Improvement of Peritoneal Catheter Placement in VPS With a Splitable Trocar

Study Overview
=================
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.

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

Conditions
-----------------
Hydrocephalus

Intervention / Treatment
-----------------
* Procedure: Open Mini-Laparotomy
* Procedure: Abdominal Puncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Initial diagnosis of hydrocephalus requiring ventriculoperitoneal shunt or shunt failure requiring secondary surgery to replace the shunt. Provided written informed consent. Exclusion Criteria: Previous abdominal surgery (except ventriculoperitoneal shunt). Pregnancy Peritonitis Patients with cognitive impairment and inability to communicate. Expected survival less than 6 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open Mini-laparotomy Group (OLG)<br>Distal shunt placement through open mini-laparotomy. | Procedure: Open Mini-Laparotomy<br>* A 5-cm paraumbilical skin is made, and the abdominal wall is incised in layers. The distal catheter tip is inserted into the peritoneal cavity in a craniocaudal direction, and the abdominal wound is sutured in layers.<br>|
| Experimental: Abdominal Puncture Group （APG）<br>Distal shunt placement through abdominal puncture. | Procedure: Abdominal Puncture<br>* An about 0.5-cm paraumbilical incision made to allow introduction of a splitable trocar. The trocar is pierced through the abdominal wall into the abdominal cavity. Pull out the puncture cone, and adjust the trocar towards the pelvis. The distal catheter tip is inserted into the peritoneal cavity through the puncture cannula. Then the splitable puncture cannula is split apart and removed. The skin incision requires only one stitch.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of shunt failure | Overall rate of shunt failure requiring revision | 6 months | 
| Duration of the abdominal catheterization | Duration of the abdominal catheterization, defined as the time from abdominal incision to abdominal skin suture completed. | During the surgery | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hydrocephalus, Ventriculoperitoneal Shunt, Distal shunt failure, Trocar, Complications