This trial is active, not recruiting.

Conditions hereditary spherocytosis, idiopathic thrombocytopenic purpura
Treatments single incision splenectomy, laparoscopic splenectomy
Sponsor Children's Mercy Hospital Kansas City
Start date October 2009
End date October 2016
Trial size 30 participants
Trial identifier NCT01276561, 09 09 196


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Patients will undergo splenectomy through a single incision in the umbilicus regardless of the technique or equipment used
single incision splenectomy SILS
Patients will undergo laparoscopic splenectomy through a single incision
(Active Comparator)
Patient will undergo standard laparoscopic splenectomy, port placement is surgeon dependent
laparoscopic splenectomy Standard
Patients will undergo laparoscopic splenectomy with 4 ports, placement is surgeon dependent

Primary Outcomes

Operative time
time frame: 1 day

Secondary Outcomes

operative complications
time frame: 1 day
wound complications
time frame: 1 month
time frame: 6 months
length of stay
time frame: 1 week
operative difficulty
time frame: 1 day

Eligibility Criteria

Male or female participants from 1 year up to 18 years old.

Inclusion Criteria: - Need for splenectomy Exclusion Criteria: - Splenomegaly

Additional Information

Official title Single Incision Versus Standard Laparoscopic Splenectomy
Principal investigator Shawn D St. Peter, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Children's Mercy Hospital Kansas City.