Single Incision Versus Standard Laparoscopic Splenectomy

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention
Hereditary Spherocytosis
Idiopathic Thrombocytopenic Purpura
Procedure: Single Incision Splenectomy
Procedure: Laparoscopic Splenectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Incision Versus Standard Laparoscopic Splenectomy

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • Operative time [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    operative time


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: October 2009
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Single Incision Splenectomy
Patients will undergo splenectomy through a single incision in the umbilicus regardless of the technique or equipment used
Procedure: Single Incision Splenectomy
Patients will undergo laparoscopic splenectomy through a single incision
Other Name: SILS
Active Comparator: Laparoscopic Splenectomy
Patient will undergo standard laparoscopic splenectomy, port placement is surgeon dependent
Procedure: Laparoscopic Splenectomy
Patients will undergo laparoscopic splenectomy with 4 ports, placement is surgeon dependent
Other Name: Standard

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.

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Need for splenectomy

Exclusion Criteria:

  • Splenomegaly
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01276561

Contacts
Contact: Shawn D St. Peter, MD 816 983 6479 sspeter@cmh.edu
Contact: Susan W Sharp, PhD 816 983 6479 swsharp@cmh.edu

Locations
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Shawn D St. Peter, MD    816-983-6479    sspeter@cmh.edu   
Contact: Susan W Sharp, PhD    816 983 6479    swsharp@cmh.edu   
Principal Investigator: Shawn D St. Peter, MD         
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Shawn D St. Peter, MD Children's Mercy Hospital Kansas City
  More Information

No publications provided

Responsible Party: Shawn St. Peter, MD, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT01276561     History of Changes
Other Study ID Numbers: 09 09 196
Study First Received: January 11, 2011
Last Updated: February 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
laparoscopy
splenectomy
single site
trial

Additional relevant MeSH terms:
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Spherocytosis, Hereditary
Purpura
Blood Coagulation Disorders
Hematologic Diseases
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Hemorrhagic Disorders
Autoimmune Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on September 16, 2014