- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01276561
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
Kansas City, Missouri, United States, 64108
- Children's Mercy Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Need for splenectomy
Exclusion Criteria:
- Splenomegaly
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Single Incision Splenectomy
Patients will undergo splenectomy through a single incision in the umbilicus regardless of the technique or equipment used
|
Patients will undergo laparoscopic splenectomy through a single incision
Other Names:
|
ACTIVE_COMPARATOR: Laparoscopic Splenectomy
Patient will undergo standard laparoscopic splenectomy, port placement is surgeon dependent
|
Patients will undergo laparoscopic splenectomy with 4 ports, placement is surgeon dependent
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operative time
Time Frame: 1 day
|
operative time
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
length of stay
Time Frame: 1 week
|
1 week
|
operative complications
Time Frame: 1 day
|
1 day
|
wound complications
Time Frame: 1 month
|
1 month
|
cosmesis
Time Frame: 6 months
|
6 months
|
operative difficulty
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Hematologic Diseases
- Hemorrhage
- Hemorrhagic Disorders
- Genetic Diseases, Inborn
- Anemia
- Blood Coagulation Disorders
- Skin Manifestations
- Thrombocytopenia
- Blood Platelet Disorders
- Anemia, Hemolytic, Congenital
- Anemia, Hemolytic
- Thrombotic Microangiopathies
- Purpura
- Purpura, Thrombocytopenic
- Purpura, Thrombocytopenic, Idiopathic
- Spherocytosis, Hereditary
Other Study ID Numbers
- 09 09 196
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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