Single Incision Versus Standard Laparoscopic Splenectomy

This study is currently recruiting participants.
Verified February 2013 by Children's Mercy Hospital Kansas City
Sponsor:
Information provided by (Responsible Party):
Shawn St. Peter, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT01276561
First received: January 11, 2011
Last updated: February 13, 2013
Last verified: February 2013

January 11, 2011
February 13, 2013
October 2009
October 2013   (final data collection date for primary outcome measure)
Operative time [ Time Frame: 1 day ] [ Designated as safety issue: No ]
operative time
Same as current
Complete list of historical versions of study NCT01276561 on ClinicalTrials.gov Archive Site
  • operative complications [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
  • wound complications [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • cosmesis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • length of stay [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • operative difficulty [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Single Incision Versus Standard Laparoscopic Splenectomy
Single Incision Versus Standard Laparoscopic Splenectomy

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hereditary Spherocytosis
  • Idiopathic Thrombocytopenic Purpura
  • Procedure: Single Incision Splenectomy
    Patients will undergo laparoscopic splenectomy through a single incision
    Other Name: SILS
  • Procedure: Laparoscopic Splenectomy
    Patients will undergo laparoscopic splenectomy with 4 ports, placement is surgeon dependent
    Other Name: Standard
  • Active Comparator: Single Incision Splenectomy
    Patients will undergo splenectomy through a single incision in the umbilicus regardless of the technique or equipment used
    Intervention: Procedure: Single Incision Splenectomy
  • Active Comparator: Laparoscopic Splenectomy
    Patient will undergo standard laparoscopic splenectomy, port placement is surgeon dependent
    Intervention: Procedure: Laparoscopic Splenectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
April 2014
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Need for splenectomy

Exclusion Criteria:

  • Splenomegaly
Both
1 Year to 18 Years
No
Contact: Shawn D St. Peter, MD 816 983 6479 sspeter@cmh.edu
Contact: Susan W Sharp, PhD 816 983 6479 swsharp@cmh.edu
United States
 
NCT01276561
09 09 196
No
Shawn St. Peter, Children's Mercy Hospital Kansas City
Children's Mercy Hospital Kansas City
Not Provided
Principal Investigator: Shawn D St. Peter, MD Children's Mercy Hospital Kansas City
Children's Mercy Hospital Kansas City
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP