Improvement of Peritoneal Catheter Placement in VPS With a Splitable Trocar

NCT05476874 | Unknown Phase 1 DMC

• 1 other identifier: ZJH-003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydrocephalus

Keywords

Hydrocephalus; Ventriculoperitoneal Shunt; Distal shunt failure; Trocar; Complications

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Rate of distal shunt failure

  6 months

• The incidence of adverse reactions

  6 months

• Abdominal incision size

  During the surgery

• The incidence of anargesic drug use

  Day 5 after surgery

• Duration of hospita stay

  During perioperative period

Study Arms (2)

Open Mini-laparotomy Group (OLG)

ACTIVE COMPARATOR

Distal shunt placement through open mini-laparotomy.

Procedure: Open Mini-Laparotomy

Abdominal Puncture Group （APG）

EXPERIMENTAL

Distal shunt placement through abdominal puncture.

Procedure: Abdominal Puncture

Interventions

Open Mini-Laparotomy PROCEDURE

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.

Open Mini-laparotomy Group (OLG)

Abdominal Puncture PROCEDURE

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.

Abdominal Puncture Group （APG）

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Southern Medical University, China: lead

Study Sites (1)

Zhujiang Hospital, Southern Medical University

Guangzhou, Guangdong, 510282, China

RECRUITING

Related Publications (3)

• Schucht P, Banz V, Trochsler M, Iff S, Krahenbuhl AK, Reinert M, Beck J, Raabe A, Candinas D, Kuhlen D, Mariani L. Laparoscopically assisted ventriculoperitoneal shunt placement: a prospective randomized controlled trial. J Neurosurg. 2015 May;122(5):1058-67. doi: 10.3171/2014.9.JNS132791. Epub 2014 Dec 23.

  PMID: 25534231 RESULT

• Gravbrot N, Aguilar-Salinas P, Walter CM, Dumont TM. Laparoscopically Assisted Ventriculoperitoneal Shunt Placement Is not Cost-Effective nor Preventive for Distal Shunt Malfunction. World Neurosurg. 2020 May;137:e308-e314. doi: 10.1016/j.wneu.2020.01.193. Epub 2020 Feb 3.

  PMID: 32028009 RESULT

• Lou M, Zhou G, Zhao Y. The application of improved abdominal wall punctures technique in ventriculoperitoneal shunt for hydrocephalus: a retrospective analysis versus open mini-laparotomy. Br J Neurosurg. 2018 Dec;32(6):650-652. doi: 10.1080/02688697.2018.1429564. Epub 2018 Jan 24.

  PMID: 29363332 RESULT

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Zhen-Zhou Chen, Dr.

  Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhen-Zhou Chen, Dr.

CONTACT

+86-2062782768; czz1020@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 27, 2022
• Study Start: January 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)