We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Single Incision Versus Standard Laparoscopic Splenectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01276561
Recruitment Status : Withdrawn
First Posted : January 13, 2011
Last Update Posted : February 3, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Hereditary Spherocytosis Idiopathic Thrombocytopenic Purpura Procedure: Single Incision Splenectomy Procedure: Laparoscopic Splenectomy

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Incision Versus Standard Laparoscopic Splenectomy
Study Start Date : October 2009
Primary Completion Date : October 2016
Estimated Study Completion Date : April 2017

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Operative time [ Time Frame: 1 day ]
    operative time

Secondary Outcome Measures :
  1. operative complications [ Time Frame: 1 day ]
  2. wound complications [ Time Frame: 1 month ]
  3. cosmesis [ Time Frame: 6 months ]
  4. length of stay [ Time Frame: 1 week ]
  5. operative difficulty [ Time Frame: 1 day ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Need for splenectomy

Exclusion Criteria:

  • Splenomegaly
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01276561

United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Principal Investigator: Shawn D St. Peter, MD Children's Mercy Hospital Kansas City
More Information

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
First Posted: January 13, 2011    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Shawn St. Peter, Children's Mercy Hospital Kansas City:
single site

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