Single Incision Versus Standard Laparoscopic Splenectomy

• operative complications [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
• wound complications [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
• cosmesis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
• length of stay [ Time Frame: 1 week ] [ Designated as safety issue: No ]
• operative difficulty [ Time Frame: 1 day ] [ Designated as safety issue: No ]

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.

• Hereditary Spherocytosis
• Idiopathic Thrombocytopenic Purpura

• Procedure: Single Incision Splenectomy
  Patients will undergo laparoscopic splenectomy through a single incision
  Other Name: SILS
• Procedure: Laparoscopic Splenectomy
  Patients will undergo laparoscopic splenectomy with 4 ports, placement is surgeon dependent
  Other Name: Standard

• Active Comparator: Single Incision Splenectomy
  Patients will undergo splenectomy through a single incision in the umbilicus regardless of the technique or equipment used
  Intervention: Procedure: Single Incision Splenectomy
• Active Comparator: Laparoscopic Splenectomy
  Patient will undergo standard laparoscopic splenectomy, port placement is surgeon dependent
  Intervention: Procedure: Laparoscopic Splenectomy

Inclusion Criteria:

• Need for splenectomy

Exclusion Criteria:

• Splenomegaly