The main objective of the study is to address the relative efficacy of botulinum toxin and 2-duct ligation in children with cerebral palsy, who suffer from severe drooling despite maximal conservative treatment.
ID
Source
Brief title
Condition
- Congenital and peripartum neurological conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of the study is the extent of drooling. This is mainly
assessed using the drooling quotient and a VAS-score. Both methods have been
used significantly.
The drooling quotient is a validated tool to semi-objectively quantify the
extent of drooling. During two ten-minute sessions, the absence or presence of
new saliva on the lip is recorded every fifteen seconds. The first session is
performed while resting, the second while a child is distracted. The drooling
quotient is obtained by dividing the number of observed drooling episodes by
0.4. The resulting quotient reflects the relative time a person drools.
The VAS is recorded by parents or caretakes, to investigate therapy results as
experienced in the home situation. Scales of exactly 10 cm without visible
subdivisions are presented, on which the average degree of drooling severity
during the 10 to 14 days before assessment is to be indicated. A mark at the
left end represents severe drooling; a mark at the right end means no drooling.
Secondary outcome
Secondary outcomes are the extent of drooling, quality of life, complications,
admission time and duration of the procedure.
Background summary
Drooling is a serious clinical issue, affecting approximately 10-37% of all
children with cerebral palsy. Involuntary loss of saliva is associated with
significant morbidity. Although various treatments have been developed, little
evidence exists regarding the relative efficacy of these approaches. It is,
however, clear that surgery is among the most effective interventions.
Rerouting the duct of the submandibular gland from the front of the mouth to
the base of the tongue (submandibular duct relocation) has been the most common
surgical technique for the past 20 years. Although this procedure is effective
and relatively safe, it requires a hospital admission of several days,
including one night of observation on an intensive care unit. This procedure is
therefore a 'last resort' for involuntary saliva loss in the UMC St Radboud.
The invasiveness of submandibular duct relocation has led to the rise of a less
invasive operation for various forms of drooling. This procedure involves
ligating or clipping the submandibular ducts rather than rerouting them. Case
series have described this as an effective and safe technique. Its main
advantage over other approaches are drastically reduced operative times and
days of admission. The procedure is commonly performed in daycare surgery and
does not require admission to an intensive care unit. Especially for these
vulnerable children, the reduced operative morbidity is a tremendous advantage.
Experience with this procedure in the UMC St Radboud is so favourable that we
intend to use it extensively in the future.
The most important alternative to surgery are botulinum toxin injections into
the salivary glands. This procedure is in broad use since the beginning in the
millennium, and has been extensively studied in the UMC St Radboud (among other
international academic centres). This treatment is minimally invasive, and is
therefore a first-line treatment for patients that do not respond well to (or
are not eligible for) conservative measures. The main disadvantage of botulinum
toxin is the fact that its effects are by definition temporary. Children will
therefore frequently have to undergo multiple repeated injections. The decision
of whether a repeated intervention has to be in the form of another botulinum
toxin injection, or a more permanent solution in the form of surgery, is
therefore often difficult.
The introduction of duct ligation as a treatment for drooling has made this
choice even more complex. The reduced morbidity of the procedure compared to
submandibular duct relocation, could for instance mean that wider use of
surgery (rather than repeated injection with botulinum toxin) is indicated. To
date however, there is absolutely no comparative information regarding the
relative effectiveness, duration and morbidity of botulinum toxin and 2-duct
ligation. It is important to address this gap in scientific knowledge, as the
choice between these treatments will frequently occur in clinical practice.
Good comparative information would allow further development of an optimal
treatment protocol for this vulnerable group of children.
Study objective
The main objective of the study is to address the relative efficacy of
botulinum toxin and 2-duct ligation in children with cerebral palsy, who suffer
from severe drooling despite maximal conservative treatment.
Study design
The study is designed as a randomized controlled trial. Included patients are
treated by (repeated) injection of botulinum toxin, or surgical ligation of the
submandibular ducts (2-duct ligation).
Intervention
Participants in the study undergo either injection with botulinum toxin or
2-duct ligation. Both procedures are performed in daycare surgery.
A) 2-duct ligation
The patient is put under general anesthesia. The floor of the mouth is
infiltrated with a lidocaine/adrenaline solution. The floor of the mouth is
opened around the orifice of the submandibular duct, and the submandibular duct
is dissected distally. When the submandibular duct has been dissected
sufficiently, it is clipped with vascular clips on two positions approximately
1 cm apart. The procedure is repeated on the contralateral side, and the floor
of the mouth is sutured.
Standard peri-operative medication consists of co-amoxiclav for 7 days, and
diclofenac for analgesia.
B) Botulinum toxin
Using general anesthesia, 25U of botulinum toxin (Botox; Allergan, Nieuwegein,
Netherlands), reconstituted with 0.9% sodium chloride solution, is injected
bilaterally in the submandibular glands using a 25-G needle and a 1-mL syringe.
On injection, each dose is fractionated and divided over minimally 3 sites in
the gland using ultrasound guidance.
Study burden and risks
The study does not carry any specific risks. The treatments in the study are
also performed routinely in regular clinical practice, and have a good record
for safety. The follow-up protocol of the study is not associated with
increased risks.
The additional burden of participation is relatively limited, and adds up to a
total of 1.5 hrs (informed consent, additional follow-up two weeks after
procedure).
Philips van Leydenlaan 15
6525EX
NL
Philips van Leydenlaan 15
6525EX
NL
Listed location countries
Age
Inclusion criteria
- Age 6 years or above
- Cerebral palsy or other non-progressive neurological disease
- Severe drooling (Drooling Frequency >=3; Drooling Severity >=2)
- Conservative treatment has not led to adequate reduction of droolng
- Informed consent
- Cognitive ability of parents is adequate to participate in the study, as judged by the researchers.
- Participants are motived to return for follow up after 2, 8 and 32 weeks.
Exclusion criteria
- Concurrent participation in other medical study
- Previous surgery or anatomical abnormalities that prohibit either application of botulinum toxin or surgery
- Concurrent other treatment for drooling
- Use of benzodiazepines
- Allergy to botulinum toxin or other contraindication for botulinumtoxin or surgery.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL26144.091.11 |