CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
VP Shunt Surgery for laparoscopic insertion of the peritoneal catheter +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01739179
NCT01739179N/ACompleted

Laparoscopically Assisted Ventriculoperitoneal Shunt Placement: A Prospective, Randomized Two-arm Study

Insel Gruppe AG, University Hospital Bern·observational·Posted Dec 3, 2012·Updated Dec 18, 2012

In Brief

An observational study evaluating VP Shunt Surgery for laparoscopic insertion of the peritoneal catheter and VP Shunt Surgery for open insertion of the peritoneal catheter for Ventricular Peritoneal Shunt and 3 related conditions. Completed, enrolled 120 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSwitzerland
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 3, 2012
Enrollment StartMar 1, 2007
Primary CompletionFeb 1, 2012
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 13.6 years ago

Interventions

VP Shunt Surgery for laparoscopic insertion of the peritoneal catheterprocedure

Patients in this Study Arm will receive a VP Shunt inserted laparoscopically

VP Shunt Surgery for open insertion of the peritoneal catheterprocedure

Patients in this Study Arm will receive a VP Shunt inserted openly