Improvement of Peritoneal Catheter Placement in VPS With a Splitable Trocar

July 27, 2022 updated by: Zhen-Zhou Chen, Southern Medical University, China

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Zhen-Zhou Chen, Dr.
  • Phone Number: +86-2062782768
  • Email: czz1020@163.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510282
        • Recruiting
        • Zhujiang Hospital, Southern Medical University
        • Contact:
          • Zhen-Zhou Chen, MD., phD.
          • Phone Number: +86-20-62782768
          • Email: czz1020@163.com
        • Principal Investigator:
          • Zhen-Zhou Chen, MD., phD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southern Medical University, China

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

July 21, 2022

First Submitted That Met QC Criteria

July 25, 2022

First Posted (Actual)

July 27, 2022

Study Record Updates

Last Update Posted (Actual)

August 1, 2022

Last Update Submitted That Met QC Criteria

July 27, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZJH-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hydrocephalus

Clinical Trials on Open Mini-Laparotomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe