Improvement of Peritoneal Catheter Placement in VPS With a Splitable Trocar

• Sponsor: Southern Medical University, China (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05476874
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 17.9
• Patients Per Site Per Month: 2.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hydrocephalus	Procedure: Open Mini-Laparotomy; Procedure: Abdominal Puncture	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Study on Improvement of Peritoneal Catheter Placement in Ventriculoperitoneal Shunt Surgery With a Splitable Trocar
• Actual Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Rate of shunt failure [6 months]

   Overall rate of shunt failure requiring revision

2. Duration of the abdominal catheterization [During the surgery]

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

Secondary Outcome Measures

1. Rate of distal shunt failure [6 months]

   Rate of distal shunt failure requiring revision

2. The incidence of adverse reactions [6 months]

   The overall incidence of various adverse reactions

3. Abdominal incision size [During the surgery]

   Abdominal incision size

4. The incidence of anargesic drug use [Day 5 after surgery]

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

5. Duration of hospita stay [During perioperative period]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhujiang Hospital, Southern Medical University	Guangzhou	Guangdong	China	510282

Sponsors and Collaborators

• Southern Medical University, China

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhen-Zhou Chen, Clinical Professor, Southern Medical University, China
• ClinicalTrials.gov Identifier: NCT05476874
• Other Study ID Numbers: ZJH-003
• First Posted: Jul 27, 2022
• Last Update Posted: Aug 1, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zhen-Zhou Chen, Clinical Professor, Southern Medical University, China: Hydrocephalus; Ventriculoperitoneal Shunt; Distal shunt failure; Trocar; Complications
• Additional relevant MeSH terms: Hydrocephalus

Study Results

No Results Posted as of Aug 1, 2022