Single Incision Versus Standard Laparoscopic Splenectomy

Idiopathic Thrombocytopenic Purpura Clinical Trial

Official title:

Single Incision Versus Standard Laparoscopic Splenectomy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01276561
• Other study ID #: 09 09 196
• Status: Withdrawn
• Phase: N/A
• First received: January 11, 2011
• Last updated: February 1, 2017
• Start date: October 2009
• Est. completion date: April 2017

Study information

• Verified date: February 2017
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

• Need for splenectomy

Exclusion Criteria:

• Splenomegaly

Related Conditions & MeSH terms

• Hereditary Spherocytosis
• Idiopathic Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

Procedure:
• Single Incision Splenectomy
Patients will undergo laparoscopic splenectomy through a single incision
• Laparoscopic Splenectomy
Patients will undergo laparoscopic splenectomy with 4 ports, placement is surgeon dependent

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	operative time	1 day
Secondary	operative complications		1 day
Secondary	wound complications		1 month
Secondary	cosmesis		6 months
Secondary	length of stay		1 week
Secondary	operative difficulty		1 day