Keyhole Surgery for the Positioning of the Distal Catheter in Ventricular Peritoneal Shunt Placement
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|ClinicalTrials.gov Identifier: NCT01739179|
Recruitment Status : Completed
First Posted : December 3, 2012
Last Update Posted : December 18, 2012
Ventriculoperitoneal shunting (VPS) was first described at the beginning of the 20th century as a diversionary procedure in patients with a hydrocephalus. After the introduction of silastic catheters in the 1970's this method became the treatment of choice for children and adults with communicating hydrocephalus. The average patient necessitating VPS will undergo at least two shunt revisions every three years, with some patients requiring more than twenty revisions within the first year. Therefore, any technical improvement with a positive impact on the revision rate not only benefits the patient through a reduction of the surgical burden but may also have economic advantages.
Distal shunt failures - either due to improper placement or secondary dislocation of the distal catheter out of the peritoneal cavity - have been reported in 10-30% of cases. Catheter placement in obese patients and in patients with adhesions owing to previous abdominal surgery remains challenging. Most neurosurgeons will carry out a mini-laparotomy to allow for the placement of the distal catheter end within the peritoneal cavity, which rarely requires the help of a general or visceral surgeon.
An alternative to laparotomy is the laparoscopic placement of the peritoneal catheter in VPS. Retrospective series have since shown the safety of this procedure and suggested an advantage of laparoscopic VPS in terms of operation duration, length of hospital stay and the rate of distal (and thus potentially overall) shunt dysfunction.
The evidence concerning the effect of laparoscopic surgery for VPS placement is so far based on non-randomized studies, in which a selection bias may have influenced the outcomes.
|Condition or disease||Intervention/treatment|
|Ventricular Peritoneal Shunt Shunt Complications Shunt Failure Randomized Controlled Trial||Procedure: VP Shunt Surgery for laparoscopic insertion of the peritoneal catheter Procedure: VP Shunt Surgery for open insertion of the peritoneal catheter|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||120 participants|
|Official Title:||Laparoscopically Assisted Ventriculoperitoneal Shunt Placement: A Prospective, Randomized Two-arm Study|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||March 2012|
VP Shunt Surgery for laparoscopic insertion of the peritoneal catheter
Procedure: VP Shunt Surgery for laparoscopic insertion of the peritoneal catheter
Patients in this Study Arm will receive a VP Shunt inserted laparoscopically
VP Shunt Surgery for open insertion of the peritoneal catheter
Procedure: VP Shunt Surgery for open insertion of the peritoneal catheter
Patients in this Study Arm will receive a VP Shunt inserted openly
- Number of patients with overall shunt failure [ Time Frame: 12 months ]
- Number of patients with distal shunt failure [ Time Frame: 6 Weeks, 6 Months, 12 Months ]
- Number of days to resumption of full oral food intake [ Time Frame: 7 Days ]
- Amount of analgesic (NSAID) drug intake as evaluated on day 5 postoperatively, measured in mg [ Time Frame: 5 Days ]
- Duration of Operation [ Time Frame: 10 hours ]
- Duration of Hospital Stay [ Time Frame: 20 Days ]
- Time to recover full mobility [ Time Frame: 15 Days ]
- Number of patients with correct proximal and distal catheter positioning [ Time Frame: 12 Months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01739179
|Department of Neurosurgery|
|Berne, Switzerland, 3010|
|Principal Investigator:||Philippe E Schucht, MD||Department of Neurosurgery|