Improvement of Peritoneal Catheter Placement in VPS With a Splitable Trocar

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Brief Title

Improvement of Peritoneal Catheter Placement in VPS With a Splitable Trocar

Official Title

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

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 Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Rate of shunt failure

Secondary Outcome

 Rate of distal shunt failure

Condition

Hydrocephalus

Intervention

Open Mini-Laparotomy

Study Arms / Comparison Groups

 Open Mini-laparotomy Group (OLG)
Description:  Distal shunt placement through open mini-laparotomy.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

40

Start Date

January 1, 2022

Completion Date

June 30, 2023

Primary Completion Date

June 30, 2023

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Zhen-Zhou Chen, Dr., +86-2062782768, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT05476874

Organization ID

ZJH-003


Responsible Party

Principal Investigator

Study Sponsor

Southern Medical University, China


Study Sponsor

Zhen-Zhou Chen, Dr., Principal Investigator, Zhujiang Hospital


Verification Date

July 2022