Improvement of Peritoneal Catheter Placement in VPS With a Splitable Trocar

Phase 1

• Conditions: Hydrocephalus
• Interventions: Procedure: Open Mini-Laparotomy; Procedure: Abdominal Puncture

• Registration Number: NCT05476874
• Lead Sponsor: Southern Medical University, China

Brief 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.

Detailed 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 Timeline

• Study Start: 2022-01-01
• Status Verified: 2022-07
• Study First Submitted: 2022-07-21
• Study First Submitted QC: 2022-07-25
• Study First Posted: 2022-07-27
• Last Update Submitted: 2022-07-27
• Last Update Posted: 2022-08-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open Mini-laparotomy Group (OLG)	Open Mini-Laparotomy	Distal shunt placement through open mini-laparotomy.
Abdominal Puncture Group （APG）	Abdominal Puncture	Distal shunt placement through abdominal puncture.

Primary Outcome Measures

Name	Time	Method
Rate of shunt failure	6 months	Overall rate of shunt failure requiring revision
Duration of the abdominal catheterization	During the surgery	Duration of the abdominal catheterization, defined as the time from abdominal incision to abdominal skin suture completed.

Secondary Outcome Measures

Name	Time	Method
Abdominal incision size	During the surgery	Abdominal incision size
The incidence of anargesic drug use	Day 5 after surgery	The incidence of anargesic drug use as evaluated on day 5 postoperatively
Rate of distal shunt failure	6 months	Rate of distal shunt failure requiring revision
The incidence of adverse reactions	6 months	The overall incidence of various adverse reactions
Duration of hospita stay	During perioperative period	Duration of hospita stay, defined as day of admission until discharge from the neurosurgical ward.

Trial Locations

Locations (1)

Zhujiang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China