Single Incision Versus Standard Laparoscopic Splenectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Single Incision Versus Standard Laparoscopic Splenectomy

Conditions
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Hereditary Spherocytosis, Idiopathic Thrombocytopenic Purpura

Intervention / Treatment
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* Procedure: Single Incision Splenectomy
* Procedure: Laparoscopic Splenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Need for splenectomy Exclusion Criteria: Splenomegaly

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single Incision Splenectomy<br>Patients will undergo splenectomy through a single incision in the umbilicus regardless of the technique or equipment used | Procedure: Single Incision Splenectomy<br>* Patients will undergo laparoscopic splenectomy through a single incision<br>* Other names: SILS;|
| Active Comparator: Laparoscopic Splenectomy<br>Patient will undergo standard laparoscopic splenectomy, port placement is surgeon dependent | Procedure: Laparoscopic Splenectomy<br>* Patients will undergo laparoscopic splenectomy with 4 ports, placement is surgeon dependent<br>* Other names: Standard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | operative time | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative complications |  | 1 day | 
| wound complications |  | 1 month | 
| cosmesis |  | 6 months | 
| length of stay |  | 1 week | 
| operative difficulty |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopy, splenectomy, single site, trial