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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01276561
Other study ID # 09 09 196
Secondary ID
Status Withdrawn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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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