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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Incision Splenectomy | Active Comparator | Patients will undergo splenectomy through a single incision in the umbilicus regardless of the technique or equipment used |
|
| Laparoscopic Splenectomy | Active Comparator | Patient will undergo standard laparoscopic splenectomy, port placement is surgeon dependent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Incision Splenectomy | Procedure | Patients will undergo laparoscopic splenectomy through a single incision |
|
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | operative time | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| operative complications | 1 day | |
| wound complications | 1 month | |
| cosmesis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shawn D St. Peter, MD | Children's Mercy Hospital Kansas City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
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| ID | Term |
|---|---|
| D013103 | Spherocytosis, Hereditary |
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| Laparoscopic Splenectomy | Procedure | Patients will undergo laparoscopic splenectomy with 4 ports, placement is surgeon dependent |
|
|
| 6 months |
| length of stay | 1 week |
| operative difficulty | 1 day |
| D006425 |
| Hemic and Lymphatic Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |