Improvement of Peritoneal Catheter Placement in VPS With a Splitable Trocar

Hydrocephalus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05476874
• Other study ID #: ZJH-003
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2022
• Source: Southern Medical University, China
• Contact: Zhen-Zhou Chen, Dr.
• Phone: +86-2062782768
• Email: czz1020[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hydrocephalus

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Zhujiang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Southern Medical University, China

Country where clinical trial is conducted

China, 

References & Publications (3)

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 — View 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 — View Citation

Schucht P, Banz V, Trochsler M, Iff S, Krähenbühl 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 — View Citation

Outcome

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