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Improvement of Peritoneal Catheter Placement in VPS With a Splitable Trocar

Primary Purpose

Hydrocephalus

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Open Mini-Laparotomy

Abdominal Puncture

About this trial

This is an interventional treatment trial for Hydrocephalus focused on measuring Hydrocephalus, Ventriculoperitoneal Shunt, Distal shunt failure, Trocar, Complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Zhujiang Hospital, Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Open Mini-laparotomy Group (OLG)

Abdominal Puncture Group （APG）

Arm Description

Distal shunt placement through open mini-laparotomy.

Distal shunt placement through abdominal puncture.

Outcomes

Primary Outcome Measures

Rate of shunt failure

Overall rate of shunt failure requiring revision

Duration of the abdominal catheterization

Duration of the abdominal catheterization, defined as the time from abdominal incision to abdominal skin suture completed.

Secondary Outcome Measures

Rate of distal shunt failure

Rate of distal shunt failure requiring revision

The incidence of adverse reactions

The overall incidence of various adverse reactions

Abdominal incision size

The incidence of anargesic drug use

The incidence of anargesic drug use as evaluated on day 5 postoperatively

Duration of hospita stay

Duration of hospita stay, defined as day of admission until discharge from the neurosurgical ward.

Full Information

NCT ID

NCT05476874

First Posted

July 21, 2022

Last Updated

July 27, 2022

Sponsor

Southern Medical University, China

1. Study Identification

Unique Protocol Identification Number

NCT05476874

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2022 (Actual)

Primary Completion Date

June 30, 2023 (Anticipated)

Study Completion Date

June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Southern Medical University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hydrocephalus

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Open Mini-laparotomy Group (OLG)

Arm Type

Active Comparator

Arm Description

Distal shunt placement through open mini-laparotomy.

Arm Title

Abdominal Puncture Group （APG）

Arm Type

Experimental

Arm Description

Distal shunt placement through abdominal puncture.

Intervention Type

Procedure

Intervention Name(s)

Open Mini-Laparotomy

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Abdominal Puncture

Intervention Description

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.

Primary Outcome Measure Information:

Title

Rate of shunt failure

Description

Overall rate of shunt failure requiring revision

Time Frame

6 months

Title

Duration of the abdominal catheterization

Description

Duration of the abdominal catheterization, defined as the time from abdominal incision to abdominal skin suture completed.

Time Frame

During the surgery

Secondary Outcome Measure Information:

Title

Rate of distal shunt failure

Description

Rate of distal shunt failure requiring revision

Time Frame

6 months

Title

The incidence of adverse reactions

Description

The overall incidence of various adverse reactions

Time Frame

6 months

Title

Abdominal incision size

Description

Abdominal incision size

Time Frame

During the surgery

Title

The incidence of anargesic drug use

Description

The incidence of anargesic drug use as evaluated on day 5 postoperatively

Time Frame

Day 5 after surgery

Title

Duration of hospita stay

Description

Duration of hospita stay, defined as day of admission until discharge from the neurosurgical ward.

Time Frame

During perioperative period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhen-Zhou Chen, Dr.

Phone

+86-2062782768

czz1020@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhen-Zhou Chen, Dr.

Organizational Affiliation

Zhujiang Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhujiang Hospital, Southern Medical University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510282

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhen-Zhou Chen, MD., phD.

Phone

+86-20-62782768

czz1020@163.com

First Name & Middle Initial & Last Name & Degree

Zhen-Zhou Chen, MD., phD.

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25534231

Citation

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.

Results Reference

result

PubMed Identifier

32028009

Citation

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.

Results Reference

result

PubMed Identifier

29363332

Citation

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.

Results Reference

result

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Improvement of Peritoneal Catheter Placement in VPS With a Splitable Trocar

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