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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
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.
Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGRate of shunt failure
Overall rate of shunt failure requiring revision
Time frame: 6 months
Duration of the abdominal catheterization
Duration of the abdominal catheterization, defined as the time from abdominal incision to abdominal skin suture completed.
Time frame: During the surgery
Rate of distal shunt failure
Rate of distal shunt failure requiring revision
Time frame: 6 months
The incidence of adverse reactions
The overall incidence of various adverse reactions
Time frame: 6 months
Abdominal incision size
Abdominal incision size
Time frame: During the surgery
The incidence of anargesic drug use
The incidence of anargesic drug use as evaluated on day 5 postoperatively
Time frame: Day 5 after surgery
Duration of hospita stay
Duration of hospita stay, defined as day of admission until discharge from the neurosurgical ward.
Time frame: During perioperative period
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