperatively, duration of hospital stay. Moreover, neurological function of patients (mRS, maxillary hydrocephalus scale) and CT measurement of Even index will also be evaluated. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05476874
Study type Interventional
Source Southern Medical University, China
Contact Zhen-Zhou Chen, Dr.
Phone +86-2062782768
Email czz1020@163.com
Status Recruiting
Phase Phase 1/Phase 2
Start date January 1, 2022
Completion date June 30, 2023
View Details
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