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Improvement of Peritoneal Catheter Placement in VPS With a Splitable Trocar

S

Southern Medical University

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Hydrocephalus

Treatments

Procedure: Abdominal Puncture
Procedure: Open Mini-Laparotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT05476874
ZJH-003

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Patients aged 18 years or older with new-onset hydrocephalus, including obstructive hydrocephalus, traffic hydrocephalus and special types of hydrocephalus, normal pressure hydrocephalus (NPH), idiopathic intracranial hypertension (IIH), benign intracranial hypertension, pseudotumor cerebri, etc., regardless of gender.
  2. Initial diagnosis of hydrocephalus requiring ventriculoperitoneal shunt or shunt failure requiring secondary surgery to replace the shunt.
  3. Provided written informed consent.

Exclusion criteria

  1. Previous abdominal surgery (except ventriculoperitoneal shunt).
  2. Pregnancy
  3. Peritonitis
  4. Patients with cognitive impairment and inability to communicate.
  5. Expected survival less than 6 months

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Open Mini-laparotomy Group (OLG)
Active Comparator group
Description:
Distal shunt placement through open mini-laparotomy.
Treatment:
Procedure: Open Mini-Laparotomy
Abdominal Puncture Group (APG)
Experimental group
Description:
Distal shunt placement through abdominal puncture.
Treatment:
Procedure: Abdominal Puncture

Trial contacts and locations

1

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Central trial contact

Zhen-Zhou Chen, Dr.

Data sourced from clinicaltrials.gov

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