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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01739179
First received: November 27, 2012
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

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 Intervention
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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Laparoscopically Assisted Ventriculoperitoneal Shunt Placement: A Prospective, Randomized Two-arm Study

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Number of patients with overall shunt failure [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients with distal shunt failure [ Time Frame: 6 Weeks, 6 Months, 12 Months ] [ Designated as safety issue: No ]
  • Number of days to resumption of full oral food intake [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
  • Amount of analgesic (NSAID) drug intake as evaluated on day 5 postoperatively, measured in mg [ Time Frame: 5 Days ] [ Designated as safety issue: No ]
  • Duration of Operation [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
  • Duration of Hospital Stay [ Time Frame: 20 Days ] [ Designated as safety issue: No ]
  • Time to recover full mobility [ Time Frame: 15 Days ] [ Designated as safety issue: No ]
  • Number of patients with correct proximal and distal catheter positioning [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: March 2007
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
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
2
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Randomized are all patients who are 18 years or older; who are treated at the Department of Neurosurgery, Inselspital Bern; who are diagnosed with a Hydrocephalus and need a VP Shunt; Patients who have a Shunt malfunction and Patient who have given the written approval (informed consent)

Criteria

Inclusion Criteria:

  • Age 18 years or older
  • newly diagnosed hydrocephalus needing VP Shunt according to a board certified neurosurgeon
  • Patients with shunt-malfunction needing VP Shunt revision and replacement of the peritoneal catheter
  • Written Informed Consent

Exclusion Criteria

  • Age younger than 18 years
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739179

Locations
Switzerland
Department of Neurosurgery
Berne, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Philippe E Schucht, MD Department of Neurosurgery
  More Information

Publications:

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01739179     History of Changes
Other Study ID Numbers: 199/06
Study First Received: November 27, 2012
Last Updated: December 17, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
Ventricular peritoneal Shunt
Shunt Complications
Shunt Failure
Hydrocephalus

ClinicalTrials.gov processed this record on September 16, 2014