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Keyhole Surgery for the Positioning of the Distal Catheter in Ventricular Peritoneal Shunt Placement

NCT01739179 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2012-12-18

No results posted yet for this study

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.

Conditions

  • Ventricular Peritoneal Shunt
  • Shunt Complications
  • Shunt Failure
  • Randomized Controlled Trial

Interventions

PROCEDURE

VP Shunt Surgery for laparoscopic insertion of the peritoneal catheter

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

PROCEDURE

VP Shunt Surgery for open insertion of the peritoneal catheter

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

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Philippe E Schucht, MD · Department of Neurosurgery

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2012-02-29
Completion
2012-03-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01739179 on ClinicalTrials.gov