Clinical trial NCT05476874: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Hydrocephalus
Keywords: Hydrocephalus
Ventriculoperitoneal Shunt
Distal shunt failure
Trocar
Complications
Lead sponsor: Southern Medical University, China
Sponsor class: OTHER
First posted: 2022-07-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of shunt failure
timeFrame: 6 months
measure: Duration of the abdominal catheterization
timeFrame: During the surgery
Secondary outcomes:
measure: Rate of distal shunt failure
timeFrame: 6 months
measure: The incidence of adverse reactions
timeFrame: 6 months
measure: Abdominal incision size
timeFrame: During the surgery
measure: The incidence of anargesic drug use
timeFrame: Day 5 after surgery
measure: Duration of hospita stay
timeFrame: During perioperative period
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Zhujiang Hospital
name: Zhen-Zhou Chen, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.