Single Incision Versus Standard Laparoscopic Splenectomy
|ClinicalTrials.gov Identifier: NCT01276561|
Recruitment Status : Withdrawn
First Posted : January 13, 2011
Last Update Posted : February 3, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Hereditary Spherocytosis Idiopathic Thrombocytopenic Purpura||Procedure: Single Incision Splenectomy Procedure: Laparoscopic Splenectomy||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single Incision Versus Standard Laparoscopic Splenectomy|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||October 2016|
|Estimated Study Completion Date :||April 2017|
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
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|