Idiopathic Thrombocytopenic Purpura Clinical Trial
Official title:
Single Incision Versus Standard Laparoscopic Splenectomy
This is a prospective trial of single incision versus standard 4-port laparoscopic
splenectomy.
The hypothesis is that there may be a difference in wound infection rates, operative time,
doses of analgesics post-operatively, and patient/parent perception of scars. However, the
technical difficulty is considerable and the primary outcome is operative time which will be
expressed in minutes.
This will be a prospective, randomized clinical trial involving patients who present to the
hospital with an indication for splenectomy. We will offer enrollment to several
institutions provided they reach institutional approval.
This will be a definitive trial design. Based on our operative times with SILS compared with
our recent experience in standard laparoscopy, a sample size of 30 patients will give us a
power of 0.8 with an α of 0.05. Thus operative time is the primary outcome variable by
definition. This is recorded and reported in MINUTES.
After the procedure, both groups will be managed in the same manner per routine care. They
will be discharged when tolerating a regular diet and their pain is well-controlled on oral
pain medication.
Secondary outcome measures include days in the hospital (measured in days), doses of
analgesics (measured in doses) and perception of cosmesis as recorded by a scar assessment
form which will be filled out by the patient and/or parents at 6 weeks and 6 months. This is
a validated quality of life survey with 39 questions and each has 4 categories from best to
worst.
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