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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Mini-laparotomy Group (OLG) | Active Comparator | Distal shunt placement through open mini-laparotomy. |
|
| Abdominal Puncture Group (APG) | Experimental | Distal shunt placement through abdominal puncture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open Mini-Laparotomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of shunt failure | Overall rate of shunt failure requiring revision | 6 months |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of distal shunt failure | Rate of distal shunt failure requiring revision | 6 months |
| The incidence of adverse reactions | The overall incidence of various adverse reactions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhen-Zhou Chen, Dr. | Contact | +86-2062782768 | czz1020@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhen-Zhou Chen, Dr. | Zhujiang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhujiang Hospital, Southern Medical University | Recruiting | Guangzhou | Guangdong | 510282 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25534231 | Result | 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. | |
| 32028009 | Result |
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| ID | Term |
|---|---|
| D006849 | Hydrocephalus |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Abdominal Puncture | Procedure | 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. |
|
| 6 months |
| Abdominal incision size | Abdominal incision size | During the surgery |
| The incidence of anargesic drug use | The incidence of anargesic drug use as evaluated on day 5 postoperatively | Day 5 after surgery |
| Duration of hospita stay | Duration of hospita stay, defined as day of admission until discharge from the neurosurgical ward. | During perioperative period |
| 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. |
| 29363332 | Result | 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. |