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.
|Hereditary Spherocytosis Idiopathic Thrombocytopenic Purpura||Procedure: Single Incision Splenectomy Procedure: Laparoscopic Splenectomy|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Single Incision Versus Standard Laparoscopic Splenectomy|
- Operative time [ Time Frame: 1 day ]operative time
- operative complications [ Time Frame: 1 day ]
- wound complications [ Time Frame: 1 month ]
- cosmesis [ Time Frame: 6 months ]
- length of stay [ Time Frame: 1 week ]
- operative difficulty [ Time Frame: 1 day ]
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||April 2017|
|Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Single Incision Splenectomy
Patients will undergo splenectomy through a single incision in the umbilicus regardless of the technique or equipment used
Procedure: Single Incision Splenectomy
Patients will undergo laparoscopic splenectomy through a single incision
Other Name: SILS
Active Comparator: Laparoscopic Splenectomy
Patient will undergo standard laparoscopic splenectomy, port placement is surgeon dependent
Procedure: Laparoscopic Splenectomy
Patients will undergo laparoscopic splenectomy with 4 ports, placement is surgeon dependent
Other Name: Standard
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276561
|United States, Missouri|
|Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|Principal Investigator:||Shawn D St. Peter, MD||Children's Mercy Hospital Kansas City|