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Ventricular Peritoneal ShuntNCT01739179

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

An observational study of Ventricular Peritoneal Shunt and Shunt Complications, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
VP Shunt Surgery for laparoscopic insertion of the peritoneal catheter and VP Shunt Surgery for open insertion of the peritoneal catheter
Type of treatment
Surgery or procedure
How many people
120 participants
Where
1 siteSwitzerland
Study dates
Mar 2007to Mar 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Who may be able to join

  • 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

Who cannot join

  • Age younger than 18 years
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Department of Neurosurgery

    Bern, 3010

Other trials in Switzerland

About this study

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

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.

Read more

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.

Read the detailed description

Background

Ventriculoperitoneal shunting (VPS) as diversionary procedure in patients with hydrocephalus was first described in 1908. After the introduction of silastic catheters during the 1970s this method has become the treatment of choice for children and adults with communicating hydrocephalus. However, the average patient having had VPS will undergo 2.1 shunt revisions every 3 years of life, with a wide range from no revisions during the first decade to up to 21 revisions within the first year. For this reason technical improvements impacting positively on the revision rate and on the surgical burden are strongly needed.

In the standard VPS procedure the proximal part of the shunt is first placed in one of the lateral ventricles. The distal part of the shunt is then tunneled subcutaneously from the head to the abdomen, where 20-25 cm of the distal catheter and the tip are introduced in the peritoneal cavity through a paraumbilical mini-laparotomy. The intraperitoneal placement of the distal catheter is performed blindly, whereby the tip of the catheter is directed caudally in direction of the pelvis in order to avoid kinking and potential strangulation of the catheter. In this setting the functionality of the system can be estimated by feeling the resistance to out- and inflow while manually pumping the reservoir near the valve at the cranial level.

Distal shunt failure has been reported to occur in 10-30% of cases. Secondary dislocation of the peritoneal catheter in the subcutaneous tissue or its improper placement in the peritoneal cavity during the procedure both contribute to this high shunt failure rate. Furthermore, blind catheter placement in obese patients and in patients with adhesions from previous abdominal surgery can be a challenge and may lead to injuries of the intra-abdominal organs.

In 1993, Bassauri et al reported on the laparoscopic placement of the peritoneal catheter in VPS. Since then several, small retrospective series have shown good results in laparoscopic VPS, both in terms of efficacy and safety, in adults and in children. Two larger series were published recently. Schubert et al. reported a prospective study on 50 adult patients using the laparoscopically assisted peritoneal shunt insertion. A retrospective cohort of 50 matched patients served as a control. They reported no intraoperative complications, a longer operation time in the laparoscopic group (59 versus 49 minutes), 2 malfunctions (4%) and 1 infection in the laparoscopic group (2%) and 6 malfunctions (12%) and 6 infections (12%) in the historic cohort, the difference being statistically significant in favour of the laparoscopic group. In the most recent and largest series published to date, Bani et al. report on their experience with 151 patients, where the peritoneal catheter was implanted using a laparoscopic technique. They also used a retrospective cohort of 50 non-laparoscopy patients as a control. The operation time was slightly longer using the laparoscopic technique (35-130 versus 30-120 minutes), the infection rate was 2% in both groups. They describe no dislocation of the distal catheter in the abdominal wall and no malpositioning of the distal catheter in the laparoscopic group and 4 such cases in the non-laparoscopy group (8%).

In summary, these non-randomized trials suggest the safety of the procedure. The laparoscopic technique offers at least theoretically some significant advantages over the standard technique. The laparoscopic introduction of the peritoneal catheter allows for intra-abdominal inspection, lyses of adhesions whenever necessary, confirmation of the catheter position, and the visual assessment of cerebrospinal fluid (CSF) flow through the catheter tip during the procedure. Due to the minimal trauma to the abdominal wall the laparoscopic access also has the potential of reducing postoperative adhesions, wound complications and the overall postoperative morbidity. Despite these theoretical advantages, however, comparative, randomized data are lacking and ventriculoperitoneal shunting is still performed through a minilaparotomy in the vast majority of neurosurgical centres. The absence of scientific evidence favouring the laparoscopic technique, the lack of training of neurosurgeons in laparoscopic techniques and the potential prolongation of the operating time (and potentially a higher risk of infection) are probably the main reasons to explain why the shift to the laparoscopic technique has not yet taken place. Also, theoretically, the inflation of the peritoneal cavity for laparoscopy could potentially generate an acute hydrocephalus (e.g. during a distal revision) due to the elimination of the pressure gradient necessary to obtain flow of CSF into the peritoneal cavity.

These potential limitations warrant, in our view, a prospective, randomized, controlled trial comparing the standard (minilaparotomy) technique. The demonstration of the superiority of the laparoscopic technique in a prospective, randomized study has the potential of changing the standard of care for patients with hydrocephalus needing shunting.

Methods

120 patients scheduled for VPS surgery were randomised for laparoscopic or open insertion of the peritoneal catheter. The primary endpoint was the rate of overall shunt complication/failure after 12 months. Secondary endpoints were distal shunt failure rate at 6 weeks, 6 months and 12 months, overall complication/failure at 6 weeks and 6 months, duration of surgery and hospitalisation, and morbidity.

