Single Incision Versus Standard Laparoscopic Splenectomy

Not Applicable

Withdrawn

• Conditions: Idiopathic Thrombocytopenic Purpura; Hereditary Spherocytosis
• Interventions: Procedure: Single Incision Splenectomy; Procedure: Laparoscopic Splenectomy

• Registration Number: NCT01276561
• Lead Sponsor: Children's Mercy Hospital Kansas City

Brief Summary

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.

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 Timeline

• Study Start: 2009-10
• Study First Submitted: 2011-01-11
• Study First Submitted QC: 2011-01-12
• Study First Posted: 2011-01-13
• Primary Completion: 2016-10
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-01
• Last Update Posted: 2017-02-03
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Need for splenectomy

Exclusion Criteria

• Splenomegaly

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Incision Splenectomy	Single Incision Splenectomy	Patients will undergo splenectomy through a single incision in the umbilicus regardless of the technique or equipment used
Laparoscopic Splenectomy	Laparoscopic Splenectomy	Patient will undergo standard laparoscopic splenectomy, port placement is surgeon dependent

Primary Outcome Measures

Name	Time	Method
Operative time	1 day	operative time

Secondary Outcome Measures

Name	Time	Method
operative complications	1 day
wound complications	1 month
cosmesis	6 months
length of stay	1 week
operative difficulty	1 day

Trial Locations

Locations (1)

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States