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

NCT01739179 | Completed

• 1 other identifier: 199/06
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ventricular peritoneal Shunt; Shunt Complications; Shunt Failure; Hydrocephalus

Outcome Measures

Primary Outcomes (1)

• Number of patients with overall shunt failure

  12 months

Secondary Outcomes (7)

• Number of patients with distal shunt failure

  6 Weeks, 6 Months, 12 Months

• Number of days to resumption of full oral food intake

  7 Days

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

  5 Days

• Duration of Operation

  10 hours

• Duration of Hospital Stay

  20 Days

Study Arms (2)

1

VP Shunt Surgery for laparoscopic insertion of the peritoneal catheter

Procedure: VP Shunt Surgery for laparoscopic insertion of the peritoneal catheter

2

VP Shunt Surgery for open insertion of the peritoneal catheter

Procedure: VP Shunt Surgery for open insertion of the peritoneal catheter

Interventions

VP Shunt Surgery for laparoscopic insertion of the peritoneal catheter PROCEDURE

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

1

VP Shunt Surgery for open insertion of the peritoneal catheter PROCEDURE

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• Age younger than 18 years
• Pregnancy

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Neurosurgery

Bern, 3010, Switzerland

Location

Related Publications (13)

• 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.

  PMID: 6019744 RESULT

• 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.

  PMID: 6065126 RESULT

• 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.

  PMID: 4431676 RESULT

• 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.

  PMID: 9457261 RESULT

• 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.

  PMID: 6888697 RESULT

• 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.

  PMID: 5916956 RESULT

• 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.

  PMID: 8443096 RESULT

• 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.

  PMID: 8845504 RESULT

• 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.

  PMID: 16636616 RESULT

• 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.

  PMID: 8231270 RESULT

• 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.

  PMID: 10890971 RESULT

• 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.

  PMID: 15492657 RESULT

• 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.

  PMID: 25534231 DERIVED

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Philippe E Schucht, MD

  Department of Neurosurgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: December 3, 2012
• Study Start: March 1, 2007
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: December 18, 2012

Record last verified: 2012-12

Locations

CH (1)