Single Incision Versus Standard Laparoscopic Splenectomy

Children's Mercy Hospital Kansas City

Status: Withdrawn

Conditions: Hereditary Spherocytosis; Idiopathic Thrombocytopenic Purpura

Treatments: Procedure: Laparoscopic Splenectomy; Procedure: Single Incision Splenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01276561

09 09 196

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Need for splenectomy

Exclusion criteria

• Splenomegaly

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Single Incision Splenectomy

Active Comparator group

Description:

Patients will undergo splenectomy through a single incision in the umbilicus regardless of the technique or equipment used

Treatment:

Procedure: Single Incision Splenectomy

Laparoscopic Splenectomy

Active Comparator group

Description:

Patient will undergo standard laparoscopic splenectomy, port placement is surgeon dependent

Treatment:

Procedure: Laparoscopic Splenectomy