Being tested
VP Shunt Surgery for laparoscopic insertion of the peritoneal catheter, VP Shunt Surgery for open insertion of the peritoneal catheter
Keywords
Ventricular peritoneal Shunt, Shunt Complications, Shunt Failure, Hydrocephalus
Medical subject headings
Hydrocephalus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VP Shunt Surgery for laparoscopic insertion of the peritoneal catheterProcedure or surgery

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

  • VP Shunt Surgery for open insertion of the peritoneal catheterProcedure or surgery

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

Study groups in NCT01739179
Study groupRoleWhat they receive
1VP Shunt Surgery for laparoscopic insertion of the peritoneal catheter
Receives: Procedure: VP Shunt Surgery for laparoscopic insertion of the peritoneal catheter
2VP Shunt Surgery for open insertion of the peritoneal catheter
Receives: Procedure: VP Shunt Surgery for open insertion of the peritoneal catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with overall shunt failure

    Measured: 12 months

Secondary outcomes (7)
  1. Number of patients with distal shunt failure

    Measured: 6 Weeks, 6 Months, 12 Months

  2. Number of days to resumption of full oral food intake

    Measured: 7 Days

  3. Amount of analgesic (NSAID) drug intake as evaluated on day 5 postoperatively, measured in mg

    Measured: 5 Days

  4. Duration of Operation

    Measured: 10 hours

  5. Duration of Hospital Stay

    Measured: 20 Days

  6. Time to recover full mobility

    Measured: 15 Days

  7. Number of patients with correct proximal and distal catheter positioning

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2012 (estimated)
  2. Study startMar 2007
  3. Primary completionFeb 2012
  4. Study completionMar 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01739179
Sponsor's protocol ID
199/06
Status last verified
Dec 2012
First submitted
27 Nov 2012
Last updated
18 Dec 2012
Results posted
No
Data monitoring committee
No

Publications

  • Raimondi AJ, Matsumoto S. A simplified technique for performing the ventriculo-peritoneal shunt. Technical note. J Neurosurg. 1967 Mar;26(3):357-60. doi: 10.3171/jns.1967.26.3.0357. No abstract available.

    PubMed 6019744
  • Ames RH. Ventriculo-peritoneal shunts in the management of hydrocephalus. J Neurosurg. 1967 Dec;27(6):525-9. doi: 10.3171/jns.1967.27.6.0525. No abstract available.

    PubMed 6065126
  • Grosfeld JL, Cooney DR, Smith J, Campbell RL. Intra-abdominal complications following ventriculoperitoneal shunt procedures. Pediatrics. 1974 Dec;54(6):791-6. No abstract available.

    PubMed 4431676
  • Khosrovi H, Kaufman HH, Hrabovsky E, Bloomfield SM, Prabhu V, el-Kadi HA. Laparoscopic-assisted distal ventriculoperitoneal shunt placement. Surg Neurol. 1998 Feb;49(2):127-34; discussion 134-5. doi: 10.1016/s0090-3019(97)00357-1.

    PubMed 9457261
  • Abu-Dalu K, Pode D, Hadani M, Sahar A. Colonic complications of ventriculoperitoneal shunts. Neurosurgery. 1983 Aug;13(2):167-9. doi: 10.1227/00006123-198308000-00011.

    PubMed 6888697
  • Wilson CB, Bertan V. Perforation of the bowel complicating peritoneal shunt for hydrocephalus. Report of two cases. Am Surg. 1966 Sep;32(9):601-3. No abstract available.

    PubMed 5916956
  • Basauri L, Selman JM, Lizana C. Peritoneal catheter insertion using laparoscopic guidance. Pediatr Neurosurg. 1993 Mar-Apr;19(2):109-10. doi: 10.1159/000120711.

    PubMed 8443096
  • Cuatico W, Vannix D. Laparoscopically guided peritoneal insertion in ventriculoperitoneal shunts. J Laparoendosc Surg. 1995 Oct;5(5):309-11. doi: 10.1089/lps.1995.5.309.

    PubMed 8845504
  • Bani A, Hassler WE. Laparoscopy-guided insertion of peritoneal catheters in ventriculoperitoneal shunt procedures: analysis of 39 children. Pediatr Neurosurg. 2006;42(3):156-8. doi: 10.1159/000091858.

    PubMed 16636616
  • Schievink WI, Wharen RE Jr, Reimer R, Pettit PD, Seiler JC, Shine TS. Laparoscopic placement of ventriculoperitoneal shunts: preliminary report. Mayo Clin Proc. 1993 Nov;68(11):1064-6. doi: 10.1016/s0025-6196(12)60899-4.

    PubMed 8231270
  • Reardon PR, Scarborough TK, Matthews BD, Marti JL, Preciado A. Laparoscopically assisted ventriculoperitoneal shunt placement using 2-mm instrumentation. Surg Endosc. 2000 Jun;14(6):585-6. doi: 10.1007/s004640020078.

    PubMed 10890971
  • Kirshtein B, Benifla M, Roy-Shapira A, Merkin V, Melamed I, Cohen Z, Cohen A. Laparoscopically guided distal ventriculoperitoneal shunt placement. Surg Laparosc Endosc Percutan Tech. 2004 Oct;14(5):276-8. doi: 10.1097/00129689-200410000-00009.

    PubMed 15492657
  • 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.

    PubMed 25534231

Questions about this trial

What is this clinical trial studying?

An observational study of Ventricular Peritoneal Shunt and Shunt Complications, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with overall shunt failure (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01739179, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2012.

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